Can the FDA and MedTech Work Together?

Medical technology is advancing at an accelerated rate as patients seek cheaper, more sophisticated, long-term options for healthcare. But as MedTech develops, the U.S.’s Food and Drug Administration (FDA) is a big barrier to success for many MedTech firms.

In fact, as of February 19th of this year, the FDA removed more than 2,500 MedTech firms from its active registration database. That brought the number of MedTech companies down to less than 25,000 registered organizations. What can be done to improve the relationship between these two extremely important entities?

Big Help or Big Brother?

To help innovation, the FDA should be focused on creating an open, safer space where industry leaders can comfortably speak up about issues facing their companies. But this is difficult to do when most MedTech companies view the FDA as more of a policing figure than a guiding mentor. In turn, the FDA must work harder to open a discussion that everyone can join in.

Garth Conrad, Vice President of Quality for Bard Peripheral Vascular and Bard Biopsy, remembers how bad it was in 2011. “Back in 2011, when compliance was the key focus, you got in those meetings and nobody in the industry wanted to talk… Because the challenge was, if we open our mouths, they’re going to know we’re not compliant, we’re going to tell them we have problems. We can’t do that, it’s the FDA.”

Standing on the Shoulders of Giants

Conrad contended, though, that after the larger MedTech manufacturers broke the silence, every company felt safer speaking up. He recalls, “There was this general feedback that was coming from the industry that we want to improve quality; however, everything we’re focused on from a regulation compliance standpoint really inhibits us from truly driving after the quality improvement of our products.”

As a result, the FDA finally heeded the experts’ and leaders’ concerns and began to push for quality, rather than compliance. It also prioritized transparency and stakeholder engagement.

It Takes Two to Improve

On the other side, MedTech companies need to meet the FDA halfway and follow regulations put into place in order to remain in good standing with the FDA and the federal government.

Why did so many companies get dropped off the list of active entities this month? Because they’re not keeping up to date with their registrations. In fact, the FDA gives MedTech companies 2-3 months of leeway after the deadline, but many companies don’t bother with renewing their annual registrations.

Entities established outside of the U.S. must designate a U.S. agent for FDA communication. If the agent does not confirm the designation, i.e. the company lied, the FDA will remove the offending companies from their active list. If any of the unregistered or falsely registered companies try to continue marketing their product in the U.S., the FDA is liable to enforce the appropriate punishment. So, MedTech companies: don’t bite the hand that feeds you.

Rebuilding a Bridge Once Burned

To address this quandary, the FDA recently started a pilot program, dubbed the “Medical Device Discovery Appraisal Program” (MDDAP), to review quality standards for the patient’s benefit. It allows for minimal business interruption as the FDA pokes around and offers insights into what can and should be adjusted for compliance and quality control.

Edwards Lifesciences is one of the first companies to participate in the program; the MDDAP’s compliance audit cost the Toronto-based developer of medical equipment nearly $75,000, whereas it normally costs $140,000. That’s a reduction in cost of almost 50%.

This new program demonstrates that cooperation between the FDA and MedTech industry can not only exist but actually reduce costs, save time, and generate positive, lasting relationships for everyone involved. As is the case with most conflicts, opening a broader dialogue that allows both sides to be heard as well as speak is key to burying hatchets. And in this case, keeping that dialogue open is essential to innovation that could save lives.