tag:blogger.com,1999:blog-710219114088610692024-03-18T02:48:25.674-07:00Global HealthcareHealthcare innovations from emerging markets that are important to improving healthcare globally
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.comBlogger22125tag:blogger.com,1999:blog-71021911408861069.post-91938852183377912122016-08-24T05:02:00.001-07:002016-08-24T05:02:34.436-07:00Transcutaneous Bilirubin Meters For All<div dir="ltr" style="text-align: left;" trbidi="on">
<b><u>Improving Newborn Health In India</u></b><br />
This blog has already written about the widespread problem of infant jaundice in <a href="http://www.globalhealth.care/2015/06/brilliance-firefly-reducing-infant.html">our post</a> on phototherapy devices like Brilliance & Firefly. The typical diagnostic approach is to look for yellowing of the skin and eyes of an infant that does not go away within 5 days of birth. If it does not, then an infant may be subjected to invasive blood tests using needles. This can be painful and dangerous to the infant, and it is often difficult to draw blood from infants.<br />
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Two devices widely used in India are able to diagnose jaundice using high-pressure liquid chromatography, the Pharos device from Rural Diagnostics and D-Rev & the <a href="http://www.usa.philips.com/healthcare/product/HC989805644871/bilichek-bilirubinometer">Philips BiliChek</a> system. Both are portable, low-cost, non-invasive diagnostic tools for use in monitoring the serum bilirubin levels of neonates before, during, and after phototherapy.<br />
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<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.usa.philips.com/healthcare/product/HC989805644871/bilichek-bilirubinometer">Philips BiliChek System</a></td></tr>
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The opportunity to scale these technologies in India was enabled in part by the creation of Accredited Social Health Activists (ASHAs) by the <a href="http://www.mohfw.nic.in/">Ministry of Health and Family Welfare</a> in 2005, with the goal of having 250,000 ASHAs nationwide by 2012, or at least one per village. The total number of ASHAs reported in 2013 was much larger than the target at 870,089, and this widespread basic health monitoring capability enticed firms like Rural Diagnostics to equip them with bilirubin monitors for newborns.<br />
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At resale prices of ~$5,000, the Philips BiliChek device may still be out of reach for most ASHAs, so it will be up to Pharos and Rural Diagnostics to bring the price to a level that can scale the use of the technology among India's ASHA's, and ensure reliable diagnosis of neonatal jaundice to the 15 million Indian babies born outside the hospital system each year. However, an internet search does not return a current website for the Pharos product, which may have been acquired, discontinued, or changed names. If you know, please let us know in the comments section below.<br />
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<b><u>Opportunity in U.S. What is currently being done?</u></b><br />
One skilled nurse friend working at a birthing and neonatal care center in Salt Lake City recently asked a colleague about their process for diagnosing jaundice in newborns. Her colleague said that they first check bilirubin levels with a scanner as part of a standard workup; if they see a concerning reading, they will do a heel stick blood draw to verify. She also mentioned that their scanning devices 'suck,' and she wishes they had something more accurate. In this sense the technology may be parallel to old fashioned bladder scanning devices that are essentially blind and less accurate in their readings of bladder volume. In other words, the opportunity in developed healthcare markets may be sustaining innovation leading to better, more accurate bilirubin monitors, whereas the opportunity in resource-constrained markets remains disruptive innovation to make basic devices accessible to all.<br />
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com37Cambridge, MA, USA42.3736158 -71.109733542.3266968 -71.1904145 42.420534800000006 -71.0290525tag:blogger.com,1999:blog-71021911408861069.post-21109155104327560722015-08-13T09:48:00.000-07:002015-08-13T09:48:58.455-07:00Medtronic's Micra Pacemaker: Game-Changer, or Business As Usual? <div dir="ltr" style="text-align: left;" trbidi="on">
<b><u>The Incumbent Market</u></b><br />Pacemakers are indicated for use in some patients with arrhythmias (irregular heart beats) where electronic pacing is helpful; for example, pacemakers are the most common treatment for bradycardia (a slow heartbeat) and <a href="http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2034837">over 1 million are implanted each year</a> around the world.<div>
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Pacemakers require a skilled cardiologist to implant the device under the skin near the collar bone and then affix the leads to whichever areas of the heart need pacing. <a href="http://www.tedmed.com/talks/show?id=7049">The leads are a weak feature of pacemakers</a> as they sometimes fracture, and the risk of infection from implanting a large foreign object into the body is also substantial.<br /><br />Depending on the patient's particular arrhythmia, either single- or dual-chamber pacemakers are indicated. The price of a pacemaker can run from $3,000 - $7,000, but the average price seems to be about <a href="http://www.modernhealthcare.com/article/20140512/NEWS/305129923">$4,000</a>. Assuming that average price holds around the world, the pacemaker market is worth about $4 billion per year in new device sales alone. <br /><br /><br /><b><u>The Disruptor</u></b><br />Medtronic has developed the Micra, a vitamin pill-sized 'Transcatheter Pacing System' only 1/10th the size of a traditional device. While<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
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<tr><td class="tr-caption" style="text-align: center;"><a href="http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2034837">Medtronic Micra TPS</a></td></tr>
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much of the engineering for this device has likely occurred across international borders, the Indian market and Medtronic's long-standing presence there was a big part of the company's motivation to develop this technology. <div>
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In a <a href="http://www.tedmed.com/talks/show?id=7049">2010 TEDMED talk</a> Dr. Oesterle, SVP for Medicine and Technology at Medtronic, explained that, "Right now, in the United States, for our population, we have somewhere in the region of 3,000 cardiologists who are trained in implanting pacemakers." By contrast, there are only about <a href="http://www.medtroniceureka.com/innovation-articles/inspiration/innovating_for_the_wider_world">1,000 implanters in India</a>, for a population of more than one billion. By providing a technology that aligns better with the skill sets of more physicians, pacemaker technology can be delivered to more patients. That's good business for Medtronic. </div>
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The benefits of the Medtronic Micra TPS include cosmetic invisibility, implantation directly into the heart, minimally invasive and easier implantation procedure, and a lead-less form factor. The device's battery life is estimated to be nearly 10 years and, once positioned, it can be easily repositioned and retrieved if necessary. The device was <a href="http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2034837">awarded the CE Mark </a>in Europe after initial findings from Medtronic's global clinical trial were positive. </div>
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<b><u>Could Medtronic's Micra TPS Succeed in The U.S.?</u></b></div>
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Medtronic could go one of two marketing routes with this device. On the one hand, they could market it disruptively as a pacemaker that performs less well on some dimensions (it's only indicated for single valve right atrial fibrillation representing about <a href="http://www.oregonlive.com/health/index.ssf/2014/11/providence_implants_tiny_wirel.html">10% of those who need a pacemaker</a> in the U.S. per year), but better on others (less invasive, less risk of lead fractures and infections, and easier to implant), and costing <i>less than</i> incumbent models in the hopes of expanding the market size by targeting the needs of those who've been over-served or left out altogether by existing offerings. </div>
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In this scenario, the 'rebar' Medtronic could target initially would be the 10% of patients indicated for single-chamber rather than dual-chamber pacemakers. Over time the technology would likely progress to the point of overtaking traditional pacemakers on most relevant dimensions and provide Medtronic, and potentially St. Jude's who is also developing a lead-less pacemaker called the <a href="http://www.sjm.com/leadlesspacing/intl/options/leadless-pacing">Nanostim</a>, with a huge competitive advantage as the smaller form factor becomes the normal therapy for most patients indicated for heart pacing. There would also be a very attractive increase in the volume of international sales as Medtronic offers the smaller, more easily implantable device at accessible price points around the world. I also wonder whether physicians could treat arrhythmias indicating dual-chamber pacemakers by implanting two Micra devices: One in each chamber, further increasing the volume of sales. Another potential source of significantly increased volume of sales are additional pacing applications enabled by the 'deep miniaturization' research Medtronic has been doing to build Micra. Dr. Oesterle mentions some of these applications in his TEDMED speech, and they are very exciting, including things like neurological pacing for mood disorders. </div>
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On the other hand, Medtronic faces short-term financial pressure to recoup expenses incurred in the development of Micra that could amount to over $100 million according to <a href="http://www.innovationsincrm.com/cardiac-rhythm-management/2014/november/655-potential-impact-of-leadless-pacing-therapy">one observer</a> who estimated that Medtronic will probably charge in excess of over $10,000 per device and will seek a new, higher reimbursement code from CMS. This is business as usual and it's the kind of behavior that's been driving our healthcare costs to unsustainable levels in the U.S. </div>
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Even if the latter scenario reflects Medtronic's pricing strategy for Micra in the U.S., the company should seriously consider selling the Micra TPS at very low prices in emerging markets like India. The promise of increasing access to life-saving pacing technologies by simplifying the implantation procedure will be squandered if the price remains an insurmountable barrier for most patients. </div>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com190tag:blogger.com,1999:blog-71021911408861069.post-23384562033329977762015-08-04T07:42:00.000-07:002015-08-14T05:40:08.659-07:00ReMotion: An $80 Prosthetic Knee<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: inherit;"><b><u>The Incumbent Market</u></b><br />There are an estimated <a href="http://www.forbes.com/sites/tjmccue/2014/08/31/3d-printed-prosthetics/">10-20 million amputees in the world</a> with about <a href="http://www.gizmag.com/exo-prosthetic-leg-3d-printing/35297/">2 million in the U.S. alone</a>. Nearly 190,000 amputations are performed in the U.S. per year, and over 90% of these, or about 170,000, deal with the lower limbs.<br /><br />Lower extremity prosthetic limbs for Western markets range in price from <a href="http://www.pbs.org/newshour/bb/20-prosthetic-knee-change-lives-india/">$8,000</a> to <a href="http://www.forbes.com/sites/tjmccue/2014/08/31/3d-printed-prosthetics/">$50,000</a> and will need to be replaced every 2-4 years, mostly due to degradation of the device. A good example of a high end incumbent leg prosthesis is <a href="http://biomed.brown.edu/Courses/BI108/2006-108websites/group07HighTechProsthetics/pages/cleg.htm">Ottobock's C-Leg</a> costing approximately $50,000 in the U.S.<br /><br />The U.S. market alone for lower extremity prosthetic limbs could therefore include $3.5 billion per year in new amputee fittings, plus another $9 billion per year in replacement fittings assuming that 25% of the 1.8 million lower extremity amputees in the U.S. replace their prosthetic each year and that the average price of a lower limb prosthetic is $20,000. This is a total market size of approximately $12 billion per year!<br /><br /><br /><b><u>The Disruptor</u></b><br /> The additional 8 to 18 million amputees in the world, most living outside of wealthy countries, face wrenching financial, health, and social challenges due to limb loss. In India alone, there are an estimated <a href="http://www.pbs.org/newshour/bb/20-prosthetic-knee-change-lives-india/">5.5 million people living with locomotor disabilities</a> arising from polio, congenital <table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
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<tr><td class="tr-caption" style="text-align: center;"><a href="http://d-rev.org/assets/images/remotion/remotion.png">The ReMotion Knee</a></td></tr>
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conditions or amputations largely due to agricultural and traffic accidents. Most of these people cannot afford Western prosthetics, so disruptive companies like the famous <a href="http://jaipurfoot.org/">Jaipur Foot</a> in northern India have risen to meet the challenge of providing suitable, safe, and affordable prosthetics for Indian patients and low income patients across the globe. In fact, Jaipur Foot is the world's largest fitter of prosthetic limbs by volume, having provided prosthetics to over 1.4 million patients since their founding in 1975.</span><br />
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<span style="font-family: inherit;">Jaipur's original prosthetic knee joint for above knee amputees, the <a href="http://jaipurfoot.org/what_we_do/prosthesis/stanford_jaipur_knee.html#.VbofTTBVikq">Polycentric Jaipur Knee</a>, although low cost and reliable caused problems of undesirable clicking sound, rotational instability and alignment. Over 7000 of these Knees have been fitted since the product's introduction in 2008. The Jaipur Knee was named as one of the world's best inventions by <a href="http://content.time.com/time/specials/packages/article/0,28804,1934027_1934003_1933963,00.html">Time Magazine in 2009</a>. </span></div>
<span style="font-family: inherit;"><br />D-Rev has helped design Jaipur Foot's next generation above the knee prosthetic leg, the <a href="https://d-rev.org/impact/remotion/">ReMotion Knee</a>, which still retails for <a href="http://www.ted.com/talks/krista_donaldson_the_80_prosthetic_knee_that_s_changing_lives?language=en">less than $80</a> and operates as a poly-centric knee with world-class performance. More than 79% of patients fitted with the knee are still wearing it, and <a href="http://www.ted.com/talks/krista_donaldson_the_80_prosthetic_knee_that_s_changing_lives?language=en">D-Rev's rules to create world-class products, be user-obsessed, and market driven</a> have resulted in several design improvements that help dampen sound, improve the prosthetic aesthetics, and still maintain low-cost, scalable production potential.<br /><br /><br /><b><u>Could The Re-Motion Knee Succeed In the U.S.?</u></b><br /> Jaipur and D-Rev are rightly celebrated for providing affordable high-quality prosthetics to the developing world and the need for them to do so is urgent and large. But is there also a market for the ReMotion Knee in the U.S.? Which patients, payers, and providers might welcome the opportunity to fit a $100 above the knee prosthetic that performs 'well enough' to justify the cost savings? Are there enough of them to comprise a viable market and justify the additional cost of seeking FDA approval for ReMotion? How much cost would operating in the U.S. add to the device?<br /><br />There are indications of demand for more disruptive prosthetics in the U.S. and North America generally. A <a href="http://www.youcaring.com/medical-fundraiser/carleton-university-student-needs-new-prosthetic-leg/224234">recent crowd-funding campaign</a> to fund the other half of a Carleton University student's new prosthetic leg came about because, after insurance coverage, he was still left with an out-of-pocket charge of over $10,000. He is not the only one who would find it difficult to pay that bill every 2-4 years.<br /><br />One non-profit organization called <a href="http://enablingthefuture.org/">e-NABLE</a> seeks to donate 3-D printed prosthetic limbs to those in need and most of their activity has been within Western markets so far. They have over 5,500 members and have received a Google award of $600,000 for their work.<br /><br />How many of the approximately 170,000 lower-limb amputees in the U.S. per year would be interested in fitting themselves with a ReMotion Knee?</span><br />
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<span style="font-family: inherit;"><br />_______________________________________________________________<br /><br /><i>Addendum from Dr. Pooja Mukul, Technical Director of Paul Hamlyn International Center of Prosthetics & Orthotics at BMVSS, Jaipur:</i></span></div>
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<i><span style="font-family: inherit;">In 2007 when Mr. D R Mehta, Founder & Chief Patron of BMVSS, was visiting San Francisco he was introduced to some of the faculty at Stanford University by Dr. Armand Neukermans. Mr. Mehta gave a presentation about the work we do at BMVSS which was greatly appreciated at Stanford. Following his visit Dr. Neukermans informed Mr.Mehta that the Stanford University was interested in collaborating with BMVSS and this led to the signing of a formal MOU between BMVSS & Stanford University.</span> </i></blockquote>
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<i><span style="font-family: inherit;">The first research project that was jointly undertaken was designing a Prosthetic Knee Joint. The team of Stanford students visited BMVSS and after several brainstorming sessions it was decided to base the Knee joint on the Polycentric concept. Therefore from the very outset the design was Polycentric and not monocentric as you had noted in the draft for your blog.</span> </i></blockquote>
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<i><span style="font-family: inherit;">The first prototype of the Polycentric Jaipur Knee was ready in August 2008. After successfully going through the laboratory tests,clinical trials were commenced.</span><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">The initial user feedback in respect to stability in stance, ease of initiation of swing, toe clearance, acceptability, compliance and durability was very positive.</span><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">As you may have seen,the Jaipur Knee featured in the Time Magazine's November 2009 issue as one of the 50 best inventions of the world for that year.</span> </i></blockquote>
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<i><span style="font-family: inherit;">However, on long term follow up, we did have a few mechanical failures and patients voiced some concerns. The patients disliked the clicking sound that the joint made at terminal stance, after prolonged use the threaded portions became loose resulting in sudden rotation of the prosthesis, patients living in hilly or desert terrain suggested that an optional lock would enhance their confidence while negotiating challenging terrain and they also felt that the aesthetics needed to be improved. The joint was designed to interface with the existing prosthetic componentry at BMVSS but after observing the success of the design it was felt that to permit a more widespread use of the design it should be compatible with conventional prosthetic componentry commonly used in centers around the world. The user feedback was shared with the Stanford team that made several trips to BMVSS during the project. Many design modifications were made between 2008 - 2011.</span> </i></blockquote>
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<i><span style="font-family: inherit;">In 2011 the students graduated and the design was passed on to D-Rev a non profit organization for further development. A formal agreement was then drawn up between BMVSS and D-Rev and we have been working together since. D-Rev rechristened the Jaipur Knee as "ReMotion Knee" after incorporating changes that addressed the problems raised by the users at BMVSS.</span> </i></blockquote>
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<i><span style="font-family: inherit;">In 2013 we received the Indo-US Science & Technology Forum (IUSSTF) grant to carry out design and cost optimization for mass manufacturability and India Pilot Trials for the ReMotion Knee (which was technically the Version 3 of the Jaipur Knee).</span><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">We carried out trials of 41 ReMotion Knees as part of the IUSSTF project. The feedback was passed on to D-Rev, some design modifications were carried out and a Version 4 is now in the process of being manufactured.</span> </i></blockquote>
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<i><span style="font-family: inherit;">We continue to use the Jaipur Knee (Version 1) and have so far fitted 7350 patients of which 1900 were in 14 countries outside India.</span> </i></blockquote>
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<i><span style="font-family: inherit;">We are currently working on another project with the Stanford University , in which we are developing a Terminal device for upper extremity amputees. </span><span style="font-family: inherit;">This has all been made possible by Dr. Armand Neukermans who is an ardent supporter of BMVSS.</span></i><br />
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com33tag:blogger.com,1999:blog-71021911408861069.post-16264408697656119822015-06-13T17:54:00.000-07:002015-06-18T11:30:46.307-07:00Brilliance & Firefly: Reducing Infant Mortality With Blue Light<div dir="ltr" style="text-align: left;" trbidi="on">
<b style="font-family: inherit;"><u>What Is Infant Jaundice?</u></b><br />
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<span style="font-family: inherit;"><br />Mild jaundice is a condition shared by most newborn infants where an excess of bilirubin--a yellowish byproduct of the body's destruction of old red blood cells--results in a yellowish tint to the skin and the whites of the eyes. These symptoms typically appear within the first 5 days of life and disappear naturally within a week or two; however, about <a href="http://www.designthatmatters.org/impact/#firefly">10% of all newborns</a> worldwide are unable to process bilirubin quickly enough and require jaundice treatment to prevent death or lifelong disability. This amounts to about <a href="http://www.theworldcounts.com/stories/How-Many-Babies-Are-Born-Each-Day">13 million infants</a> per year.<br /><br />The most common treatment for serious cases of newborn jaundice is phototherapy (PT) where an infant's skin is exposed to blue light until the jaundice abates. As the light is absorbed through the infant's skin it helps to break down the bilirubin making it easier for the infant's organs to absorb and process it.<br /><br />While PT is a straightforward treatment, many infants in developing countries do not have access to it due to traditional machines' limited affordability and form factor appropriateness for these environments. Every year over <a href="http://d-rev.org/projects/newborn-health/">6 million</a> infants needing PT treatment do not receive it. Of course this gap in device fit between developed and developing countries is typical: One <a href="http://www.ncbi.nlm.nih.gov/pubmed/17664669">Duke study</a> found that 98% of medical equipment sent to developing countries is broken within 5 years.<br /> <br /></span><b><u>Firefly & Brilliance: Better Phototherapy For The World </u></b><span style="font-family: inherit;"><b><u><br /></u></b><br /> To address this gap, at least two innovation design firms--<a href="http://d-rev.org/">D-Rev</a> and <a href="http://www.designthatmatters.org/impact/#firefly">Design That Matters</a> (DtM)--have developed PT machines that are designed for success in emerging markets. The machines use more effective, efficient light sources, distribution and manufacturing partners local to the target </span></div>
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<span style="font-family: inherit;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFApICq1V4g1j3VI4QYms89HEpGEDwtiFYUgrD1Y4UdCL0obFQHOHE8_VDE1_MzRQiGIMj4KfDYlN8SLdVvRq3-FQJxHZf3btmyNcLgbnDMlY_3fbCFDAk-Uaq44YszgTAUZgwv4qhQj8/s1600/Brilliance.jpeg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="275" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFApICq1V4g1j3VI4QYms89HEpGEDwtiFYUgrD1Y4UdCL0obFQHOHE8_VDE1_MzRQiGIMj4KfDYlN8SLdVvRq3-FQJxHZf3btmyNcLgbnDMlY_3fbCFDAk-Uaq44YszgTAUZgwv4qhQj8/s320/Brilliance.jpeg" width="320" /></a></span></div>
<span style="font-family: inherit;">markets, they can cost as little as one-sixth the price of standard PT machines at retail plus they save over $250 per year in bulb replacement costs by switching from Compact Fluorescent Lamps (CFLs) to special blue LED lights. At right is a photo of D-Rev's Brilliance.<br /><br /> Brilliance and Firefly are making an impact. For example, the <a href="http://thrivenetworks.org/">East Meets West Foundation</a> installed over 40 Firefly devices across Myanmar in 2014, where before Firefly there were over 100 exchange blood transfusions taking place every week across the nation due to lack of phototherapy and long travel distances to hospitals.</span><br />
