This is a guest post by medical technology entrepreneur Chase Curtiss
Healthcare is undergoing an unprecedented shift in technology adoption.
Innovation that has made digital health one of the hottest tech trends. The market is expected to grow from $20 billion to over $50 billion by 2018 and investments in digital health have also dramatically increased over the last 24 months. Everyone is building products in the digital health space from activity trackers to mobile diagnostics, with very little understanding of the industry and the role of its gatekeepers. The best known gatekeeper is the Food and Drug Administration (FDA), which has been front and center in the growing conflict over the role of regulation in digital health.
The FDA recently took on one of the darlings of the digital health industry, Google-backed 23andMe. The FDA warning letter very clearly spelled out the frustration with the claims 23andMe had made in marketing their product and the complete lack of “any evidence that it has tested the accuracy of (the product).”
Related: Read our in-depth analysis about the dispute between 23andMe and the FDA here.
The outrage over the FDA’s treatment of 23andMe is the wrong response.
We should be holding 23andMe accountable for the claims they make in marketing their product. Even a product with such great potential should have to support its claims with valid evidence.
23andMe is not an isolated instance. Companies marketing products without the proper clearance are happening all over the digital landscape from prestigious institutions like the Cleveland Clinic (with concussion assessment mobile products that have dodged regulation to get to market for a quick profit) to small development outfits wanting to cash in on blossoming field.
What is often forgotten in the bashing of the FDA, is the vital role the organization plays in ensuring the safety and efficacy of medical products to consumers as well as to healthcare professionals. The FDA doesn’t hold extremist views; it isn’t difficult to work with and can help companies adhere to the appropriate standards.
A recent exchange with Congress over the Software Act, an attempt to remove the FDA from the digital health industry, showcased a level headed and reasonable approach from Dr Jeffrey Shuren of the Center for Devices and Radiological Health:
Simply because (medical devices) got smaller and I can pick it up and walk out of the room with it, doesn’t change the risk to the patients. Why for that reason alone would we treat it differently?”
This statement exemplifies the misconception about the FDA’s role in regulation. It doesn’t exist to stifle innovation. The FDA exists to ensure the proper marketing of safe and effective products, no matter the platform for distribution. This distinction is critical when you evaluate the future drivers of digital health, which will be centered on the prescription of digital health solutions through the medical provider and not simply purchased by the consumer. The motivation and oversight of your medical care team will be the single greatest driver to adoption and adherence necessary for the heralded “disruption of healthcare.”
Without the regulatory clearance of a product, very few healthcare systems will allow the use of a digital health solution. Smaller healthcare providers on the other hand have started dabbling in tech-driven solutions without assurances of a quality system or any credible validation.
Those driving the attempt to deregulate digital health are actually doing more harm than good for future generations. Instead of supporting the FDA and pushing Congress to support a streamlined review process, the tech industry’s approach to digital health has been to discredit, ignore, and vilify the gatekeeper.
The direct disregard of the necessary regulatory oversight needed to market medical products will lead to an increase in malpractice lawsuits, which will set back the much-desired innovation in healthcare technology.
By simply embracing the FDA, and meeting the completely realistic standards, digital health companies can help spark widespread adoption of digital solutions in health care systems. This embrace of regulation could unlock opportunities to build new software products for a wider range of providers.
A simplistic view of the decision process on whether to seek FDA clearance:
“Leaders who wrestle with what’s best vs. simply what’s financially feasible/profitable.”
– John Schumann, MD @glasshospital
All too often our mindset shifts towards that latter and instead of better understanding the barriers, we choose to dance around them in the hope of short-term gain.
Chase Curtiss is a healthcare entrepreneur and clinical exercise physiologist with internationally published research in biomechanics and human performance. Chase currently serves as the CEO and Founder of Sway Medical, a mobile health startup with an FDA-cleared platform changing the way healthcare professionals monitor conditions that alter balance. Follow him on Twitter @SwayMedical
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