It used to be that obtaining CE mark in Europe was a relatively simple process and many companies would start there.
However, now that has changed. We might even consider the FDA as the more streamlined regulatory process.
How did that happen?
Listen to Ethan and Omar discuss that in this podcast!
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This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Omar Ford: [00:00:11] Hello and welcome to Let’s Talk MedTech, the premiere podcast for the medical device and diagnostic industry. I’m Omar Ford, managing editor of MDDI, an online publication owned by Informa. This episode is amazing. We’re going to be talking about the regulatory process, especially the ins and outs of the European Union Medical Device Regulation. EU MDR with Ethan Drower, Operating Partner and Co-founder of Citemed. Buckle up, gang. This is going to be a good one. So let’s jump right on in. Let’s talk MedTech with Citemed, Ethan Drower. Ethan, welcome to Let’s Talk MedTech. Thanks for joining us. I know we have a ton to talk about today with Citemed, but I wonder if you could start off by telling us a little bit about the company and its mission and where did the inspiration for Citemed come from?
Ethan Drower: [00:01:13] Sure, absolutely Omar, and thanks for having me on the podcast. I really appreciate it. Um, Citemed was founded based on a perceived need in the medical device regulatory space for combining technology and innovating with essentially incredibly talented regulatory affairs professionals. The inspiration from the company came from EU MDR. And as everybody knows, it’s a regulation that has caused a lot of pain, a lot of suffering for for many manufacturers, both big and small. Everybody has different challenges. And we saw an opportunity specifically within the clinical evaluation and scientific literature space to kind of blend technology, use innovative software and combine it with the right people to create a solution that actually will ease the burden for companies that are struggling with costs and timelines on their clinical evaluation submissions for MDR. So we saw the need, everybody was everybody was suffering either paying too much or just couldn’t get their documents in order in time. And we saw the need and the opportunity to innovate and use software, and bring in the right people, and ever since then, you know, it’s kind of just it’s kind of just taken off and gone from there.
Omar Ford: [00:02:51] Well, you bought up and I know, we’re going to talk about this EU MDR, such a broad, broad topic that and you’re right, it’s caused a lot of pain for a lot of companies, a lot of executives. I’ve been in the industry now reporting on it since 2007, and the easy, I’m not going to say easy. I’m not going to say that. But the path that companies would usually take to get approval would first be they would first go and get a CE mark. They would go to Europe first. Europe was an easier or much more, it was easier to navigate through. Yeah. Low hanging fruit. But now when you look at it, it’s reversed. Um, FDA is a more streamlined is a, I won’t say the lower hanging fruit, but it’s a simpler process. What has happened? Can you tell us about the European Union Medical device regulation process right now? Where are we with it and why is it so confusing to a lot of medical device companies?
Ethan Drower: [00:04:02] Well, you know Omar, you know we’re in trouble when we start describing the FDA processes as streamlined. So, um, yeah, let’s, let’s talk about MDR. You know, on the device side, it’s in full enforcement right now. Everybody’s in kind of a different stage of trouble and, there are a few big issues with the regulation currently that manufacturers are facing. The first and foremost is that there are a lot of details to be named later and companies are expected to come up with foolproof postmarket surveillance plans when the reg is not exactly clear on what is going to be acceptable and what is not going to be acceptable. So we have some issues with clarity. And that’s that’s always a, that always can cause some pain to executives, because if it’s a toss up and you’re not really sure until you try it, it’s very hard to budget timelines and manage expectations for that. Um, the other very big issue we’re seeing right now is inconsistencies with the notified bodies and their standards. What can fly in with one notified body can be completely marked up with red line non-conformities for another. And a lot of our clients are really struggling to get a grasp in and kind of get that certainty as to what’s going to work with theirs. Um, and, and that’s before we even start talking about the timelines. Most, most submissions, your documents aren’t even getting reviewed for 6 to 9 months after you submit them to your notified body. So it’s, it’s a new regulation. It’s always going to be messy. It’s always going to be a little bit like the Wild West at first. And I think everybody is really just struggling with that level of uncertainty. You know, we’re regulatory affairs people, we don’t like uncertainty. We like black and white and our checklists. Right?
Omar Ford: [00:06:12] Exactly. Yeah. Yeah, yeah. What are some of the mistakes to avoid during this process? And I know that’s probably a tough question to ask considering that, you know, it’s so nebulous right now. The ground isn’t firm.
