Will Regulatory Transitions Cause Some to Change Course?

Now, perhaps more than ever before, there are significant changes occurring to the worldwide regulatory landscape, all within a relatively small window. This includes FDA, the EU’s MDR, Asia (see the article in this issue on India’s new rules), and MDSAP. The transformations have the industry scrambling to ensure compliance across the board within their respective markets. With this in mind, I reached out to several regulatory thought leaders to hear what they had to say about the changing environment and what it would mean for the medical device industry.

“Brexit, the new MDR regulation, MDSAP, and increased regulatory requirements in countries such as Brazil are increasing international regulatory requirements. Meanwhile, the U.S. FDA is focused on lowering the regulatory burden for regulated industry, however, with only marginal success,” explained James A. Dunning, principal at QPC Services. “The result of these changes is that the U.S. and global regulatory requirements will be more aligned. U.S. medical device companies will be more likely to launch new products in the U.S. first, and then launch globally.”

“The FDA’s regulatory process remains the gold standard for safety and efficacy of medical technology innovation, and it is critical that we maintain this global leadership position,” stated Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA). “While there have been challenges over the years, there continues to be significant improvements in the FDA’s regulatory pathways. MDMA worked closely with the FDA and various stakeholders to build on these improvements on the recent MDUFA reauthorization, and Congress strengthened the innovation ecosystem in the ‘Cures Act.’”

“Global regulatory landscapes are undergoing a major transformation. Gone are the days of first to market in the EU, with many companies looking to introduce devices in the U.S. first. The U.S. FDA is working to streamline the regulatory framework for introducing innovative medical devices as well as making it more efficient and predictable,” said Daniel R. Matlis, president at Axendia Inc. “On the other hand, new EU rules on medical devices will impose tighter controls on devices. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. In addition, once devices are available for use on the market, manufacturers will be obliged to collect data about their performance to support tighter post-market surveillance.”

Sandra K. Rodriguez, market analyst at Axendia Inc., added, “Companies are still evaluating the impact of EU MDR compliance on their products and processes, reassessing their product portfolios to determine if it makes sense to invest in the necessary resources, time, and technology to support compliance. The challenge we’ve seen is the still unknown cost of EU MDR compliance as companies struggle to justify the investment in legacy products. Another interesting trend was the concern over master data management as a result of silo’d and distributed systems across functional areas. Total product lifecycle management can only happen with the right infrastructure to support master data management.”

“The MDR will significantly change the European market when it takes effect in 2020. For example, claiming equivalence will be much more difficult to prove. As a result, many device manufacturers may not choose to release their products in Europe first,” predicted Alex Butler, manager of medical device solutions at MasterControl. “I see the MDSAP program as a win-win for medtech firms and regulatory bodies. The harmonized program will ease compliance burdens of companies and free-up resources for regulators.”

“The medical device and IVD regulations are now officially in place in Europe, making it harder for medical devices to get to—and stay in—the EU market. Prior to the mid-2017 changes, Europe was the go-to market to launch a medical device product while waiting on FDA and Health Canada approval. Now, many are beginning to rethink their go-to-market strategy,” explained Jon Speer, founder and VP of QA/RA at Greenlight Guru. “Going forward, manufacturers will need to place greater emphasis on risk management, clinical data, and evaluations to remain in compliance.”

“We have not seen and don’t anticipate a shift in market strategies associated with the many changes occurring in the regulatory landscape until the Notified Bodies (NB) for the MDR have been designated and the level of scrutiny experienced,” said Maria Fagan, co-founder and president of Regulatory and Quality Solutions (R&Q). “The first round of NB designations is expected in Q1 2019. If the NB interpretation rigor is high, as we anticipate based on our industry perspective, companies will begin shifting their market strategies to allow for more time to get into the EU and perhaps enter other countries first, depending on their EU medical market size and the risk to their business revenue.”