Keynoter highlights medical and consumer device convergence

Boston, MA. Despite a history of significant differences, consumer electronics products and medical devices are converging, according to Bill Betten, medical technology director at TechInsights and a former vice president of engineering at a medical device company. Betten made the remarks while delivering a keynote address titled “When Worlds Collide–Medical Devices Meet Consumer Technology” to attendees of Electronics New England and the co-located BIOMEDevice event on April 11.

Betten is in a position to know because his firm, an IP professional services company, has performed teardowns of more than 50 medical devices over the past two years and has a 20-year history of tearing down consumer products.

Betten described the traditional gaps that have appeared between medical and consumer products, extending from development philosophies to the regulatory environment. For example, consumer devices are designed quickly with manufacturers facing pressure to keep prices low. The medical device community traditionally faces longer design cycles and less price sensitivity.

Nevertheless, the need for low-cost medical devices is becoming increasingly important as aging populations face an increase in chronic disease. As an example, Betten provided data from the International Diabetes Association showing that in 2011 the number of people worldwide living with diabetes was 366 million—a figure estimated to increase to 552 million by 2030 if urgent action is not taken.

A TechInsights and Espicom research report summary describes requirements for diabetes monitoring and treatment: “Successful diabetes management is dependent on being able to accurately monitor blood glucose levels. That requires a range of both clinician and patient devices are accurate, reliable, and convenient. In addition, products that enable simple and convenient insulin delivery are need by the quarter of diabetes patients that are insulin-dependent. The burgeoning diabetes burden represents a fast-growing marketplace for companies who can supply those products.”

Consumer mobile technology, Betten said in his keynote address, has increased in capability to the point where it has a role to play in monitoring and treatment products that can, for example, let a patient move from a $10,000 per day intensive-care unit to a much less expensive assisted living facility. Such products, he said, need to be small, portable, and easy to use. And most significantly, they must be connected to enable remote monitoring—often via the data cloud—by trusted, trained experts.

As an example of the importance wireless connectivity can play in health care, Betten cited the GSM Association's mHealth program, which enlists mobile operators, governments, healthcare providers, funders, and end users to improve health outcomes in emerging markets.

Betten cited several products that exemplify the closing gap between consumer electronics and medical devices: the Withings blood-pressure monitor, the AliveCor heart monitor, and the Sanofi iBGSTAR blood glucose monitor.

He also cited the AirStrip Technologies mobile-technology platform that supports enhanced communication of patient information. In January the company announced that labor and delivery teams using its AirStrip OB have delivered more than 1.4 million babies since the initial deployment in 2006, adding that of the total, more than 2,400 at-risk deliveries have been positively impacted.

The Tandem t:slim insulin pump also serves as an example of consumer and medical technology convergence. That product's consumer-driven emphasis, Betten said, is apparent in its small size, color touch-screen display, rechargeable batteries, USB connectivity, and unobtrusiveness. “It looks like a phone—not a pump,” he said.

Betten presented a bell curve, with medical device manufacturers occupying one tail while consumer electronics makers occupy the other. The later pursue low costs, less-than-one-year development cycles, open-source software, moderate reliability and security, and volumes in the millions. The medical companies, on the other hand, find less price sensitivity. They pursue differentiation through proprietary software, experience three- to five-year development cycles, require high reliability, maintain security in accordance with HIPAA patient privacy mandates, and reach volumes of about 1000 to 1 million units per year. He added that 2.8 million hearing aides were sold in the U.S. last year, calling that a huge number for a medical device.

But, Betten concluded, while some manufacturers will operate at the bell-curve tails, there is a huge battleground in the middle in which both medical and consumer manufacturers will participate. “Convergence,” he said, “is changing both worlds.”