An Inside View of FDA and Three New Guidance Documents on the 510(k) Process

Written By Patrick Kothe
 
 
 
 

Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients.  In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.

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Episode Transcript

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

[00:00:00] Pat Kothe: Welcome! To many people, the US Food and Drug Administration is a mysterious agency. That should be treated with fear and respect. The truth is that FDA is made up of hardworking diligent, but often overworked individuals that take their role seriously. Trying to assure that safe and effective products are available to healthcare providers and patients. However, not all of us get an inside look at what it's like to work in the agency. Today we will. Our guest is Ken Riordon. Regulatory affairs project manager at telos partners. Ken brings a unique but essential perspective to his clients, having worked in both the public. And private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken's broad experience in the private sector with Bayer Pharmaceuticals, Philips Resperonics and others, enables him to apply creative and effective solutions to his clients. In this episode, Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new guidances on the 510(k) process that were recently released, and how Telos partners helps medical device companies. Here's our conversation.

Ken, uh, for someone that's a little bit on the younger side, you've got quite a bit of, great experience. And I want to ask you, you moved from industry to FDA and then back again. So was that always part of your plan or is it something that,just occurred?

[00:02:28] Ken Riordan: I wish I could say that I had everything mapped out right as I got out of school, but that would be a lie. So as I progressed through my career, I always looked for opportunities to continue to grow because I think that's really important to focus on what you're doing, but keep the future in mind. I started out in industry after school, working in the orthopedics. And various reasons moved me around both roles within design and development into quality and manufacturing and within therapeutic areas. So I started in orthopedics, I moved to radiology, and then I did a little bit in durable medical devices. And then I got an opportunity to work at the FDA. And it was perfect timing for me because I had been on the quality side for a few years and I had experience with the FDA, but it was still a little bit of this black box of what's really going on inside there. And so I was able to work at the FDA, really learn about the workings, about the people there, about the processes and how they view industry. And when I started there, I didn't think I was going to be an FDA lifer. so I knew at some point or thought at some point I'd go back to industry. I think it happened a little bit quicker than I had expected. But I'm happy with the path, and I think I gained a lot of valuable insight in my time there.

[00:04:07] Pat Kothe: So let's go back, to you entering the industry, entering into orthopedic space, was medical device always, interesting to you? Why did you decide to enter medical device?

[00:04:17] Ken Riordan: Yeah, it was always interesting to me. I grew up really into sports, and I had an engineer for a father. So I looked for a way to combine my interest in engineering and sciences. With my interest in sports and how the human body works, and as I was looking at college programs, I found biomedical engineering.

And then as I was going through my undergraduate and graduate programs, medical devices, specifically orthopedics, really caught my interest because it couples those two so well. so there wasn't much of a question what I would go into for sure. It was just when and exactly how I would help out that industry.

[00:05:03] Pat Kothe: So when you came into the industry, was it what you expected it to be?

No.

[00:05:09] Pat Kothe: How, how, why, why was it different?

[00:05:11] Ken Riordan: yeah, I think it's just because it's hard to set realistic expectations when you're in undergrad of what industry actually is. But you picture this very innovative environment where things are always moving quickly and new ideas are coming through the pipeline and going out to market.

But it's much slower and there's so many different boxes that you need to go through, meaning the design phase, the quality phase, the manufacturing, and, specific to what I'm in now, the regulatory phase, which is so important and present in every step of the process.

[00:05:51] Pat Kothe: Part of, entering into the workforce is, the technical part of the job. It as you described, the other part is just being working in a company and, and have, have, having a job. Uh, so you, you kind of described the one, what about the other?

It is very different to have, you know, I don't want to say a classic nine to five. But to go from your schoolwork, which is segmented into semesters where, you know, for three or four months, you are in a class, you're working on it nonstop, and then you move on to the next one, and maybe you carry a little bit over with, but it's a whole new professor, it's a whole new environment.