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Both companies have partnered with other organizations to achieve significant inroads across primarily southeast Asia and Africa. To-date, over <a href="http://d-rev.org/impact/brilliance/">1,000 installed Brilliance devices have treated almost 70,000 babies</a>. Brilliance devices are currently installed in 13 countries. They are located in South Asia, East Africa and South America (Colombia, Ecuador, India, Malawi, Malaysia, Myanmar, Nepal, Pakistan, Philippines, South Africa, Tanzania, Thailand, Uganda). <a href="http://www.phoenixmedicalsystems.com/">Phoenix Medical Systems</a>, D-Rev’s India-based partner, continues to expand into new markets. As of April 2015, DtM partners East Meets West Foundation and Vietnamese manufacturing partner MTTS have installed Firefly in fourteen developing countries across Asia (Cambodia, East Timor, Laos, Malaysia, Myanmar, Nepal, Philippines, Singapore, Thailand, Vietnam), Sub-Saharan Africa (Burundi, Ghana, Nigeria), and the Caribbean (Haiti). These devices have already treated over 12,000 newborns and will treat at least 88,000 over their lifetime. Each company has plans to expand significantly.</div>
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<span style="font-family: inherit;"><br /></span><b><u>Could D-Rev's and DtM's PT devices succeed in the U.S.?</u></b><span style="font-family: inherit;"><br /></span></div>
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<span style="font-family: inherit;"><br /></span></div>
<span style="font-family: inherit;">With their fresh design approach, D-Rev and DtM have ended up creating devices poised to succeed in Western markets as well as developing markets. Brilliance has the CE Mark and Firefly shortly will. The Firefly device has 2-sided lighting that can cut the time required for therapy from 3 days to only 24 hours. Both devices are very easy to use and clean.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">Standard PT devices in the U.S. cost about <a href="http://www.newscientist.com/article/dn24396-portable-jaundice-therapy-could-save-infants-lives.html#.VXh90GTBzGc">$3,000 each</a> at retail. At comparable levels of performance, devices like Brilliance and Firefly might sell for under $1,000 at retail. The current blue light LEDs in use across most devices are estimated to last up to 120,000 hours, so replacement costs for these are negligible amortized over the device lifetime. </span><br />
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<span style="font-family: inherit;">One potential challenge in the U.S. is that newborns with no other health issues than jaundice are increasingly cared for at home using devices like PT blankets such as those offered by <a href="http://www.biliblanketrentals.com/">Biliblanket Rentals</a> for $95 per day. However, plenty of providers treat jaundiced infants in NICUs and a U.S. market for Brilliance and Firefly may lie with providers who would welcome the opportunity to provide PT in a more cost-effective, efficient way.</span><br />
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<span style="font-family: inherit;"><b><u>Question For Discussion:</u></b></span><br />
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<li>Could Brilliance and Firefly disrupt phototherapy devices in the U.S.?</li>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com23tag:blogger.com,1999:blog-71021911408861069.post-6403065325098718482015-04-11T13:05:00.005-07:002015-04-11T13:15:18.977-07:00Hearables: When Will They Appear in Your Ear? <div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="white-space: pre-wrap;"><i>Note: Guest post by Klas Johansson, <a href="https://twitter.com/DisruptiveMT">@DisruptiveMT</a></i></span><br />
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<span style="font-weight: bold; line-height: 1.38; white-space: pre-wrap;"><u><span style="font-family: inherit;">What Is A Hearable? </span></u></span></div>
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<span style="font-family: inherit;"><span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">The term "hearable" was introduced in April 2014 as a subclass of wearables related to hearing. The hearing industry has for decades been working on what we today call wearables. Miniature electronics, software driven technology and 3D printing out of impressions of individuals ear canals have been standard practice for decades within the largest manufacturers of hearing aids. Some attempts have been made to use that hearing aid knowledge and introduce consumer products for non-hearing-impaired people. Examples are wireless custom made ear protectors, in-ear health monitors and Bluetooth headsets. These products have been very successful in niche segments such as very active hunters and audiophiles. No real product has been launched with the potential to attract a larger customer base, but this may change in the near future: The hearable market is expected to explode to <a href="http://hearingmojo.com/hearables-market-heats-up/">$7.5 billion</a> by the end of 2018</span><span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">.</span></span></div>
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<span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: bold; vertical-align: baseline; white-space: pre-wrap;"><u><span style="font-family: inherit;">Why Now? </span></u></span></div>
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<span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><span style="font-family: inherit;">One important trend to keep in mind is the fitness wave and the possibility to use a smartphone to do everything from listening to music to recording exercise data. To do both of these activities today, a person would need both a pair of headphones and a fitness band. But not with a pair of in-ear hearables: With only a Bluetooth connection they measure heart rate, calories burned, oxygen level, and steps taken, all while playing music wirelessly. Afterwards, the user can analyze her training data and vital statistics on her smartphone and even get voice feedback during training. One exemplary innovator in this space is the German company <a href="http://www.bragi.com/">Bragi</a> who has, with their product The Dash, also focused on the fitness segment of the hearables market.</span></span></div>
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://lh3.googleusercontent.com/9HXpnEyqGOnJOojkEltE8JqSp1bqtxUnkT6wD3s0Xqv4KpR8Kb-5A5wHrvJ42mMz9TVywjqNwqf8oYQOhpbHheOstLvW7pNaonAAGdTG3O8GjS906aqImujOChbS82In43jXur4" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="326" src="https://lh3.googleusercontent.com/9HXpnEyqGOnJOojkEltE8JqSp1bqtxUnkT6wD3s0Xqv4KpR8Kb-5A5wHrvJ42mMz9TVywjqNwqf8oYQOhpbHheOstLvW7pNaonAAGdTG3O8GjS906aqImujOChbS82In43jXur4" style="-webkit-transform: rotate(0rad); border: none; transform: rotate(0rad);" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.earin.com/">Earin by Epickal</a></td></tr>
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<span style="font-family: inherit;"><span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">Traditionally, the big argument against Bluetooth hearables criticizes the devices’ size, design and battery capacity. No one wants ugly, clumsy products requiring constant charging. A lot of R&D dollars have been focused on limiting the battery usage of Bluetooth technology, and today there are already products in the marketplace that address the size issue. A Swedish startup, <a href="http://www.earin.com/">Epickal</a>, raised $1.7 Million and got preorders of about 8,000 units for their Earin product during a <a href="http://www.mobil.se/mobilbusiness/startups/earins-framg-ngsrecept-p-kickstarter#.VSADDd5eLZh">40-day Kickstarter campaign</a> last summer</span><span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">. Their main focus is a small, wireless Bluetooth earbud with excellent sound quality. The dimension of these earbuds are only 14.5mm x 20mm with a rechargeable Li-Ion Button Cell battery, as shown at right. </span></span></div>
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<span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: bold; vertical-align: baseline; white-space: pre-wrap;"><u><span style="font-family: inherit;">The Giants Are Moving </span></u></span></div>
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<span style="background-color: transparent; color: black; font-style: normal; font-variant: normal; font-weight: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><span style="font-family: inherit;">There are several more startups in the hearables space, but what are the real giants planning to do? One hint came in May 2014 when Apple bought Beats for $3.2 billion. A lot of speculation has followed that this acquisition will become Apple’s platform for entering the hearables market. Data from the hearables could be used in conjunction with other Apple products such as HealthKit and ResearchKit. Other giants have also expressed interest in this area; for example, Intel has partnered with the artist 50 Cent. When a cool product with nice design, good functionality, high ease of use, and high battery endurance is introduced it could be a real game changer. We can expect that the 6 largest manufacturers of hearing aids are following this field closely together with leaders such as Apple, Google, Samsung, Intel, Sony and HTC. Data from optical sensors in a hearable will be used to improve fitness while playing music and providing other auditory value at the same time. </span></span><span style="line-height: 22.0799999237061px; white-space: pre-wrap;">So: when will hearables appear in your ear?</span></div>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com35tag:blogger.com,1999:blog-71021911408861069.post-27505512222839685972015-03-31T23:06:00.000-07:002015-04-01T02:43:43.144-07:00Embrace: A Worldwide Infant Warmer<div dir="ltr" style="text-align: left;" trbidi="on">
<b><u>The Origins of Embrace</u></b><br />
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While all innovations currently featured on Globalhealth.care are 'from' India, their geographical origins are in reality hard to place. Sometimes they arise in the mind of an MIT graduate student in Cambridge, and other times in the mind of a local entrepreneur in Chennai. But always the innovator is designing a value medtech product for low-resource settings, and India becomes the primary or initial market for the finished product.<br />
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The story of the <a href="http://embraceglobal.org/embrace-warmer/">Embrace Warmer</a> illustrates the international nature of innovation very well. Four entrepreneurs at Stanford from various academic and cultural backgrounds met in the Design School's 2007 "Design For Extreme Affordability" class, and began to look for unmet clinical needs in emerging markets. They were <a href="https://twitter.com/janemariechen">Jane Chen</a>, <a href="https://www.linkedin.com/in/rahulap">Rahul Panicker</a>, <a href="https://www.linkedin.com/pub/naganand-nag-murty/3/338/b00">Naganand Murty</a>, and <a href="https://www.linkedin.com/in/linusliang">Linus Liang</a>.<br />
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The team's first trips to South Asia keyed them into the magnitude of the high premature infant death rate problem. Worldwide, there are fifteen million premature babies born each year. About 3 million of these currently die, mostly in the developing world, and usually within their first month of life. One of the main health challenges for these infants arises from their lack of body fat. Weighing only between 500 and 2,500 grams, it is difficult for them to regulate their own body temperatures. The mother's skin-to-skin embrace is a highly effective form of warming, but it is not feasible for mothers to embrace their infants 24-7. And so families in low-resource settings that lack the infrastructure or cash for expensive incubators and electricity-hungry radiant warmers, turn to devices that under-serve their needs: Thermal boxes, hot coals, hot water bottles, tubs, or light bulbs. These homespun solutions are dangerous and inconsistent.<br />
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The team began to envision a safe product to keep premature babies warm that would cost only 1% of a traditional incubator's price tag of $20,000. In fact, incubators are the clinical gold standard for premature infant warming, but the team actually observed one being used as a filing cabinet in one Indian rural clinic! <a href="https://www.youtube.com/watch?v=OBoTilFX_qQ&feature=em-subs_digest">Jane Chen explains</a>:<br />
<blockquote class="tr_bq">
<i>"What we needed was not just a lower-cost version of what exists today. We needed something that could function without a constant supply of electricity; something that was easy enough for a mother, a midwife, a healthcare worker to use. Something that would stay at a hospital but also a village clinic." </i></blockquote>
In other words, the 'golden standard' technology is sometimes too expensive, too demanding, or otherwise too inaccessible to effectively address widely held public health challenges around the world, such as premature infant warming. <br />
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<b><u>The Embrace Warmer</u></b><br />
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<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKklVbJepVlJBA1fzEVZqHAOK9vPaz6KaHNJ9Q9f6IbOMEFS-d3vnC5xy__-nqQehTrT2HUoLN31BIwO1SuHD1P5GerytUQdhMBOkFyf9PaO_Asc1GobtoOj5LXPR01Jq95HwqxfwpmxI/s1600/embrace.png" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKklVbJepVlJBA1fzEVZqHAOK9vPaz6KaHNJ9Q9f6IbOMEFS-d3vnC5xy__-nqQehTrT2HUoLN31BIwO1SuHD1P5GerytUQdhMBOkFyf9PaO_Asc1GobtoOj5LXPR01Jq95HwqxfwpmxI/s1600/embrace.png" height="229" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 12.8000001907349px; text-align: center;"><a href="http://entrepreneursforachange.com/wp-content/uploads/2012/09/Embrace_Baby_Warmer_product_Entrepreneurs_for_Social_Change.png">Embrace Warmer</a></td></tr>
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After months of iterative prototyping, and incorporating as a non-profit, the Embrace team released the first version of <a href="http://embraceglobal.org/embrace-warmer/">Embrace Warmer</a> at an initial retail price of between $200-$300, depending on distribution logistics. Each warmer is reusable, easily cleaned, and continuously warms an infant at the optimal temperature of 98 degrees F by the means of an innovative phase-changing sheet of wax that is quickly and precisely heated by a jolt of electricity via the warming device shown at right. Once melted, the wax holds its temperature for 8 hours. To date, the Embrace Warmer has served over 150,000 infants in over 11 countries.<br />
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To accelerate access to the product, Embrace has split their mission into two entities. The non-profit <a href="http://embraceglobal.org/">Embrace</a> owns the IP, donates product to the world's neediest populations, as well as provides training and education in maternal care. The for-profit social enterprise <a href="http://www.embraceinnovations.com/">Embrace Innovations</a> licenses the IP, pays for continued R&D and manufacturing, and sells product to paying entities like governments and hospital systems. In this way, Embrace hopes to expand quickly while still remaining financially viable.<br />
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<b><u>Could Embrace Warmers Disrupt NICUs / Incubators in the U.S.?</u></b><br />
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Neonatal Intensive Care Units (NICUs) are expensive to build and maintain, so hospitals typically place infants weighing below 2,500 grams in the NICU incubators not only to be on the safe side, but also to <a href="http://www.nytimes.com/2011/03/20/us/20ttnicus.html?_r=0">cover their expenses and generate additional profits</a>. The potential overuse of NICUs in the U.S. is further highlighted by a study from Intermountain Healthcare's insurance arm, Select Health, which found that <a href="http://www.accountablecarefacts.org/case_studies/controlling-elective-inductions-at-intermountain-brings-benefits-to-mothers-and-newborns-1">electively induced infants were 2-3x more likely</a> to be placed in intensive care on average. This finding helped to curb their OBGYNs' widespread acceptance of casual elective induction, and by modifying their evidence-based guidelines for child birth, Intermountain has reduced this expensive practice. But this story is not typical among U.S. hospitals: Intermountain is one of the few truly integrated providers in the U.S., which gives them the means, will, and power to enforce obviously beneficial efficiency gains.<br />
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The gains might go further. For instance, the Embrace Warmer is indicated for use with infants weighing between 1,500 and 2,500 grams. While premature babies' weight can be as little as 500 grams, 95% of them weigh more than 1,500 grams, and do not necessarily require the 'golden standard' treatment available in hospital NICUs to survive and be healthy. What kind of savings could the U.S. realize if premature infants weighing between 1,500 and 2,500 grams without additional complications were wrapped in an Embrace Warmer and delivered to their mother's bedside rather than placed in a NICU incubator? One recent Business Insider article entitled <i><a href="http://www.businessinsider.in/Prematurity-Rates-Are-Too-High-And-Childrens-Hospitals-Are-Cashing-In/articleshow/36035153.cms">Prematurity Rates Are Too High - And Children's Hospitals Are Cashing In</a> </i>calculates average hospital stay costs for premature babies at $275,000 higher than for the average non-premature infant. There are 500,000 premature babies born per year in the U.S., apropos a proportion that has grown markedly in recent decades. Assuming that just 50% of these babies could be given a $300 Embrace Warmer instead of spending time in the NICU, the U.S. would save <i>nearly $7 billion per year</i>.<br />
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The Embrace Warmer is manufactured to the highest standards of quality, and the product has received the CE Mark, indicating the possibility of FDA clearance in the U.S.. In fact, Embrace Innovations is already planning a U.S. launch of a direct-to-consumer product called the <a href="http://www.businessinsider.in/Prematurity-Rates-Are-Too-High-And-Childrens-Hospitals-Are-Cashing-In/articleshow/36035153.cms">Little Lotus Baby</a>. The product is a high-tech blanket containing sensors enabling temperature control and likely some degree remote monitoring. The company has not yet released details, but the launch is scheduled for April 15th, 2015.<br />
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Jane Chen has stated that revenues from this product ". . . will go towards subsidizing our work in developing countries," which is an echo of the successful Tom's Shoes strategy. I hope it works, but an even more successful way to make money may be in disrupting the $15 billion U.S. NICU market with a souped-up version of the Embrace Warmer.<br />
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<b><u>Question For Discussion:</u></b><br />
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<li>Could a 'smart' version of the Embrace Warmer disrupt traditional incubators in the U.S.? </li>
</ul>
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</ul>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com21tag:blogger.com,1999:blog-71021911408861069.post-75654173241629101972015-03-24T23:05:00.003-07:002015-03-24T23:16:20.919-07:00TrueLab: A Portable Infectious Disease Diagnostic Lab for $8,000<div dir="ltr" style="text-align: left;" trbidi="on">
<b><u><span style="font-family: inherit;">The Diagnostic Promise of PCR Technology</span></u></b><br />
<span style="font-family: inherit;"><b><u><br /></u></b>
Infectious disease continues to be a major part of the health burden that emerging markets face. Diseases like Tuberculosis (TB), Malaria, Swine Flu, and Hepatitis B kill millions of people each year, and maim the lives of many millions more. Antibiotics can help with certain pathogens, but their misuse and indiscriminate application have led to the rise of drug-resistant 'super-bugs' that are now one of humanity's most serious public health risks. Such mis-directed therapies result from the over-marketing or adulteration of medications, a lack of qualified doctors, and an inability to efficiently and accurately diagnose people for precisely targeted treatment.</span><br />
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<span style="font-family: inherit;">The latter two factors are where technology can be especially helpful. Diagnostic technology that can accurately and quickly diagnose disease can provide the data necessary to make precise therapy recommendations, as well as mount targeted interventions to forestall or manage outbreaks.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">To encourage and guide appropriate diagnostic innovation for infectious diseases, the World Health Organization (WHO) developed the <a href="http://www.who.int/tdr/publications/documents/mapping-landscape-sti.pdf">ASSURED criteria</a> stating that devices should be <u>A</u>ffordable, <u>S</u>ensitive with very few false-negatives, <u>S</u>pecific with very few false-positives, <u>U</u>ser-friendly requiring minimal training to use, <u>R</u>apid to enable treatment at first visit, <u>R</u>obust, e.g. not requiring refrigeration, <u>E</u>quipment-free, and <u>D</u>elivered to those who need it, i.e. Point-of-Care (PoC). These criteria are set against a backdrop of incumbent laboratory-based diagnostic testing methods, which require specialized infrastructure and highly skilled technicians, in addition to being expensive. They are also time-intensive, running batch tests for 4-6 hours at a time, and returning individual test results 1-2 days after the order was placed. These limitations of traditional equipment ensure very low adoption rates within the markets that have the greatest need. There are Rapid Diagnostic Tests (RDTs) available for some pathogens, but their sensitivity rates are low, often around 50%.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">Polymerase Chain Reaction (PCR) diagnostic tests solve the sensitivity issue by isolating and identifying pathogen-specific nucleic acid from body fluid samples, but the PCR devices from companies like Abbott, Roche, and Cepheid still operate on incumbent models requiring air-conditioned labs, batch testing, continuous power supply, and laptops for readouts. While less expensive than traditional laboratory setups, the lowest-cost PCR systems from large players are still expensive for broad emerging market use, costing upwards of $35,000 for just the hardware. They may also perform a limited or less-relevant range of tests, e.g. Cepheid's golden standard <a href="http://www.cepheid.com/us/cepheid-solutions/systems/genexpert-systems/genexpert-i">GeneXpert</a> product only tests for TB, and still costs about $60,000.</span><br />
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<b><u><span style="font-family: inherit;">India's Answer To The ASSURED Criteria</span></u></b><br />
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<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdinVD7izokGlRvgqfRIKcp2CbVdxzFQZL0fkVG0jywihyBJGSKnUhmQsdm1aI7slwaR8nY23Sq5XcivHPSMtZHMgWSqmMr8brUrgu0urTH6AgT2c82jiRQ0caoy1Mch5f_7SAM2n0P7k/s1600/True+Lab+Uno+Photo.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><span style="font-family: inherit;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdinVD7izokGlRvgqfRIKcp2CbVdxzFQZL0fkVG0jywihyBJGSKnUhmQsdm1aI7slwaR8nY23Sq5XcivHPSMtZHMgWSqmMr8brUrgu0urTH6AgT2c82jiRQ0caoy1Mch5f_7SAM2n0P7k/s1600/True+Lab+Uno+Photo.jpg" height="305" width="320" /></span></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.molbiodiagnostics.com/products_pcr_workstation.html"><span style="font-family: inherit; font-size: small;">TrueLab Uno Dx Real Time Micro PCR Analyzer </span></a></td></tr>
</tbody></table>
