Technalysis Research
Previous Guest Columns

June 2, 2014
RIP, Device Operating Systems

April 4, 2014
Opinion: A new era for Microsoft?

March 5, 2014
Commentary: The smart wearables debate: Fashion vs. function

February 22, 2014
Commentary: The battle for the first log-in of the day

January 30, 2014
Commentary: The tablet market is slowing -- long live the smartphone

January 10, 2014
Commentary: Hardware companies try to reinvent themselves

TECHnalysis Research Guest Column

October 14, 2014
The Wearable Challenge

FOSTER CITY, Calif. -- One of the key goals of any consumer product is to improve over time. Whether it's faster performance, enhanced features or greater ease-of-use, companies are always striving to make their product better than their competitors', better than their own preceding model, or, hopefully, both.

In that light, the consumer wearables market is starting to find itself in a bit of a conundrum. Even though most industry observers would agree the current crop of wearables have a long way to go on many different levels, there's a very interesting dilemma they are likely to face on the not-too-distant horizon: becoming too accurate.

I'll explain what I mean shortly, but first, some context.

I had the pleasure and privilege of speaking on the wearable market at the USC School of Medicine's 8th annual Body Computing Conference in Los Angeles this month. Throughout the course of the day's many interesting presentations and discussions —which focused both on professional medical device technology as well as consumer-focused products — it dawned on me that there are similar needs that these diverse, but related markets are trying to meet. Essentially, the goal of both is to try and provide individuals with useful, accurate information about their bodies and health.

The big difference is medical device makers have to go through a rigorous, government-controlled regulation process that, in the U.S., for example, is controlled by the Food and Drug Administration (FDA).

FDA approval often takes many months, or even years. For medical device makers who live in a market where it's a requirement, there's little need to question that time frame or worry about it when it comes to product planning because that's just how things work. The benefit of all that pain is a higher quality output that's been put to the test by medical professionals.

No regulation in the consumer electronics market

In the consumer electronics market where wearable devices play, on the other hand, it's a different story. First, there is no regulation, and no one has to "prove" the validity of their data. Plus, even the thought of adding several months to the product development and release cycle is anathema to the device makers because their standard way of working would have them moving onto a next-generation product before a regulated product would even get through the first stages of approval. As a result, most consumer electronics makers strenuously avoid the possibility of regulation.

That brings us back to our challenge. The logical conclusion of where many wearables devices are now headed is to give consumers data and sensor readings that are as high quality as a commercial-grade, regulated medical device can. In fact, many device makers and sensor providers are working hard to improve the quality, accuracy and range of information that their devices can offer.

When (not if) they succeed at these medical grade improvements, both wearables market vendors and regulatory bodies, such as the FDA, are likely to face some difficult questions. What data can I trust? Do I need to purchase a medical device when a consumer-friendly device is just as good? These are just a few of what are bound to be a series of challenging issues posed by these improvements.

One important point to remember in this discussion is regulations exist on medical-grade devices for a good reason. The data they generate is often used to make very important decisions about medical treatments and other diagnoses that can have a profound impact on a person's health or even life. (In fact, it's around diagnosis-quality data where the FDA currently draws the line between regulated and unregulated devices.) So, it's not likely that we're going to suddenly see any kind of major rollback on medical regulations, nor, given the potential consequences, should we.

Given many people's interest in moving towards more self-directed health care, especially with all the costs and challenges that the U.S, healthcare system currently faces, this sets the stage for what are bound to be some very interesting and important debates about how far non-regulated, consumer-focused wearables can and should be able to go.

As with many healthcare-related concerns, the answers to these questions won't be easy nor are they likely to make everyone happy. But there's no doubt that the time to start answering and debating these questions is now.

Bob O'Donnell is founder and chief analyst of TECHnalysis Research in Silicon Valley.

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