[00:06:34] Ken Riordan: In the industry, projects are much longer. And reframing how you think about your work takes some time to switch over there because instead of, buckling down on something for four months, projects can easily go years in industry. If you are still in the mindset of really crank it out over some short time, it can get discouraging when you get into industry, seeing projects move slowly and take their time.

But, it's just how it works right now, and everyone wishes they could be, an agile software development company that can crank out a product in three months and continue to improve. But with the quality and regulatory needs in this industry specifically, that's just impractical.

[00:07:23] Pat Kothe: I think one of the other things that, that we learn is coming in is the importance of teamwork, the importance of understanding what other people's roles are within an organization and how you fit within an organization. So I've heard from many people that's, one of the biggest learnings is how to go to meetings, how to work with other people, how to, work with them outside of the meeting, those soft skills, really help to, make the company successful and help you be successful and learn within there too.

[00:07:52] Ken Riordan: Definitely. And it's more than just the soft skills of how to interact with people. But it's having the desire to learn about what other people in the company do. And so I've had the benefit of working in different functional areas. But if you haven't, it's really important to understand what design and development, what quality, what manufacturing, what regulatory, what sales, what sourcing, all these different departments.

That when you get into industry, you're just like, whoa, what's going on here? There's so much to this, but if you can understand how those all work, you can get a more holistic picture of the company and how you fit in it better. And I think that really can help somebody, especially when they're early in their career, do their job more efficiently.

If you see yourself as just a cog in a wheel, cranking out your day to day work, you're probably going to get bored and you're probably going to make mistakes. And you're not going to see opportunities for improvements and new solutions that can benefit you and the company greatly.

[00:08:55] Pat Kothe: So you mentioned, you're doing that work, you have an opportunity, FDA, but your view of FDA at that point was black box. Some people think, FDA's over there, there's a black box. Some people have, healthy respect for FDA. Some people have fear of the FDA.

What was your view of FDA, at that point in time?

[00:09:16] Ken Riordan: if I had to put it in one of your buckets, it might be healthy fear. I knew that you needed to do the testing. I knew you needed to compile your submission. And I knew that it was likely to be nitpicked. But I didn't have a good understanding of what actually happened in what I considered to be the nitpicking.

So once you submitted it, it wasn't clear to me what was going on at the FDA, what background processes, what review was actually occurring, and so not being immediately involved in it, I think I saw it more as just something where you submit your package to FDA and they basically grade it like a test and give it back to you and you try again until you get something that's satisfactory to them and you can put the device to market, and I am now have a totally different perspective on what goes on. I know that it's much more collaborative than that, and I think it's important that regulatory professionals understand this, but even other people in the company who are involved in creating parts of these submissions understand that it is this collaborative process. And it's not something where you just compile a submission, send it off, and wait.

[00:10:40] Pat Kothe: I'll amend what you said a little bit. It should be a collaborative process because in many instances, people still view it as the black box and just as you described, a better way to work as a collaborative process, but not everybody works that way.

[00:10:55] Ken Riordan: No, unfortunately not. And I learned that, especially at my time at the agency, um, some of the best reviews that I was a part of was when a company would come in with a pre submission or two, And ask the specific questions that they had to facilitate their future submission and their future review, because it's unlikely unless you are a huge manufacturer who is making an incremental improvement to a device that you totally understand what you need to do to get that approved or cleared. So asking those questions in that Q sub process I think is really important, because not only does it clarify on your end what you need to do, It alerts the FDA to the fact that you are trying to do what they think is best. And I think that's really important, again, from this soft skill, from this human aspect, to remember that it's not machines looking at your submission on the FDA side.

It's actually people.

[00:12:02] Pat Kothe: So let's, let's talk about you entering FDA. So you're, you're a young person, you've, you've spent a few years, uh, in industry, you move over in, into the agency. What, what was the job that you moved in? And are you a, a, a poster child, so to speak, for the type of person that they want to see with a couple of years of experience?