<span style="font-family: inherit;">Infectious disease remains a critical public safety concern in India. In fact, an <a href="http://www.msn.com/en-us/news/world/india-failing-to-tackle-massive-tb-crisis-expert/ar-AA9VSes">MSN article</a> from March, 2015 highlights the "massive TB crisis" that is killing about 1,000 Indians per day. No doubt this is a multi-faceted problem, but one facet is that very few if any imported diagnostic devices fit the WHO's ASSURED criteria. Responding to this need, <a href="http://www.csir.res.in/external/Heads/collaborations/Nmitli.htm">The New Millennium Indian Technology Leadership Initiative</a> by the Council of Scientific and Industrial Research funded Bangalore-based <a href="http://www.bigteclabs.com/">Bigtec Labs </a>to help solve this problem by creating a true PoC micro-PCR device that is easy to use, low-cost, portable, independent of continuous power, and has wireless data transfer capability. Bigtec started work on this technology in 2004 and, over the next ten years, succeeded in creating the <a href="http://www.molbiodiagnostics.com/molbio_realtime%20micro%20pcr%20system.html">TrueLab micro-PCR system</a> that does meet all of the ASSURED criteria, and is now being marketed by <a href="http://www.molbiodiagnostics.com/">Molbio Diagnostics</a>, headquartered in Goa. Molbio is a 50/50 joint venture between the <a href="http://www.tulipgroup.com/">Tulip Group</a> and Bigtec Labs, the former having deep PoC diagnostic device manufacturing and an international marketing presence.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">The two fixed components of the TrueLab micro-PCR system are a sample preparation device, and an analyzer. Together, they provide very accurate diagnosis of infectious disease with a turnaround of 1 hour, and the system can be custom programmed for automatic data transfer to any remote server at the end of every test. The testing process begins with sample collection and a loading of the sample preparation device. This currently requires about 20 minutes of hand-on time, but is estimated to fall to 12 minutes with the introduction of Molbio's next generation automated sample processor in about 2 months. The next step is to move the prepared sample onto a disease-specific micro chip for loading into the analyzer. The entire 40 cycles of analysis is a totally hands-off procedure aside from loading the chip.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">The cost of a TrueLab product set is about $8,000 within India for all of the hardware, or about 25% the cost of imports. The TrueLab system also targets a <a href="http://www.bigteclabs.com/productdescription.html#tabs-5">range of diseases</a> that represent the main infectious disease burden in India; namely, TB, H1N1, HBV, Chik V, Malaria, Dengue Fever, and Typhoid. Finally, the rugged design of the hardware includes rechargeable batteries and room temperature stable reagent microchips that make the system robust and widely usable.</span><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiY-PeKeSKptJQZh6PSRR9rKBruD6F64JhyxwImwAmwxBXoqLZcyqIZxNrX3EDOP4TK8ozl2BVteArqDlfO71eI14WQ1Mmi5c1qUSnD27t7O5SdwzI4qvSmYCFbA5N2NjHztWm9yUvbK8M/s1600/tulip+distribution.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><span style="font-family: inherit;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiY-PeKeSKptJQZh6PSRR9rKBruD6F64JhyxwImwAmwxBXoqLZcyqIZxNrX3EDOP4TK8ozl2BVteArqDlfO71eI14WQ1Mmi5c1qUSnD27t7O5SdwzI4qvSmYCFbA5N2NjHztWm9yUvbK8M/s1600/tulip+distribution.jpg" height="212" width="320" /></span></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.molbiodiagnostics.com/molbio_sales.html"><span style="font-family: inherit; font-size: small;">Sales Coverage Map of the Tulip Group</span></a></td></tr>
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<span style="font-family: inherit;">Many hospitals in India will likely continue to rely on incumbent testing models initially, but Molbio is wisely targeting rural areas where the existing PCR machines do not have any presence at all. In doing so, they could service a higher percentage of the 50,000 labs in India than incumbent PCR solutions, who currently reach less than 1%. In time, the cost and time savings data may make the case strongly for all potential customers. The Tulip Group is also well-positioned to help scale TrueLab's market presence in developing markets around the world, with the exception of the U.S. / Canadian markets: The Molbio executive I spoke with my phone was not interested in considering the United States as a potential market unless the regulatory, IP, and other 'paperwork'-related time and cost barriers are reduced. A critical element of Molbio's international strategy is expanding the scope of practice for less-skilled health workers to operate this equipment and provide definitive diagnostic data, and they will be hosting a Global Business Associates Training program in April where all global partners have agreed to send representatives for training.</span><br />
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<span style="font-family: inherit;"><b><u></u></b><br /></span>
<span style="font-family: inherit;"><b><u></u></b>
<b><u>Could Molbio's Micro-PCR System Succeed in the United States?</u></b></span><br />
<span style="font-family: inherit;"><b><u></u></b><br /></span>
<span style="font-family: inherit;"><b><u></u></b>
Let's review the basic elements of TrueLab's value proposition. First, the PCR technique increases the sensitivity of molecular testing for the presence of pathogens. Second, a PoC micro-PCR system provides the ability to make an accurate diagnosis during a patient's first visit with a provider. Third, the form factor of this product ensures portability, ease of use, and remote disease surveillance through GPRS and Wi-Fi. Fourth, the platform offers multiple disease detection; in fact, Bigtec's <a href="http://www.molbiodiagnostics.com/products_pipeline.html">pipeline assays</a> include infectious diseases that occur more commonly in the developed world including Salmonella, HCV, HIV, HPV-Cervical Cancer, Chlamydia, Gonorrhea, and Trichomonas. Presumably all pathogens known to man will eventually be added once we've sequenced their nucleic acids. All that's required for Bigtec to add them to the TrueLab platform is a new reagent microchip and a software update. Finally, these reagents do not require refrigeration, making it possible for smaller hospitals and clinics to maintain a supply of tests on-hand.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">Considering a few macro trends, the worldwide Infectious Diseases Diagnostics (IDD) market was already worth <a href="http://www.prnewswire.com/news-releases/infectious-disease-diagnostics-market-worth-181562-million-by-2019-287904311.html">$14 billion in 2014</a>, and is forecast to grow to nearly $20 billion by 2020. North America does account for the largest spend in this market, even though the prevalence of deadly infectious diseases is far below levels in emerging markets. It may therefore be the case that very expensive equipment is being purchased and underutilized as 'safety equipment' by community clinics, governmental agencies, and hospitals, the latter of which were the main end-users of the IDD market in 2014. These customers may be glad to purchase more cost-effective, PoC options, especially as there is growing demand for decentralized testing and more efficient test times.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">On the other hand, micro-PCR does face stiff competition from incumbents who are investing heavily in alternative molecular diagnostic methods seen to have higher efficiency potential than PCR such as Isothermal Nucleic Acid Amplification Tests (INAAT) and microarrays, which are forecasted to be the fastest growing markets for the next five years. The efficiency question is central: While PCR's ability to provide PoC diagnosis a huge absolute efficiency gain relative to the traditional method of ordering remote laboratory tests, each test requires some degree of attention from skilled personnel that the throughput rate may seem low and the costs of public screening high to providers who are used to simply ordering remote tests.</span><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpx9icwwKcTLU3RWlk8YSShS77BZOfMOo4U_1A5tNkNCnkCLIb49RmcgJK4W3tlpIMfc5jOQq6rwm0JrinkPv7Fgrycb0hfMu8WHMJRbMVVOkYVclitGxJAWzod0U7zvEScZ0FyhOv_no/s1600/Quattro+pic+big.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><span style="font-family: inherit;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpx9icwwKcTLU3RWlk8YSShS77BZOfMOo4U_1A5tNkNCnkCLIb49RmcgJK4W3tlpIMfc5jOQq6rwm0JrinkPv7Fgrycb0hfMu8WHMJRbMVVOkYVclitGxJAWzod0U7zvEScZ0FyhOv_no/s1600/Quattro+pic+big.jpg" height="244" width="320" /></span></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.molbiodiagnostics.com/new_quattro.html"><span style="font-family: inherit; font-size: small;">TrueLab Quattro Micro-PCR Analyzer</span></a></td></tr>
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<span style="font-family: inherit;">Molbio is reducing this bottleneck with their next generation Truelab Quattro analyzer that can run 4 tests simultaneously, as well as a fully automated sample preparation machine. An integrated multiplex platform is also planned for introduction in the next two years.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">The TrueLab products seem technically capable of obtaining any regulatory approvals, which they're already receiving on a test-by-test basis from The Drugs Controller General of India and The Director General-Indian Council of Medical Research. Their clearance in <a href="http://www.molbiodiagnostics.com/molbio_evaluations.html">February, 2015 for the H1N1</a> test recommends the product's use for "all laboratories including low level/ low volume/ peripheral level laboratories." This probably represents most in-house laboratories testing for infectious diseases within the U.S., and at least suggests that the technology behind TrueLab is sound enough for more rigorous regulatory approval. The Institute of Tropical Medicine, Antwerp has also <a href="http://www.molbiodiagnostics.com/Eval%20Report/Truenat%20MTB/TDR-TB_strain_Bank_certificate_Tulip_2012-03-22.pdf">validated the accuracy of their Malaria test</a>. Molbio certainly takes this aspect of the business seriously, as their <a href="http://www.molbiodiagnostics.com/packinserts/Truenat%20Universal%20Control%20packinsert.pdf">Universal Control Kit</a> documentation shows.</span><br />
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<span style="font-family: inherit;"><br /></span>
<b><u><span style="font-family: inherit;">Questions for Discussion:</span></u></b><br />
<ul>
<li><span style="font-family: inherit;">Would IDD purchasers in the U.S. find value in the TrueLab system? </span></li>
<li><span style="font-family: inherit;">Is TrueLab the world's first IDD device that fits the WHO's ASSURED criteria? </span></li>
</ul>
</div>
</div>
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com43tag:blogger.com,1999:blog-71021911408861069.post-65665766217619689572015-03-16T05:49:00.001-07:002016-07-14T11:26:56.713-07:00Seeing Clearly: Ultrasound = Future of Diagnostic Imaging<div dir="ltr" style="text-align: left;" trbidi="on">
<b><u>The Beauty of Ultrasound Technology</u></b><br />
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Ultrasound is an example of <a href="http://biomimicry.org/what-is-biomimicry/">biomimicry</a> <i>par excellence; </i>even in a field rife with bio-inspired devices and medications, it stands out for its fidelity to nature. Consider that the three main components of an ultrasound device--a transducer to emit and capture the echoes of sound waves, a computer to process this data, and a screen to display the data real-time--are also utilized by organisms that rely on ultrasound for navigation. For instance, the sperm whale uses a highly developed transductive organ to emit sonar waves deep into the ocean in order to locate its prey. Bats famously use echolocation to capture insects after dusk. Each of these organisms uses 'transducer' organs to emit and capture waves, and their brains act as both 'computers' and 'screens' that allow them to see the world with a high level of accuracy when eyesight cannot do the job. Ultrasound devices in medicine today use the same technology to view the inner body real time, and they do such an effective job of this that a Harvard research team published a report in the <a href="https://twitter.com/NEJM">New England Journal of Medicine</a> in 2014 entitled <i><a href="http://www.nejm.org/doi/full/10.1056/NEJMp1311944">Point-of-Care Ultrasound Imaging in Medical Education: Stop Listening and Look</a>, </i>which encourages physicians to supplement and possibly replace the stethoscope with diagnostic ultrasonography for physical examinations. <br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjS0O1JPg6mwCAF6aDqUiTGDwAEXSHdYHMGRLy1SsEvdVIDsHxwB0kFX8ymUEmZxytCmFvaI9jxIwWhTHAN115-0PnlDbq5ORdL9F_Nx3ReWqvoSPUicmgyTq2sEXeiggolbtFYb52m3hE/s1600/vscan+range+of+imaging.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjS0O1JPg6mwCAF6aDqUiTGDwAEXSHdYHMGRLy1SsEvdVIDsHxwB0kFX8ymUEmZxytCmFvaI9jxIwWhTHAN115-0PnlDbq5ORdL9F_Nx3ReWqvoSPUicmgyTq2sEXeiggolbtFYb52m3hE/s1600/vscan+range+of+imaging.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www3.gehealthcare.in/en/products/categories/ultrasound/vscan_family/vscan_with_dual_probe#tabs/tab2F193C9E26D24E9EACAC4A85B990A8D8">Clinical Areas of Vscan Ultrasound by GE Healthcare</a></td></tr>
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The visual results of 3D/4D ultrasound technology have reached astonishing levels of detail, as a quick Google search shows. Most of the results display fetuses, but the clinical applications for ultrasound go far beyond fetal screening to include a wide range of diagnostic and even therapeutic uses as the chart on the right shows. In fact, ultrasound as a medical imaging modality features several distinct advantages, including real-time viewing, speed and ease-of-use, no radiation exposure, and no pain. Ultrasound is also the least expensive internal imaging modality--the typical alternatives being X-ray, CT/PET scans, or MRIs--and does a particularly good job of displaying soft tissue.<br />
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Ultrasound does have certain limitations. Air or gas disrupts the waves, as do bones, so ultrasounds are not a good method for viewing the bowels or bones beyond infancy. Especially corpulent patients attenuate the image quality due to too much soft tissue mass, and sometimes patients are covered with bandages or other materials that make ultrasound infeasible. Finally, the resolution of the images is not high enough for all medical imaging purposes.<br />
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These limitations aside, there's a great deal of diagnostic and triage value that ultrasound provides across a continuum of conditions, as Dr. Janice Boughton describes in her article <i><a href="http://www.kevinmd.com/blog/2015/03/real-life-examples-ultrasound-developing-world.html">Real-life examples of ultrasound in the developing world</a> </i>on <a href="https://twitter.com/kevinmd">KevinMD</a>.<br />
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<b><u>Handheld Ultrasound: A Quintessential Disruptive Technology</u></b><br />
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<div style="background-color: white; color: #222222;">
<span style="font-family: inherit;">Lower-resourced clinical settings were early to foster Point-of-Care (PoC) ultrasound. In the United States, it seems that rural, county, and inner-city hospitals were early adopters of PoC in emergency and critical care situations. Dr. Resa Lewiss, in her excellent 2014 <a href="https://twitter.com/TEDMED" style="color: #1155cc;" target="_blank">TEDMED</a> talk, explains that in the early 1990s, there were fewer than five fellowships in emergency PoC ultrasound. In the early 2000s, her mentors and friends were using ultrasound for global health and disaster relief in countries such as Ethiopia, Kosovo, Sierra Leone, and Indonesia. Today there are over 90 emergency medicine ultrasound fellowships in the USA. </span></div>
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<span style="font-family: inherit;">Ultrasound continues gaining popularity as effective diagnostic and procedural tools. Emerging markets will continue to play an important role in fostering disruptive ultrasound products because of the relative ratio of patient need to paucity of clinical resources.</span></div>
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgi6IDtz1WvRVuVJnsW7I3yo5gtMrqdGtzfIZtoIoVzFxjM1SYNs2yjUk1ghj1k-ZZVRMJks2iQijz9puYZExge1ytRcv66qFjncsOdrhhK8qSKLugnKTeZrWUiyVao33NGPJ5CktnHk08/s1600/Vscan+package+dual+probe.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgi6IDtz1WvRVuVJnsW7I3yo5gtMrqdGtzfIZtoIoVzFxjM1SYNs2yjUk1ghj1k-ZZVRMJks2iQijz9puYZExge1ytRcv66qFjncsOdrhhK8qSKLugnKTeZrWUiyVao33NGPJ5CktnHk08/s1600/Vscan+package+dual+probe.jpg" width="277" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www3.gehealthcare.in/en/products/categories/ultrasound/vscan_family/vscan_with_dual_probe">GE Healthcare's Vscan with Dual Probe</a></td></tr>
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In fact, the two best-known examples of handheld ultrasound in the world were created in India. First, GE Healthcare India created the <a href="http://www3.gehealthcare.in/en/products/categories/ultrasound/vscan_family/vscan_with_dual_probe">Vscan</a> handheld ultrasound machine in 2009 as a means of providing affordable diagnostic data to physicians in India. The Vscan is a picture perfect example of a disruptive innovation in that it performs less well on certain dimensions than incumbents, but it does a 'good enough' job in the vast majority of use cases, and it does this at a price of <a href="http://boringem.org/2013/05/09/handheld-ultrasound-a-review-of-the-vscan/">$7,900</a>. This price is still high for India, but is more accessible than the $25,000 to several hundred thousand dollar price tags for incumbent models.<br />
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Not to be outdone, Philips India developed the <a href="http://www.healthcare.philips.com/main/products/ultrasound/systems/visiq/">Visiq</a> ultra-portable ultrasound device, releasing it in 2014 at a price of about <a href="http://techmoran.com/philips-unveils-the-visiq-ultra-mobile-ultrasound-system-in-kenya/#sthash.h6dR374g.dpbs">$14,500</a>. Visiq is a similarly compact setup to Vscan, but features a larger tablet-sized screen.<br />
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There's currently a lack of indigenous innovations from India to compete with these technologies as low-cost handheld ultrasound devices, though Trivitron in Chennai has made a laptop-sized ultrasound screening device called <a href="http://www.trivitron.com/imaging.htm">Prosound 2</a>. However, at a price of <a href="http://jipmer.edu.in/list-of-costly-equipment/">$20,000</a>, Trivitron does not appear to be marketing the product to compete with Visiq and Vscan.<br />
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<b><u>Disrupting the U.S. Medical Imaging Market</u></b><br />
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In a certain sense, products only have disruptive potential, and Vscan and Visiq have disruptive potential in spades. Whether a product realizes its disruptive potential depends on whether management markets it disruptively. Will GE and Philips do this outside of emerging markets? Philips is not selling or marketing Visiq in the U.S., though it does have 510(k) approval from the FDA. GE Healthcare does sell Vscans in the U.S., but I have only read about their independent use by individual doctors, or about medical schools or teaching hospitals buying them in bulk for distribution to their students as a supplement to stethoscopes. In other words, neither GE nor Philips has marketed these products disruptively <i>yet</i>. This is not at all surprising: GE Healthcare would LOVE to upgrade their stethoscope market to using Vscans, but their sales people and finance department would protest mightily should the Vscan team aggressively disrupt their incumbent ultrasound imaging market in wealthy countries.<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-9O2IvBARaBvo6SRJ1ChPUbQLxQy11dL50t5-_0Rv2f2gt9r2lcupBThS-Ow1qx0YK1I2sE2a132iG7OeqZ1cFzU0DifWUHtxuC8rRS3FjhdqDCbC7Jcl1E3YALPqJRb2eYdWzRqtB5k/s1600/mobisante.png" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-9O2IvBARaBvo6SRJ1ChPUbQLxQy11dL50t5-_0Rv2f2gt9r2lcupBThS-Ow1qx0YK1I2sE2a132iG7OeqZ1cFzU0DifWUHtxuC8rRS3FjhdqDCbC7Jcl1E3YALPqJRb2eYdWzRqtB5k/s1600/mobisante.png" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.mobisante.com/products/product-overview/">MobiUS SP1 Portable Ultrasound from Mobisante</a></td></tr>
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<span style="font-family: inherit;"><span style="background-color: white; line-height: 18.2000007629395px;">GE and Philips hesitate to disrupt themselves, but what about grassroots innovators in the U.S.? Mobisante is a company in Redmond, Washington that </span><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K102153" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">received FDA approval in 2011</a><span style="background-color: white; line-height: 18.2000007629395px;"> for a smartphone-enabled ultrasound device. </span><a href="http://www.mobisante.com/products/product-overview/" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">Mobisante's MobiUS SP1</a><span style="background-color: white; line-height: 18.2000007629395px;"> device (shown right), is priced similarly to GE's Vscan, retailing around </span><a href="http://junopower.com/blogs/news/13323113-4-must-haves-for-soon-to-be-moms" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">$8,000</a><span style="background-color: white; line-height: 18.2000007629395px;">. The company does not seem to have incurred much on the big device makers' core medical imaging turf, perhaps opting to gain a foothold first in medical education markets. Another niche market could come from supplying numerous non-medical providers of 'keepsake' fetal images, but this market may rapidly disappear: The </span><a href="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095508.htm" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">FDA issued a warning</a><span style="background-color: white; line-height: 18.2000007629395px;"> in December, 2014 against the non-medical use of ultrasound devices in capturing fetal images or videos for keepsake purposes. </span></span></div>
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<span style="font-family: inherit;"><span style="background-color: white; line-height: 18.2000007629395px;">Whether Mobisante can succeed in the core medical imaging market depends on many factors, but primarily on the quality of the product. So, has the image quality of handheld ultrasound machines achieved parity with incumbent technologies? Dr. Eric Topol, on page 119 of his new book </span><i style="background-color: white; line-height: 18.2000007629395px;">The Patient Will See You Now</i><span style="background-color: white; line-height: 18.2000007629395px;">, cites a study he and colleagues </span><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3733444/" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">conducted at Scripps</a><span style="background-color: white; line-height: 18.2000007629395px;"> showing that the image resolution from the Mobisante and Vscan devices were "as good as the standard, large ultrasound hospital machine that costs over $300,000 for performing heart imaging." With more than </span><a href="http://www.wsj.com/news/interactive/IMAGINGchrtprint" style="background-color: white; color: #ba522b; line-height: 18.2000007629395px; text-decoration: none;" target="_blank">125 million ultrasound studies performed in the U.S. per year</a><span style="background-color: white; line-height: 18.2000007629395px;"> according to WSJ's Laura Landro, and an average charge of $800 per study, Topol estimates that these handheld devices could save the U.S. $50 billion per year in ultrasound study costs alone if adoption of handheld ultrasound devices became routine in clinical care. And this estimate doesn't even count ultrasound's potential to disrupt the other imaging modalities, which account for an additional 450 million studies per year in the U.S.</span></span></div>
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Reenita Das, a partner with Frost & Sullivan, adds color to this in her recent Forbes article <i><a href="http://www.forbes.com/sites/reenitadas/2014/12/30/plug-and-play-the-future-for-healthcare-diagnostics/">Could Plug-and-Play Be the Future of Healthcare Diagnostics?</a>. </i>She points out that software enhancement tools are improving ultrasound image quality to such a degree that the technology can now be used to identify and monitor cancer and other diseases. She points out that avoiding the need for painful biopsy and dangerous radiocontrast agents where possible will "significantly reduce the pain and cost of treatment for cancer patients." In view of this, ultrasound's potential to begin replacing other imaging modalities appears much larger. Its ability to do that while simultaneously lowering costs is what makes it so valuable.<br />
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<b>Questions For Discussion</b><br />
<ul style="text-align: left;">
<li>Has the image quality of handheld ultrasound devices achieved parity with the larger, more expensive machines? </li>
<li>Can companies like Mobisante effectively target the core medical imaging market in the U.S.? </li>
<li>Could handheld ultrasound devices really save the U.S. over $50 billion per year?</li>
</ul>
</div>
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com17tag:blogger.com,1999:blog-71021911408861069.post-7672505800367421622015-03-05T22:56:00.000-08:002015-03-07T09:52:07.912-08:00The TTK Chitra Heart Valve: A High Quality Prosthesis for $350 <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: inherit;"><b><u>A Successful Class III Medical Device From India</u></b></span><br />
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<span style="font-family: inherit;">The TTK Chitra Heart Valve is a model disruptive medtech innovation for India and the world. Developed painstakingly over 12 years at the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Trivandrum, India, the device is now licensed for manufacture and marketing to TTK Healthcare in Chennai. It has nearly 90,000 implantations to date, and sold over <a href="https://www.dolcera.com/wiki/index.php?title=Strategic_Insights:Heart_Valve_Replacement_Market_-_India">10,000 in FY 2011-12 alone</a>. Additionally, TTK now exports the device to all neighboring countries, as well as South Africa. Overall, about <a href="http://www.slideshare.net/pranavshamraj/ttk-chitra-valve-a-review">250 medical centers and 300 surgeons</a> were using the TTK Chitra Heart Valve as of 2014.</span><br />
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<span style="font-family: inherit;"></span><span style="font-family: inherit;">Importantly, the TTK Chitra Heart Valve is a <a href="http://www.slideshare.net/pranavshamraj/ttk-chitra-valve-a-review">Class III medical device</a>, a status almost unique among indigenous Indian medtech. India still imports the majority of its medical devices across all classifications, but very nearly all Class III medical devices are still imported from abroad. The Chitra valve </span>definitively <span style="font-family: inherit;">shows that India has the technical capability to produce extremely high quality devices for even the most sensitive medical applications. </span><br />
