[Editor’s Note 1: This is the second of a two-part Essenvia Insights story on the interplay between MedTech regulation and medical device innovation. Read Part 1 here.]

[Editor’s Note 2: Three regulatory experts interviewed for this two-part series – Carrie Kuehn, Steve Silverman, and Jay Vaishnav – will be panelists at a July 31 Essenvia roundtable webinar, “Shaping the Future of MedTech: Insights at the Crossroads of Regulation and Innovation.” Register for this free event now!]

When Jay Vaishnav talks about the intersection of MedTech regulation and medical device innovation, one can’t help but think of a driving instructor tasked with describing the aftermath of a collision. Specifically, her words evoke the acceptance stage of grief that must be reached when regulatory requirements crash into the hopes and dreams of a manufacturer that’s attempting to develop The Next Big Disease-Curing Medical Product – especially if the company doesn’t have an adequate regulatory strategy.

“You’re asking me, does regulation inhibit innovation? And my answer is yes, by its nature it can,” said Vaishnav, a longtime MedTech regulatory expert, a fellow of the Regulatory Affairs Professionals Society (RAPS), and coeditor of the book “From X-Rays to AI: Navigating US Regulations in Radiological Health.”

“Yes, regulation is necessary and keeps harmful products off the market. But yes, navigating regulation costs money and takes time. And that burden can also keep good products off the market for months or years – or prevent them from getting there at all,” she said. “There’s not a good way around that. You just have to admit it and kind of accept that this tension will always exist. And if you accept it, you can then move on and deal with it.”

An industry professional who is also a seven-year veteran of the US Food and Drug Administration (FDA), Vaishnav said in Part 1 of this Essenvia Insights story that she has seen projects scrapped because the innovation juice wasn’t worth the cost of the regulatory squeeze.

“Many good ideas make it to market. But if you’ve been working in the industry for a while, you’ve probably also encountered situations where good ideas died,” she said. “I know of a start-up that made a promising blood test. The company actually got clearance from the FDA, but they didn’t survive to celebrate because the clearance took so long that the financial runway ran out. And that’s just one story of a product that didn’t make it to market because a company didn’t anticipate the regulatory burden. There are many other stories where potential products don’t even make it out of the concept phase because people know the regulatory burden is going to be so high that the ideas aren’t worth pursuing.”

To put it another way, Vaishnav said, “Consider Facebook. Facebook can make an algorithm that recognizes faces and push it out to the public. Now, let’s say you take the same algorithm, but you use it to recognize features on a medical image. Suddenly, you’re looking at, say, a submission that can take years and a million dollars to prepare and get through the FDA. And in the end, you still might not be able to claim that you’re recognizing disease.”

She added: “That’s just the way it is; the medical product space is more heavily regulated than other spaces. And there are very good reasons for that. I’m not saying that regulation isn’t necessary – history absolutely shows that regulatory oversight is required. But it doesn’t exactly speed up getting products to market. So you have to accept that barrier and plan for it.”

Manufacturers Say Goodbye to European Launchpad

Also consider – likely with exasperation – the EU’s oft-delayed, fumbled rollout of its Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It’s no secret that because of new hurdles and barriers placed on manufacturers by these two regs, a good portion of those companies are now launching products an ocean away, in the US, rather than in Europe.

“If you’re a small company and you have a certain amount of runway and a certain amount of funding, speed matters – it matters to get your product on the market fast. But the predictability of the timeline also matters. You need to know sort of exactly how long it’s going to take, and FDA is predictable. That’s one of its strong points,” Vaishnav said. “The agency is predictable in terms of its timelines – even if sometimes they’re longer than one would like.”

Carrie Kuehn, a teaching regulatory expert who owns Catonsville, Md.-based Evergreen Strategic Consulting, told Essenvia Insights in an interview that the dual EU regulations “changed the landscape” for manufacturers selling product there.

“There are a lot of medical device companies that simply will not continue to market their products in Europe once their CE marks expire because the regulatory requirements are simply too difficult to achieve,” she said.

The EU’s new rules are “incredibly, incredibly strict. And that’s what happens when you have reactive policy,” Kuehn continued. “Something terrible happened – we can all agree that the breast implants situation was terrible. The lack of post-market oversight with the orthopedic companies was unfortunate. But what we got as a result was the MDR – the pendulum swung too far the other way. And now there are small companies that literally can’t do it, they can’t afford to achieve the requirements of the MDR.

“The bar has been set really, really high, and a lot of companies aren’t going to make it.”

Kuehn noted that she calls the regulations “incredibly strict” mainly because manufacturers must build out their quality systems structure by adding more, onerous procedures and now have to gather more efficient clinical evidence on products, which she claims is the “No. 1 barrier for an innovative device getting into MDR.”

