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Medical Electronics – Will Fall 2013 FDA mHealth app ruling spur the next bounce?


The expansion and growth of medical electronics hold many promises for real positives to significantly improve human health care reach and treatment, alongside of opportunities for industry growth, both for the medical and for the semiconductor and electronics industry. However, while medical electronics have been well received by consumers thus far, there is a long way to go still and there remain notable challenges to this still emerging field and sector.

Are mHealth apps the growth portal?

Alongside of the rapid adoption in smartphone and tablets over the recent few years, has come the expanded use cases for these devices. Among the most disruptive of these new use cases, one can easily make an argument for mobile health (mHealth) applications (apps) for collecting biomedical information about a patient, in both in- and outpatient settings. Between skyrocketing healthcare costs, lengthy delays in seeing medical professionals, as well as providing needed care to patients in remote and rural locations, mHealth apps hold an exciting potential for solving health care problems and maximizing the capabilities of the latest hardware and software in the hands of consumers, who are also patients.

The opportunities for mHealth growth are seen as rather significant with an estimated compound annual growth rate (CAGR) of 61% by 2017, reaching a market size of US 26 billion, according to recent research by Research and Markets. This growth is seen as occurring in tandem with the smartphone and tablet market and is understood to represent the second growth phase of mHealth app growth, commercialization, according to the same report:

The general sophistication of today’s mHealth applications is low to medium, and many of the mHealth categorized applications provide a limited benefit for patients, doctors and health interested smartphone users. Nevertheless, advanced solutions do exist.

[…]Five years from now, the mHealth market will be a mass market with a reach of billions of smartphone and tablet users. By that time, 50% of these users will have downloaded mHealth applications.

[…]This growth projection is based on the assumption that private buyers will continue to be the primary spenders in the next five years, but that the integration of mHealth applications into traditional health care systems will become more and more common (integrated phase) during that time.

As a recent article in InformationWeek Healthcare noted, " In contrast, 11% of cell phone users and 19% of smartphone users had mHealth apps on their devices in 2012, according to a Pew Internet survey."

Real challenges persist but are surmountable

But there've been a few challenges to all this promised growth: standards, acceptance, adoption by health professionals, and secure data collection questions, to name just a few hurdles. While consumers adopt mHealth apps, being able to actually use the data collected in a medical (versus a fitness or self-monitoring) situation is proving more challenging. The problems stem from questions of liability and the veracity of the mHealth app data collected, should a medical decision be made or influenced by these data. But even this data liability and veracity challenge is a bit farther down the road.

Before event getting to a question of use, there are issues of standards and regulations for collection and transferring these data into mainstream healthcare applications, as the InformationWeek Healthcare article rightly underscores. Noting further that this Fall, the US Federal Drug Administration (FDA) is supposed to provide its ruling "on the use of mHealth apps as medical devices. Some observers view the absence of the FDA regulations, expected to arrive this fall, as a deterrent to investment in apps designed for people with chronic diseases." Once there are FDA regulations, the opportunities and gains from mHealth app use is likely going to first be pushed by healthcare insurance providers who will see the cost benefits to monitoring and preventative care for patients, and provide significant impetus to medical professionals to increase adoption and integration of FDA approved, mHealth data collection methods.

As noted by many in the industries, the question of significant mHealth app adoption, and therewith an increase in medical electronics for remote patient monitoring, rests with the question of the data – will this be a cloud service? How will these Big Data sets be collected, maintained and accessed? These are real questions that are still being addressed in the medical electronics sector. The answers hold promise for all of us as patients and care givers, but also from a business perspective there is promise for innovative and sustained growth for medical electronics and the supporting markets of hardware, software, networking, and servers, to name just a few.

One interesting note regarding the momentum in mHealth is that it has been a very patient/consumer driven growth – a pull chain – when there is greater acceptance from healthcare insurers and medical professionals, then the real tipping point for significant and rapid growth will take hold. Will that occur by 2017?

Lisa Ann Cairns, Ph.D.
Written on Tuesday, 13 August 2013 21:32 by Lisa Ann Cairns, Ph.D.

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