Or, uh, is it, is it a different profile person that they're bringing in?

[00:12:26] Ken Riordan: So, I moved into a lead reviewer position. I was in the cardiovascular division. My job was to... lead the review of submissions that came in, and this is pre market applications in the 510k or PMA IDEs for clinical trials and Pre submissions. I wouldn't say that I was the poster child because I'm not sure there is a poster child. When they're looking specifically at lead reviewers, I think having some years in industry does help, but they also will take people right out of higher level education, especially masters or PhD programs, because the people in that role are really engineers and scientists who have this desire to learn about the medical device industry, to be a part of it, but also have more of this public servant aspect of their personality that comes out. Because the mission of the FDA is to protect the public health. And when I was there, I felt like that was pervasive in the culture there, that people were most interested, especially at the reviewer level, in making sure the devices were safe and effective. And it wasn't in any way, make it hard for industry.

It was, we want to help you, but we're here to serve the public first.

What was the training like moving into a lead reviewer position? It was a lot of mentorship, so people who had been in that job, helping you to, in my case, helping me to reframe how I thought about things, helping me to understand where my resources were, you know, where to look for the standards and the guidances, the actual regulations, and then also how to work collaboratively within the agency, because as the lead reviewer, It was a file would come in and it was quote unquote my file that I was looking at and I would review the engineering aspects of it.

But if it had clinical data, we would have clinicians. There are veterinarians if we were looking at animal models, statisticians for, more of these complex clinical trials with varying endpoints. And being able to know who to reach out to, being able to get that team together to understand what needs to be done, and then understanding all the work at the end of it, and coming to a collaborative decision on, is this product safe and effective.

If not, try to clearly communicate back to the sponsor what needs to be fixed or what new data needs to be submitted to demonstrate that the concerns we have are addressed.

[00:15:30] Pat Kothe: So, uh, a submission comes in, how does it get divided out to different lead reviewers?

Yeah, it comes in and it sort of works its way down to division level I would say that FDA has a hierarchical structure and most people are familiar with the FDA and then the centers underneath it. So you have CDER for drugs, CBER for biologics, and then CDRH for devices, which is where I live.

[00:16:03] Ken Riordan: And under CDRH, they break out into the Office of Product Evaluation and Quality, which then has different therapeutic areas. and these are the divisions. So there's orthopedics, there's cardiovascular, neurology. I think there's about seven right now. And, as it works its way down there, it goes through from the device's description and intended use into the right team.

And then there's a team leader who will divvy out work to the reviewers based upon bandwidth and based upon, uh, subject matter expertise. And then at that point, it's the lead reviewer's job to go reach out to what's called consults within the agency. Again, these are the statisticians. the clinicians, the veterinarians, whoever may need to consult on this file to make sure that we have the right expertise looking at it.

[00:16:59] Pat Kothe: So you mentioned, different pathways, 510K, exempt, non exempt, PMA devices. Everyone's available to do all of those different, types of filings?

[00:17:12] Ken Riordan: In general, yes, I wouldn't say that there is a specific lead reviewer who is only looking at 510ks, but as you go through the different types of submissions there, they generally get more complex, so your 510k submission tends to be the most straightforward. but then IDEs and PMAs can be a little more complicated because they often come in modular components or pieces.

They're longer timelines, they're higher risk devices with more testing. So your senior reviewers tend to look at that more often, but it's not as structured as this reviewer will only review 510ks. This one will only review PMAs. This one will only review IDEs.

[00:17:59] Pat Kothe: You're in the cardiology, um, section. Approximately how many, um, reviewers, lead reviewers are, were in in your section?

[00:18:08] Ken Riordan: Great question. So my team, I think, had about seven lead reviewers. but there were three teams within my, uh, subdivision, so you're looking at 20 and then there were probably, I think I want to say 3 or 4, so maybe somewhere in the ballpark of 50 to 100 reviewers in the CV, and that could be off, I don't recall exactly how many we had, but again it was so hierarchical that it's a little bit difficult to track exactly how many there are, but. You know, specific teams will have 10 ish lead reviewers.