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<b><u>The TTK Chitra Heart Valve Story</u></b><br />
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The Chitra story begins with a glaring clinical and social need in India, where the incidence of Rheumatic Fever and Rheumatic Heart Disease (RHD) remains high among children. An estimated <a href="http://icmr.nic.in/ijmr/2013/april/centenary%20review%20article.pdf">2-2.5 million patients</a> suffer from RHD in India, and this is the leading cause of structural heart valve damage in the country. This is an important difference between India and the U.S., where the leading cause of cardiac valvular stenosis or regurgitation (the two symptoms indicating structural damage and the need for replacement surgery) is Degenerative Heart Disease, a potential condition of old age.<br />
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For decades, India relied on imports of expensive artificial valve replacements to meet domestic need, but many families whose children developed RHD were also among the poorest in India, and could not afford even the heavily discounted price tags of imported valves, which hovered around $1,200 each. And so their children died, or lived drastically shortened and unhealthy lives. <br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitLvdrIZ0graVgt3zHQ2IR__kgtqpBmtFtfLFAwIb2duQXT__swnpbCl7sLoWk_TYqMsVF-WmOuGvJ2VJVXGEf2T8WTWZLAk-sVIZJBDQMLxFc0-H-f6L0ksiNoMX8i122OIGCOMMUSig/s1600/chitra+valve.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Chitra Heart Valve" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitLvdrIZ0graVgt3zHQ2IR__kgtqpBmtFtfLFAwIb2duQXT__swnpbCl7sLoWk_TYqMsVF-WmOuGvJ2VJVXGEf2T8WTWZLAk-sVIZJBDQMLxFc0-H-f6L0ksiNoMX8i122OIGCOMMUSig/s1600/chitra+valve.jpg" height="400" title="Chitra Heart Valve" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://upload.wikimedia.org/wikipedia/commons/5/56/Chitra_Valve.jpg">The Chitra Heart Valve</a></td></tr>
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The Chitra valve project sought to address this significant public health challenge by creating an affordable, high quality artificial heart valve for India. The project succeeded. Not only does it feature <a href="http://www.ttkhealthcare.com/heartvalve/heartvalve_features.htm">genuine design and material science innovations</a> around in-vitro noise reduction, blood flow resistance reduction, and durability, but the valve also uses the highest quality materials and manufacturing for the frame, occluder, and sewing ring components. One would think such quality and a 12-year product development cycle with extensive clinical trials would raise the price considerably, but <a href="http://blog.ochre-media.com/trivitron/">TTK Healthcare sells each valve for just $315-$400</a>, a price range it has maintained since 1995, even in the face of considerable inflation in India. Facing such disruption from an indigenous entrant, the MNCs all lowered their prices for replacement valves to parity with Chitra's as a way to stay in the market.<br />
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This cost reduction story is compelling, but there's an important caveat. The SCTIMST is a public institution, so the product development costs over 12 years were therefore likely funded by grants from the <a href="http://www.birac.nic.in/">Biotechnology Industry Research Assistance Council of India</a> and other public funds. Depending on the terms of investment and licensure to TTK, the Chitra valve's public genesis may have obviated the need to recoup any product development costs, potentially a major factor in its low price. From the perspective of the Indian public, the device may have fulfilled its purpose by crashing prices for most artificial heart valves. The fact that the Chitra valve continues to gain ground in India and around the world is a testament to its quality and adaptability.<br />
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<b><u>Could the TTK Chitra Heart Valve Succeed in the U.S.?</u></b><br />
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The structural challenges facing the TTK Chitra Heart Valve in the U.S. are considerable. First, as a Class III medical device, price becomes less important relative to quality, and the bileaflet artificial valve models--though much more expensive--have marginally better performance in many use cases. Only serious cardiovascular surgery centers perform heart valve replacements, and these will likely opt for products that exhibit even marginal medical benefit over others, at least to protect themselves from unnecessary legal liabilities.<br />
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Second, there are homegrown disruptive medtech innovations for certain operations in this space. For example, the <a href="http://www.beaumont.edu/heart/treatments-procedures/mitraclip-valve-repair/">MitraClip</a> is a device approved by the US FDA as a less invasive way to treat mitral regurgitation due to degenerative disease in patients with prohibitive risk for mitral valve surgery. This targets a substantial portion of the market for valve replacement as mitral valve regurgitation is <a href="http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/Problem-Heart-Valve-Regurgitation_UCM_450736_Article.jsp">the most common form of heart valve disease</a> in the U.S., suggesting that there are even more Mitral Valve Replacement surgeries per year than the <a href="http://www.heart-valve-surgery.com/heart-surgery-blog/2009/03/07/annual-data-number-yearly-aortic-valve-replacement/">20,000 or so Aortic Valve Replacement</a> surgeries per year.<br />
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Third, <a href="http://cardiac.surgery.ucsf.edu/conditons--procedures/aortic--mitral-valve-disease.aspx">biological valve replacements</a> are often preferred for placement is elderly patients, who form the bulk of patients requiring heart valve replacement surgeries in the U.S.. While biological valves are not as durable as artificial valves like Chitra, they don't require additional blood-thinning medicines, and are associated with a lower risk for blood clots. <br />
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While the TTK Chitra Heart Valve's low price could be a major boon to certain U.S. patients shopping for low-cost heart valve replacement surgeries, these patients may need to content themselves with medical tourism for the time being. One good option may be <a href="http://www.narayanahealth.org/Cayman-Islands">Narayana Health's</a> hospital in the Cayman Islands, which specifically targets medical tourists from the Americas.<br />
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<b><u>Question for Discussion: </u></b><br />
<ul style="text-align: left;">
<li>Is there demand for a low-cost heart valve like the TTK Chitra Heart Valve in the U.S.? </li>
</ul>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com114tag:blogger.com,1999:blog-71021911408861069.post-20554343809323072852015-02-27T02:24:00.002-08:002015-02-27T02:52:19.751-08:00Smartphones Enable Patients To Manage Early Diabetes for Under $100 Per Year<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: white; font-family: inherit; white-space: pre-wrap;"><b><u>The IoT and the Changing Healthcare Environment </u></b></span></div>
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<span style="background-color: white; font-family: inherit; white-space: pre-wrap;">The world is filling up with internet-enabled sensors of all kinds, generating a huge amount of storable data about everything, including our health. This Internet of Things (IoT) in healthcare represents an array of wearables, phones, and specialty medical devices that are already producing, analyzing, and sharing medical grade data. </span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;">In fact, the smartphone, with its numerous embedded sensors, plugin capabilities, and app development ecosystem, is very likely now the highest-utilized medical device in the world. Going far beyond basic physiology monitoring functions like step counting, certain device extensions are functioning as 'labs on a chip</span><span style="background-color: white; white-space: pre-wrap;">,' using biochemistry and microfluidics to do the same diagnostic work previously confined to large, expensive, time-intensive, and centralized laboratory testing facilities.</span><span style="background-color: white; white-space: pre-wrap;"> All of the new data being generated is not only useful to individuals and their doctors, but can be aggregated to provide population-level insights about health. For example, Walgreens is now displaying patient-reported information on medication side effects from </span><a href="http://www.betaboston.com/news/2015/02/19/walgreens-partners-with-patientslikeme-for-online-information-on-drug-reactions/" style="white-space: pre-wrap;">PatientsLikeMe</a> <span style="background-color: white; white-space: pre-wrap;">on their pharmacy website. PatientsLikeMe is heavily involved in the new <a href="http://hdexplore.calit2.net/wp/guest-post-a-few-thoughts-about-patient-health-data/">Health Data Exploration</a> project, an effort to better define the parameters and methods of collecting and managing both passive and active personal health data. Much of this data will come directly from smartphones. </span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;">The IoT has been slower to disrupt medicine than many other industries. On a macro level, healthcare is a sensitive area, requiring carefully coordinated regulatory, security, and safety measures. On a micro level, many specific policies and delivery models are outdated, and will eventually need to modify to take the new and emerging models of care into account. </span><span style="background-color: white; white-space: pre-wrap;">This is already happening; for example, the <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf#page=23">FDA has eased approval requirements</a> for low-risk mobile medical apps. </span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;">The emerging IoT, the lower time and cost barriers for regulatory approval, and the increasing demand for low-cost treatment methods is throwing fuel onto the fire of smartphone-enabled medtech growth. </span></span><br />
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<span style="font-family: inherit;"><span style="background-color: white; white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;"><b><u>New Opportunities to Improve Chronic Care: The Case of Type II Diabetes</u></b></span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><b><u><br /></u></b></span><span style="background-color: white; white-space: pre-wrap;">The case of diabetes is illustrative: In the U.S., about 50 million people have diabetes; in India, the number jumps to at least 65 million, a number growing quickly due to changes in diet, and because many Indians are at least <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3024348/">30% more genetically predisposed</a> to developing diabetes than whites. Type II diabetes accounts for about 90% of total cases. </span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"></span><br /><span style="white-space: pre-wrap;"></span><span style="background-color: white; white-space: pre-wrap;">In response, entrepreneurs in India have developed a range of intriguing, low-cost, user-friendly products bringing basic but effective diagnostic, monitoring, and management capabilities to people with diabetes. </span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;">First, there are the multiple parameter testing devices, exemplified by our earlier-featured <a href="http://www.globalhealth.care/2014/12/indias-new-health-tablet-performs-30.html">Swasthya Slate</a>, which can conduct about 30 biochemical tests on body fluids, or the more focused <a href="http://bplmedicaltechnologies.com/lifephoneplus/">BPL Lifephone Plus</a>, which </span><span style="background-color: white; white-space: pre-wrap;">measures just ECG, blood glucose, heart rate, calories burnt, and steps taken. The former, largely developed for clinical screening use, may retail around $1,000, whereas the Lifephone retails for around $200, in-line with the comparable cue.me and Scanadu devices shortly hitting the U.S. market for $150 and $200, respectively. India-based <a href="http://www.biosense.in/uchek.html">Biosense's uCheck Universal</a> kit runs over 10 urine-based tests in addition to blood glucose, and retails for about $80. </span><span style="background-color: white; white-space: pre-wrap;"></span><br /><span style="background-color: white; white-space: pre-wrap;"></span></span><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFPnjgmztGIr6xEjtfB9ofoaqcdZyzUxXQxDSsLIJ3_U1nnkSzvVzxEzvV82AYN7JusSI0Ss1GfC_m8ddmiaKrgVNKC1YYOqgyZ4y1zWT_HYDOtF3vU9nI2fhplIhJ_EcrJph4do1cKGI/s1600/photo+(12).JPG" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><span style="font-family: inherit;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFPnjgmztGIr6xEjtfB9ofoaqcdZyzUxXQxDSsLIJ3_U1nnkSzvVzxEzvV82AYN7JusSI0Ss1GfC_m8ddmiaKrgVNKC1YYOqgyZ4y1zWT_HYDOtF3vU9nI2fhplIhJ_EcrJph4do1cKGI/s1600/photo+(12).JPG" height="200" width="150" /></span></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="font-family: inherit; font-size: small;">Low-cost Glucometers</span></td></tr>
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<span style="background-color: white; font-family: inherit; white-space: pre-wrap;">While the same range of diabetes-specific devices is available in India, the high-end continuous glucose monitoring systems are not yet affordable for most people. On the low-end, J&J has developed the <a href="http://www.jnjindia.com/whats_new/simplicity_matters">OneTouch</a> glucometer for India, selling the device and a supply of strips anywhere from $10-$25. But standalone glucometers have become somewhat commoditized, with many local entrants undercutting branding efforts. This photo from the historical Cash Pharmacy in Bangalore shows a local Dr. Morepen's GlucoOne for $17 obviously outshining a duller ad for Bayer's Contour TS glucometer. These devices are sold as part of a BoP strategy favoring scale over unit margins, and they are often just a part of companies' product portfolios. </span><br />
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<span style="font-family: inherit;"><span style="background-color: white; white-space: pre-wrap;">Other indigenous companies are taking a more integrated approach to diabetes care in India. One startup called <a href="http://www.janacare.com/">Jana Care</a>, operating in Bangalore with roots from Harvard & MIT, has developed a small device that plugs into smartphones to run a full 'diabetes panel' of tests: </span><span style="background-color: white; white-space: pre-wrap;">HbA1c, b</span><span style="background-color: white; white-space: pre-wrap;">lood glucose, lipids, creatinine, and haemoglobin. They are in process of receiving international regulatory approval for all tests, positioning them as the only company offering smartphone-based HbA1c tests, and one of the only companies offering the full 'diabetes panel' at point of care using the same low-cost form factor. They've also closed the loop on the training side with their </span><a href="http://www.habitsprogram.com/" style="white-space: pre-wrap;">Habits Program</a><span style="background-color: white; white-space: pre-wrap;"> app, a 3-month curriculum based on the </span><a href="http://www.webmd.com/diabetes/prevention-program" style="white-space: pre-wrap;">Diabetes Prevention Program</a><span style="background-color: white; white-space: pre-wrap;"> that includes weekly phone calls from a trained health worker to discuss personal progress. The cost to the patient varies by provider, but is only marginally higher than a standalone glucometer, and is affordable to most patients in India. </span></span><br />
<span style="font-family: inherit;"><span style="white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;">Could Jana Care successfully commercialize in the U.S.? Low cost is not their only comparative advantage. </span><span style="background-color: white; white-space: pre-wrap;">Another is that their products have already been developed to target a large number of 'non-digital natives,' so that the training materials, notification processes, and general usability of the products is very friendly for users of all ages and backgrounds. This may be a marked advantage in serving people with Type II diabetes in the U.S., whose ranks skew heavily towards the middle-aged and elderly for whom complicated digital solutions will likely not be attractive. </span></span><br />
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<span style="font-family: inherit;"><span style="background-color: white; white-space: pre-wrap;"><br /></span><span style="background-color: white; white-space: pre-wrap;"><b><u>Question for Discussion:</u></b></span></span><br />
<span style="font-family: inherit;"><br /><span style="background-color: white; white-space: pre-wrap;">Would the Jana Care package provide real value to people with diabetes, and to their care providers, in the U.S.? </span><span style="background-color: white; white-space: pre-wrap;"><br /></span></span><br />
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com53tag:blogger.com,1999:blog-71021911408861069.post-91332557877931844052015-02-09T05:25:00.002-08:002015-02-10T00:02:33.084-08:00Bending the Cost Curve: Medtech Will Do What the ACA Cannot<div dir="ltr" style="text-align: left;" trbidi="on">
In his new book <i><a href="http://americasbitterpill.com/">America's Bitter Pill</a></i>, Steven Brill tells the story of ObamaCare (ACA) as a political effort to reform U.S. healthcare, a system he compares to a jalopy that <a href="http://www.globalhealth.care/2015/01/20-facts-about-healthcare-costs-in-us.html">costs too much</a> to drive. A jalopy healthcare may be, but Brill's premise that the ACA represents the right service crew to fix up the old car seems incomplete when reading about the fascinating medical technology advances that Dr. Eric Topol shares in his new book <i><a href="http://www.forbes.com/sites/davechase/2014/12/29/medical-blockbuster-book-of-the-year-the-patient-will-see-you-now/">The Patient Will See You Now</a>. </i>Whereas Brill seems to look at healthcare reform from the 30,000 foot level of Washington policymaking, Topol simply looks at the technological advances enabling more accessible, effective medicine. These two views, both top-down, and bottom-up, must be considered in developing broadly informed opinions on improving healthcare in the U.S.<br />
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<b><u>Brill's View of Healthcare</u></b><br />
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Brill repeatedly frames the dilemma of healthcare reform as a political choice between 'bending the cost curve,' and extending coverage. The story of ObamaCare amply demonstrates that materially decreasing costs through policy is too difficult to achieve politically, though ObamaCare did result in over 10 million newly insured Americans. That's the ACA's main contribution so far, and it suggests that government's role is less to fix up the jalopy than to decide how many people can ride in it.<br />
<br />
The failure to bend the cost curve was not for lack of trying on the part of the economic team. Peter Orszag and other economists fought hard to include provisions targeted at cutting costs, but few of these passed with any teeth. In <a href="http://www.bloombergview.com/articles/2015-01-12/what-brills-bitter-pill-gets-wrong-on-obamacare">critiquing Brill's book</a>, Orszag argues that the curve may still bend, pointing to the continued expected growth of ACOs, increasing digitization practices among providers, increasing price transparency in the market, and additional instruments like HDHPs that help patients self-regulate spending. These provisions may help decrease costs over time, but they haven't yet, and at the end of the day, the ACA was only estimated to result in savings of $30 billion per year. That's a lot of money, but it still only represents about 1% of annual healthcare spend in the U.S., and only 4% of the $750 billion of <i>wasted</i> annual healthcare spend estimated by McKinsey.<br />
<br />
The shocking gap in Brill's ultimate analysis is that it elides the powerful forces of technological progress by which costs often decrease over time. He does point to 'Integrated Finance & Delivery Systems'--a special kind of ACO that attains market dominance within its region or specialty--as a potential solution for controlling costs. In fact, transforming hospitals into ACOs is a key, if <a href="http://www.modernhealthcare.com/article/20150208/NEWS/302069958">difficult to enforce</a>, part of the ACA. Even this transformation does not dramatically reduce healthcare costs <i>per se</i>, but only opens the door for the adoption of new delivery models by partially aligning the financial incentives of providers towards saving money while continuing to provide quality care.<br />
<br />
In Brill's telling, we are left with a story about increased health insurance coverage, but little in the way of fixing the leaky jalopy. Hope springs instead from the world of grassroots technological innovations, a ground-level scientific view that Dr. Eric Topol knows well.<br />
<br />
<br />
<b><u>Topol's View of Healthcare</u></b><br />
<br />
<i>The Patient Will See You Now </i>is a non-stop documentation of extraordinary scientific, technological, and process innovations that are enabling the democratization of healthcare. The number of new technologies he cites runs into the hundreds, but a few trends most noteworthy for our purposes here include advances in the diagnostic use of genetic sequencing; the creation of a personal Graphical Information System (GIS) containing visual data on one's physiome, anatome, genome, proteome, metabolome, microbiome, epigenome, and exposome; near-ubiquitous sensors providing multi-dimensional diagnostic data and monitoring of most major medical conditions; and the emergence of efficient medtech for low-resource settings. Of course, hundreds of startup companies have sprung up to participate in the commercialization of these technologies, many of which hold promise for lowering costs while improving outcomes.<br />
<br />
<br />
<b><u>The Innovator's View of Healthcare</u></b><br />
<br />
It's not likely that many of the fledgling companies advancing disruptive medtech innovations were at the table during the prolonged, anguished ObamaCare discussions, and in Washington, 'If you're not at the table, you're on the menu.' Indeed, the ACA in its current form contains both provisions that encourage and discourage <a href="http://www.christenseninstitute.org/key-concepts/disruptive-innovation-2/">disruptive innovation</a>, according to the authors of <i><a href="http://www.christenseninstitute.org/publications/aca/">Sieze the ACA</a> </i>at the Christensen Institute. Here are the most salient ones:<br />
<ul>
<li><u>Provisions Encouraging Innovation</u></li>
<ol>
<li>Individual mandate</li>
<li>Employer mandate</li>
<li>ACOs</li>
<li>Wellness programs</li>
<li>CMS Innovation Center</li>
</ol>
</ul>
<ul>
<li><u>Provisions Discouraging Innovation</u></li>
<ol>
<li>Essential Health Benefits</li>
<li>Insurance exchanges coverage requirements</li>
<li>Cost-sharing funnels buyers into Silver-level plans</li>
<li>Fixing the medical loss ratio</li>
<li>Medicaid expansion</li>
</ol>
</ul>
<div>
</div>
<br />
<div>
Smart innovators will be able to navigate the current regulatory environment to succeed, but they may increasingly choose to do so in other markets first. The geographical advancement of medical technology has often resulted in confluences of market conditions that seem to turn raw scientific knowledge into low-cost, effective medtech applications. One such market is India, whose often internationally-trained entrepreneurs are developing low-cost, high quality medtech at a dizzying pace. Topol mentions several in his book, such as Manu Prakash's 'origami' microscope that costs $1 to assemble, or Sangeeta Bhatia's urine test for cancer detection developed at MIT. There are many more, some of which are listed in our <a href="http://www.globalhealth.care/p/running-list-of.html">database</a>. </div>
<div>
<br /></div>
<div>
Regardless of the point of geographical origination for disruptive medtech, the delivery models that will emerge with these new technologies hold the potential to providing affordable, quality healthcare for everyone. Policymakers in Washington should seek to pave the way for the success of emerging medtech, an outcome that should be a central part of any discussion about refitting the jalopy of U.S. healthcare into a shiny new model for the world.</div>
</div>
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com11tag:blogger.com,1999:blog-71021911408861069.post-50400988709304532462015-01-26T00:29:00.001-08:002015-02-10T00:03:22.445-08:00ECG Tech from India Could Save U.S. $50 Million Today<div dir="ltr" style="text-align: left;" trbidi="on">
<b><u>Electrogardiography: A Brief Review</u></b><br />
<br />
<a href="http://en.wikipedia.org/wiki/Electrocardiography">Electrocardiography</a> (ECG) is a diagnostic method of recording the electrical activity of the heart. This is traditionally performed by attaching electrodes to the skin, which then pick up waveform electrical impulses generated by the polarization and depolarization of cardiac tissue. These are mapped on an electrocardiogram and interpreted to measure heart performance and health.<br />
<br />
