Regulatory Divisions Pressured by More Demands and Cost Cuts

Regulatory affairs professionals have the mounting pressures of revised regulations, more PMAs, IDEs, and change requests to contend with, but don’t have the higher headcounts or larger budgets to match.

Marie Thibault

More work and fewer resources to do it with — that’s the state of regulatory affairs (RA) in the medical device industry today, at least according to a few RA professionals at major device companies.

That was one of the major trends identified in a survey by Best Practices, LLC, “Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies.” The survey included insights in recent years from eight RA executives from the following well-known device and diagnostics firms: Bausch & Lomb, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Ethicon, Medtronic, Roche Diagnostics, and Zimmer.

Cameron Tew, business head of Research Services and Business Operations at Best Practices, writes in an e-mail to MD+DI that legislation in the past few years led device manufacturers to incorporate regulatory functions into more areas of the medical device lifecyles, “from concept through post-market surveillance.” Research like this Best Practices survey gives manufacturers a way to compare themselves against other industry players, Tew explains. “In taking this new approach, companies also wanted to ensure that the resources that they utilized were being used optimally and at the right times during the product approval process. Our research provides benchmarks that would allow companies to measure their performance to their industry peers.”

The survey finds that regulatory requirements are increasing at the same time as more cost reductions are being implemented. “These twin pressures are causing turbulence for all in the medical device sector,” according to the survey.

It seems this increasing workload is par for the course for these professionals. One director interviewed for the survey said, “Doing more with less is consistent across the industry. For medical devices in general, FDA is requiring more and more information whether it’s 510(k), products and/or PMA devices. The Medical Device Directive and In-Vitro Diagnostics Directive are being revisited at the EU Commission level, so they are going to be changing and requirements are going to continue to increase there for data required for device registration with more clinical data required for medical devices. It’s going to be a challenge to improve operating efficiency for internal procedures and processes.”

In addition to a bigger workload, the executives surveyed also felt that cost-cutting trends would cut the amount of expenses allocated to the regulatory department.

One surveyed executive said, “One of the issues that I have is just keeping up with base business, let alone new product introductions and new submissions, and supporting the new submissions. Just to keep up with base business, we’re really in a tight squeeze. We’re already talking about cutting more heads in RA and I just need all the help that I can get to say, ‘No, this absolutely cannot be done.’ We need these people if we’re going to keep our business healthy.”

Unsurprisingly, the stress of bigger workloads has led to professionals leaving the RA department. One interviewee said, “We have gone through a significant attrition of people recently. We’ve struggled to replace some of those heads, and we’re still having huge battles with regard to headcount for RA. With budget cuts and everything, RA seems to be a sort of ‘dumping ground’ or the appropriate place to go and get heads from and it really isn’t.”

What can companies do to help their RA department? Prioritization by corporate leadership might help RA professionals get the important tasks done. Tew writes that “When a function must do more with less resources, we ask the functional leadership to take a step back and review the core critical activities and processes that they must undertake to achieve corporate goals. The companies must ensure that the must-dos get handled and look for ways to limit the less valuable activities that they are tasked with. This can be achieved by outsourcing or offshoring some less critical activities.”

Marie Thibault is the associate editor at MD+DI. Reach her at and on Twitter @medtechmarie.


Originally published at