[00:18:49] Pat Kothe: It's, what's interesting there is, you know, when I've, uh, been part of companies and we've submitted different things at different times, it seemed like we were getting, the same reviewer quite often. is that because of the device, the types of devices, or is that because they specialize, uh, or, um, working with a particular company?

How does that work?

[00:19:14] Ken Riordan: It was, uh, process efficiency, I think on the FDA side. It makes the most sense that if you have a reviewer who has worked with a sponsor, or even more specifically with this device before, give them the file again, because they understand the device well, they understand how the company works, and they understand the history.

And 510k, where you're relying on predicate devices. To understand the history of the primary predicate, but also this predicate waterfall as it works its way back in time, is really important because then you can be aware of any safety signals that have emerged, you can be aware of any testing that is particularly important to this device because of things you have seen in the past.

[00:20:03] Pat Kothe: So you go into FDA, you've got, The black box. you didn't quite know what to expect. What were some of the things that were, most, unusual to you that you didn't know about FDA that you thought, wow, this is, opening my eyes up to, how the agency really works.

[00:20:21] Ken Riordan: Yeah, one that was stuck out to me and is still important is. The collaborative environment culture that FDA had, um,

[00:20:33] Pat Kothe: When you say collaborative, are you talking about collaborative inside the FDA or collaborative with FDA and industry?

[00:20:41] Ken Riordan: both. inside the FDA, there's all these lead reviewers, and sometimes in industry, I feel like, for good or for bad, there is this idea that I am trying to get ahead, and therefore, helping somebody out may not help me get ahead, if that makes sense. And, you know, It sounds a little selfish, but I think it does exist in certain aspects.

That was completely absent in the FDA because profits didn't matter. And it was very, like I said earlier, public service oriented. So if you had a question, if you needed to learn, people were always really happy to help you be the best lead reviewer you could be at that time. And then also the collaboration externally.

Because of this black box idea, I didn't understand how reviews worked and,in the what they call the substantive review process of the 510 K, which is the bulk of this review period after you clear the RTA and you're actually reviewing the work. It's not only possible, but it's recommended that reviewers reach back out to the sponsor with questions or with concerns that are relatively simple and can be addressed in, a time frame of a couple weeks so that I don't sit here on my review, mark down all these things that are wrong, and then at day 90 give you an AINN letter, meaning that I'm not going to clear your device until you address these concerns, but at day 30, maybe I have this list of a few things that you could do that will help me make a clearance decision at the end, if it's you forgot to submit a test report, you know, additional data that I think you can capture quickly, wording changes to 510k summaries, things of that nature, which I didn't realize the reviewers could communicate with the industry in that way.

And I think, demonstrates this collaboration this we're here to help you get through the hurdle of FDA and not just be the hurdle.

[00:22:59] Pat Kothe: So you mentioned one thing and I want to talk just a minute about perceptions because industry's had perceptions of different things that the agency has done. Some of them, I think well earned some of them probably just urban legends. But one of them is that, wait till day 90 and you get a list of questions to restart the clock.

I certainly have had that experience in the past. What type of pressure does a reviewer have to keep things moving? And is that a valid, a valid, um, assumption or a valid, observation of what, sometimes happens at the agency?

[00:23:37] Ken Riordan: Yeah, it does sometimes happen. And I think, like you said, it used to happen a lot more often and perceptions are really difficult to change, you have this impression of how something was that way for 10, 20 years. It's probably going to take 10, 20 years for you to change your opinion on it, because, it might change once or twice, but you still aren't thinking this is the new normal.