“Devices that previously would not have needed any pre-market clinical data now have to somehow provide some sort of clinical evidence and safety and effectiveness data to get on the market in Europe,” Kuehn said. “But for an innovative brand-new product, a company is not going to have any of that unless they market it somewhere else for a while, do a post-market surveillance study, and then take it to EU MDR. So it has essentially ensured that innovative devices will be delayed getting to Europe unless a company is willing to do a pre-market clinical study in Europe to get their approval. So that is absolutely one of the greatest barriers to innovation.”

The European Commission has bumped back compliance dates for both the MDR and IVDR in the widespread belief that manufacturers simply aren’t ready for the transition, Kuehn said, but she noted that regulators might not be considering the large number of firms that are simply electing to leave the European market and therefore aren’t putting forth any effort to engage with notified bodies to become certified to the MDR.

“Initially it was thought that there weren’t going to be products in Europe because there wasn’t enough time, so the deadlines for the regulations were extended. But even with the extensions put in place, it’s becoming more and more clear that companies simply aren’t going to do MDR, they’re not going to sell their products in Europe. And that’s alarming,” Kuehn said.

Kwame Ulmer, managing partner of MedTech Impact Partners consultancy in Los Angeles, said in an interview that it has been apparent for years that the MDR has been a strong force in driving medical device manufacturers to the US.

“This was two years ago – we surveyed a hundred MedTech companies. It was research we did with UCLA [University of California Los Angeles], and the respondents definitively said, ‘The MDR screwed everything up. We go to the US first because of it,’” said Ulmer, who is also a member of Essenvia’s Board of Directors.

Ulmer said manufacturers selling product in Europe have been undergoing a “SKU rationalization process” to determine if staying on the market there is worth the time, money, and effort. If it’s not, “then they’ll just say, ‘OK, we’re going to sunset this model in Europe,’” he said. “This is more so for the large companies. Obviously for start-ups, they usually have only one product. But for the large manufacturers that have a huge portfolio of products, they’ll say, ‘No, no, no, yes, no, no, yes’ – they’ll work their way through the portfolio and decide which ones they want to try and keep on the market, and which they don’t.”

FDA’s QMSR: A Lighter Burden?

While the MedTech industry shakes its collective fist at the MDR, by contrast it has been a relatively quiet rollout for the FDA’s new Quality Management System Regulation (QMSR), which takes effect in early 2026.

The QMSR will replace the decades-old Quality System Regulation (QSR), which is the agency’s bedrock rule for ensuring that only safe and effective devices make their way to market. In developing the QMSR over a number of years, the FDA created a hybrid regulation that combines agency-specific requirements with those of quality systems standard ISO 13485:2016 from the International Organization for Standardization (ISO). (RELATED INSIGHTS: “8 Expert Tips for Cleaning Up SOPs Before FDA’s QMSR Reg Takes Effect,” Part 1 and Part 2.)

“Over time, ISO 13485 became more and more aligned with the FDA’s Quality System Regulation. And so we’re now at a point where the FDA is essentially just implementing by reference ISO 13485 for the QMSR,” consultant Kuehn said. “With a couple of exceptions, essentially, if you’re an ISO 13485-compliant medical device company, you’re now also essentially an FDA quality systems-compliant company as well. So that actually makes things a lot easier, particularly for small companies.

She went on: “Honestly, if a company can’t achieve compliance with the QMSR, they shouldn’t be making a medical device. It’s that fundamental. This is fundamental quality by design, hard stop. So if you think the QMSR is too hard, then you have no business being a medical device company.”

Kuehn pointed out that an overall lack of harmonized regulations – like the QMSR – poses another key challenge to product innovation.

“For things like the use of real-world evidence and AI [artificial intelligence] regulation, you’re seeing different regulatory policies being implemented globally, and global companies will have to navigate each of those individually as opposed to navigating harmonized documents,” she said. “Companies that want to market their device globally must be aware of, and then be compliant with, all of these different regulatory frameworks depending on what it is they’re making.”

Kuehn also warned industry at large: “Lack of harmonization is a big issue and it’s only going to get bigger because it’s a barrier to getting innovative products to patients around the globe.”

AND THE CONVERSATION CONTINUES!

Mark your calendar now for a July 31 Essenvia roundtable webinar, “Shaping the Future of MedTech: Insights at the Crossroads of Regulation and Innovation.” This can’t-miss panel discussion with regulatory experts Carrie Kuehn and Jay Vaishnav, former FDA medical device compliance office director Steve Silverman, and Essenvia regulatory affairs VP Dhriti Roy will dissect and expand on points made in this two-part Insights story. Register for this free event now!