Ethan Drower: [00:06:29] It is nebulous. So that’s that’s how you have to that’s how you have to operate. The biggest mistake. Is, is assuming that your timelines with your notified body will be met. Um, the biggest mistake is waiting to see. Um, it’s a much better approach in our opinion to try and be overly thorough and overly prompt with your deadlines and getting your documents in so that you can get that feedback and, and correct course as necessary. Gone are the days of being able to just submit your documentation and then not even not even worry about ib t. Something’s going to come back. There’s going to be things that need to be corrected and these revision processes take time. So if you have less than six months on your med dev cert coming up, then you’re already putting yourself at a disadvantage because of that unpredictability.
Omar Ford: [00:07:31] Wow. Interesting. Interesting. I want to kind of pivot a little bit. We were talking about MDR, but what about other government regulations in other areas such as the US? How do you, how can companies ensure their new products abide by these regulations? And where do Citemed come in to help them with that?
Ethan Drower: [00:07:58] Sure. You know, wherever you are, wherever you are in the world, there’s different sandboxes to play in. There are different rules, right? So we like to advise our clients with general principles, right? Principle number one, definitely don’t wait. Don’t wait until the last minute. Get your documents in. Try and be as early as possible so that you can. You can fix them. Um, the other thing that we’re seeing globally is regulations are increasing everywhere. They’re not decreasing. Andd what we advise people to do is you need to be you need to actually allocate resources and you need to make your regulatory strategy much more of a priority than it has been in the past. For for many companies and many devices, the regulatory affairs is kind of the last minute you put the bow on the box and send it out there and you just get it done. And we’re seeing small manufacturers just get absolutely hammered with this kind of afterthought process. So from an executive standpoint, that means you need to start seeing the more direct correlation between having your documentation and your regulatory affairs department sorted, and the actual viability and profitability of your products. Because we’re getting to a point in a lot of countries where if you don’t get those documents in your certs getting pulled and you’re unable to do business until it’s sorted out. So we strongly advise companies either bring on more talent in-house, that have the experience and are of the type of people that can navigate this uncertainty or, just accept the fact that you’re going to need to pay for specialized, specialized help and specialized services. This is an extra cost. Nobody likes it. Nobody, no executive likes spending money on things that don’t directly affect profitability when they could be advertising. But unfortunately, this is now become something that has to be dealt with. And if you don’t, you can suffer the consequences. So that’s one of the big, that’s one of our big you know, one of the big things that we preach from our soapbox to companies. This is, this can bite you and it’s becoming a much more serious thing in the global market.
Omar Ford: [00:10:29] You know what we often see on our side on the Let’s Talk Med-tech side is, we see this entrepreneur coming from the tech side and they have an awesome consumer product that can have some health benefits and they want to jump into this crazy industry called medtech. And when they get to the regulatory process, it eats them alive and they’re pulling out their hair. And I can’t tell you how many interviews I’ve had with, um, excuse me, how many interviews I’ve had with executives or entrepreneurs who say, hey, I’m just overwhelmed by all these regulations. It wasn’t like that when I was just trying to get my consumer product onto the market. But now I have to check off all these boxes and it’s different for each area. You know, it becomes a nightmare.
Ethan Drower: [00:11:30] And it really, this is the reason why we exist, because regulations by their very nature, they stifle innovation. They have a lot of good. We love them. We need them. But what they do is they make it harder for the upstart to get their product out there and actually start selling it to people. Now, you can either sit at home and cry and complain about it. You can say, this is unfair, we need to change things or, you can do what we are trying to do, which is take the more positive route and say, okay, this means if the regulatory burden is so great that good companies with good products are not able to get their devices to market, then it means that we need to we need to innovate the tools that we’re using for regulatory compliance. We need to get better. And that’s that’s kind of my mission and everybody at Citemed shares that vision. We want a safer world. We want these devices to be vetted and carefully monitored. So we need to get better at, we need to get better at doing that. And that’s innovating on the technology side and that’s innovating an industry that isn’t as sexy as the startup world. And there’s a lot of, there’s so much to be done. There’s so much to be done with improving these processes for companies. It will make their devices safer and it will allow the smaller players to bring new innovative ideas to the world, which is what we’re all about.
Omar Ford: [00:13:12] Yeah. Yeah. I think it needs to happen because there’s a huge level of intimidation for, I’ll throw out a company name, you know, there’s a huge level of intimidation for that young startup. But whereas you might have a more seasoned veteran like Medtronic, a medtech giant, a giant in the industry, there’s not as much you know, they’re used to it. There’s not as much pain associated with it. But, you know, for that young startup and that awesome idea, that could potentially change the way that we deliver care. Sometimes their ideas get shot down because of the red tape, because of trying to put some sense of trying to get some sense of understanding about the regulatory process.