The use of ECGs is ubiquitous and popular among providers, and especially tertiary care hospitals. The Mayo Clinic, for example, performs about <a href="http://www.mayoclinic.org/tests-procedures/electrocardiogram/multimedia/vid-20122181">240,000 ECG tests</a> per year in their laboratory, and the global market for ECG machines is set to grow to over <a href="http://www.marketsandmarkets.com/Market-Reports/Diagnostic-ECG-global-Market-173.html">$5 billion</a> by 2020. This growth is driven by the wide range of increasingly common conditions ECGs are able to effectively monitor, including heart arrhythmias, anginas, pericarditis, most symptoms of heart disease, the thickness of the heart's walls, the rate and regularity of heartbeats, the size and position of the chambers, and the presence of any changes to the heart's function in response to surgery, devices, or medications.<br />
<br />
The average cost of a provider-administered ECG test in the U.S., which is comprised of the test itself + the interpretation of results by a trained Cardiologist, is <a href="http://www.newchoicehealth.com/procedures/electrocardiogram">$1,750</a>. As usual, the prices vary substantially from provider to provider, the lowest in the U.S. being $550, and the highest being $3,300.<br />
<br />
<br />
<b><u>The U.S. Market for ECG Machines</u></b><br />
<br />
ECG machines vary in diagnostic ability, physical footprint, and price. The current market for these machines can be divided between the 'incumbent' products most of us associate with ECGs, and emerging 'disruptive' products that are portable and less expensive. The incumbents are made by about 16 manufacturers from the developed world, including <a href="http://www.medsupplier.com/browse-burdick.aspx">Burdick</a>, <a href="http://www.welchallyn.com/en.html">Welch Allyn</a>, <a href="http://www.schilleramerica.com/">Schiller</a>, <a href="http://www.ge.com/">GE</a>, <a href="http://www.bionetus.com/">Bionet</a>, <a href="http://www.usa.philips.com/healthcare">Philips</a>, and <a href="http://www.nihonkohden.de/products/cardiology.html?L=1">Nihon Kohden</a>. They are often equipped for use with 12-leads, often include printing capabilitieg, and they are large enough to be wheeled around. They cost between $1,200 and $3,000 each.<br />
<br />
By contrast, the disruptive class of ECGs are made by an (almost) entirely separate set of manufacturers, mostly from the developing world, including <a href="http://www.dcbiomed.com/webls-en-us/ReadMyHeart:V2.0.html">ReadMyHeart</a>, <a href="http://www.dcbiomed.com/webls-en-us/InstantCheck:V4.0.html">InstantCheck</a>, <a href="http://www.creative-sz.com/Easy-ECG-Monitor/Easy-ECG-Monitor-PC-80A.html">PC-80</a>, <a href="http://www.alivecor.com/home">AliveCor</a>, <a href="http://www.ecgcheck.com/">ECG Check</a>, <a href="http://www.dimetekus.com/Micro-Ambulatory-ECG-Recorder_p238.html">Dimetek DiCare</a>, <a href="http://www.choicemmed.com/info.aspx?m=photo&id=537">MD100E</a>, <a href="http://www.creative-sz.com/Easy-ECG-Monitor/Easy-ECG-Monitor-PC-80C.html">PC-80B Color</a>, <a href="http://www.theheartcheck.com/products/pen_device.html">HeartCheck PEN</a>, <a href="https://www.rekahealth.com/en/">REKA E100</a>, and <a href="http://www.lohmantech.com/">Afib Alert</a>; they often use 1 to 3 leads, rely solely on integrated digital displays, are handheld, and cost between <a href="http://www.ebay.com/sch/ECG-EKG-Systems-/100005/i.html">$25</a> to $500. Dr. Grier at North Dakota State University has compiled an exceptional review of available 1-lead, handheld ECGs on his <a href="http://www.ndsu.edu/pubweb/~grier/Comparison-handheld-ECG-EKG.html">research page</a>. Most of the 1-lead devices are from China, but some, like AliveCor, are U.S.-based companies. All of them have faced limited adoption among healthcare providers in the U.S., where the incumbent technologies are still used. As a group of physicians <a href="http://www.imedicalapps.com/2013/03/physician-review-iphone-alivecor-ecg-heart-monitor/">evaluating AliveCor</a> stated,<br />
<blockquote class="tr_bq" style="text-align: justify;">
". . . This device has significant limitations in the acute evaluation of chest pain associated with heart attacks. A single lead tracing will miss many real ischemic events, enough that even if it was stone cold normal it would not change our suspicion of myocardial ischemia. If there are significant elevations or depressions, it would probably raise our suspicion for myocardial ischemia, but we would still need a 12 lead ECG, begging the question of how it changes management."</blockquote>
Indeed most of the disruptive handheld ECGs above--at least in the U.S. context--have competed against non-consumption by offering patients and homecare nurses the ability to run ECG tests they could not run before. While additional monitoring increases the risks of false positives, the physicians above also concluded such portable testing could be useful for post-operative heart monitoring during convalescence.<br />
<br />
<br />
<b><u>A More Immediately Disruptive Class of ECG From India</u></b><br />
<br />
India has produced a number of 12-lead handheld ECGs that may be more disruptively positioned than the 1-lead ECGs above, which begin to look like 'hobby devices' in comparison. One of the first major advances was <a href="http://www.ge.com/in/always-open">GE's</a> famous <a href="http://newsroom.gehealthcare.com/ecgs-india-reverse-innovation/">MAC India</a> model released in 2007, which brought the price down to $500 from $2,000 - $10,000 for their other hospital-grade ECG machines.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggzxjcAtR5wfoQ2YhtRSoWAoWK5XJHPxqB2LCTgMnoE8Zh57MlOze2X70kVZnUSnw5bL1faQlBjVkV-_4iSW6ViRVFGKTHXqcXrGEEf83OF6r5w60oYZC4Gl45-ZRC8QsYLsMPy0h5HLA/s1600/MAC+India.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggzxjcAtR5wfoQ2YhtRSoWAoWK5XJHPxqB2LCTgMnoE8Zh57MlOze2X70kVZnUSnw5bL1faQlBjVkV-_4iSW6ViRVFGKTHXqcXrGEEf83OF6r5w60oYZC4Gl45-ZRC8QsYLsMPy0h5HLA/s1600/MAC+India.jpg" height="140" width="200" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;"><a href="http://www3.gehealthcare.in/en/products/categories/diagnostic_ecg/resting/mac_i">GE's MAC India</a></td></tr>
</tbody></table>
In the past 8 years, other Indian companies have released 12-lead ECG devices that achieve greater portability, as well as allow for diverse methods of test data transmission, remote analysis, and storage.<br />
<br />
Maestros Mediline launched the <a href="http://www.maestros.net/PDFDocuments/EUno%20R10%20White%20paper%20v2%200.pdf">E UNO R-10</a> device in 2010 in partnership with <a href="https://www.vodafone.in/pages/index.aspx">Vodafone</a>. The device relied heavily on <a href="http://us.blackberry.com/">Blackberry</a> phones, and was designed mostly for remote consultation use, just as ECGs are in the U.S., except that ECG technicians in India will often travel to administer tests, the results of which are then transmitted to a centralized doctor at a hospital for interpretation. Developers have built applications allowing for use on the Android platform, but the device was not less expensive than GE's MAC India, costing <a href="http://telecomtalk.info/vodafone-and-blackberry-introduces-tele-medicine-application-in-india/29892/">about $500</a>.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvcEGBjh1N3tyzCcGFqPb8p6JXoopwtB_U0F75wrXkUlkPMG-ViRVc2AOyWC6Cl1iHWaDDw6ldOcDX4pcAhsjOImMxCYKOFtwi-6m9u864ZOUdmhWxyLqNeFLFAkkrpR2SiB0gcXqkXgE/s1600/EUno+R10.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvcEGBjh1N3tyzCcGFqPb8p6JXoopwtB_U0F75wrXkUlkPMG-ViRVc2AOyWC6Cl1iHWaDDw6ldOcDX4pcAhsjOImMxCYKOFtwi-6m9u864ZOUdmhWxyLqNeFLFAkkrpR2SiB0gcXqkXgE/s1600/EUno+R10.jpg" height="200" width="139" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;"><a href="http://www.maestros.net/PDFDocuments/EUno%20R10%20White%20paper%20v2%200.pdf">Maestro Mediline's E UNO R-10</a></td></tr>
</tbody></table>
<br /><a href="http://www.lifeplot.in/">Lifeplot</a> CCD1 was another offering developed in Pune, India, that does not rely on any specific network or device for transmission of test results, making it potentially more versatile. Though the original model was more expensive at <a href="http://www.lifeplot.in/Lifeplot_in_Pune_headline_news.pdf">$2,000</a>, LifePlot released a more advanced product just 2 years ago for only $700.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4o3w4sspSimjAiIv8tQWAenMIelbI0hUBM2DETY56iT8zCXkrRyT-uV9aVBtcPdnQKKDUhaHuSPQLhRmxTg8KE3lsJxMD02AA2fByMAihXBcWJ9ylhfCqxzRJIoECK5WNFv2cC4nho5M/s1600/lifeplot+page1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4o3w4sspSimjAiIv8tQWAenMIelbI0hUBM2DETY56iT8zCXkrRyT-uV9aVBtcPdnQKKDUhaHuSPQLhRmxTg8KE3lsJxMD02AA2fByMAihXBcWJ9ylhfCqxzRJIoECK5WNFv2cC4nho5M/s1600/lifeplot+page1.jpg" height="200" width="141" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://lifeplot.in/Lifeplot_UNIQ.html">LifePlot UNIQ</a></td></tr>
</tbody></table>
<br />
The prices for these devices have likely come down, but there are less feature-rich ECG devices appearing in the Indian market from both indigenous and international sources. AliveCor has signed an <a href="http://www.alivecor.com/press/press-releases/apollo-hospitals-and-alivecor-r-announce-exclusive-collaboration">exclusive agreement</a> with the highly respected <a href="https://www.apollohospitals.com/">Apollo Hospitals</a> chain to use its ECG technology for clinical tests, begging the question about whether the U.S. cardiologists' review of AliveCor's limitations above reflects incumbent biases more than solid clinical rejection, whether something is just better than nothing for India, or whether AliveCor's 1-lead technology has reached a point of relative parity with 12-lead testing. At a price point of $75, perhaps the tradeoff of some marginal performance is worth it.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiubk3S7C3SU9GN1v8THwaqg8o9LTi21_PytEfNFeBjVF1fCZtwAfAQIDYnxhWRM_YTMPTGs6PSSv6yspgi_raLnF7-XqySqYKGDwGob_4mrdOnOFPWXwTem3p5P9IjeiRg68AoyLj5VLQ/s1600/AliveCor.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiubk3S7C3SU9GN1v8THwaqg8o9LTi21_PytEfNFeBjVF1fCZtwAfAQIDYnxhWRM_YTMPTGs6PSSv6yspgi_raLnF7-XqySqYKGDwGob_4mrdOnOFPWXwTem3p5P9IjeiRg68AoyLj5VLQ/s1600/AliveCor.jpg" height="114" width="200" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;"><a href="http://mobihealthnews.com/39217/alivecors-third-generation-is-thinner-lighter-and-less-than-half-the-price/">AliveCor's ECG Device</a></td></tr>
</tbody></table>
<br />
The appearance of the indigenous <a href="http://agatsa.com/">Sanket PiE</a> by Agatsa follows past patterns of the introduction of disruptive technology into the Indian market by foreign firms, followed by the release of indigenous versions which may or may not be better-suited for indigenous market conditions. Since Sanket is not yet available on the market, it's not clear what the price will be, but it will presumably be comparable to AliveCor.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCkirl4MbnPAvCUlPfm25vyEGYEktYq6r-8pqRlHKoSMBS0n0q6lPKESEXvL1FkZe9QMcWHRvEla5xWM8ghRUiFL4h13EsURglE4FeFZ837Ri8xZ_DrFAv3hdFH58KHFYDDgj156frJj4/s1600/Sanket.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCkirl4MbnPAvCUlPfm25vyEGYEktYq6r-8pqRlHKoSMBS0n0q6lPKESEXvL1FkZe9QMcWHRvEla5xWM8ghRUiFL4h13EsURglE4FeFZ837Ri8xZ_DrFAv3hdFH58KHFYDDgj156frJj4/s1600/Sanket.png" height="129" width="200" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;"><a href="http://agatsa.com/">Agatsa's Sanket PiE</a><br />
<br /></td></tr>
</tbody></table>
One of the most immediate differences between the handheld ECGs being widely sold in India vs. those in the U.S. is that they are 12-lead ECGs, while those from <a href="http://www.ndsu.edu/pubweb/~grier/Comparison-handheld-ECG-EKG.html">Dr. Grier's page</a> are all single-lead devices. This signals a serious disruptive position relative to traditional ECGs in the Indian market, which is a nice illustration of how the context of innovation shapes its ultimate shape. Many elements of the Indian market demand a fully functional, low-cost, handheld ECG: Sheer in-affordability of existing technology for huge numbers of needful patients, the necessity of portability for ambulatory community health workers, and a large supply of IT talent.<br />
<div>
<br /></div>
<br />
<b><u>Would the U.S. Benefit from Adopting Indian ECG Technology? </u></b><br />
<br />
The U.S. market context is much different from that of India, which explains the strategies of handheld ECG devices like <a href="http://www.alivecor.com/home">AliveCor</a>, <a href="https://www.scanadu.com/">Scanadu</a>, and <a href="http://www.bgr.in/news/hands-on-with-wello-an-iphone-case-that-tracks-your-blood-pressure-ecg-and-more-video/">Wello</a>, which--so far--have not competed directly against incumbent technologies, preferring instead to position themselves mostly as patient-centric devices for self-use, providing only supplemental data to traditional provider-based ECG machines. This could still represent the beginnings of disruption, which often incubates in a foothold market that can sustain a nascent technology until it improves to the point of dominance across all or most of the dimensions of quality that matter to customers. At that point, the incumbent technologies quickly fade away. This is the story of transistor radios disrupting vacuum tube radios throughout the 1950s and early 1960s.<br />
<br />
However, one of the biggest issues behind lack of serious medical adoption of handheld ECGs in the U.S. is that the alternative processes / delivery models are not yet in place for the use of these machines within provider settings, whereas in a market like India, the new devices are often competing against non-consumption, so in many cases they've had much more 'experience' in serious clinical use. What might the U.S. learn from the delivery models that have emerged around the use of these portable devices?<br />
<br />
Adopting leaner delivery models and technology is likely where the real savings lie, but even if the U.S. were to switch over to the equivalent technology available in India today, substantial savings would immediately materialize. Just taking GE's MAC India at a $500 price point, if the average price of an incumbent machine is $2,000, and each of the 7,000 hospitals in the U.S. purchases 5 new ECG machines per year (as benchmarked against the yearly purchases of a <a href="http://www.wwl.nhs.uk/Library/FOI/Requests/2014_2015/November_2014/2355_ECG_Machines.pdf">UK hospital</a> with 5 sites), this results in over $50 million in yearly savings on equipment costs alone, not including the lead replacement cost, which is also material judging from the UK hospital's spending. <br />
<br />
<br />
<b><u>Question for Discussion: </u></b><br />
<ul>
<li>What barriers prohibit the U.S. from purchasing lower-cost ECGs for clinical use? </li>
</ul>
</div>
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com32tag:blogger.com,1999:blog-71021911408861069.post-69826790747163091042015-01-09T12:16:00.000-08:002015-01-09T12:16:26.880-08:0020+ Facts About Healthcare Costs in the U.S.<div>
<b><br class="Apple-interchange-newline" />General Healthcare Spend*</b></div>
<div>
<ol>
<li>The U.S. spends nearly 20% of its yearly GDP on healthcare. Other developed countries spend about half that, but the additional spend in the U.S. does not generally result in improved patient outcomes</li>
<li>The healthcare-industrial complex spends more than 3x the amount of the military-industrial complex on lobbying each year</li>
<li>Prices for U.S. prescription drugs are ~50% higher than those in other developed countries</li>
<li>McKinsey estimated an annual healthcare overspend of $750 billion in the U.S.</li>
<li>Company financials seem to indicate that if the U.S. payed for healthcare at similar levels to other developed countries, the profit margins for medtech and pharma companies would remain high enough to continue encouraging innovation</li>
</ol>
<div>
<br /></div>
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgcQ8ogyTr07GWuNd8uvPM0M0QGCuftMQeGTcTtfsI41n-qPkOplrUPJs_1EObE3v6VQvEnKBOM95W626kTNPpexGQSS0mCJnifZbd59JXGYCDCmaSlfqzXJ_jIwfP3ekw2i6E5AMumwSQ/s1600/truth.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgcQ8ogyTr07GWuNd8uvPM0M0QGCuftMQeGTcTtfsI41n-qPkOplrUPJs_1EObE3v6VQvEnKBOM95W626kTNPpexGQSS0mCJnifZbd59JXGYCDCmaSlfqzXJ_jIwfP3ekw2i6E5AMumwSQ/s1600/truth.jpg" height="229" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;">Image Courtesy of Sweetpsychic.com</td></tr>
</tbody></table>
<b><br /></b></div>
<div>
<b>Hospital Economics</b><ol>
<li>Hospital <a href="http://en.wikipedia.org/wiki/Chargemaster" target="_blank">chargemaster</a> prices are often capricious, and reach levels 10-15x higher than Medicare reimbursement rates</li>
<li>Medicare price models are imperfect, but they are cost-based, and attempt to factor in all direct costs and allocated expenses required to provide a given product or service</li>
<li>Hospitals around the U.S. market aggressively to Medicare patients</li>
<li>The average hospital collection rate is ~35% of the total amount billed</li>
<li>Average operating profit for non-profit hospitals is ~12%</li>
<li>Medtronic sells its products at a 4x markup to COGS, and hospitals routinely sell devices to patients at a 2.5x markup to the wholesale price</li>
<li>Pharma companies commonly offer wholesale prices at 10x to COGS, and hospitals routinely sell these drugs at a 4-5x markup to the wholesale price</li>
<li>Hospitals routinely double- and triple-charge for items on the chargemaster that could reasonably be included under their general facility and room charges</li>
<li>Doctor groups with in-house IVD labs seem to order more tests than those using outside labs</li>
<li>A typical PET / CT piece of equipment will pay for itself within 1 year by carrying out 10-15 procedures per day. The equipment has an expected life span of 7-10 years</li>
</ol>
<b>Patient Economics</b><br /><ol>
<li>60% of personal bankruptcy filings in the U.S. per year are related to medical bills</li>
<li>Patients are often delivered large portions of medical bills not covered by their insurance plans</li>
<li>'Medical billing advocates' often achieve discounts of 30-50% on medical bills just by calling in to negotiate on behalf of patients</li>
</ol>
<div>
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<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi0YlUOeVyGjxZv1ieqTu8LGP4AAmEaJwGk3-K6IB4i0AH4ype9YnhTmPWpGig6WHUnJ1prtyYVXPsR6_zK4zVaRx7Ez6UfFpru53Zxqy0RmB1mDBYH2Nl5m-bdG7AZvLgK1UBB1L2vibs/s1600/pie+chart.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi0YlUOeVyGjxZv1ieqTu8LGP4AAmEaJwGk3-K6IB4i0AH4ype9YnhTmPWpGig6WHUnJ1prtyYVXPsR6_zK4zVaRx7Ez6UfFpru53Zxqy0RmB1mDBYH2Nl5m-bdG7AZvLgK1UBB1L2vibs/s1600/pie+chart.jpg" height="320" width="244" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;">Image Courtesy of <a href="http://www.theatlantic.com/health/archive/2013/01/patients-share-of-health-care-costs-is-actually-shrinking/267158/">The Atlantic</a></td></tr>
</tbody></table>
<b><br /></b></div>
<div>
<b>Payer Economics</b><br /><ol>
<li>Healthcare insurance premiums under ObamaCare will rise mainly due to 3 provisions: </li>
<ol>
<li>Prohibitions on exclusion of pre-existing conditions</li>
<li>Restrictions on co-pays for preventive care</li>
<li>End of annual or lifetime payment caps</li>
</ol>
<li>The largest payers have historically negotiated reimbursement rates at 30-50% higher than Medicare rates, but increasing hospital consolidation is shifting more collective buying power back to the providers, so that the final negotiated reimbursement rates are moving closer to chargemaster prices</li>
<li>FDA-approved drugs are reimbursed by Medicare at 'average sales price' + 6%. The manufacturer calculates and provides the average sales price</li>
<b></b></ol>
<div>
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</div>
<div>
*All facts in this post are from Steven Brill's article <a href="http://www.uta.edu/faculty/story/2311/Misc/2013,2,26,MedicalCostsDemandAndGreed.pdf">Bitter Pill: Why Medical Bills are Killing Us</a>, and his newly published book, <a href="http://americasbitterpill.com/">America's Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System</a> . They represent only a small portion of his findings, but are among the most objective and meaningful to me.<div>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com26tag:blogger.com,1999:blog-71021911408861069.post-62435903982652370142014-12-15T01:08:00.003-08:002014-12-15T04:25:07.754-08:00GE India Could Save U.S. PET/CT Scan Patients $7.5 Billion Per YearCancer is abnormal cell growth with the potential to spread to other parts of the body and disrupt normal functions, resulting in illness or death. Claiming over <a href="http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/" target="_blank">half a million</a> lives per year, cancer is the second leading cause of death in the United States, second only to heart disease. There are over <a href="http://www.cancer.gov/cancertopics/cancerlibrary/what-is-cancer" target="_blank">100 known cancers</a> effecting humans, some being more lethal than others. In all cases, early detection is crucial for improving the chances of successful treatment.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqpq5GfTAMexGn14nepc_ehY3TG7W603qW3LCylX1vQro9_mWEeACV3F-uC4VpzdirRCRTaQGk4tzjWAVpB8QbDSGTDR4HOp6KMc08WJSs9hhumA1JSaa0Cjl-1-uOB0pNz19dzlalk_A/s1600/cancer.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqpq5GfTAMexGn14nepc_ehY3TG7W603qW3LCylX1vQro9_mWEeACV3F-uC4VpzdirRCRTaQGk4tzjWAVpB8QbDSGTDR4HOp6KMc08WJSs9hhumA1JSaa0Cjl-1-uOB0pNz19dzlalk_A/s1600/cancer.jpg" height="216" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Cancer Cells, from <a href="http://img.webmd.com/dtmcms/live/webmd/consumer_assets/site_images/articles/health_tools/prostate_cancer_overview_slideshow/princ_rm_photo_of_prostate_cancer_cells.jpg" target="_blank">WebMD</a></td></tr>
</tbody></table>
<br />
Cancer detection typically involves a range of methods and tests but is broken into two stages: Screening and diagnosis. Researchers have provided <a href="http://www.cancer.org/healthy/findcancerearly/cancerscreeningguidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer" target="_blank">cancer screening guidelines</a> to encourage regular screenings for potential symptoms of cancer, which differ for each type. Cancer symptoms might include heightened levels of proteins or other byproducts of cancer in the blood, abnormal growths, pain, bleeding, or discoloration of tissue. If potential symptoms appear, the doctor will move towards diagnosis, ordering <a href="http://www.medicinenet.com/cancer_detection/page2.htm" target="_blank">additional tests</a> to gather more data. These tests can be numerous and costly, and might include PET/CT scans, ultrasound, endoscopy, and MRI for imaging; lab testing on bodily fluids to detect tell-tale biomarkers; and biopsy to collect cell samples for microscopic evaluation by a Pathologist. Using data from these tests, doctors attempt to provide a definitive diagnosis and prognosis to the patient.<br />
<br />
Many of the tests above are very expensive, but entrepreneurs in India are working on addressing an enormous and unmet domestic need for early cancer detection through innovative, low-cost product design. For example, GE Healthcare has developed the gorgeous <a href="http://www3.gehealthcare.com/en/products/categories/pet-ct/pet-ct_scanners/discovery_iq" target="_blank">Discovery IQ</a> PET/CT, representing $15 million and 3 years of R&D at its center in Bangalore. Innovating within the constraints of India, they have succeeded in creating a scanner that's <a href="http://www.medicaldevice-network.com/news/newsge-healthcare-introduces-new-economical-petct-system-for-early-cancer-detection-4204164" target="_blank">40% more affordable</a> than comparable alternatives, is modular and scalable to allow for price discrimination, offers a unified service of detection, planning, and assessment through state of the art hardware and software, and is a beautiful machine. The cost savings have come from conducting R&D in India, from redesigning a more cost-effective machine from the ground up, and from manufacturing the machine in India.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBzQfDJ9vFeiBX0uKcYwUo3yOHndwj0AbxcQDW-aQcGHOHMH-o1IkMen9cJq7X92ORfjv0d6bYBgEvs8CPn_7WMDoVeTs3TNGRhdtzwM_NUjBQGG7CTOqtTjZp8fx496truz_OTyT_Y-o/s1600/GEHC-Discovery-IQ_spotlight_1_product_shot.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBzQfDJ9vFeiBX0uKcYwUo3yOHndwj0AbxcQDW-aQcGHOHMH-o1IkMen9cJq7X92ORfjv0d6bYBgEvs8CPn_7WMDoVeTs3TNGRhdtzwM_NUjBQGG7CTOqtTjZp8fx496truz_OTyT_Y-o/s1600/GEHC-Discovery-IQ_spotlight_1_product_shot.jpg" height="202" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Discovery IQ PET/CT Scanner, from <a href="http://www3.gehealthcare.com/en/products/categories/pet-ct/pet-ct_scanners/discovery_iq" target="_blank">GE Healthcare</a></td></tr>
</tbody></table>
<br />
Currently, India only has about <a href="http://www.genewsroom.com/press-releases/ge-healthcare-unveils-discovery-iq-first-ever-petct-designed-india-tackling-cancer" target="_blank">120 PET/CTs</a> operational in the country, whereas the required number of units to adequately address patient demand is over 1,000. Judging from the CEO & President of GE South Asia <a href="https://www.youtube.com/watch?v=yaP2oprR2S0&feature=em-subs_digest" target="_blank">Terri Bresenham's remarks</a> on Discovery IQ, GE hopes that the price elasticity of demand for PET/CT scanners in India is flexible enough that a 40% price reduction will help to fill this gap. I hope so, but it may be that more disruptive technologies like <a href="http://cellmaxlife.com/" target="_blank">CellMax Life</a> may ultimately be what brings early stage cancer detection to the masses of India.<br />
<br />
