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Et Tu, FDA? Why Medtech Needs to Stop Feeling Betrayed by the FDA

Posted by Brian Chapman on October 31, 2018



2602_Brian_Et_Tu_FDA_blog_image-877634-editedFor shame! How could the FDA approve a silly touch screen watch to do the job of serious cardiologists—and rush it through the approval process, too? How could a high-end stereo-equipment-maker suddenly become a supplier of medical devices? And then there’s the notion that this device could be fitted without the help of a qualified professional!

Joking aside, now is an important time for the FDA and non-traditional entrants from tech and consumer products entering the healthcare market. I’ve written before about the thoughtful approach that the FDA is taking to encourage innovation while maintaining its mandate. We've talked a lot about the FDA and the Apple Watch, but what might be even bigger news is the Bose hearing aid that flew under the radar.

What’s significant with the Bose development is the decision to allow fittings to be done without a licensed professional, even if some questions remain regarding distribution. Intuitively, it’s reasonable that the fitting process could be automated since it’s essentially an algorithm executed based on user feedback, but the notion of removing the paid professional from the process is an important development. Could this happen in vision care? That would be no small development, at least for the U.S. market, and it’s easy to imagine other areas in medical devices and diagnostics where this encroachment could continue.

At the moment, the response from the medtech industry is indignation with a pinch of disdain. There’s a meaningful gap between what’s currently being offered by the incumbents and what has been cooked up by the disrupters. It’s easy to view this chasm as a defensible moat around the status quo of medtech companies, providers and payers. And indeed, this moat might deter poorly funded startups that focus too much on the product and not enough on consumer and go-to-market strategies. But I would argue that like many seemingly impassable moats of the past, time, money and persistence will build a bridge.

Beyond thinking about defensive strategies, of which there are several important ones, I think there are some bigger implications for medtech. First, we need to stop acting as though tech interest in healthcare is a passing trend, or that regulating bodies and payers are betraying us in choosing to interact with, approve and take seriously these innovative disrupters. Many won’t graduate from toy to tool and become legitimate, and plenty others will only access the consumer health space and never get to the big money controlled by payers. But the barbarians are at the gate, and they aren’t planning on leaving the kingdom without some spoils.

Second, we need to realize that while the FDA is an important ally in our quest to improve patient lives, the organization also is an important facilitator of innovation in a vibrant health economy. The FDA shouldn’t be thought of in simple terms of friend or foe, and we certainly need to get over the feeling of aggrievement and betrayal when the FDA approaches entrants with a reasonable amount of warmth when their mission aligns. This isn’t a battle to fight with lobbyists and lawyers. If we learned one thing from Uber and AirBnB, government agencies struggle to protect incumbent regulatory monopolies in the face of overwhelming public demand.

The most important takeaway for me, though, is what it says about patient strategies for medtech. Many medtech companies have what they call a “patient strategy.” They do patient research. They have websites. They make brochures. Some will consider patient awareness and demand for their technology in market development strategies. Companies with a patient-facing component of their product will look at engineering form factors for the patient, like how to avoid claustrophobia in an MRI or a color touch screen for an insulin pump, but I would argue that this is only a small step in becoming patient-centric. Most of these strategies are about using patient preference to ultimately influence physician preference.

Instead, we should be asking why consumer product companies are making headway. I would argue that the biggest lesson we should be taking away is how consumer companies are able to remove barriers to adoption. Often, patients are reluctant to enter the big scary healthcare system, with all the fears, costs and complexity that come with it, but consumers are willing to take more modest steps when they’re offered. This makes the distinction between consumer and patient an important one, not only just between who’s paying but also how individuals think of themselves.

In the end, what we in medtech need to learn from recent developments is just how much improvement companies need to make when it comes to patient centricity. The patients aren’t merely another stakeholder to influence the clinician choice—they represent a critical decision maker, a propulsive force in seeking care and even a source of revenue. In short, the onslaught of consumer tech companies needs to provide medtech the much-needed catalyst to overhaul patient strategies.


RELATED CONTENT 

BLOG POST: The Apple Watch Wake-Up Call

BLOG POST: It's Time for Medtech to Turn Digital


 

Topics: medtech, medical devices, FDA, Apple Watch, Apple, hearing aid, Bose, healthcare marketplace, medtech startups, go-to-market strategy

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AUTHORS
Brian_Chapman_thumbnail
Brian Chapman
Principal,
ZS Associates
Tobi_Laczkowski_thumbnail
Tobi Laczkowski
Principal,
ZS Associates
Will_Randall_thumbnail
Will Randall
Manager,
ZS Associates
Matt-Scheitlin-London_thumbnail
Matt Scheitlin
Associate Principal,
ZS Associates
Andy-kach_thumbnail
Andy Kach
Associate Principal,
ZS Associates
Bhargav_Mantha_thumbnail
Bhargav Mantha
Associate Principal,
ZS Associates
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