Just a few short years ago, a four letter word in the medical device industry was actually a three-letter acronym — FDA.
Back then, FDA reviewers were, rightly or wrongly, asking multiple questions even in the so-called fast track 510(k) submission route, delaying product clearance timelines and frustrating venture capitalists. Stung, medical device companies cast their eyes across the pond to greener pastures: Europe where product clearances were far easier. And in droves companies began introducing their products there.
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That pendulum has now appeared to swing back in the direction of the U.S., at least as far as innovative, new products go. That was the message that panelists presented to the audience at the Wilson Sonsini Goodrich & Rosati (WSGR) Medical Device Conference in San Francisco on Friday.
How is America at the forefront again?
Well, it appears that EU regulators are taking a page out of the FDA playbook and asking more questions about efficacy, a departure from past convention.
“Now, I actually think the new regulations that will take effect in a year or two [in Europe], they’re going to lengthen both clinical trial requirements and approval times,” said Edwards Andrle, senior vice president, new ventures and business development, LivaNova. ”
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As a result of the impending regulations and other factors, EU has become a lot less certain for device entrepreneurs looking to snag a quick and easy CE Mark. At the same time that EU has become difficult, FDA has become far more predictable.
In fact, the agency, which one conservative regulatory attorney once derided as the mercurial and fickle Queen of Hearts character from Alice’s Adventures in Wonderland, has made strides to help companies introduce innovative products first in the U.S.
“They’ve got this Early Feasibility Study now that they are offering companies that are doing first-in-man [trials] in the U.S.,” Andrle explained. “While the times to approval and the clinical trial requirements are still long, I would say the U.S. path is more predictable now so you know what you have to do and you know with some certainty what you have to do.”
Another speaker amplified Andrle’s comments.
As an example of how FDA’s Early Feasibility Study protocol works, Sabir Rassiwalla, manager of venture investments, Abbott pointed to the product being developed by Tendyne, a company that Abbott acquired in 2015. Tendyne is one among several startups swallowed by the likes of Abbott, Medtronic and Edwards to develop a viable transcatheter mitral valve replacement product.
“We are using the Early Feasibility Study protocol right now and will use that eventually for a CE Mark,” Rassiwalla said. “The number of U.S. patients and the patient experience in the U.S. has been far faster and more expedited than what we are seeing in Europe.”
He added that the competent authorities in Europe are asking more questions about efficacy than they have done in the past. That has led to some consternation.
FDA has done more than just work to encourage innovative products to be introduced in the U.S. first through its EFS program. It is also coordinating with the Centers for Medicare and Medicaid Services, Andrle pointed out.
All of which is making the industry look anew at the U.S. It may not be too far in the future when a favorable regulatory environment means that many companies will exclusively pursue an America First policy.
Photo: MarianVejcik, Getty Images
