The market for consumer grade home/mobile devices will look very different than the market for medical devices, and we’re already seeing evidence of this. These technologies promise disruption, not migration.

For example, take a look at remote patient monitoring (RPM) technologies. Almost all the companies in this field are start ups, not medical device companies that see a down market opportunity. In fact, it’s just the opposite – the medical device companies generally see RPM as disruptive of their existing business models.

Today RPM is still largely in a medical model – used mostly by home health agencies or disease management companies, with recommendations for use being made by someone in the medical system. Pricing for individual units can be as high as $7-8K, but there is already tremendous pressure to reduce prices.

Where is RPM technology headed? Many of us can foresee the day when a home RPM system will be purchased by the patient at Circuit City or Best Buy, and the price will be around $500. It will be plug and play with your PC or your digital home network. The more visionary RPM companies are already designing their systems for this scenario.

The key point to recognize is that consumers will be using these devices for different purposes than people in the medical system. Doctors need a device that is accurate enough for diagnosis, but consumers in many cases will need a device for helping them to look for trend patterns, to help with self management and behavior change, and to provide feedback about whether changes in their behavior are resulting in biometric changes. In Harvard Business School professor Clay Christensen’s vernacular, the technology that in many cases is “good enough” for consumers understandably won’t be “good enough” for doctors or nurses.

You raise at least two key questions regarding accuracy and the role of validation. I agree that accuracy isn't as salient, but some form of validation seems important regardless of consumer interest (think profitable herbal supplements and other well-known snake oils as cautionary tales), though maybe consumer interest can jump-start RPM ahead of rigorous validation.

In either case, validation seems more important than accuracy. Accuracy implies that there is a direct apples-to-apples comparison to be made, but perhaps there is no way to directly compare the ‘accuracy’ of blood pressure measurements made twice a year in a doctor’s clinic by a licensed professional versus blood pressure measured 400 times a year in a home by a layperson. Or no way to directly compare the ‘accuracy’ of a sleep study performed in a sterile hospital lab versus a simpler sleep study performed at home. Is it unreasonable to make the analogy to measuring an astronaut’s weight on the moon using a scientific balance scale versus measuring his weight in a bedroom on Earth using an Acme scale? More important is the following: what does the new technology do in terms of patient health and quality of life, and how much does it change costs? And, from the stand-point of a physician and researcher, I think either requires careful validation.

Some more conjecture: in the near-term, connected health will only reduce costs for those conditions in which the alternative involves expensive, intensive healthcare resources. Candidates include preventing CHF decompensations, early home convalescence post-hospitalization, and sleep studies at home rather than a night spent in a hospital suite. Cost reductions for other applications of connected health, in which the benefit materializes years later, will take more time and energy to validate.

Better and more economical healthcare through connected health will occur as the underlying technologies mature. Specifically, devices will become more reliable in uncontrolled environments (e.g. outside traditional health care). For instance, imagine a ‘smart’ blood pressure cuff that ensured it was being used with proper technique. Interpretive computerized algorithms will become more effective at processing large volumes of data, automatically discarding unreliable measurements and detecting important but subtle trends in the data. Adjustments of therapy will become more and more autonomous of the caregivers (using, for instance, automated computer algorithms). The key to a successful launch of connected health is to identify and deploy those niche applications which will be effective given today’s technologic capabilities (and legal liability environment), and let these early efforts drive technology forward until many new applications become attractive. I think that the Programs and Initiatives detailed on this website are an excellent set of projects with which to begin.

I think one of the underappreciated requirements of consumer based RPM is that there actually be a sense of "connection" between self-management activities and the care delivery enterprise. That enterprise doesn't need to be the traditional doctor driven model, and can be comprised of educators, mid-level practitioners and even others with similar medical conditions and concerns. Physiologic data collection isn't an end, its a beginning. I suspect that the vast majority of patients will only find this of interest if it also includes connectivity to some reliable source of "partnering" for care management. I suspect that "communication" involves more than just the exchange of information. It also includes the building and maintaining of complex relationships where roles, responsibilities and expectations are both implicitly and explicitly developed and maintained. It's only then that we can achieve the ultimate end goal of communication, which is the coordination of effective action. If this hypothesis is even partly true, then we need to be thinking as much about process re-engineering on the provider side (including changes in provider education and reimbursement) as the RMP capabilities of the device technology in the patients homes or workplaces per se, in order to ultimately experience the benefit that these technologies potentially offer.