Even if the Discovery IQ does not realize substantial financial returns or market share gains in India, GE and the world can still benefit tremendously because GE has created a superior, low-cost product. Producing 50-slice equivalent CT speed imaging, the highest PET axial view available on the market, the Q.SUITE platform for improved PET quantitation, and the Q.CLEAR platform for up to 2x image improvement (SNR) + 2x improvement in PET quantitation accuracy, Discovery IQ is a PET/CT that gets the job done. Certainly there are PET/CTs that may perform better on any one of these dimensions, but does it matter? For example, some PET/CTs are now capable of taking 512 slices, but since no meaningful diagnosis accuracy improvement was found from the jump between 64-slice and 128-slice scanners, 64-slice scanners generally make for the best value. In fact, <a href="http://www.jsonline.com/business/ge-healthcares-waukesha-business-units-at-the-forefront-of-big-iron-b99349785z1-275905571.html" target="_blank">according to Niharika Midha</a> at <a href="http://www.globaldata.com/" target="_blank">GlobalData</a>, the PET/CT "Hardware has reached this plateau . . . There is only so much that can be changed to the machine."<br />
<br />
If GE India has tightly engineered Discovery IQ for maximum value (ROI), then this device may sit at the very rim of the performance plateau, including all of the right features, but not overloaded with cutting edge technology and experimental features that price it out value-conscious procurement networks.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgWtFEYg4PB5THel3YByL_mM1dOVZ8y9z26ZFpBcE7eqogmZMSEnvvx1HA9drBimB4-gim9mE6lqUwtR7UgZ_CM1qk8elK0NzOcUaNR8BKOA1cSZTXQMwp-Si3E-4YnbOOg0308RUn11fk/s1600/GE.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgWtFEYg4PB5THel3YByL_mM1dOVZ8y9z26ZFpBcE7eqogmZMSEnvvx1HA9drBimB4-gim9mE6lqUwtR7UgZ_CM1qk8elK0NzOcUaNR8BKOA1cSZTXQMwp-Si3E-4YnbOOg0308RUn11fk/s1600/GE.jpg" height="208" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">GE Logo and Slogan from <a href="http://www.inroads.org/sites/default/files/images/GE.jpg" target="_blank">Inroads</a></td></tr>
</tbody></table>
<br />
Given that most PET/CTs cost between $2 and $3 million, the 40% price reduction for Discovery IQ puts it between $1.2 and $2.8 million for cost of acquisition. The median prices for CT scans charged by providers hover between <a href="http://www.nerdwallet.com/blog/health/2014/10/28/how-much-does-a-ct-scan-cost/" target="_blank">$700 and $900</a>, and the U.S. government estimates that <a href="http://www.ucdmc.ucdavis.edu/publish/news/newsroom/8766" target="_blank">80 million</a> scans are performed annually. The price for PET scans is about <a href="http://www.newchoicehealth.com/pet-scan-cost" target="_blank">$5,000</a>, but only <a href="http://www.forbes.com/sites/johnfarrell/2014/01/10/pet-imaging-market-poised-to-grow-with-new-compounds/" target="_blank">2 million</a> are performed annually for Oncology diagnostics. Adding these up, approximately $75 billion is spent on PET/CT imaging per year in the U.S.<br />
<br />
Of course, only a minor portion of this total spend could be chalked up to equipment cost, so if we instead look at the <i>lowest </i>PET/CT scan costs, and assume the imaging centers offering such low prices are highly efficient so that the overhead and profit margins per procedure are small, we might say that the 40% equipment cost savings generated by Discovery IQ could be passed on rather directly to the end payer. The lowest prices charged for CT scans seem to be around <a href="http://www.nerdwallet.com/blog/health/2014/10/28/how-much-does-a-ct-scan-cost/" target="_blank">$200</a>, and the lowest for PET scans around <a href="https://healthcarebluebook.com/page_ProcedureDetails.aspx?id=490&dataset=MD&g=PET+Scan+Image+(with+CT+of+whole+body)" target="_blank">$1,200</a>. Reducing these costs by 40% and multiplying by the yearly number of procedures shows a potential costs savings of nearly $7.5 billion per year.<br />
<br />
This begs many questions. Could GE keep the cost this low in selling to PET/CT providers in the U.S.? If not, how much of the 40% cost saving be eaten up, and by what? Would GE even want to disrupt their home PET/CT market by importing Discovery IQ? Certainly short-term financial analysts held captive by Wall Streets valuation process would balk, as would the sales force taking lower per sale commissions. On the other hand, volume <i>can </i>make up for decreased unit margins, and such a move may gain GE significant additional market share. Also, the modularity of Discovery IQ might result in natural price discrimination, where the highest-end clients are able to pay for additional functionality, and could widen the base of the market by making a basic PET/CT available to clinics previously unable to afford one. <br />
<br />
<br />
<b>What Do You Think?</b><br />
<ul>
<li>Should GE disrupt themselves by importing and commercializing Discovery IQ in the U.S.? If so, what main barriers would they face? </li>
</ul>
<br />
<br />Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com34tag:blogger.com,1999:blog-71021911408861069.post-63956044690966900082014-12-06T09:41:00.001-08:002014-12-06T09:41:16.875-08:00India's New Health Tablet Performs 30+ PoC Diagnostic TestsThe <a href="http://www.swasthyaslate.org/index.php" target="_blank">Swasthya Slate</a> ('Health Tablet') is a portable diagnostic device that enables users to conduct <a href="http://www.swasthyaslate.org/#tests" target="_blank">33 diagnostics tests</a> with a simple box, power source, test sensors, and a smart device using the Android OS. The videos on <a href="http://www.swasthyaslate.org/howitworks.php" target="_blank">this page</a> give an excellent view into how the testing, analysis, and reporting process works. Of the <a href="http://www.bgr.in/news/road-to-500-the-next-growth-wave-towards-dream-500-million-smartphones-in-india/" target="_blank">120m</a> or so smart phone users in India, about <a href="http://www.slideshare.net/akshaykakkar90/android-ppt-40431720" target="_blank">80%</a> are using an Android OS, so the technological infrastructure is already in place for Slate to quickly scale up.<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh19cKpcJLYCzLBDHgvIVdrRN2lFmBcD59Og2nH4XeiVtv-PJHtjhh1FsqHZ-ZbFAZi7sXTiCJC94Fc3XBdde2BRAxZ5wMg9f4p-8ILXjHtzwcg-fgDWuUwj_gRJgLOL3egcp5YpGGm5kc/s1600/swasthya+box.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh19cKpcJLYCzLBDHgvIVdrRN2lFmBcD59Og2nH4XeiVtv-PJHtjhh1FsqHZ-ZbFAZi7sXTiCJC94Fc3XBdde2BRAxZ5wMg9f4p-8ILXjHtzwcg-fgDWuUwj_gRJgLOL3egcp5YpGGm5kc/s1600/swasthya+box.png" height="256" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Photo Credit: <a href="http://www.swasthyaslate.org/index.php" target="_blank">Swasthya Slate</a></td></tr>
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Launched in March, 2014, the Slate is the work of the <a href="http://www.phfi.org/" target="_blank">Public Health Foundation of India</a>, which also manufactures the device. The project is led by Dr. Kanav Kahol, formerly a bioinformatics professor at Arizona State University. With all sensors included, the device is being manufactured in India for only <a href="http://www.forbes.com/sites/stephenwunker/2014/11/22/how-the-swasthya-slate-is-revolutionizing-healthcare-and-why-it-steers-clear-of-the-united-states/" target="_blank">$800</a>, a price expected to drop by 20% as it further scales. At this price, the primary target customers are health ministries, agencies, and clinics who will purchase the devices for public health management, putting them into the hands of community health workers (CHWs) who canvas the country as frontline care providers. The new diagnostic processes enabled by the device show the real value it's created, described in the following <a href="http://www.swasthyaslate.org/usecasehw.php" target="_blank">steps</a>, and enabled by the components illustrated in the photo below:<br />
<br />
<ol>
<li>CHW visits village</li>
<li>CHW conducts PoC diagnostic tests within minutes per individual</li>
<li>Diagnostic box sends test results to smart device via Bluetooth</li>
<li>Smart device uploads patient EMR to secure cloud</li>
<li>Slate's data management software analyses data</li>
<li>Slate's software communicates results to stakeholders via multiple channels</li>
</ol>
<div>
<br /></div>
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhHy7CUEbtCiqgxGtxsicelJTRJ7Ci1yDUauShppGEO_CeE_LTjE42wjpgCqx9qMI8drZUZtnZDXQqMJMHVynoyXKknOroC8uqa7BWGQPyz4wRvYxawaB24bBppF9ZaJag_VEOUWnzk3Nw/s1600/Swasthya+Slate.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhHy7CUEbtCiqgxGtxsicelJTRJ7Ci1yDUauShppGEO_CeE_LTjE42wjpgCqx9qMI8drZUZtnZDXQqMJMHVynoyXKknOroC8uqa7BWGQPyz4wRvYxawaB24bBppF9ZaJag_VEOUWnzk3Nw/s1600/Swasthya+Slate.jpg" height="203" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Photo Credit: <a href="http://forbesindia.com/article/work-in-progress/swasthya-slate-scripting-newage-diagnostics/37556/0" target="_blank">Forbes India</a></td></tr>
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<div>
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<div>
The time and cost savings resulting from this process are substantial. Not only do the patients avoid costly travel for multiple tests when needed, but Slate only <a href="http://forbesindia.com/article/work-in-progress/swasthya-slate-scripting-newage-diagnostics/37556/0#ixzz3L6jgNQxX" target="_blank">charged $1.25</a> for a panel of 10 standard biometric tests during their pilot. Referencing the table below, this is nearly 1/20th the cost of what the government was charging before at subsidized prices for the same 10 tests. <a href="http://www.globalhealth.care/2014/10/theranos-worlds-best-healthcare-company.html" target="_blank">Theranos</a>, a highly disruptive lab diagnostics company featured in an <a href="http://www.globalhealth.care/2014/10/theranos-worlds-best-healthcare-company.html" target="_blank">earlier post</a>, charges in the range of the government prices, but does not appear to offer Urine Glucose tests or the more manual tests like blood pressure, temperature, ECG and Malaria. And standard laboratory diagnostic test prices are sky high in comparison, as the prices from <a href="http://anylabtestnow.com/">anylabtestnow.com</a> show. Slate's measurement accuracy performance is within <a href="http://www.forbes.com/sites/stephenwunker/2014/11/22/how-the-swasthya-slate-is-revolutionizing-healthcare-and-why-it-steers-clear-of-the-united-states/" target="_blank">99.9%</a> of the traditional path lab technologies, and they continue to <a href="http://www.swasthyaslate.org/SwasthyaSlateDevicetestingSummary.pdf" target="_blank">publicly track</a> their clinical evaluation data to improve the device's performance. </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOy0jWqq2F3n_u9Lkmn0p2McIkiNswRHOc4OcvuGEEkA6ftc4NYeXdWBXSTmKb20mvN72U8tu596m2INBARSX44mRi99J9bWt9DBKcfBtfH7F1jMaPZOA128wnr07w87u4PNboilAwzho/s1600/Screen+Shot+2014-12-06+at+10.15.06+PM.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOy0jWqq2F3n_u9Lkmn0p2McIkiNswRHOc4OcvuGEEkA6ftc4NYeXdWBXSTmKb20mvN72U8tu596m2INBARSX44mRi99J9bWt9DBKcfBtfH7F1jMaPZOA128wnr07w87u4PNboilAwzho/s1600/Screen+Shot+2014-12-06+at+10.15.06+PM.png" height="184" width="400" /></a></div>
<div>
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<br />
<b>How Transferable is the Slate Device to U.S. Healthcare? </b><br />
<br />
<a href="http://www.globalhealth.care/2014/10/theranos-worlds-best-healthcare-company.html" target="_blank">Theranos</a> is valued at $9 billion because they are providing essentially the same laboratory diagnostics as traditional labs at a fraction of the cost (often 1/10th-1/20th), using less invasive methods, and at much faster speeds. Slate appears to provide PoC diagnostic test results even faster than Theranos using RDT strips, at another huge price discount (1/20th of Theranos's prices from the chart above), and in similarly non-invasive methods. They have also developed <a href="http://www.swasthyaslate.org/apps.php" target="_blank">18 apps</a> so far to fulfill the true meaning of 'software as a service.' On the other hand, Slate only offers 33 tests, whereas Theranos is set to offer the full range of possible laboratory diagnostic tests, which number into the thousands. Convincing the medical establishment that the diagnostic results from Slate represent medical grade data would be difficult. EHRs have been slow to become truly personal due to hospital policies and HIPPA. Many of Slate's apps are culturally-bounded, and would need to be re-written.<br />
<div>
<br /></div>
<div>
Nevertheless, I am optimistic of Slate's potential to disrupt clinical laboratory diagnostic testing in the U.S. Here's why:</div>
<div>
<br /></div>
<div>
Firstly, there are encouraging signs that both the FDA and the medical establishment are <a href="http://many%20of%20their%20apps%20are%20culturally-bounded%2C%20but%20the%20relative%20ease%20of%20app%20development%20means%20this%20is%20not%20a%20large%20barrier%20to%20entry./" target="_blank">beginning to approve</a> diagnostic biometrics from wearables, and if from wearables, why not from Slate? At any rate, <a href="http://www.globalhealth.care/2014/10/theranos-worlds-best-healthcare-company.html" target="_blank">Theranos</a> is operating as a CLIA-approved lab without FDA approval due to the unique classifications for laboratory diagnostics, and because Slate is already <a href="http://www.swasthyaslate.org/SwasthyaSlateDevicetestingSummary.pdf" target="_blank">tracking their clinical evaluation data</a> carefully and cheaply, this may not be such a large barrier even if their system does require approval. Secondly, apps are relatively easy to write. Thirdly, if Slate's battery of tests represent the <i>most</i> <i>commonly ordered</i> <i>tests</i>, then it could disrupt Theranos even as Theranos is disrupting <a href="http://www.questdiagnostics.com/home.html" target="_blank">Quest</a> and <a href="https://www.labcorp.com/wps/portal/" target="_blank">LabCorp</a>. After all, the device is affordable, portable, and modular enough for use by school nurses, the smallest retail clinics, and even by patients themselves. If a device like Slate becomes the go-to for routine diagnostic tests, how commonly will people need to level-up and go to a Walgreens to order a Theranos test that costs 10x the price, or to a hospital where the test will cost 200x the price? </div>
<br />
According to Dr. Kahol's <a href="https://twitter.com/kanavkahol" target="_blank">Twitter feed</a>, he has already received requests for the device from both emerging and developed health markets, such as Pakistan, South Africa, Malaysia, and the UK. Field workers from at least 8 different countries, representing both developed and emerging markets, are already using the device on a pilot basis, as <a href="http://www.swasthyaslate.org/map.php" target="_blank">this usage map</a> shows.<br />
<br />
<br />
<b>Question for Comments: </b><br />
<br />
<ul>
<li>What barriers prevent Swasthya Slate from transferring to U.S. healthcare markets, and how might you recommend they reduce these? </li>
</ul>
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<br />
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<br />Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com108tag:blogger.com,1999:blog-71021911408861069.post-29199405756957059222014-12-01T02:21:00.000-08:002014-12-04T01:04:37.784-08:00$100 Stents from India in the OffingSince the USFDA approved cardiac <a href="http://en.wikipedia.org/wiki/Stent" target="_blank">stents</a> in <a href="http://www.webmd.com/heart-disease/guide/stents-types-and-uses?page=2" target="_blank">1994</a>, there has been tremendous growth in their use, to where <a href="http://www.bloomberg.com/news/2013-09-26/deaths-linked-to-cardiac-stents-rise-as-overuse-seen.html" target="_blank">700,000</a> are implanted in patients annually in the U.S. alone. Manufacturers' sales of stents reached <a href="http://www.bloomberg.com/news/2013-09-26/deaths-linked-to-cardiac-stents-rise-as-overuse-seen.html" target="_blank">$5.5 billion</a> in 2012.<br />
<br />
In the U.S. about <a href="http://www.bloomberg.com/news/2013-09-26/deaths-linked-to-cardiac-stents-rise-as-overuse-seen.html" target="_blank">50% of stent implants</a> are for acute conditions, such as unstable angina, or chest pain caused by the buildup of plaque in the arteries surrounding the heart. The other half are for elective-use patients in stable condition. This video from the <a href="http://www.mayoclinic.org/" target="_blank">Mayo Clinic</a> illustrates Percutaneous Coronary Intervention (PCI), the procedure for which the large majority of stents are used:<br />
<br />
<div class="separator" style="clear: both; text-align: center;">
<iframe allowfullscreen='allowfullscreen' webkitallowfullscreen='webkitallowfullscreen' mozallowfullscreen='mozallowfullscreen' width='320' height='266' src='https://www.youtube.com/embed/S9AqBd4RExk?feature=player_embedded' frameborder='0'></iframe></div>
<br />
The price of stents has followed the broad pattern of decline typical among innovation life cycles. Bare Metal Stents (BMSs) were first priced wholesale around $1,600 in the early 90s, but today the average cost is around $700 each. Drug-eluting Stents (DESs) were a new model introduced in the early 2000s that have helped marginally reduce potentially fatal angioplasty complications, such as blood clotting. These were originally priced around $3,000, and now cost about <a href="http://www.healthcarefinancenews.com/blog/purchasing-insight-coronary-artery-stents" target="_blank">$1,500</a> each. According to <a href="http://www.bloomberg.com/news/2013-09-26/deaths-linked-to-cardiac-stents-rise-as-overuse-seen.html" target="_blank">Bloomberg</a>, "Hospitals receive an average payment of about $25,000 per stent case from private insurers . . . [and] Doctors who implant stents earn a separate fee that averages about $1,000." The stent cost, then, only comprises ~5% of the total price of implantation, not to mention the ongoing costs for the patient, including blood-thinning medications, which are prescribed as a matter of course to mitigate the risk of <a href="http://en.wikipedia.org/wiki/Restenosis" target="_blank">restenosis</a>.<br />
<br />
Until 2001, India imported nearly 100% of stents used, although there were successful early innovation efforts at lowering the cost of stents through indigenous innovation. A network of doctors and engineers at Care Hospitals, Mediciti Hospitals, and the <a href="http://www.sbmtindia.org/index.html" target="_blank">Society for Biomedical Technology</a> pioneered a low-cost coil stent patented as the <a href="http://carefoundation.net.in/index.php/technology/kalam-raju-stent.html" target="_blank">Kalam-Raju</a> in 1995, crashing the prices of imported stents by several factors, and remained about 50% less expensive, costing around $250. One of their main reasons for creating a low cost stent was that the reason for the "very low number of cardiac procedures carried out in India is poor affordability arising from the high cost of imported <a href="http://carefoundation.net.in/index.php/technology/kalam-raju-stent.html" target="_blank">consumables</a>." Depending on the report, there were about 2,000 Kalam-Raju stents implanted before mesh designs replaced the coil stents.<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2DiIp9UuZ4VeDBIPA84mPeriBmPZfjvTzLx8DVzoTPdTUgOhwAvbWUwSfhvyCEYZl1uhEf-q4J_PiSfR-uhCss7pBo61KnALVVgGJtCRKS2u95qd65mQk_gYA7h4j_AfK0QPIwRUiJIA/s1600/kalam+raju+stent.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2DiIp9UuZ4VeDBIPA84mPeriBmPZfjvTzLx8DVzoTPdTUgOhwAvbWUwSfhvyCEYZl1uhEf-q4J_PiSfR-uhCss7pBo61KnALVVgGJtCRKS2u95qd65mQk_gYA7h4j_AfK0QPIwRUiJIA/s1600/kalam+raju+stent.jpg" height="215" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="font-size: 13px;"><a href="http://carefoundation.net.in/index.php/technology/kalam-raju-stent.html" target="_blank">Kalam-Raju Coil Stent, 1995</a></td></tr>
</tbody></table>
Indian innovators have generally <a href="http://www.downtoearth.org.in/content/not-so-young-heart?page=0,1" target="_blank">trailed</a> the major OEMs in stent innovations, so the design shift from mesh to scaffolding, and the biochemical shift to drug-eluting stents have not been kind to the market for indigenous stents in India. There remains a general mistrust of locally manufactured products among large, urban hospital systems, who remain the largest buyers of stents. These developments have maintained a high import price for foreign stents in India, and some reports show patients paying up to <a href="http://timesofindia.indiatimes.com/india/Patients-pay-three-times-import-price-for-stents/articleshow/42483945.cms" target="_blank">three times the import price</a> for stents! Needless to say, the penetration of angioplasty in the Indian market remains tragically low. Of course, the high price of consumables is not the only reason for this. Another is the very low number of <a href="http://www.downtoearth.org.in/content/not-so-young-heart?page=0,1" target="_blank">cardiologists</a> in the country.<br />
<br />
Nevertheless, it's clear that any solution to providing stents when and where they're needed in India will require low cost, high quality stents as part of the solution. Efforts to create affordable indigenous stents have continued in India, such as Relisys' <a href="http://relisysmedicaldevice.com/mission.html%20and%20http://www.24-7pressrelease.com/press-release/cinvention-and-relisys-medical-devices-enrol-first-patients-in-clinical-trial-of-the-corelc-drugeluting-stent-26994.php" target="_blank">Corel+C</a> in 2007, a collaboration between Dr. Balram Bhargava, Relisys, and Germany's CINVENTION to create a non-polymer-based DES that was both safer and 50% the cost of imported DESs. Ultra efficient cardiac care centers like <a href="http://www.narayanahealth.org/" target="_blank">Narayana</a> continue to ensure foothold markets for indigenous stents that are 'good enough.' While some may scoff at the use of 'good enough' applied to Class 3 implantable devices where quality is at a premium, we should all keep in mind that some device features are luxuries, and that having the basic version of a device that's almost as good, but that costs multiple factors less is far more valuable to a patient whose alternative is nothing at all. And the benefits of the 'best-performing' stents <i>are </i>quite marginal. A <a href="http://www.forbes.com/sites/larryhusten/2014/07/01/study-offers-reassurance-about-newer-drug-eluting-stents/" target="_blank">recent study</a> found the rates of late stent Thrombosis to vary only marginally from one stent type to another as follows:<br />
<ul>
<li>BMS stents: 1.5% </li>
<li>Old generation DES: 1.1% </li>
<li>New generation DES: .9%</li>
</ul>
<div>
Insured patients in the U.S. will pick the new generation DES every time for a .2% risk reduction, but the potential for disruptive innovation lives on in Indian healthcare, where only some <a href="http://en.wikipedia.org/wiki/Health_insurance_in_India" target="_blank">25% of the population </a>even has access to some form of insurance, so that patients often haggle extensively with providers on costs for which they pay out of pocket. </div>
<div>
<br /></div>
<div>
The implicit question of each globalhealth.care post is always, 'could this device disruptively transfer into the U.S. healthcare market?' Let's compare the prices first: </div>
<div>
<ul>
<li>Avg cost of BMSs and DESs in the U.S.: <a href="http://www.healthcarefinancenews.com/blog/purchasing-insight-coronary-artery-stents" target="_blank">$700 and $1,500</a></li>
<li>Avg cost of BMSs and DESs in India: <a href="http://www.thehindu.com/news/cities/Kochi/when-the-stent-pricing-could-give-a-heartache/article4982734.ece" target="_blank">$200 and $500</a></li>
</ul>
<div>
$200 is a already a low price for a stent, but the Indian OEMs give a further <a href="http://www.thehindu.com/news/cities/Kochi/when-the-stent-pricing-could-give-a-heartache/article4982734.ece" target="_blank">25% discount</a> to hospitals who buy directly from them, bringing the cost to $150. Furthermore, the Indian Council of Medical Research is currently conducting a <a href="http://www.indiamedicaltimes.com/2013/10/25/icmr-to-undertake-comparative-analysis-of-indigenous-drug-eluting-stents-and-fda-approved-stents/" target="_blank">study</a> comparing the quality of imported vs. indigenous stents made by companies like Opto Circuits India, Sahajanand, Translumina Therapeutics, Vascular Concepts, and Vasmed Technologies. If they find similar levels of clinical outcomes, this would help drive domestic uptake, and further decrease the price through economies of scale, perhaps to around $100 each. </div>
</div>
<div>
<br /></div>
<div>
Hospitals using fee-for-service reimbursement may desire to purchase lower cost stents, where 'cathlabs' have become valuable sources of profit at fixed reimbursement rates. Just switching to a $500 Indian DES from a $1,500 U.S. DES would save a hospital performing 2,000 implants per year $2,000,000. In time, payers will reduce reimbursement rates as low-cost stents contribute to low-cost implant procedures, further enabled through <a href="http://www.bbc.com/future/story/20140516-i-operate-on-people-400km-away" target="_blank">remote surgery trends</a> and other efficiency gains. In the meantime, it may already be the case that ACOs and other specialized surgery centers in the U.S. who are incentivized to reduce costs at or above average outcomes would be interested in offering patients a choice between a $100 BMS with a 1.5% chance of Thrombosis, or a DES for $1,500 with a .9% chance of Thrombosis.<br />
<br /></div>
<div>
<div>
<b><br class="Apple-interchange-newline" />Starter Question for Comments: </b></div>
<div>
<ul>
<li>What's stopping low cost stents from being adopted in the U.S. today? </li>
</ul>
</div>
<div>
</div>
</div>
