Friday 27 February 2015

Smartphones Enable Patients To Manage Early Diabetes for Under $100 Per Year

The IoT and the Changing Healthcare Environment

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. 

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,' using biochemistry and microfluidics to do the same diagnostic work previously confined to large, expensive, time-intensive, and centralized laboratory testing facilities. 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 PatientsLikeMe on their pharmacy website. PatientsLikeMe is heavily involved in the new Health Data Exploration 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. 

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 On a micro level, many specific policies and delivery models are outdated, and will eventually need to modify to take the new and emerging models of care into account. This is already happening; for example, the FDA has eased approval requirements for low-risk mobile medical apps. 

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. 

New Opportunities to Improve Chronic Care: The Case of Type II Diabetes

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 30% more genetically predisposed to developing diabetes than whites. Type II diabetes accounts for about 90% of total cases. 

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. 

First, there are the multiple parameter testing devices, exemplified by our earlier-featured Swasthya Slate, which can conduct about 30 biochemical tests on body fluids, or the more focused BPL Lifephone Plus, which 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 and Scanadu devices shortly hitting the U.S. market for $150 and $200, respectively. India-based Biosense's uCheck Universal kit runs over 10 urine-based tests in addition to blood glucose, and retails for about $80.

Low-cost Glucometers
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 OneTouch 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.

Other indigenous companies are taking a more integrated approach to diabetes care in India. One startup called Jana Care, 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: HbA1c, blood 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 Habits Program app, a 3-month curriculum based on the Diabetes Prevention Program 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. 

Could Jana Care successfully commercialize in the U.S.? Low cost is not their only comparative advantage. 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. 

Question for Discussion:

Would the Jana Care package provide real value to people with diabetes, and to their care providers, in the U.S.?

Monday 9 February 2015

Bending the Cost Curve: Medtech Will Do What the ACA Cannot

In his new book America's Bitter Pill, 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 costs too much 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 The Patient Will See You Now. 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.

Brill's View of Healthcare

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.

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 critiquing Brill's book, 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 wasted annual healthcare spend estimated by McKinsey.

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 difficult to enforce, part of the ACA. Even this transformation does not dramatically reduce healthcare costs per se, 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.

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.

Topol's View of Healthcare

The Patient Will See You Now 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.

The Innovator's View of Healthcare

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 disruptive innovation, according to the authors of Sieze the ACA at the Christensen Institute. Here are the most salient ones:
  • Provisions Encouraging Innovation
    1. Individual mandate
    2. Employer mandate
    3. ACOs
    4. Wellness programs
    5. CMS Innovation Center
  • Provisions Discouraging Innovation
    1. Essential Health Benefits
    2. Insurance exchanges coverage requirements
    3. Cost-sharing funnels buyers into Silver-level plans
    4. Fixing the medical loss ratio
    5. Medicaid expansion

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 database

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.