Tuesday, 31 March 2015

Embrace: A Worldwide Infant Warmer

The Origins of Embrace

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.

The story of the Embrace Warmer 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 Jane ChenRahul PanickerNaganand Murty, and Linus Liang.

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.

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! Jane Chen explains:
"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." 
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.

The Embrace Warmer

Embrace Warmer
After months of iterative prototyping, and incorporating as a non-profit, the Embrace team released the first version of Embrace Warmer 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.

To accelerate access to the product, Embrace has split their mission into two entities. The non-profit Embrace 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 Embrace Innovations 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.

Could Embrace Warmers Disrupt NICUs / Incubators in the U.S.?

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 cover their expenses and generate additional profits. 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 electively induced infants were 2-3x more likely 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.

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 Prematurity Rates Are Too High - And Children's Hospitals Are Cashing In 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 nearly $7 billion per year.

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 Little Lotus Baby. 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.

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.

Question For Discussion:
  • Could a 'smart' version of the Embrace Warmer disrupt traditional incubators in the U.S.? 

Tuesday, 24 March 2015

TrueLab: A Portable Infectious Disease Diagnostic Lab for $8,000

The Diagnostic Promise of PCR Technology

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.

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.

To encourage and guide appropriate diagnostic innovation for infectious diseases, the World Health Organization (WHO) developed the ASSURED criteria stating that devices should be Affordable, Sensitive with very few false-negatives, Specific with very few false-positives, User-friendly requiring minimal training to use, Rapid to enable treatment at first visit, Robust, e.g. not requiring refrigeration, Equipment-free, and Delivered 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%.

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 GeneXpert product only tests for TB, and still costs about $60,000.

India's Answer To The ASSURED Criteria

TrueLab Uno Dx Real Time Micro PCR Analyzer 
Infectious disease remains a critical public safety concern in India. In fact, an MSN article 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, The New Millennium Indian Technology Leadership Initiative by the Council of Scientific and Industrial Research funded Bangalore-based Bigtec Labs 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 TrueLab micro-PCR system that does meet all of the ASSURED criteria, and is now being marketed by Molbio Diagnostics, headquartered in Goa. Molbio is a 50/50 joint venture between the Tulip Group and Bigtec Labs, the former having deep PoC diagnostic device manufacturing and an international marketing presence.

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.

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 range of diseases 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.

Sales Coverage Map of the Tulip Group
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.

Could Molbio's Micro-PCR System Succeed in the United States?

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 pipeline assays 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.

Considering a few macro trends, the worldwide Infectious Diseases Diagnostics (IDD) market was already worth $14 billion in 2014, 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.

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.

TrueLab Quattro Micro-PCR Analyzer
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.

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 February, 2015 for the H1N1 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 validated the accuracy of their Malaria test. Molbio certainly takes this aspect of the business seriously, as their Universal Control Kit documentation shows.

Questions for Discussion:
  • Would IDD purchasers in the U.S. find value in the TrueLab system? 
  • Is TrueLab the world's first IDD device that fits the WHO's ASSURED criteria? 

Monday, 16 March 2015

Seeing Clearly: Ultrasound = Future of Diagnostic Imaging

The Beauty of Ultrasound Technology

Ultrasound is an example of biomimicry par excellence; 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 New England Journal of Medicine in 2014 entitled Point-of-Care Ultrasound Imaging in Medical Education: Stop Listening and Look, which encourages physicians to supplement and possibly replace the stethoscope with diagnostic ultrasonography for physical examinations.

Clinical Areas of Vscan Ultrasound by GE Healthcare
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.

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.

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 Real-life examples of ultrasound in the developing world on KevinMD.

Handheld Ultrasound: A Quintessential Disruptive Technology

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 TEDMED 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. 

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.
GE Healthcare's Vscan with Dual Probe
In fact, the two best-known examples of handheld ultrasound in the world were created in India. First, GE Healthcare India created the Vscan 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 $7,900. 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.

Not to be outdone, Philips India developed the Visiq ultra-portable ultrasound device, releasing it in 2014 at a price of about $14,500. Visiq is a similarly compact setup to Vscan, but features a larger tablet-sized screen.

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 Prosound 2. However, at a price of $20,000, Trivitron does not appear to be marketing the product to compete with Visiq and Vscan.

Disrupting the U.S. Medical Imaging Market

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 yet. 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.

MobiUS SP1 Portable Ultrasound from Mobisante
GE and Philips hesitate to disrupt themselves, but what about grassroots innovators in the U.S.? Mobisante is a company in Redmond, Washington that received FDA approval in 2011 for a smartphone-enabled ultrasound device. Mobisante's MobiUS SP1 device (shown right), is priced similarly to GE's Vscan, retailing around $8,000. 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 FDA issued a warning in December, 2014 against the non-medical use of ultrasound devices in capturing fetal images or videos for keepsake purposes. 

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 The Patient Will See You Now, cites a study he and colleagues conducted at Scripps 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 125 million ultrasound studies performed in the U.S. per year 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.

Reenita Das, a partner with Frost & Sullivan, adds color to this in her recent Forbes article Could Plug-and-Play Be the Future of Healthcare Diagnostics?. 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.

Questions For Discussion
  • Has the image quality of handheld ultrasound devices achieved parity with the larger, more expensive machines? 
  • Can companies like Mobisante effectively target the core medical imaging market in the U.S.? 
  • Could handheld ultrasound devices really save the U.S. over $50 billion per year?

Thursday, 5 March 2015

The TTK Chitra Heart Valve: A High Quality Prosthesis for $350

A Successful Class III Medical Device From India

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 10,000 in FY 2011-12 alone. Additionally, TTK now exports the device to all neighboring countries, as well as South Africa. Overall, about 250 medical centers and 300 surgeons were using the TTK Chitra Heart Valve as of 2014.

Importantly, the TTK Chitra Heart Valve is a Class III medical device, 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 definitively shows that India has the technical capability to produce extremely high quality devices for even the most sensitive medical applications. 

The TTK Chitra Heart Valve Story

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 2-2.5 million patients 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.

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.

Chitra Heart Valve
The Chitra Heart Valve
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 genuine design and material science innovations 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 TTK Healthcare sells each valve for just $315-$400, 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.

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 Biotechnology Industry Research Assistance Council of India 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.

Could the TTK Chitra Heart Valve Succeed in the U.S.?

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.

Second, there are homegrown disruptive medtech innovations for certain operations in this space. For example, the MitraClip 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 the most common form of heart valve disease in the U.S., suggesting that there are even more Mitral Valve Replacement surgeries per year than the 20,000 or so Aortic Valve Replacement surgeries per year.

Third, biological valve replacements 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.

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 Narayana Health's hospital in the Cayman Islands, which specifically targets medical tourists from the Americas.

Question for Discussion: 
  • Is there demand for a low-cost heart valve like the TTK Chitra Heart Valve in the U.S.?