Ethan Drower: [00:14:02] Yes. And it can be it can be debilitating for the small manufactures. The large players, they have their own set of issues in terms of managing massive portfolios. But for for the startup, that’s what it is. It can make or break your company getting these things approved and getting them to market. Startups are race against the clock. So we need to do better as an industry with providing resources and tools that these companies can use.
Omar Ford: [00:14:32] Well, let’s talk about the clinical evaluation report one on one, what every medical device company needs to keep in mind? I saw that and said, wow, I’ve got to ask you about that. Let’s talk about that a little bit.
Ethan Drower: [00:14:46] Sure. We live and breathe the clinical evaluation report every day and you know, under the umbrella of MDR. Things have gotten tough. Things have gotten more stringent. The general safety and performance checklist is significantly larger and more comprehensive than the central requirements of Med dev. Generally, I’ll just give you the biggest the biggest tips here. The biggest tips are, the literature reviews, the systematic literature review that you were doing before under Medvedev, 95% of those literature reviews, as they were done previously, will no longer be acceptable. So the standards for systematic literature review have gone up 20 fold. And companies need to understand that they’re not going to be able to just simply submit what they had before and move move on their way. They will get flagged. They will have to redo it. And they’ll have to do it in a much more thorough scientific way. So the literature review, that’s our big focus for companies. That’s where we do most of our let’s call it emergency assistance, where we’re coming in and trying to correct a bad process and get it up to standards. The other big area we’re seeing people have confusion on and get hit with is the, within the CER, is in their post-market clinical follow up and post-market surveillance planning. Now in the CER, they’re not doing the work, but they have to commit to a plan in the strategy that’s going to be acceptable and obviously one that is actually feasible for them to carry out. So, we urge our clients to make sure that they know what they’re getting into. They understand what’s required of them, number one. But number two, they’re actually going to commit to the plans and carry them out, because you can’t just say that you’re going to do it and then forget about it. Those days are over as well. There will be much more scrutiny, scrutiny. They will be checked. They will be checked more thoroughly and it will cause significant issues down the line, if these documents aren’t updated as per your, um, as per your standards and your process. So those are kind of the big ones.
Omar Ford: [00:17:21] Have you ever seen a nightmare scenario with a company in the regulatory process? I’m wondering if you could maybe share an anecdotal story or something you’ve seen while you’ve been, you know, Citemed has seen in the past?
Ethan Drower: [00:17:40] Sure. And one of our big value propositions to clients is our our speed and and efficiency of these deliverables. So naturally we get a lot of, let’s call them, frantic phone calls from manufacturers that say, oh boy, we’ve got our first set of feedback. We have X amount of days to get things turned around. Here’s our list of 50 things that need to be corrected. Can you help us get this done? And especially, as I mentioned, around the systematic literature review.
Omar Ford: [00:18:17] So let me break in. Let me break in and ask this really quickly. Yeah. Is that waiting until the last minute? Should you guys have been involved a little bit earlier? Let me ask that. Yeah. Could you tell that to our audience now? Should you guys have been is it almost too late at that point or should you have been involved a little bit beforehand?
Ethan Drower: [00:18:39] Well, I would say. If you’re waiting, if you’re waiting until after you’ve submitted to have anybody with experience, look at your documentation, look at your templates, look at your CEP, look at your processes for search. Then I would say you’re generally shooting yourself in the foot. It is too late. Um, gotcha. However, that being said, we have and I’ll share you a story with you in a second. Um, we, we have always managed to, to get the job done, even on these tight timelines. So knock on wood, we have not had to turn a manufacturer away and say, sorry, guys, this is this is untenable. Nobody can do this. Um, so a quick story for you Omar is, I received a call on, it was a Wednesday morning from a manufacturer, a small manufacturer, you know, regulatory team of maybe two people. And they said, you know, hey, we’re just, um, we just got some feedback from our notified body and it’s a bit of a tight timeline, but they’re saying we essentially need a brand new literature review. And I was like, great, this is what we do. This is why we’re here. Our process is bulletproof for lit reviews. This is our focus. And I said, great, just let me know when you need it by. And she got very quiet for a second and she was like, you guys said, you do you do you have good timelines? Could you do this Friday? And I was like, you mean in two days, this, this, this Friday afternoon? And she was like, regrettably, yes. That is our deadline. We’ve waited, we have worked with, you know, quote unquote, consulting firms. Everybody took too long to get back to us. And now, we’re going to lose our shirt if we can’t get these if we can’t get these nonconformities revolved around our scientific literature review. So fortunately, we had the capacity and we have such a great team at Citmed. They really are passionate and they really get into, they really take on the challenges of the manufacturers. So the team was able to rally. We put in two, two sleepless nights. Fortunately, we have a lot of software tools that we’ve built that organize the research and organize the output, which is how we save so much time. So we were able to, just under the wire, get them their literature review in the morning on Friday. Um, I think I probably slept for, you know, 24 hours straight after that. Um, the rest of the team took the weekend off, but, but we got it done. And that’s with the clients working alongside us to help shore up their other non-conformities. So you know, we are seeing the toll that it takes on these small manufacturers. It’s not right to have your full time employees have to put in all nighters for a week to get these documents done. Something has to change. This cannot be the new standard. It’s just not fair.
