Is That Car a Medical Device?

By Daniel R. Matlis

As wireless technology began converging with Health Care and consumer devices, the Wireless-Life Sciences Alliance (WLSA) was organized to bring together business leaders and researchers in Healthcare and Technology. WLSA’s mission is to improve access to affordable high quality healthcare, globally, by accelerating innovation in wireless connected medical devices, services and applications. WLSA focuses on identifying collaboration opportunities within the wireless health and consumer sectors. As a result, members of the association represent a very diverse group of companies including AT&T, Qualcomm, CareFusion, Johnson & Johnson, Procter & Gamble, Ascension Health, Sanofi, 3M and California Healthcare Foundation.

I recently had the opportunity to speak with Robert B. McCray, President & CEO of the WLSA, to discuss the impact the convergence of medical technology, connectivity and consumer devices is having on the delivery of healthcare. Mr. McCray has over 25 years of experience as a business owner, senior operating executive, legal and transactional advisor to private and public companies including the Healthcare industry.

A crucial area for the applicability of this convergence is the management of chronic diseases such as asthma and diabetes. “The first challenge here is how you capture the information needed to manage chronic disease in a way that’s really effective.” said Mr. McCray. “This quickly drives you toward a discussion of how to gather these data more passively, kind of ‘invisibly’ to the consumer.”

A great example of the use of convergence to support this challenge is Ford’s In-Car Health and Wellness Solutions. Researchers at Ford, in partnership with Medtronic and WellDoc, have developed a series of in-car health and wellness apps and services aimed at monitoring people with chronic illnesses or medical disorders so they can manage their condition while on the go. Ford leveraged SYNC® and its ability to connect devices via Bluetooth, access cloud-based Internet services and control smartphone apps, to develop voice-controlled in-car connections to an array of health aids from glucose monitoring devices to diabetes management services, asthma management tools and web-based allergen alert solutions.

“We had one of the cars on site at the Wireless Health 2011 Conference last month” Mr. McCray noted “We’re using the announcement that Ford made with Medtronic and WellDoc about their connected car with the diabetes and asthma applications as a focal point, since that’s the first time they’ve shown it in public.” At the conference, Ford’s senior technical leader, K. Venkatesh Prasad, discussed these innovations on a “Health and Wellness Connectivity Services on the Go” panel discussion with Anand Iyer, COO of WellDoc, and H. James Dallas, SVP at Medtronic.

The announcement begs the question: Is the Ford Car a medical device? “As much as the question is fun to ask, I am sure that Ford will not market the vehicle as a 3000-lb. medical device. It is an example of creative thinking applied to the problem of how to gather information when convenient for consumers,” said Mr. McCray. (see The Inside Scoop on FDA Healthcare IT Regulation )

According to Mr. McCray, the Healthcare industry needs to “take advantage of the consumer electronic technology to drive costs down through volume and by using existing tools, such as phones and global wireless systems, and really repurpose existing technology to meet healthcare goals.”

Mr. McCray also pointed out that “healthcare and medicine are moving very rapidly from analog to digital systems. In every other sector where this shift has happened, it has transformed the sector. It is my analysis that fundamentally, knowledge makes purchasers more powerful. This drives down the costs of knowledge and decreases its value to incumbents. For healthcare, I translate that into the value of diagnoses declining rapidly and freeing up more time to be spent on therapeutics and treatments, which is going to lead to really happier customers.”

I asked Mr. McCray: What does he see as barriers to the implementation or adoption of these technologies, whether they are Regulatory, cultural, usability, interoperability or others? What are the kinds of things that he sees hindering adoption?

According to Mr. McCray, “The key barriers are institutional. They are partially due to regulatory structures such as the control of professions over licensure and the state-by-state regulatory system that we have with respect to healthcare services. Professions don’t like competition. There are opportunities to rationalize how you deliver services and deliver diagnoses, but you can’t cross state lines if there are professions involved. And then, the FDA, too, is concerned about the potential that the technology will have on public health or the potential of bad publicity because someone home alone didn’t get the signal on her monitor. If they are worried about that and don’t let that kind of device go to market or make it really expensive, then we are just not going to realize the potential benefits. You can have the best technology and the life science know-how bundled up, but if you cannot figure out how to engage the consumer, it simply will not work and your market will not develop.”

There is certainly a revolution going on in healthcare, with the converging capabilities of technology and knowledge and the ability to get it out there. There are already wireless health applications and products in the market today that are saving lives. According to Mr. McCray, “They are not on a separate revenue line. The best example that I am aware of is what Medtronic, Boston, and St. Jude have done with their implanted defibrillators and their monitors.” A study involving patients with implanted cardiac defibrillators demonstrated that the five-year survival rate for patients followed up with only in office visits was 50 percent lower than for patients who were followed up on the network using a connected bedside monitor. (Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up; The ALTITUDE Survival Study. Leslie A. Saxon, MD; et al.
Circulation. 2010; 122: 2359-2367 Published online before print November 22, 2010, doi: 10.1161/CIRCULATIONAHA.110.960633).

We concluded the interview with Mr. McCray’s forecast on this trend.
“We have the opportunity to move the needle on the key issues of access to care, access to affordable care, and access to quality care on a global basis. It’s the biggest business opportunity in the world and the biggest need in the world. And that comes out of five billion cell phone subscribers or more, six or seven billion people on the planet in range of cell service, even if they don’t have their own phone. This is the biggest distribution channel that’s ever existed. With the digitization of content, to and from devices and people, we can take advantage of that distribution channel and use the knowledge that has been built up in the U.S. and other research centers in rich countries and apply it to billions of new people around the world. Price, where they can afford it, is going to make care and services more affordable in the rich countries that need it due to the economic conditions and budget challenges that we are all facing. So to me, it is the biggest thing in the world, and it is a problem that we can actually tackle. Clean water is something that billions of people in the world need, but there’s nothing you can do globally to tackle clean water. You just have to knock that out neighborhood by neighborhood. But with healthcare, powered digitization and wireless connectivity converging, we can actually move the needle and tackle markets of billions of people. That’s pretty exciting stuff. If I were thirty years old, I’d pick this sector again. More fun for the next thirty years than the last, probably.”

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