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<br />Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com16tag:blogger.com,1999:blog-71021911408861069.post-37838278651349962132014-11-18T22:10:00.000-08:002014-11-19T04:28:55.348-08:00Could Low Cost Cameras from India Disrupt $5B U.S. Ophthalmoscopy Market? <a href="https://www.vsp.com/retinal-exam.html" target="_blank">Ophthalmoscopy</a>, or fundus photography, is the practice of taking high quality pictures of the eye for medical purposes. It is a standard part of an eye examination, and is used to screen for a wide array of conditions like macular degeneration, cancer, diabetic retinopathy, glaucoma, hypertension, or retinal detachment. In 2012, there were <a href="http://www.visionexpowest.com/Press/Vision-Voice-Newsletter/Eye-Exam-Incidences-Increasing-Among-US-Population/" target="_blank">105 million eye exams</a> performed in the U.S., representing 43.8% of the adult population.<br />
<br />
There is a range of testing quality to ophthalmoscopy. For the highest quality photos, a cutting edge <a href="http://visionquest-bio.com/low-cost.html" target="_blank">deformable mirror-based adaptive optics device</a> costing in excess of $500K might be used, but most clinics are using devices that cost anywhere from <a href="http://www.iapb.org/sites/iapb.org/files/Emerging%20Technology%20for%20DR%20Screening_David%20Friedman_14Sept2013.pdf" target="_blank">$1K to $20K for non-mydriatic (not requiring dilation of the eye) fundus cameras</a>, as well as the slit lamp / mydriatic fundus camera configurations with prices in the $15K to $50K range. The slit lamp / mydriatic method produces higher quality photos, and is recommended for a comprehensive eye examination; however, the non-mydriatic cameras have been closing the performance gap in classic disruptive fashion, and they already comprise <a href="http://www.transparencymarketresearch.com/fundus-cameras.html" target="_blank">over half of the $220M fundus camera market</a>. They may also be a <a href="http://lowvision.preventblindness.org/therapies-treatments-and-procedures/non-mydriatic-retinal-cameras-offer-safer-examination" target="_blank">safer device</a> for patients.<br />
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<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHMAIg2l7xIUEwmJPjm0q-N-YttemRN_pmW3x09oLhNlJC5VCrTJHaPVIGdv92SdN7WZp3XW0E2uVvjLFGC9qddQ-kKgKfyof6ZHgaGQzhX5Aj3NtbRRmjIiMgygj6Y2x0egkZff5nV0A/s1600/Slit+Imager.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHMAIg2l7xIUEwmJPjm0q-N-YttemRN_pmW3x09oLhNlJC5VCrTJHaPVIGdv92SdN7WZp3XW0E2uVvjLFGC9qddQ-kKgKfyof6ZHgaGQzhX5Aj3NtbRRmjIiMgygj6Y2x0egkZff5nV0A/s1600/Slit+Imager.jpg" height="203" title="Aurolab's slit imager" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">PC: <a href="https://www.facebook.com/pages/Aurolab/305719559546681" target="_blank">Aurolab's Slit Imager</a></td></tr>
</tbody></table>
At a price range of $1K to $500K, there's a fundus camera for every ophthalmologist in the U.S., but innovation has taken prices even lower in India. The push seems to have begun with the famous <a href="http://www.aravind.org/" target="_blank">Aravind Eye Care System</a>, which succeeded in <a href="https://www.youtube.com/watch?v=c8dg6q9JWNU" target="_blank">mounting a Canon A800 camera into a slit frame</a> in 2012 for routine eye exams. <a href="https://www.facebook.com/pages/Aurolab/305719559546681" target="_blank">Aurolab's Slit Imager</a> is a recent iteration of this model, and though they are careful to say the device is not a replacement for fundus cameras, their kit includes a camera + basic accessories, a professional quality eye piece for capturing photos of the anterior and posterior of the eye, and a sleeve for attachment to the slit lamp. The total cost is only $200, which seems great compared with the prices above, except for two fatal flaws. Firstly, the device requires a slit lamp, whose prices <a href="http://www.ophthalmologyweb.com/Tech-Spotlights/115648-Buyers-Guide-to-Slit-Lamps/" target="_blank">often run into the thousands of dollars</a>. Secondly, the device is not officially approved or recommended to replace fundus camera images even in India, though I imagine it's often used to do just that. After all, something is better than nothing when a number of conditions are likely sufficiently diagnosed using a device like this. In fact, it seems likely one could use this device without a slit lamp. Even so, the U.S. ophthalmoscopy market does not seem amenable to disruption from devices like Slit Imager due to the following market characteristics:<br />
<ul>
<li><b>Upmarket: The Incumbent View</b></li>
<ul>
<li>Today's expensive slit lamp / mydriatic camera configurations still seem to be the backbone of thorough eye exams, and therefore a central piece of equipment in eye clinics. <a href="http://bainbridgeeyephysicians.com/dr-cheungs-blog/" target="_blank">Dr. Cheung's May 1st post</a> articulates the current incumbent view well, which has not even reached the point of accepting good-enough non-mydriatic cameras, not to mention a device like Slit Imager.</li>
</ul>
</ul>
<ul>
<li><b>Midmarket: Disruption Today</b></li>
<ul>
<li>The non-mydriatic cameras are closing the performance gap with the more expensive setups, and hybrid fundus cameras (allowing for both mydriatic and non-mydriatic modes) are predicted to have a <a href="http://www.transparencymarketresearch.com/fundus-cameras.html" target="_blank">faster CAGR than other segments</a> in the coming decade. A particularly disruptive example of a non-mydriatic camera is <a href="http://www.jedmed.com/products/portable-fundus-camera" target="_blank">Jedmed's portable fundus camera</a>, which is modular enough to also function as a camera for general, dermatological, and ear, nose & throat exams. At an <a href="https://www.ciamedical.com/handle-horus-scope-and-charging-cradle-each" target="_blank">estimated price point of ~$2,500</a>, this is comparably affordable to Aurolab's Slit Imager if including the cost of the slit lamp. But it is approved, more versatile, and probably provides higher quality images.</li>
</ul>
</ul>
<ul>
<li><b>Downmarket: Disruption Tomorrow</b></li>
<ul>
<li>The most exciting disruptive ophthalmoscopy innovations are occurring at price points far below even that of Slit Imager. Take EyeGo for example, a <a href="http://www.reviewofophthalmology.com/content/d/technology_update/i/3076/c/51484/" target="_blank">$15 ophthalmoscopic adapter for smart phones</a> out of Stanford University. EyeGo's value proposition is very similar to Slit Imager's, which is "triaging when no other alternative is available," but this model enjoys serious advantages in terms of cost, ubiquity of devices, and seamless modularity with existing infrastructure through phones' photo management and email applications. </li>
</ul>
</ul>
Of course, current market conditions aren't everything: They are just a snapshot, and several nascent trends signal international opportunity for Indian ophthalmoscopic innovators in the coming years. Firstly--as evinced by the Aravind case above--, India is already working hard to decrease costs through substantial reengineering, but have only just begun as of 2012. Secondly, there is a large base of talented software engineers in Bangalore, and <a href="http://online.wsj.com/articles/india-satellite-reaches-mars-orbit-on-first-try-1411574420" target="_blank">India's engineers recently put a satellite in orbit around Mars</a>. These conditions are ripe in encouraging India to realize the true, large-scale disruptive potential within this market, namely by combining extremely low-cost, ubiquitous devices with software applications allowing for accurate diagnoses from photos patients take themselves. This technology is already emerging within certain academic settings, as in the case of <a href="http://eyemitra.com/" target="_blank">eyeMITRA</a>. An integrated product like this would profoundly change the retinal scanning market, drastically increasing the number of 'tests' performed on a routine basis, automating most of the basic spot-checking and triaging, and ensuring that the expensive and highly trained Ophthalmologists and Optometrists are utilized mostly to confirm complex diagnoses and manage complex treatment regimens.<br />
<div>
<br /></div>
<div>
Being in Silicon Valley, EyeGo is in a privileged geographical and cultural position to develop a SaaS platform that works well, or to form relationships with companies like eyeMITRA. On the other hand, market pressures in the U.S. may not be great enough to encourage and sustain an aggressive commercialization strategy. After all, an <a href="http://www.visionexpowest.com/Press/Vision-Voice-Newsletter/Eye-Exam-Incidences-Increasing-Among-US-Population/" target="_blank">eye exam in the U.S. currently only costs an average of ~$50</a>, and since nearly half of the adults in the U.S. are already getting eye exams each year, the unmet need may not be acutely painful. Therefore, my advice to innovators like EyeGo, eyeMITRA, and Aurolab is to build this disruptive product of tomorrow in markets like India <i>first</i>, where there is a vast need and a real market.<i> </i>Once the right product and business model arises from there, export the result around the world. </div>
<div>
<br /></div>
<div>
<br /></div>
<div>
<b>Starter Question for Comments: </b></div>
<div>
<ul>
<li>What's stopping devices like EyeGo and Slit Imager from being widely adopted in the U.S. today? </li>
</ul>
</div>
<div>
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<br />
<span class="text_exposed_show" style="background-color: white; color: #141823; display: inline; font-family: Helvetica, Arial, 'lucida grande', tahoma, verdana, arial, sans-serif; font-size: 14px; line-height: 20px;"><span style="color: black; font-family: Tahoma, Arial, Helvetica, sans-serif; font-size: 13px; line-height: normal;"><br /></span></span>Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com18tag:blogger.com,1999:blog-71021911408861069.post-66489045691634803282014-11-05T00:40:00.000-08:002014-11-05T00:48:42.422-08:00How Mitra Industries Could Save Kidney Disease Patients in the U.S. over $1.7 Billion per Year<div class="MsoNormal" style="background-color: white; color: #222222;">
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<span style="font-family: Arial, Helvetica, sans-serif;">Nearly $3 billion per year is spent by U.S. patients on a form of kidney failure dialysis treatment whose cost the Indian firm <a href="http://www.mitraindustries.com/" target="_blank">Mitra Industries</a> has decreased, with the potential to realize savings of nearly $1.9 Billion in dialysate solution alone.</span></div>
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2rveq5j_AamWhrlicqRI6Okrr0m3lHmx-qjafQdrZAhkdWnbvCxcjiATY4fmMGN7XUZ2P7nAm_RWTZBntP01uiWPknjIvJfW7G68jFze3FZmnJ3-iM2ZoeLy6w6Z2BQLwVAVxkc2n8PE/s1600/230px-Peritoneal_dialysis.gif" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img alt="Peritoneal Dialysis" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2rveq5j_AamWhrlicqRI6Okrr0m3lHmx-qjafQdrZAhkdWnbvCxcjiATY4fmMGN7XUZ2P7nAm_RWTZBntP01uiWPknjIvJfW7G68jFze3FZmnJ3-iM2ZoeLy6w6Z2BQLwVAVxkc2n8PE/s1600/230px-Peritoneal_dialysis.gif" height="200" title="Peritoneal Dialysis" width="184" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="font-size: small;">Peritoneal Dialysis</span></td></tr>
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<span style="background-color: transparent; font-family: Arial, Helvetica, sans-serif;">End Stage Renal Disease (ESRD) is a condition requiring either a kidney transplant or an artificial process (mostly dialysis) to clean the blood as a replacement for healthy kidneys. Transplant is the best option, but of the half-million patients with ESRD in the U.S., <a href="http://ndt.oxfordjournals.org/content/20/12/2587/T2.expansion.html" target="_blank">nearly 4/5</a> require dialysis treatment, and nearly all of these undergo hemodialysis (HD), an extracorporeal process of removing, cleaning, and replacing the blood using machines. The remaining patients, currently <a href="http://ispd.org/NAC/wp-content/uploads/2010/11/FDA-LetterAug2014FinalVersion.pdf" target="_blank">~40,000</a>, opt for <a href="http://en.wikipedia.org/wiki/Peritoneal_dialysis" target="_blank">peritoneal dialysis</a> (PD)* therapy, a process whereby a permanent catheter embedded through the abdominal cavity is used to exchange medicated dialysate with waste from the blood via the peritoneal membrane at least 3x per day. This is a process the patient manages herself. The outcomes for PD and HD are comparable, but the main advantages of PD over HD are increased patient empowerment, and cost savings. <a href="http://ndt.oxfordjournals.org/content/23/6/1982.full.pdf" target="_blank">Several studies</a> in recent years have argued convincingly for the general superiority of PD over HD on a number of <a href="http://www.pdiconnect.com/content/early/2013/04/30/pdi.2011.00309.full.pdf+html" target="_blank">relevant dimensions</a>. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">With per patient costs of ~$72,000 per year in the U.S., PD does cost less than HD, which runs ~$88,000 per year. The main cost drivers for PD are the dialysate solution, requiring 1 bag per session, as well as the general management of anaemia, the latter being common to any dialysis treatment. A quick look at the prices of PD supplies on <a href="http://www.baxter.com/downloads/patients_and_caregivers/therapies/renal/bplpc.pdf" target="_blank">Baxter's product listings</a> confirms their high price as each bag of solution costs ~$45, summing to a yearly cost of nearly $50,000 in solution alone for just thrice daily treatment. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">While improvements in <a href="http://en.wikipedia.org/wiki/Home_hemodialysis" target="_blank">home hemodialysis</a> technology could change this, PD is currently the most disruptive form of dialysis. But could costs be even lower for ESRD patients opting for the low cost dialysis route? </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Mitra Industries, a manufacturing company in Transfusion Medicine & Renal Services based in New Delhi, India, has developed a <a href="http://www.mitraindustries.com/download/Cat-mNOB.pdf" target="_blank">novel one-bag solution (NOB)</a> for PD that has decreased the monthly per patient cost to a shockingly low <b>$235</b>. Even assuming that all of this cost is attributable to solution, with thrice per day therapy, that's a per bag cost of $2.6 compared with $45 from Baxter. Other product benefits are named in their release video below. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">In my correspondence with Atul Rishi, the Country Manager for Mitra, he prefaced his introduction of the NOB by listing the environmental constraints that shaped Mitra's innovation efforts. These are: </span></div>
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<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>India Is a Large Country: </b>True both in terms of area & population</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>Education: </b>The majority of the population is not educated</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>Limited Medical Resources: </b>Main cities have excellent facilities but smaller towns are still lacking basics, and the majority of the population in India still resides in smaller towns. For example HD machines are only available in large cities</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>No Medical Reimbursement: </b>Only limited government employees get medical reimbursement and all private patients are self-paid, so they know the costs</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>High Medical Costs: </b>India still imports many medical devices and medications from abroad, and distribution costs are high to reach rural patients, e.g. consider the cost of transporting sufficient quantities of the standard 2 liter bags used in PD therapy</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>High Non-Consumption: </b>80% to 85% of kidney failure patients go without renal therapy in India as a result of the factors above</span></li>
<li><span style="font-family: Arial, Helvetica, sans-serif;"><b>Emerging Manufacturing Capability: </b>The first indigenous designer and manufacturer of PD products in India began work only in 2000, and started manufacturing supplies nearly identical to those India had been importing from Western countries. </span></li>
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<span style="font-family: Arial, Helvetica, sans-serif;">When Mitra began manufacturing PD products in 2006, they did so at the same price points as the competition, but as Atul says, "[We] were constantly thinking on how to reduce cost per bag so that it is not only more economical than existing PD company bags, but also equivalent to or lower than HD monthly cost" (HD, though generally more expensive than PD in developed countries, is sometimes cheaper in developing countries, likely due to much higher resource utilization).</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Innovating to the market constraints above, Mitra reduced 2 bags to 1 by reusing the solution bag as the drain bag, and thereby also eliminated the Y connector & tube. This has decreased material cost and waste, and also reduced transportation cost of materials by 15%, leading to a price point not only 95% cheaper than PD bags in the USA, but also 33% cheaper than alternatives in India. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Whether Mitra can make the leap into the U.S. healthcare market to disrupt existing offerings with its NOB depends on many factors outside the scope of this post's analysis; however, the need for innovations such as this is especially dire at this time. Baxter, which supplies about 90% of supplies for PD patients in the U.S., <a href="http://ispd.org/NAC/wp-content/uploads/2010/11/FDA-LetterAug2014FinalVersion.pdf" target="_blank">limited the number of PD referrals across their entire base of customers this year, as well as announced there will be an unexpected and large shortage in supplies of peritoneal dialysis solution for patients with kidney failure in the U.S</a>. Other U.S. manufacturers have stated they cannot make up the shortfall. Given that PD has been rapidly growing as a viable form of low-cost, effective dialysis treatment in the U.S. in recent years, the FDA would do well to consider extending import and marketing approvals to companies such as Mitra, which not only have the capacity to serve patients at scale, but have also structurally innovated their products to decrease the cost of PD therapy. Baxter may well leave the game due to the loss of margins for provision of PD equipment, but they already seem to have lost interest in this market. Should we succeed in allowing entrance to laudable innovators such as Mitra, the real winners will be the patients and <a href="http://www.usrds.org/2013/pdf/v2_ch11_13.pdf" target="_blank">payers</a> of America.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">*All subsequent use of 'PD' in this post refers more specifically to continuous ambulatory PD, as opposed to automated PD</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Photo Credit: http://upload.wikimedia.org/wikipedia/commons/4/4e/Peritoneal_dialysis.gif</span></div>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com90New Delhi, Delhi, India28.635308 77.2249600000000128.1893855 76.579513 29.081230499999997 77.870407000000014tag:blogger.com,1999:blog-71021911408861069.post-11553254449925962382014-10-13T16:39:00.001-07:002014-10-14T14:53:45.305-07:00Theranos: The World's Best Healthcare Company <b><u>Introduction to Theranos</u></b><br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9tkENfsbv7GmLsQArlpwHX08DpZNvM2QjVTUDHEs2VHfMxUeoQoCyHT3IH3hoGt_UZpt6JQcP616tF4VNl19sNRcF6c9H2gUwX2k3Bn38uFQDghg2hg0YBvjUHEHYoZ6v5NDx4DmwCrk/s1600/theranos-logo.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Theranos" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9tkENfsbv7GmLsQArlpwHX08DpZNvM2QjVTUDHEs2VHfMxUeoQoCyHT3IH3hoGt_UZpt6JQcP616tF4VNl19sNRcF6c9H2gUwX2k3Bn38uFQDghg2hg0YBvjUHEHYoZ6v5NDx4DmwCrk/s1600/theranos-logo.jpg" height="36" title="Theranos Logo" width="200" /></a>Ever since their debut article in <a href="http://fortune.com/2014/06/12/theranos-blood-holmes/" target="_blank">Fortune</a> this June, in which Theranos unveiled its stature as a $9B-valued company poised to completely disrupt the $78B per year laboratory diagnostics industry, Theranos has been lavishly featured in the media as a herald of the new healthcare: Affordable, personal, transparent, and accessible. Theranos is built around a proprietary new high-complexity diagnostics lab that allows for a large range of tests (they currently list 229 on their website, but the Fortune article tells us they'll soon offer over 1,000) to be run on blood and other bodily fluids using much smaller sample sizes (70 separate tests can be run on a single sample of a few drops of blood: 1/1000th the amount of blood needed for traditional tests) for a very low cost (Theranos's prices are <a href="http://www.aspenideas.org/session/personalized-medicine-future-now" target="_blank"><i>always </i>50-90% less than the Medicare reimbursement codes</a>. For example, <a href="http://video.foxbusiness.com/v/3668767850001/theranos-ceo-on-companys-blood-testing-system/?playlist_id=933116627001#sp=show-clips" target="_blank">a standard metabolic panel would cost ~$46 at a standard lab, Medicare would reimburse $14.74, and Theranos charges only $7.27</a>. The average price across their 229 tests is $12.92), and at exceptional speed (whereas traditional testing services would take days to return results, Theranos's labs take mere hours). The Theranos labs also require less footprint, allowing them to be housed in small corners of retail clinics, hospitals, and other existing healthcare outlets. They have signed a non-exclusive <a href="http://news.walgreens.com/article_print.cfm?article_id=5794" target="_blank">agreement with Walgreens</a> (the pharmacy chain currently boasts over <a href="http://news.walgreens.com/article_display.cfm?article_id=1044" target="_blank">8,200 brick-and-mortar pharmacy locations</a> in the U.S.) to build Theranos Wellness Centers in each location as quickly as possible. They are already operating out of 39 Walgreens stores in Arizona, and 1 in Palo Alto, California. They have also inked agreements with several hospital systems, such as Intermountain Healthcare and Dignity.<br />
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<b><u>Whence Theranos on Globalhealth.care? </u></b><br />
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Before explaining why Theranos is the best healthcare company in the world, it's worth explaining why globalhealth.care is featuring Theranos in the first place; after all, the company maintains over 500 employees in a 111,000 square-ft. facility at Stanford University, and even manufacturers their labs at a 262,000 square-ft. factory in Newark, California. Their <a href="http://www.theranos.com/our-company" target="_blank">board</a> is also unusually stacked with American civil heroes such as Henry Kissinger, William Perry, and James Mattis. Theranos is as American a company as they come, but there are good reasons to feature Theranos as the first innovation profile on a site dedicated to researching technologies originating from emerging markets. The first is that Holmes's (Elizabeth Holmes is the Founder and CEO of Theranos, a very focused and brilliant person who dropped out of Stanford's Chemistry program as a Sophomore to start this company) idea for Theranos seems to have originated from a 2003 summer internship (Holmes founded Theranos in the fall of 2003) at the Genome Institute of Singapore during their work with Roche Diagnostics to make <a href="http://www.gis.a-star.edu.sg/internet/site/about/press_centre.php?year=2003&cat=News%20Article" target="_blank">highly affordable, accessible, and fast SARS testing kits available</a> to the Asia-Pacific region using their nobel-prize-winning PCR technology. </div>
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The second reason is that Theranos is such a <i>complete</i> example of a healthcare innovation, a standard by which all of the individual foreign technologies globalhealth.care will feature must aspire to within the transplanted context of the U.S. healthcare market. The fact is that any technological innovation in isolation is naked, and really not worth much until it is clothed in the appropriate vestments of an integrated market application and comprehensive business model that delights each of its stakeholders. Like Edison, true disruptors must invent more than just a lightbulb: They must also design and execute a workable electrical grid into which the lightbulb can integrate.</div>
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<b><u>Why Theranos is the World's Best Healthcare Company</u></b><br />
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<b>Reason 1: Theranos's Market Position in Diagnostics</b></div>
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Successfully designing their 'electrical grid' is the second-most important reason why Theranos is the world's best healthcare company. The first is that they may credibly become the 'gatekeeper of healthcare' by owning the market for laboratory diagnostics, the data of which already form the basis of <a href="http://techcrunch.com/video/jon-shieber-gets-some-blood-work-done-with-elizabeth-holmes-of-theranos-2/518405804/" target="_blank">70-80% of clinical decisions</a>. This number will only increase as the speed, reliability, accuracy, breadth, price, and accessibility of diagnostic information increases--all of which Theranos is accomplishing. Additionally, diagnostics is the nexus of healthcare most amenable to expanding the scope of practice of lower-cost providers for well-understood medical conditions. As <a href="http://www.globalhealth.care/2014/10/why-india-could-lead-way-in-global.html" target="_blank">another of our posts</a> explores, this is one of the surest ways to decrease healthcare costs in the U.S. </div>
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<b>Reason 2: Theranos's Business Model</b><br />