Omar Ford: [00:22:12] Yeah, yeah, yeah. It seems like it. And it goes back to an important point. Um, uh, with the regulatory process, it seems the early, like the earlier Citemed is involved, the better it will be. Because you can’t wait until the last minute and you can’t wait even a few minutes before the last minute to you know, seek out and get help. But, it’s yeah, it’s just a difficult process. I’m struggling for words because the regulatory process is just so complicated and it’s just so stressful for so many small medtech companies and manufacturers. And trust me, I’ve heard this story over and over and over again time and time again. So you all are really doing some good work out there.
Ethan Drower: [00:23:05] We are trying our best. We’re trying our best to help. And to your point, yes, earlier is better. Obviously the real world doesn’t quite work out that way. So we have to we have to be prepared and we have to have options and tools to get things done in a pinch and really close that gap of compliance. But, you know, in the perfect world, sure, we can prioritize our regulatory documents. We can get them done 6 to 9 months in advance. And then whether it’s us or somebody else, pay somebody that has significant experience submitting these documents and going through the audits to take a look, and give you that precious feedback. It is worth the money in just in terms of time saved from your own people having to pull their hair out over over not knowing. Right.
Omar Ford: [00:24:01] Yeah, exactly. Exactly. Now, I know a lot of companies want to stand out in their respective industries, but how can a medtech company be a major disruptor? What advice would you give them?
Ethan Drower: [00:24:16] I would say, and we’ve worked with the gamut. We’ve worked with some small, innovative start ups. We’ve worked with with the big players. I would say my biggest my biggest advice for somebody that wants to, that they want to disrupt in this industry is make strategic alliances and make sure that, you know, the more out there and the more innovative your technology is, the more people you have in your corner supporting you, whether that’s with financial resources or whether that’s with industry knowledge or whether that’s with a, you know, more of a brand building trust perspective. It’s very it’s very difficult to do it all and just put your product out there and then start selling it. You need, it’s a hard industry to break into as an innovator, you need to spend the time to make those friends in higher places and not be afraid to solicit, to solicit help. If your device is going to change the world and you can convince people of it. It shouldn’t be a problem. But that’s that’s my biggest piece of advice.
Omar Ford: [00:25:27] Awesome. And ultimately, where do you see the medical device industry going with all this regulation?
Ethan Drower: [00:25:35] Well, we are we are both excited and dismayed at it, at the notion. Overall, I’m very optimistic and very excited. There’s there’s an incredible renaissance happening with with artificial intelligence and our ability to aggregate massive amounts of data and make useful decisions. You combine that with the unbelievable, you know, wearable micro technology boom that we’ve had, I think we’re going to start to see some very, very helpful and world changing devices that integrate with the human body, at a feedback level that we’ve never really seen before. So that’s where we see that going. In terms of regulatory affairs, it’s lagging in terms of the innovation space, and that’s what we’re really working to change. I see a future in which there are massive, massive shared data sets that are accessible to all manufacturers where they can actually make better decisions about their device and be alerted. More so in real time as to any kind of safety or risk profile issues. Right now, a lot of people still still do this on paper and so I’m excited for the opportunity ahead of the regulatory industry. I think we can get faster, we can get leaner and ultimately we can make safer devices and you know, help more people, which is which is why we do it, right?
Omar Ford: [00:27:17] Yeah. Yeah, exactly. Ethan, if people if medtech companies want to find out more information on Citemed, where should they go? How can they get in contact with you?
Ethan Drower: [00:27:28] Yeah, they can check us out on LinkedIn or our website Citemedical.com has all of the of the details, has all of the info on what we do and what we are, what we’re trying to do to help as many device companies as possible.
Omar Ford: [00:27:47] Sounds good. Well, Ethan. Thanks for coming on to Let’s talk MedTech. Appreciate having you here today.
Ethan Drower: [00:27:54] Thank you so much for your time. I really appreciate it. Great, great chat, as always.
Omar Ford: [00:27:58] Awesome. Take care. Bye bye now. That’s it for this episode of Let’s Talk Med Tech. Thanks again to our guest, Ethan Drower, the Co-founder and Operating Partner for Citemed. For more on Citemed, be sure to visit Citemedical.com. Until then, see you next episode.