While there are and will be "consumer" markets for accurate body monitoring products, there is a somewhat separate issue in my mind. Compliance is a chronic problem across all of healthcare and body monitoring (either for diagnosis or as part of an intervention) is by no means immune to this issue. One of the biggest reasons to make a body monitor "consumer grade" may have nothing to do with releasing the manufacturer from the accuracy obligations of a medical product. Instead the "consumer grade" may be an additional requirement added onto the marketing specification for the product that demands a high degree of friendliness to the consumer for the purpose of improving compliance. In the extreme, this may involve not only better physical design and interaction design of the product, but actually giving some of the monitored information to the patient so that he/she feels empowered about wearing the monitor, thereby further improving his/her compliance.

These posts all highlight various nuances of the challenge of integration of consumer devices into health and health care. Our experience with willingness to pay has been that consumers spend on wellness and alternative medicine, but that patients feel their insurer should cover all costs. Thus, it'll be interesting to see if Vince's vision of a $500 device will get market traction and when. I fully agree that physiologic data is only one part of the overall successful self management picture (neccesary but not sufficient) and that connectedness is an important part of success. Andrew's reminder that accuracy and validation are two very seperate matters is well worth emphasizing. Astro's comment about the consumer grade part being about compliance is also well taken.

I still worry about the trend I see of large companies getting into the monitoring marketplace through consumer channels in an apparent effort to make an end-run around the health care system. Seems like the FDA and convincing reluctant physicians are business goals that are too lofty and long term.

The problem is that we in health care (or sick care, if you will) need the technology most. The growth curve for chronic illness is far outstripping the capacity of providers. We must adopt a different care model and technology can be an important part of the solution. We look forward t continued dialogue around this difficult challenge.

The challenge I see is getting the large companies and the healthcare system to work together on standards and guidelines. I'm not sure what the motivation is for large companies to do that. The market for self-monitoring devices is huge and consumers will buy what they afford, have easy access to and is sexiest. I believe this new and growing industry must be invited to become part of the clinical discussions with a fresh approach to what constitutes healthcare or even "sickcare" as you noted, Joe. We will be sponsoring a health & fitness pavilion at the ATA meeting for the first time this year, Astro Teller is keynoting the opening session and our president-elect has identified consumer healthcare technology as one of his priorities for the coming year. I think that indicates how seriously ATA continues to feel this topic is. While the discussion was begun two years ago with Joe Kvedar's presidency, I think we are all surprised to see the extent to which this topic has emerged front and center in such a short time.

Joe’s article and the interesting discussion it has provoked has centred around the idea of the consumer as a driver of a future healthcare market. I wonder if there might be benefit in a reflection on what drives consumers to consume and what suppliers need to do when they do so, and in large numbers. Henry Ford’s use of advertising to stimulate people to want something they might otherwise not have wanted is credited as bringing about the birth of consumerism. He moved us on from the idea of the customer – whose needs are met – to the idea of the consumer - whose needs can be stimulated to want things that organisations produce. It worked - and Ford met the huge demand that followed through industrial scale, standardised production units.

Medicine has so far mainly been about meeting ‘customer’ needs that arise without much stimulation – we get sick and people help us. Stimulating and meeting consumer demand in the healthcare sector is a whole new ball game and the winners will probably be those organisations that can create demand and respond through mass production. As for standardisation, I think we can expect this to happen. Interoperability has been an essential element, for example, in the exponential growth of the telecoms market and I believe it will be one of the main drivers for uptake of new products and services in the healthcare sector. ‘Consumer grade’ medical devices will possibly be poor cousins of medical grade devices but they will connect better to each other and will be easier to use. Others will have no counterpart in existing medical practice and will take us into a brave new world of healthcare consumerism – Henry would have been delighted!