device industry is one year away from a seismic regulatory shift in the form of MDR. Without a holistic understanding of the regulation and its impact, organizations will face major compliance challenges. In our recent conversations with clinical research thought leaders, one thing is clear: MDR is on the industry’s mind.
Verna Manty Rodriguez is one such thought leader. A veteran of the medical device world, Ms. Rodriguez is the founder of the medical device consulting firm Manty Medtech. On April 23, she’ll be hosting a webinar with Medrio on risk reduction in medical device clinical trials. We sat down with Ms. Rodriguez for a deep dive into MDR, covering critical historical context behind the regulation, what you need to know about its implications for the clinical research industry, and other big topics.
Diving deep into MDR
Medrio: Thanks for taking the time to chat with us, Verna. Can you start by providing some background into MDR? How did the regulation come about? What was the impetus for it?
Verna Manty Rodriguez: There are a number of factors at play here. One is simply the changing of the times. When MDD, the regulatory predecessor of MDR, came into effect in the early 1990’s, things were a lot different. Software as a medical device didn’t exist. There were no health monitoring apps or other products of the kind you see today. So technology has changed. We’re seeing demographics and culture change, too – the population in Europe and elsewhere is aging; there’s a greater push for transparency coming from the public.
So that’s the general backdrop of the regulation. But MDR has also been catalyzed by a number of specific cases that pointed to the need for more oversight, more data, and better data quality. These include things like the recall of a hip replacement product in 2011, the discovery of almost 4,000 adverse events related to a surgical mesh product, and the use of non-medical grade silicone in breast implants. These really spurred regulators to discuss better ways to ensure patient safety, and those discussions eventually set the stage for MDR.
M: A lot of the clinical research regulatory shifts happening around the world are part of a larger effort to harmonize the regulatory frameworks of different regions. Is that what this is? Does MDR bring Europe’s medical device regulations closer to FDA regulations, or does it create a chasm?
VMR: It brings them much closer. This is indeed a part of the worldwide push for harmonization. Historically, in Europe, the EU Commission’s approach to medical device governance was seen as a bit lax compared to regulations in the US and Japan, for example, so one of the drivers of MDR was to ensure a high level of health and safety. You could say there was a general consensus that technological advancements created new treatment possibilities in the medical device space, but that it was also causing new safety risks. I think one way to describe MDR is as an effort address those risks.
But in many ways, the regulatory harmonization we’re seeing – which, again, includes MDR – is a product of the same globalization that affects so many aspects of our lives. The world is becoming smaller and more connected. Smaller or less wealthy nations used to have their own regulatory frameworks which were not as robust as places like the EU and US, and wealthy people in those nations would fly to Europe, for example, to get medical care, because they felt more protected. Now, even these nations are looking to the US and EU as regulatory standards to follow. We’re getting to a point in time when a country like the Phillipines might have the same medical device regulatory landscape as Japan or Great Britain. Ultimately, I think this is better for the safety of patients around the world.
M: Based on what you’ve seen, do you think the medical device industry is doing enough to prepare for MDR? Where, if any, are there areas where you think organizations are falling short?
VMR: The answer here is really drawn along the lines of business size. Big companies have been preparing for MDR for years. They have the resources to scale up their infrastructure to meet the new requirements. Smaller business are having a harder time. Many of them are taking a wait-and-see approach to determine what exactly will be required of them, before they invest limited resources in making challenging changes. The regulation will truly have a broad impact, affecting databases, labeling, quality systems, and lots more, and scaling all of these up to comply with MDR will be tough. There are also cost implications. I’ve heard from companies who are thinking of discontinuing certain products if they determine that the cost of updating those products is not going to generate an ROI.
M: What are the implications for clinical researchers? Will the classification changes in MDR lead to more clinical trials being required?
VMR: Yes. MDR will expand the definition of “medical device” to include some products that weren’t previously considered medical devices. A good example of these are devices for cosmetic procedures like lasers or liposuction equipment. So there are certainly devices that currently don’t need clinical trials, but which will require clinical trials once MDR takes effect. Moreover, device equivalence, which companies have long relied upon for clinical justifications, will be increasingly challenged – especially for higher-risk devices. There will also be reclassifications that raise standards on devices that are already subject to clinical evidence requirements. In other words, some devices for which organizations already have provided a clinical evaluation will now require even more clinical data than before. Implants that are in contact with the spinal column are an example of this.[
Really, though, I’m just scratching the surface here. There are more elements of MDR that will lead to a need for more clinical data and more trials. And even beyond MDR, the in-vitro diagnostics sector has its own regulatory reform, called IVDR, on the horizon for 2022, just a couple years after MDR. So really it’s an industry-wide regulatory shakeup that we’re seeing here, affecting the entire clinical research industry.
M: So with cost pressures high and more clinical trials likely on the horizon, what do you see as the role of eClinical technology in helping companies adapt to, and comply with, MDR?
VMR: MDR is really all about patient safety, and so organizations are going to need provide much more in-depth clinical data that proves safety, as well as any performance claims they make. Any EDC or other platform that helps reduce the cost of generating this data is going to be extremely helpful. But these platforms obviously have an upfront cost to organizations, and this cost can be prohibitive unless the EDC can be shown to reduce costs significantly enough to contribute to savings down the line.
Speed is also going to be huge. With the focus on safety, organizations will need to report adverse events much more quickly. MDR actually cuts the time limit for reporting AEs in half, from 30 days to 15. So eClinical software will have to play a large role in streamlining the reporting of AEs, to make that kind of reporting happen much more quickly.
M: Verna, thanks so much for this wealth of insight at this pivotal regulatory moment for clinical research.
VMR: It’s my pleasure. Thank you!