Afflicting nearly 350 million people worldwide, diabetes is a lifelong condition that can be effectively managed, but not yet cured. Prevalence is set to dramatically rise in developing countries, as greater numbers of people adopt a Western lifestyle, with all its attendant consequences. This will place an increasing burden on health systems everywhere, posing a major policy and delivery challenge. Research by the consultancy firm Booz Allen highlights the magnitude of this issue, noting that “diabetes is the most expensive disease cost-wise in the U.S.”, accounting for one-out-of-four of every health care dollar spent. The direct medical cost of treating diabetes is only the tip of the iceberg, with billions of dollars of additional indirect costs incurred due to lost productivity and social welfare support.
Diabetes is also big business. The global diabetes products market was estimated to be over $40 billion in 2010, and is expected to grow to nearly $120 billion by 2018. Blood glucose (BG) test strips alone accounted for $10 billion in annual sales—which is five times the size of the much ballyhooed molecular diagnostics market. But size isn’t everything and all is not rosy for the big manufacturers, as competition and price pressures have ruthlessly eroded margins to the point that some of the major players (eg, Roche, Bayer) are understood to be looking to exit the BG monitoring market.
A market this large facing uncertain headwinds is ripe for innovation and disruption. When a big problem meets a big business opportunity, innovators, investors and entrepreneurs take heed! Indeed, diabetes has inspired many start-ups dedicated to delivering better products and solutions. This is an exciting field, ripe with potential; and one where I’ve been active by leading an investment from NBGI Ventures in Cellnovo, which has developed a mobile diabetes management system (more about this in a subsequent post).
Role of Medical Devices in Patient-Centric Care
Innovation in medical devices—particularly in the areas of insulin delivery and BG monitoring—has played an important role in improving diabetes care by empowering patients and enabling self-care. Diabetes management is a leading area of patient-centric medicine, serving as a validation test bed and exemplar for solutions relevant to a range of other chronic diseases. The goals and methods of the patient-centric care model also align strongly with another powerful medtech trend: the emerging digital health movement that embraces the convergence of mobile connectivity, information technology and data analytics with medical devices and healthcare delivery. Therefore, it should come as no surprise that diabetes is a major focus area for advocates of digital health solutions, as reflected by the GSMA’s (the global industry alliance of mobile operators) prioritization of diabetes in its mHealth initiative for connected living.
The patient-centric care paradigm also respects the importance of product design, usability and patient choice in achieving better outcomes and improved quality of life. A good example of the commercial relevance of this is the rapid adoption of the discreet OmniPod patch pump by Insulet—driven largely by patient preference—at the expense of market share lost by traditional tubed insulin pumps such as the MiniMed by Medtronic.
The appeal of incorporating “consumer electronics” design principles is also visually evident by comparing Sanofi’s iBG Star (a BG meter integrated with an iPhone) with the rather clunky design traditional BG meters:
Perspectives from the recent ADA
Of course, innovation goes far beyond just good product design. At the recent American Diabetes Association (ADA) congress in Chicago, a range of promising approaches were reported and discussed, including improved continuous glucose monitors (CGM), closed-loop pumps integrating CGM feedback (ie, an artificial pancreas), dual drug delivery systems, improved glucagon formulations and even wilder ideas such as engineered/regenerative pancreatic tissue, exercise mimetics and neuromodulation-based therapies.
Neuro-Modulation/Stimulation (NMS) is a particularly interesting field having a broad range of potential medical applications that are just now being explored more widely. A rather conventional application for NMS relates to pain management, which Neurometrix has developed with its SENSUS TENS device for treating diabetic neuropathy. SENSUS is a body-worn transcutaneous electrical nerve stimulator designed to provide symptomatic relief from pain through the excitation of nerve fibers to block transmission of pain signals to the brain (ie, exploiting “gate theory”). An even more novel NMS approach is being pursued by a Metacure with its DIAMOND (TANTALUS) “gastric pacing” implanted stimulation device for treating obesity and type 2 diabetes (T2D) by inducing satiety and, putatively, modulating signaling to the brain, affecting glucose and fatty acid metabolism. This echoes the bariatric approach being pursued by another device startup, GI Dynamics, which has recently raised almost $60m to further fund the development and commercialisation of its orally inserted intestinal liner EndoBarrier that prevents food absorbtion, mimicking the effects of a gastric bypass to treat obesity and T2D by affecting mechanisms broadly underlying metabolic syndrome.
For me, as a medtech investor, one of the most notable commercial developments at the ADA was the emergence of new players in the insulin pump space. Targeting the established market segment of tubed pumps for type 1 diabetes (T1D) patients, Tandem’s t:slim very much embraces the principles of attractive product design and usability. Meanwhile, the V-Go from Valeritas—targeting the nascent, but potentially much larger T2D market segment—is a “cheap and cheerful” disposable insulin delivery device seeking to capture market share from prefilled insulin pens.
In an upcoming post, I will dig deeper into insulin pumps and CGM. For the time being, as a final note for anybody interested in following developments in diabetes, I’d just like to mention a few of the many excellent blogs being written by patients and physicians: