This is our discussion with Richard Vincins which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and not a transcript. This was done to improve readability.
Interviewer: Welcome to the latest episode of the podcast. Today, I have the great pleasure of speaking with Richard Vincins, a regulatory affairs and quality assurance consultant with extensive experience in the USA and Europe.
He has degrees in chemical engineering and biomedical science. Those of you who are members of the Regulatory Affairs Professional Society will know him very well from the Regulatory Exchange Forum, where Richard provides advice to colleagues working in medical device companies. He’s always extremely helpful and one of the leading experts in the field, so I’m very pleased that he agreed to speak to me today.
As you may have guessed already, we are going to talk about medical devices and, more specifically, the challenges that small and mid-sized companies face when obtaining CE marking in Europe.
Now, for those of you who are not familiar with the process, I know some people working in drug studies, and I just want to clarify. If you want to place a medical device on the market in Europe, you need to have CE marking, which all companies must obtain before they go to market.
In order to do it, they need sufficient clinical data and technical documentation to support the registration. Independent companies called notified bodies (NBs) are responsible for assessing the data and authorising the medical device. So that’s part of the regulatory framework in Europe.
Thank you, Richard, for joining me today. I’ll ask you first to tell me a bit about your business, the services you offer, and the regions you cover. Tell me whatever you think will be interesting.
Richard Vincins: Thanks, Olga, for inviting me to this. I’ve never done a podcast before. I can’t say I’ve seen very many in real life, either. My life is a bit busy, I think, for it, but thank you for the opportunity. It’s nice to chat with you.
We seem to talk just on the forums and are quite aligned on many of our responses. I’m part of MD Compliance. We are a quality assurance and regulatory affairs consulting company based in Scotland, but we’re primarily focused on the UK and Europe. However, as you can tell from my accent, I’m originally American. I’ve lived in the UK for over 15 years, and our company primarily focuses on quality systems and regulatory affairs activities.
We don’t get into testing, clinical trials, or similar work, but in quality systems, we conduct audits for companies, including internal audits and preparation audits for inspections. Having both US and EU experience, we provide FDA inspection preparedness and notified body preparedness audits.
We also help companies set up their quality systems. A lot of smaller companies come to us, and we use a nice, pragmatic UK approach to set up quality systems for them. We also work on regulatory affairs. Again, being US-experienced, we work on 510(k)s. I don’t know how many Q-submissions we’ve done over the years, but it’s a great opportunity for companies to have conversations with the FDA.
So I’m a huge proponent of Q-subs, and I try to do those as much as I can because it’s nice to see what needs to be done rather than trying to think about it off the top of your head. We also work on technical documentation in the European Union.
It’s certainly been a challenge in the last 10 years or so with the new regulations. We started working with companies back in the CE mark days during the MDD in the late 90s, and it’s shocking and amazing to see how much it has changed over the last 20–30 years. We support companies with their technical documentation as well, helping them obtain CE marking.
So that’s a little bit about what we do. We try to be quite general in providing the services companies want, and we work with many different companies and products. We have quite a vast experience across different product types.
Interviewer: That’s very interesting, and it’s brilliant that someone helps, especially with quality management systems. I think many, particularly small companies, always struggle with that. So that’s a really brilliant thing that you’re doing, Richard.
So I’ll get to my next big question. I wanted to ask you about the unique challenges that you think small companies face when they’re trying to obtain their CE marking. What are your thoughts on this, about their problems?
Richard Vincins: Yes, I think we’ve worked with very large companies, multi-billion-dollar companies, on specific projects and doing specific audits. But we primarily work, I would say most of our work is with small companies of even 10 people or less.
I think the challenges they face are, of course, resource-related. If companies have a well-seasoned Quality Assurance and Regulatory Affairs professional in their budgets, that would be awesome. But then, of course, other people and I wouldn’t have jobs as consultants if that were the case. So, I think small companies need to find the right person to help them. Some consulting companies focus on certain activities or certain products, so sometimes it is a challenge trying to find the right fit.
From a regulatory and quality standpoint, I mean, they are medical devices, they’re regulated, and there are certain requirements that have to be met. But when I look at how small companies dealt with things 20 years ago compared to today, there’s just so much work that has to be done.
Between the regulations, the standards, and meeting guidance documents, which they say are guidance, but we all know the expectation is that companies follow them, there’s just a struggle to have enough resources and enough experience. Plus, regulations are always changing. And I think specifically in the European Union, CE marking may not be so transparent, and I think it hasn’t been so consistent.
So if you are working with one notified body versus another notified body, or you’re even speaking with a health authority in one country, they may not have the same view as another country. So I think the inconsistencies within the European Union have always been a struggle.
It was that way for quite some time when you compare it to other countries, like Japan, Korea, or the United States, that have a single regulatory authority. When you’re dealing with different groups with different opinions, different views, and even different healthcare systems, we’ve seen small manufacturers that have wanted to go into the market in, say, Spain or Italy. And then when they try to go into places like Germany, they’re quite shocked because the expectations are different.
So I think, between the amount of work that has to be done from a quality and regulatory perspective and some of the inconsistencies in Europe, we really try to help small manufacturers meet what they need to do.
Interviewer: That’s brilliant, thank you so much for it. It’s very interesting. I think, in terms of consultants, there are people who are more used to working with bigger companies. There are consultants with experience in bigger companies, and there are consultants who work with smaller companies.
I’ve always been a great supporter of the idea that people should find a consultant who has experience in their area. If you’re a small company, you really need to find someone who has experience with small companies, rather than hiring someone who’s worked for a big company and has a completely different mindset, if you want to put it that way. Thank you so much for confirming that it really is important.
So, when you’re talking about the European Union, I know it’s always complicated. There are plenty of inconsistencies, but what do you think are the biggest obstacles for innovation that companies face in the European market?
Richard Vincins: I think beyond funding in general, companies getting funding, because everybody wants investment and investment companies want to see something out there making money, it’s always difficult to invest in the unknown.
Even though I’ve talked with lots of small companies or even individuals that have these nice innovative products, and they’re very passionate about it, and their belief in helping people is tremendous, it’s always great. I always want to be able to help these companies get through the regulatory pathways. But as we know, it takes money to do clinical studies. It takes money to put in quality systems. It takes fees to get submissions done.
So getting funding is one challenge. But I think from a quality and regulatory perspective, especially in the European Union, it’s about understanding and planning early. We see too often smaller, innovative companies that come up with a product that is kind of true and actually works, but they’ve already gone all the way through the design process and haven’t put all the design steps in place.
It’s always challenging for us to try to move those companies back through their design process, even back to the beginning, to define the requirements document or something of that nature. Or even worse, talking to them about having to do some additional non-clinical testing. Maybe there were some biocompatibility tests that they did, but they didn’t do the right ones according to the standard. And even worse, sometimes having to go to them and say, “Well, we’re probably going to have to look at doing a clinical study.” Looking at a million-pound or million-euro study puts a lot of companies off.
I think in our experience, being able to work with small and innovative companies at the very beginning, I wish there were more of a forum for that type of thing to get people started earlier rather than waiting. Because we often see that it’s so much more difficult to try to put things in later rather than doing it from the beginning.
Interviewer: Talking about this, I saw that there is a program, like a pilot program in the UK, helping medical device companies with their design and everything. But I think it’s more focused on the UK and getting into the UK healthcare system rather than generally helping them with their products. Do you have any experience, or have you heard anything about this one?
Richard Vincins: Yeah, we have. In fact, in the UK there are actually small hubs of the innovation network. I was working with a group up in the north, in Yorkshire, and they have an innovation hub there. I think you’re right. It’s maybe not focused primarily on medical devices, and it doesn’t really talk to them about the regulatory side. It’s more about how they get funding, how they can talk to investors, and things like that.
I have spoken in front of some of those groups. There are other countries that have something similar. I know Sweden and Germany have something like that. But again, I think those groups may need to reach out to the medical profession and get them more involved to talk about the regulations and what they are going to need to do, rather than worrying about getting Class A funding or something like that.
Interviewer: Yeah, I think that’s the main problem. Even when it comes to funding, I spoke to a guy who has software as a medical device, and it’s a startup company. He said that “When we compete for funding in the European Union, there’s one funding stream for everything. So it doesn’t matter if it’s rocket science or something else, we all compete for the same funding.”
I think even the way funding is structured for startups and medical device companies is not really well thought through. That’s my feeling so far from what I’ve heard from people and the feedback I’ve received.
