Brenda Lewis is Principal of Greenwich, CT-based Transactions Marketing, Inc., which provides strategy, marketing, business development, and first round institutional funding for mission critical enterprise mobile systems, software, and services. Brenda has 18 high tech launches under her belt and was responsible for organizing Connecticut’s first ever Mobile Summit for CT NEXT and the Crossroads Ventures Group, recruiting MEA Mobile as sponsor, and tapping the Connecticut Technology Council for event support.
When we think of global healthcare, we tend to think four things: inefficient, fast-growing, costly, and short of MDs.
All those things are true today, but mobile healthcare (mHealth) is rapidly changing that negative equation by putting powerful healthcare tools in the hands of consumers using smartphone and sensor technology. According to Research 2 Guidance, a specialist firm focused on mobile healthcare, 500 million smartphone users worldwide will be using a healthcare application by 2015, and by 2018, 50 percent of all smartphone and tablet users will have downloaded mobile health applications.
The industry is vast; to get a view of the promise of mobile diagnostic and monitoring from a leading physician, I highly recommend a short video about iDoctor and Dr. Eric Topol. Dr. Topol is a leading cardiologist who has become a champion of mobile health solutions. If you have more time, read his book: The Creative Destruction of Medicine: How the Digital Revolution will Create Better Health Care.
Opportunity on the Palmtop
Transparency Research estimates the mobile health monitoring and diagnostic market was $650 million in 2012 and forecasts $8.03 billion revenues in 2019, a compound annual growth rate (CAGR) of 43.3%. The market is segmented into 1) diagnostic instruments and 2) monitors for blood pressure, sleep apnea, cardio, glucose, pulse and multi-parameters. Research 2 Guidance projects the monitor or sensor market alone – in 2013 about 200 different devices – will grow to $5.6 billion globally by 2017 at CAGR of 69% with 61 million sensors shipped. The diagnostic instruments side is smaller but holds enormous promise. The mobile monitoring and diagnostics market contributes the maximum share of revenue, about 85%, to the overall mobile healthcare solutions market, which also includes 100,000 apps in smartphone catalog stores, many free. The majority of these companies are startups.
Venture capital activity in mobile health is soaring. In 2012, $900 million was invested; in 2013, nearly $1.2 billion and in the first quarter of 2014, $310 million. Mobile strategic investors are also active. Formed in December 2011, Qualcomm Life, Inc. aims to connect medical devices wirelessly via cloud-based services to both device users and health care providers. It provides an encrypted, HIPPA-compliant open platform for manufacturers which is registered with the FDA as MDDS.
The company has also established a $100 million fund to invest in wireless health companies. This month Apple announced it will bring third party apps under a common platform called Healthkit, which would enable (as an example) a blood pressure reading app to connect to an MD alert app.
In the New Haven area we have several exemplary young companies in the mobile monitoring and diagnosis market, among them Applivate, whose product ShugaTrak is a glucose monitoring app for diabetics, and Tangen BioSciences, a mobile medical instrument for molecular diagnosis.
Working with the FDA
ShugaTrak‘s mobile app for both iOS and Android smartphones connects via Bluetooth adaptor to the most widely used glucose meters in the US market. Born out of personal family experience, ShugaTrak has very modest monthly fees ($4.99 per month) and is actively seeking new customers. They differentiate their offering with software which provides instant data capture and real-time, cloud-based analytics and alerts for the diabetic end user.
Founder John Fitzpatrick shares some good news for app developers on the FDA regulation side: “FDA regulation of mobile apps was still evolving when we were building the initial version of ShugaTrak, so, as a small startup without the resources to go through an expensive, time-consuming approval process, we deliberately excluded features that might have drawn regulatory scrutiny. Recently, however, the FDA has been more specific about how it intends to regulate mobile apps, stating just two weeks ago, for example, that it does not intend to regulate ‘Mobile apps that allows a user to collect, log, track and trend data such as blood glucose . . .’ We at Applivate welcome this lighter regulatory touch and believe it will speed the delivery of helpful technologies to patients without posing any undue risk.”
Technology that Bypasses Infrastructure
A local representative of the fast growing mobile diagnostics segment of the market is Tangen Biosciences of Guilford. Tangen has developed an instrument capable of delivering cost-effective mobile molecular diagnostics at the point of care anywhere in the world. Today there is no truly portable DNA-based diagnostic device in the worldwide in vitro diagnostics market. Tangen fills this gap with a patent pending technology that enables portable, high speed, sample-to-answer diagnostics that are infrastructure independent, requiring neither lab, power grid, refrigeration, nor highly skilled medical technicians.
John Nobile and John “JD” Davidson formed Tangen in January 2013 and developed both the technology and the prototype instrument, which successfully performed rapid amplification and detection of DNA in April 2013. Tangen’s prototype instrument delivers rapid DNA detection with the same sensitivity of lab-based DNA techniques. Their compact, simple to manufacture, and safely-disposable test kit enables cost-effective high margin production.
The rapidly growing, global in vitro diagnostics industry is projected to reach $36.5 billion by 2018 and includes opportunities for Tangen in food contamination detection, crop and food identification, water quality assessment, bio-defense, and clinical disease diagnostics. DNA-based clinical disease diagnostics alone represented an $8.3 billion dollar market in 2012 according to Point of Care Diagnostic Testing World Markets (TriMark Publications), of which Tangen’s point of care market opportunity for molecular diagnostics is forecast to have a CAGR of 8.7% between 2011 and 2018.
Tangen has initially targeted the diagnosis of active pulmonary tuberculosis (TB). It is estimated that approximately 3% of the global population will at some point become infected with contagious pulmonary TB. In spite of being a highly curable disease, it has a 50% mortality rate, largely due to poor access to effective diagnosis. The World Health Organization (WHO) estimates that roughly $1 billion is spent annually on TB testing, with less than 70% of that testing in the developing world where there is limited access to testing laboratories. Because early detection is critical to stopping this disease, Tangen’s point of care solution is well-positioned to have a substantial impact.
Unlike the monitoring side of mobile medical devices market, FDA regulations are part of the equation for Tangen in the US market. As a result, like many young companies before them, they will launch the product outside the United States and use their early overseas results to accelerate acceptance of the instrument by the FDA.
Keep your eye on these young ventures and others like them as New Haven continues to create a stronger presence in the mobile health arena.