Every component of a good business model flows from, and seeks to balance and reconcile, the foundational stakeholder value propositions (VPs) upon which the success of the business depends. These VPs are responses to stakeholder <a href="http://www.christenseninstitute.org/key-concepts/jobs-to-be-done/" target="_blank">jobs-to-be-done</a> (JTBD). Below are some examples of the primary stakeholders, their JTBD related to lab diagnostics, and the resultant VPs that Theranos has so expertly constructed its offerings around:<br />
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<ul>
<li>Patients</li>
<ul>
<li>Jobs-to-be-done (JTBD)</li>
<ol>
<li>Feel less pain / fear around extracting samples</li>
<li>Pay less $$ for routine tests</li>
<li>Gain anytime access to personal health information </li>
</ol>
<li>Value Propositions (VPs)</li>
<ol>
<li><a href="http://www.theranos.com/the-experience" target="_blank">Proprietary, painless micro-stick</a> technology to extract a few drops of blood</li>
<li>Pricing 50-90% less than Medicare reimbursement prices</li>
<li>Creation of <a href="http://www.theranos.com/our-tools" target="_blank">theranos.me, mobile apps, and easy graphical displays</a> to learn and track important data</li>
</ol>
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<li>Providers</li>
<ul>
<li>JTBD</li>
<ol>
<li>Fast, accurate test results</li>
<li>Easily place orders and follow-up orders</li>
<li>Easily consumable reporting</li>
<li>Not take up much space (hospitals)</li>
</ol>
<li>VPs</li>
<ol>
<li>Results w/in hours instead of days; <a href="http://www.theranos.com/our-lab" target="_blank">high illustrative accuracy</a> </li>
<li>Send samples using existing infrastructure OR send patient to Wellness Center</li>
<li><a href="http://www.theranos.com/our-tools" target="_blank">Alerts and easily consumable graphs</a> via software</li>
<li>Theranos labs require <a href="http://fortune.com/2014/06/12/theranos-blood-holmes/" target="_blank">10x-100x less space</a> than traditional labs </li>
</ol>
</ul>
<li>Payers</li>
<ul>
<li>JTBD</li>
<ol>
<li>Pay less $ for procedures</li>
</ol>
<ul>
</ul>
<li>VP</li>
<ol>
<li>Pricing 50-90% less than Medicare reimbursement prices, estimated to <a href="http://video.foxbusiness.com/v/3232709552001/one-drop-of-blood-equals-two-huge-steps-for-medical-industry/#sp=show-clips" target="_blank">save Medicare / Medicaid $200B </a>over next 10 years</li>
</ol>
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</ul>
</ul>
<li>Regulators</li>
</ul>
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<ul><ul>
<li>JTBD</li>
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<li>Ensure safe, effective healthcare for the public</li>
<li>Not have to chase down irresponsible startups</li>
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</ul>
<li>VPs</li>
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<li><a href="http://www.theranos.com/for-providers" target="_blank">CLIA</a>, FDA, WHO, and ICH certified </li>
<li><a href="http://www.aspenideas.org/session/personalized-medicine-future-now" target="_blank">Proactively sends FDA testing accuracy results</a></li>
</ol>
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</ul>
</ul>
<li>Pharma</li>
<ul>
<li>JTBD</li>
<ol>
<li>Easily track real-time results of drug trials in test patients </li>
</ol>
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</ul>
<li>VPs</li>
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<li>Creates a 'movie' of physiological reaction to drugs within patients (<a href="http://fortune.com/2014/06/12/theranos-blood-holmes/" target="_blank">Glaxo-Smith Kline and Pfizer have been paying Theranos for this since 2005</a>)</li>
</ol>
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</ul>
</ul>
<li>Investors ('good' investors who are supportive of long-term returns)</li>
<ul>
<li>JTBD</li>
<ol>
<li>Realize high return on investment</li>
<li>See cash from operations supporting increasing share of the business</li>
</ol>
<ul>
</ul>
<li>VPs</li>
<ol>
<li>Has not accepted investors seeking short-term exit</li>
<li><a href="http://techcrunch.com/video/jon-shieber-gets-some-blood-work-done-with-elizabeth-holmes-of-theranos-2/518405804/" target="_blank">Generating cash from operations since 2005</a></li>
</ol>
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</ul>
</ul>
</ul>
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<b><u>Challenges In Emerging Markets for Theranos</u></b><br />
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Theranos is a careful company. They were in stealth mode for 10 years making sure to nail each piece of their business model before starting to scale, and they are doing that very deliberately so far with Walgreens. Holmes has indicated that <a href="http://techcrunch.com/video/jon-shieber-gets-some-blood-work-done-with-elizabeth-holmes-of-theranos-2/518405804/" target="_blank">Theranos is systematically evaluating a global expansion strategy</a>, which will probably not happen tomorrow. If it does happen, each new market will of course require an entirely new business model, or configuration among a separate set of stakeholders.<br />
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Research on the laboratory diagnostic market in India indicates that Theranos would today be a welcome innovation within this market since the vast majority of diagnostic labs in India are importing equipment from the same OEMs that supply the traditional diagnostic labs in the U.S., e.g. Siemens, Olympus, and Beckman Coulter. Because of this, even the Indian test prices are still higher than those of Theranos as the table below comparing the cost of a few <a href="http://www.theranos.com/test-menu?ref=for_providers" target="_blank">Theranos</a> and <a href="http://www.srlworld.com/content/62/find-a-test.html" target="_blank">SRL Diagnostics</a> tests shows:<br />
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But price is just one metric, and others may be just as important in emerging markets. For instance, Dr. Natarajan Sriram wrote a <a href="http://www.asianhhm.com/diagnostics/diagnostics_developing_world.htm" target="_blank">critical piece about existing IVDs</a> in emerging markets, and while price was at the top of the list of criticisms, there are many additional reasons that make significant market penetration difficult for laboratory-based diagnostics. Dr. Sriram outlines important performance dimensions required for IVD products to succeed in emerging markets. While Theranos performs well on several cost and reliability metrics, there are a few that Theranos will find difficult to excel on in its current form:<br />
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<ol>
<li>Simple and minimum end-to-end procedure</li>
<li>Test results require no additional equipment or accessories from site of test</li>
<li>Small pack size of IVD</li>
<li>Minimal training required w/ no professional staff</li>
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8XYekUi7mm2iiL_xX32oNYyI_n201i5h7LPe1E7UvXfihPlbz5k0sG55fJhDi_taGlbcEeWOaEB6yLaWcBjxXQQ18pjfkRJzBEXV9hBxwKCQTYKMsbQ55sTH0hN3V-5q-_i7HxbC7v-0/s1600/RDT.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img alt="Rapid Diagnostic Test" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8XYekUi7mm2iiL_xX32oNYyI_n201i5h7LPe1E7UvXfihPlbz5k0sG55fJhDi_taGlbcEeWOaEB6yLaWcBjxXQQ18pjfkRJzBEXV9hBxwKCQTYKMsbQ55sTH0hN3V-5q-_i7HxbC7v-0/s1600/RDT.jpg" height="200" title="Rapid Diagnostic Test" width="200" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Typical Rapid Diagnostic Device</td></tr>
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Dr. Sriram's own company, the <a href="http://www.tulipgroup.com/Html_New/group_productrange.htm" target="_blank">Tulip Group</a>, oversees the R&D and production of Rapid Diagnostic Tests (RDTs), which are typically single-use applications meant to test for the presence of an infectious disease, exactly like that of Roche's PCR system for SARS in 2003. While <a href="http://www.wpro.who.int/malaria/NR/rdonlyres/0A45DF24-4245-4BF3-96E7-5F1150AF333B/0/DeterminingCostEffectivenessofRDTsinruralareaswithhighprevalence.pdf" target="_blank">incremental cost advantages to RDTs have been shown</a> at high levels of a particular disease prevalence, their true advantage in emerging markets is that they satisfy the above criteria for success that Dr. Sriram outlines. </div>
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The penetration of Theranos into emerging markets in its current form might rely on how widely held and acute the JTBD of 'help me watch a movie of my micro-biological health indicators over time' is in these markets since the OEMs already supplying the equipment will likely soon provide lower-cost lab diagnostics to achieve cost parity with Theranos. </div>
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I wonder, might Theranos carry their genius of miniaturization a bit further to create portable laboratories, patches, or more versatile RDTs in order to succeed in emerging markets as they will succeed in the U.S.? </div>
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RDT photo credit: http://p.globalsources.com/IMAGES/PDT/B1055265875/Diagnostic-Test-Cassette.jpg</div>
Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com15tag:blogger.com,1999:blog-71021911408861069.post-41685989959472954612014-10-07T22:34:00.000-07:002015-03-13T01:49:09.001-07:00Could India Lead the Way in Global Medical Diagnostic Solutions?<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: inherit;">Molecular diagnostics, imaging technologies, and high-bandwidth telecommunications are important enablers for disruptive business models in healthcare because they greatly facilitate the movement of medical conditions from intuitive and empirical medicine to precision medicine, where the diagnosis and therapies for these conditions are perfectly or near-perfectly understood. </span><br />
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<span style="font-family: inherit;">Once a condition is within the realm of precision medicine, the scope of practice should be widened for less-credentialed providers to administer diagnoses and provide therapy since there is little possibility of error, the cost of care decreases, and specialists' time and attention can be refocused on true problems. Allowing for expanded practice scope results in more primary care doctors, nurses, PAs, NPs, and others solving the problem on the first visit, greatly mitigating one of the primary cost drivers of the ever-more-expensive U.S. healthcare system: Referrals. Once our understanding of a condition has graduated to the realm of precision medicine, passing the buck is no longer necessary. </span></div>
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<span style="font-family: inherit;">Of course, there are many rules and regulations in place that inhibit practice scope expansion, and thus the need for disruptive business models that prove out the value of administering precision medicine efficiently by gaining market footholds in alternative value networks. Once successful, such business models compel legislative reform on the basis of their <i>fait accompli </i>market victories. </span><br />
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<span style="font-family: inherit;">In the U.S., there are </span><span style="font-family: inherit;">currently several auxiliary efforts to disrupt diagnostics underway; important and impactful to be sure, but not sterling examples of diagnostic technology's promise to disrupt healthcare. For example,</span><span style="font-family: inherit;"> </span><a href="http://www.americanwell.com/" style="font-family: inherit;" target="_blank">American Well</a><span style="font-family: inherit;"> and </span><a href="http://echo.unm.edu/" style="font-family: inherit;" target="_blank">Project Echo</a> <span style="font-family: inherit;">both leverage telecom and mobile technology to nip as many problems and as much of each problem in the bud as possible before recommending an expensive in-person visit to either a PCP or specialist. Retail clinics also continue to spend a great deal of money lobbying for practice scope expansion on a state by state basis, e.g. CVS Minute Clinic fighting for pharmacists' of NPs' ability to perform more precision medicine procedures.</span></div>
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Medical technology can greatly aid in establishing the most efficient, low-cost care processes for precision medicine possible, and improved diagnostics should be at the center of these new business models. <span style="font-family: inherit;">But where to look for it? </span><br />
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<span style="font-family: inherit;">I believe India will be a source of truly disruptive diagnostic technology for several reasons. Firstly, it is a market forced to create alternative value networks as entrepreneurs attempt to radically expand access to care with radically affordable products and processes. Secondly, the diagnosis / therapy process in India is not necessarily constrained by rule and regulation to the degree it is in the U.S., allowing for expansion of practice scope as needed. For example, a large part of why <a href="http://businesstoday.intoday.in/story/biggest-india-innovation-narayana-health/1/205823.html" target="_blank">Narayana Hrudayalaya</a> is able to perform heart surgery at 1% the cost of the same surgery in the U.S. is that the specialist only does the grafting, which takes about an hour, while a support staff of junior doctors, trainees, nurses and paramedical staff complete the other 4 hours of work consisting of harvesting of veins/arteries, opening and closing of the chest, suturing and other procedures. </span></div>
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<span style="font-family: inherit;">Thirdly, there are several Indian medtech manufacturers that have been in operation for 1-3 decades, and have the technological and manufacturing know-how to start creating truly disruptive diagnostic products for the Indian market as a whole. For example, <a href="http://trivitron.com/about-trivitron.htm" target="_blank">Trivitron</a>--the largest medical device maker of Indian origin--claims that to "realize Dr. GSK Velu's dream of providing affordable healthcare solutions to all sections of the population, the Trivitron Group now also designs, innovates and manufactures medical equipment across the entire healthcare spectrum." </span><br />
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<span style="font-family: inherit;">Given <a href="https://www.facebook.com/TrivitronIndia" target="_blank">Trivitron's Facebook</a> post yesterday about bringing 4 new microbiology diagnostics products to market, along with Dr. Velu's closing comments at the recent <a href="http://www.moneylife.in/business-wire-news/ficci-heal-2014-inaugurated-with-the-theme-innovation-enabling-access/40527.html" target="_blank">FICCI Heal 2014</a> conference to give more focus and attention in India "due to very high import dependency," I would expect to find several promising diagnostic innovations being developed organically from within indigenous R&D centers, such as the <a href="http://www.thehindubusinessline.com/todays-paper/tp-corporate/trivitron-iitmadras-partner-for-biomedical-rd/article992807.ece" target="_blank">Trivitron-IIT Madras Innovation Center</a>. While it's true that companies like Trivitron will find breaking out of their traditional roles as manufacturers and distributors of imported products and technologies to the still-limited Indian healthcare infrastructure, developments like Trivitron's acquisition of Dubai-based <a href="http://www.thehindu.com/business/companies/trivitron-acquires-eta-star-healthcare/article4360264.ece" target="_blank">ETA Star Healthcare</a> enabling for an export strategy to other developing markets is an encouraging sign. </span><br />
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Photo Credit: http://internetmedicine.com/iphone-smart-ultrasound/ </div>
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Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com16tag:blogger.com,1999:blog-71021911408861069.post-70971439472493082292014-10-02T22:00:00.001-07:002014-10-06T16:25:31.476-07:00Why Conducting Research with an "n of 1" is BestI have pivoted the purpose and scope of globalhealth.care in order to conduct research with an 'n of 1.' The idea is that truly valuable insight into causation comes from limiting research to one subject that reflects all potential factors that might explain the dependent phenomenon in question, and then carefully studying the provenance of the phenomenon with sole reference to this particular subject. In other words, just as a medical researcher might study the pathology of a disease within one patient to understand the disease (the patient being the subject; the disease being the phenomenon), so I might study global innovation transfer within one emerging market company (the company being the subject; the global innovation transfer being the phenomenon). I wish to acknowledge Clay Christensen for this insight, who shared it in a meeting with me on September 4th, 2014.<br />
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This was a significant paradigm shift as I had originally planned to uncover and analyze as many potentially transferable healthcare innovations as possible from around the world, and then hoped to extract some real insights into which ones might be 'winners' for effectively improving healthcare through global innovation transfer. According to the advice above, it will be much more productive to carefully choose one of the companies that has successfully developed a healthcare innovation within their own emerging market, and has also made some progress in transferring the innovation globally. By making an in-depth study of how this company has navigated the conditions and constraints confronted in its journey, real insight will emerge that may help guide more global innovation transfer in the future.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1XCQi3gLV4SqI42nqK6qcsjlX3tIIlNyti9QLv9ZZr4CGWZKCq4Q84gQvYKC7xT8xOaTfBWESMMrbppbLFy2gMbsqw59l9hyphenhyphenzCcd_EGLfpGh0J4rkdrMNau1WfTx-SS7ALt1zqKFM6gs/s1600/India.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1XCQi3gLV4SqI42nqK6qcsjlX3tIIlNyti9QLv9ZZr4CGWZKCq4Q84gQvYKC7xT8xOaTfBWESMMrbppbLFy2gMbsqw59l9hyphenhyphenzCcd_EGLfpGh0J4rkdrMNau1WfTx-SS7ALt1zqKFM6gs/s1600/India.png" height="200" width="200" /></a><br />
But how to choose the right company among such a large array of promising candidates? Firstly, I will initially limit the bulk of posts to companies that have developed healthcare innovations by, for, and of the extremely constrained markets of India. There are other great innovation 'laboratory' markets, but India is a good place to start as they are famously developing a sizable number of healthcare innovations.<br />
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Each week, globalhealth.care will feature one or two snapshot posts of individual innovations from its <a href="http://www.globalhealth.care/p/running-list-of.html" target="_blank">Innovations Database</a> page, each innovation of which fits the criteria above. I will also be attending the <a href="http://www.indiabiodesign.org/events/8th-annual-indian-medtech-summit" target="_blank">8th Annual Indian Medtech Summit</a> in Delhi on December 11th and 12th, 2014, and will finalize a single Indian partner company for close study during my stay in India in January and February of 2015. Globalhealth.care will feature the research coming out of this internship as a white paper on the website.<br />
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Photo Credit: http://upload.wikimedia.org/wikipedia/commons/thumb/b/bb/India_(orthographic_projection).svg/541px-India_(orthographic_projection).svg.pngAnonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com5Cusco, Peru-13.53195 -71.967462599999976-13.655454 -72.128824099999974 -13.408446 -71.806101099999978tag:blogger.com,1999:blog-71021911408861069.post-415934028077816802014-06-22T16:25:00.000-07:002014-12-01T02:28:41.099-08:00A Brief Intellectual History of Globalhealth.care<b>The Inception</b><br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlbzmlpjV_YXvHcJrt95Bc7MmrQaof6jLVt9au6fZE3ezzs5F70GBC_EtWT9rlNS6d0KiRSdFBi4s0JGVWCRaR_wf581wKrtlb8n95hBx9gjyZyJgGAlMfT9O5mhQXzEgZGJ1Nx_XbeTM/s1600/UkrBlack2.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlbzmlpjV_YXvHcJrt95Bc7MmrQaof6jLVt9au6fZE3ezzs5F70GBC_EtWT9rlNS6d0KiRSdFBi4s0JGVWCRaR_wf581wKrtlb8n95hBx9gjyZyJgGAlMfT9O5mhQXzEgZGJ1Nx_XbeTM/s1600/UkrBlack2.jpg" height="214" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.thefreshloaf.com/node/18608/ukrainian-black-bread-laurel039s" target="_blank">Excellent Ukrainian Bread</a></td></tr>
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The idea for this project began to form during my time in Eastern Ukraine from 2003-2005. In many cases I discovered that Ukrainians' way of doing things was better than what I had known before. "Better" is always a word needing qualification, and the qualifier differs in each case. Take Ukrainian bread: It's better than the pre-sliced bread from grocery stores I was used to on dimensions of taste, nutrition, and texture; on the other hand, it was worse on dimensions of shelf life, tidiness (crumbs would fly upon slicing), and even PPP cost.<br />
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The insight for me was that societies have comparative strengths and weaknesses developed over time in response to conditions on the ground. This goes far beyond food, which after all is largely a matter of taste and habit, and into the ways in which societies organize themselves economically in general.<br />
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<b>A Theory</b><br />
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The next piece of understanding was learning <a href="http://www.claytonchristensen.com/" target="_blank">Clay Christensen's</a> theories of innovation. I read all of his books and most of his articles as a consultant at <a href="http://www.innosight.com/" target="_blank">Innosight</a> from 2009-2011. Innosight, a firm co-founded by Christensen, helps mostly large corporate clients navigate the challenges and opportunities of disruption in their markets. Clay's theories deepened my interest in the mechanisms of successful innovations, which go far beyond isolated technological advances to encompass new systems and models for delivering value in more cost-effective, accessible, and targeted ways. Large scale disruptive innovations succeed over time and are often generated within tight resource constraints. For example, consider many of the disruptive innovations that Japan was exporting to the U.S. starting in the late 1950s:<br />
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<li>The Honda Super Cub motorcycle</li>
<li>Sony's hand-held transistor radios</li>
<li>Toyota and Honda cars</li>
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Each of these innovations eventually created a robust market in the United States by targeting consumers that had been over-served by incumbent technologies. Relative to the 'jobs to be done' of these consumers, the product characteristics of physical smallness, efficiency, and low cost were all attractive. Importantly, however, these products were not created in the United States: They were originally of, by, and for the Japanese market, where conditions on the ground differed markedly from those in the United States. Products initially created for obvious markets in Japan would eventually create much larger, though initially less obvious, markets in the United States. This happened dramatically and repeatedly from the 1950s through the 1980s.<br />
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<b>Globalhealth.care</b><br />
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During my time at Harvard Business School I read Vijay Govindarajan's <a href="http://www.innovationreverse.com/innovationreverse" target="_blank">Reverse Innovation</a>, which argues that innovations developed for consumers at the bottom of the global economic pyramid, i.e. the roughly 2.5 billion people living on less than $2 per day, share qualities similar to those that characterized Japanese disruptive products starting in the 1950s; namely, they are low-cost and low-performance relative to incumbent technologies, but they succeed because they're mostly targeting non-consumption and under-consumption. Here are just a few examples of these disruptive products from the <a href="http://www.globalhealth.care/p/running-list-of.html" target="_blank">Innovations Database</a> page of this website:<br />
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<li>$2K heart surgery at <a href="http://narayanahealth.org/" target="_blank">Narayana Health</a></li>
<li>$30 eye surgery at <a href="http://www.aravind.org/" target="_blank">Aravind Eye Hospitals</a></li>
<li>Portable, $500 ECG from <a href="http://www3.gehealthcare.in/en/Products/Categories/Diagnostic_ECG/Resting/MAC_600" target="_blank">General Electric</a></li>
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Many commentators on the healthcare industry in the United States have called for various avenues of disruption to the industry, which would broaden access, lower costs, and improve outcomes. Though the barriers to disrupting healthcare in the U.S. are many, I believe adopting new, disruptive models of delivery inspired directly by successful innovations from the highly constrained markets of the world is one route that will greatly help. Globalhealth.care, then, is a research project hoping to aid the transfer of these innovations, and thus aid the continuing betterment of the U.S. healthcare system.</div>
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<br />Anonymoushttp://www.blogger.com/profile/14941137660729731586noreply@blogger.com11Cambridge, MA, USA42.3736158 -71.109733542.3266968 -71.1904145 42.420534800000006 -71.0290525