When companies are considering introducing their products to the USA or the European Union first, what are some of the factors they should consider? What do you think is the best approach?
Richard Vincins: We talk to quite a few small companies that are looking at markets first and trying to determine what would be best. Unfortunately, due to the regulations in the European Union, it’s maybe not so attractive, mostly because, as I talked about before, there is inconsistency. The US system is much more established and much more consistent because you have one regulatory agency.
We’ve spoken to innovative companies and small manufacturers who want to seek CE marking, and they get frustrated because they reach out to two or three notified bodies and receive different information and fees. That’s probably the biggest challenge. By contrast, in the United States, there’s a 510(k) or De Novo. You know what the fees are, what the process is, and how it’s going to be reviewed.
So I think a lot of companies nowadays are looking for that consistency, especially innovative companies. The United States does have some programs, such as their breakthrough designation. Whereas in the European Union, under CE marking, they’re talking about it. And certainly, the MHRA here in the UK wants to put a system in place and already has a pilot program for that.
But in the European Union, if there were a breakthrough designation or a new technology innovation pathway, I think that would attract a lot more companies back to Europe. When we compare the two, companies often decide that even though it may seem like more regulatory burden in the United States, there’s more consistency and more known information. Especially when they’re going back to their investors, they can provide a higher level of confidence in getting a product onto the market, compared with the European Union.
Interviewer: Do you think there are stricter regulations in the US? Because at least when I look into Good Manufacturing Practice (GMP), my impression is that the US is more relaxed and gives you a little bit more space to think about things. The European Union regulations are really like they want to tell you what kind of filters you have to use to do things, it’s that kind of detailed.
Do you think that’s the case with medical devices? Do you think the US has more requirements, or do you think the European Union has more requirements? What’s your overall feeling?
Richard Vincins: I actually think that between the United States and the European Union, the requirements and regulations are quite similar and even. So I don’t think one has more than the other.
I think the difference is that in the United States, there is a bit more flexibility. At the same time, I think companies in Europe and the UK are a bit more cautious about going to the United States because they don’t know the United States’ regulations. So, it’s sort of like saying, well, we have our product CE marked, let’s go to Brazil, let’s go to Japan. It’s not easy because you don’t know the local regulations, and you often need an in-country person to help.
I think that’s the benefit MD Compliance brings to some of our clients. I do have that US experience, so we can talk them through the process. After we talk to these small companies, they’re like, “Oh well, maybe that’s not so bad”. And I say “No, it’s not really”. Especially because you can have conversations with the FDA about what type of clinical study you’re going to do, what type of testing you’re going to do. You can have those open conversations. So I think, as you said, it’s a bit more flexible than in the European Union.
Interviewer: Yeah, that’s brilliant. So, what other countries do you think could be considered, apart from the European Union, for companies that want to go to market? What are your thoughts on this?
Richard Vincins: I think there are some great regulatory groups in some of the other markets, such as Japan and Korea. You most likely need to have in-country representation or an in-country expert who walks you through the process because you have to make the submission in the local language. But the processes are quite similar. I think it’s that unknown factor that scares a lot of companies away.
Countries like Korea and Japan are very good markets. Canada is also quite a good market. The challenge with Canada is that it’s not a huge market, so companies are looking at where they can make money.
So the United States and the European Union are usually the first that come to mind. But when you go to other countries like Mexico, Brazil, Japan, and Korea, the regulatory process is actually not that much different.
In fact, if you’re CE marked, you already have much of the technical information you need for submissions in those countries. It’s more about dealing with local requirements and translations, which scare a lot of companies off.
Interviewer: I had a manufacturer who had a device made in Turkey, and they had all the reports and everything in Turkish. There were tons and tons of pages that had to be translated. When they heard that, they nearly died. If it’s something easy to translate, fine. But it’s technical documentation, and it’s really difficult. You need someone with real expertise in the language to translate it properly. And particularly in the European Union, they want licensed translations. So I think the cost definitely puts them off translating their documents to enter the European market.
AI is a very popular topic at the moment. What tools or AI applications do you think are beneficial for medical device companies right now? Do you have any experience or anything you’d like to share?
Richard Vincins: Yeah, I think there are a couple of areas where AI tools are helping companies today. Certainly, in the clinical evaluation process, that’s very helpful. Depending on the type of device, you may have hundreds of literature articles that you have to go through. So, using tools with natural language capabilities, being able to take an eight-page article and boil it down to two or three paragraphs, is very helpful.
I’ve seen some tools used for putting together submissions. I don’t think they’re quite at that point yet, taking 50 documents, combining them, and putting them into a nice technical documentation file. I don’t think it’s quite there yet. But what I do see is these tools being used to generate portions of the technical documentation. For example, having maybe 15 different non-clinical testing reports and boiling them down into nice summaries that can then be inserted into a submission.
I don’t think the tools are quite at the point where it’s completely automated, as some people would like. But I do see people using them more and more for submission content, not necessarily the submission itself. I see a lot of tools being used to gather lots of information. I remember 20 years ago when I had to put together 510(k)s, going through 80 or 90 different documents and trying to figure out where to put everything and what information to include. So, I think there are opportunities there, and it will probably only get better as time goes on.
Interviewer: Yeah, I agree with you. I’ve also seen some companies using AI, but not always in the right way. I’ve seen reports and technical documents written with AI, and you read them and think, “Did anyone actually read this, or did they just put it through AI and use that as their report, hoping the regulators will never look into it?” It’s really bizarre, but I’ve seen cases like that where people used AI and didn’t even review it properly, judging by the look of it. So, I hope that will improve in the future.
As you said, there are a lot of documents. If we can use AI for summaries, that’s great. I think people are also a bit reluctant because of confidentiality. Especially for drug companies, that’s a big concern. They’re not willing to provide confidential or patent-protected information. So that’s part of the challenge with adopting AI, at least in my opinion.
And I’ll ask you the very last question: what’s on your wish list? What would you recommend for the European regulators to change, if there’s something you’d want them to change? What would you prefer them to do to maybe make our lives a bit easier?
Richard Vincins: I’d love to have conversations with people in Brussels about things that could be improved. I would say probably the two main things I’d like to see are, first, more consistency. I think the Medical Device Coordination Group (MDCG) group is doing a good job. They’ve released a lot of guidance documents. I was a bit sceptical around 2018 and wondered what was happening. But then they started releasing guidance and continue updating them. I think they just need to keep doing that and close some of the unknown areas.
They’ve done that in some cases, and like most groups, they need resources and time. But providing guidance in areas where people always have questions is very helpful. For example, when they released the MDCG guidance on authorised representative roles and on legacy devices, those were well received.
The other area I would like to see improved or put on my wish list is better stratification of regulations as intended. If you’re a Class I manufacturer, there are certain risks associated with Class I devices. If you’re a Class III manufacturer, there are different risks associated with Class III devices. But I see in the European Union that it still feels like one class overall. Yes, certain reports are required annually or every other year depending on classification, and yes, the General Product Safety Regulation (GSPR) applies differently depending on device type. However, I don’t see regulators consistently viewing the actual risk levels of devices.
We face challenges when working with Class I and lower-risk Class A devices because the regulatory expectations are still very high for those types of devices. So, my wish list would be, having lived in the UK for a while, I’ve developed a more pragmatic point of view. It would be great to see a more pragmatic approach to device risk and regulatory expectations.
I don’t think we need to lower the regulations. I think the regulations themselves are appropriate. It’s more about expectations. For lower-risk devices, like Class IIa or Class I, the expectations are sometimes too high. For example, it may just be a plaster, yes, it’s sterile, and we have all the controls in place, but we don’t need to treat it like an implant.
Interviewer: I agree with you. And that’s a great conclusion to our episode. What I was going to say is that it’s true that in the UK we have a more flexible approach. I have to say I’m quite pleased with our regulators for looking into this and trying to create more flexibility for companies. They’re even now thinking about recognition procedures for CE marking, as you know, that’s the latest development.
But in terms of the European Union, I think they need to think more about competitiveness and not make it so hard for companies to enter the market. If companies see that they have to invest a lot of money to get CE marking, they might think, “Well, I can go to the US instead, because it will be easier and I’ll get quicker access to the market. I won’t need to go through all the hurdles with healthcare systems and so on in Europe”. So definitely, we need to be a bit more competitive.
And on my personal wish list, I really hope regulators don’t create new regulations to make our lives easier. We don’t need more regulations to make things easier. Just keep the ones you have, remove the ones you don’t need, consolidate them, but don’t create new ones to make life easier. It doesn’t work that way.