You're still thinking, I had so much experience with getting that response at 90 days, it's going to happen again. Um, but internally, you get pressure, and pressure is a loose term here, but pressure from your team lead. To make sure that your reviews are on track and that you're communicating with the sponsor as much as you can be, but then again, it is the cultural pressure of getting devices that are safe and effective to market to help patients. The best way to help that patient is to get them the safe and effective device. And the best way to do that is to clear it as soon as you can. So making sure that if there's a possibility to get the data you need in that first 90 day windows, try as hard as you can to get it. it may not always happen.

Sometimes you need a test report and it doesn't exist because the sponsor didn't do the testing. Oh well, then we're going to go to that reset 90 day clock and they'll submit their AIN in response when they get it. But, try your best to see if it exists.

[00:25:10] Pat Kothe: Many times, you know, we, we like working on something and we don't like working on something else. For you, what was it? What was it? 510Ks, was it DeNovos, was it IDEs, PMAs? Did you have a favorite?

[00:25:23] Ken Riordan: I don't know that I had a favorite. I would say that 510ks were not my favorite, um, because they are standard and maybe it's just the product of seeing them so much. they account for about 90 percent of devices on the market. So you get a little bit overflowed with them. I did the Qsub, the pre submission process.

Because I felt like it gave me the opportunity to work with these companies early on and help them to develop their strategy for getting this device to market. Some questions were very straightforward, but sometimes they were a little more abstract, which generally leads to abstract answers if you come in with a non specific question to FDA.

But it can still provide a lot of valuable insight to how the company should proceed and what sort of strategies they should implement. And that kind of work has been rewarding to me and it's what I continue to do in my job now.

[00:26:30] Pat Kothe: If FDA didn't exist or regulatory bodies didn't exist many companies would have the exact exact same products because the the development process, um, done correctly. Basically the right, the right way to do it is captured within the regulations. And so in, in my opinion, uh, many devices would be the same without FDA. Some won't, some wouldn't, some people would cut some corners, but if we as medical professionals are designing products thinking that we're going to be on the table someday, or our wife, or our kids, or our family can be on the table someday, we will do everything to make sure that product is safe and effective. When you're inside the agency and you see some of the, submissions come, coming in, can you tell when someone is serious about the business and when people aren't as serious?

[00:27:33] Ken Riordan: Yeah, you can definitely tell. You know, what you said is interesting because from an idealistic standpoint, I agree. The regulations capture the right way to do it. But, if they weren't there, then I think you would get this incremental digression into people trying to cut corners, and it's too bad to say, but it happens, and that's why, industry has regulatory divisions within them so that they can say, hey, I don't want to do this, and the Regulatory affairs professional can say too bad, you have to, because it's the right way to do it.

When someone is cutting corners... Well, it's more you can tell when people are putting in the work because they've done their due diligence to find the applicable standards and guidances and regulations that apply to their product and they address the points that need to be addressed.

You know, especially with these guidances, FDA is really trying to clearly communicate to industry what they expect to see. And so when you create a submission and you address all those points, either through the testing that you've done. Or through sufficient rationale for why you didn't do it. You can tell that the sponsor put their best foot forward, and isn't just trying to rush, rush, rush, go, go, go, submit the minimal viable submission to try to get clearance, but actually doing the due diligence in every step.

Uh, you know, here's the testing we expect to see in this guidance document. Go through and either do it or write out a clear rationale for why it's not. And it helps in the review process and you don't have to dig through or ask additional questions. But it also, like you said, it helps the development process because then you're truly considering all the risks associated with that device and you're designing your device to mitigate those risks so that you're not putting something on the market that has the potential to cause harm.

[00:29:41] Pat Kothe: So I've heard, um, that one of the, one of the major reasons why you hear back from the agency and it says, we're kicking out your, your submission at this point is because people didn't. put the right things in their submission. They left things out. You know, that's kind of the the main thing It's like, you know, turning in your homework and not putting your name on on a paper Yeah It's it's uh, you know that submission process and I heard that that you know That is one of one of the top reasons from once it gets past that and it's in there Are there some areas that the agency looks at to say, this is a problem area across many companies where we see a lot of questions.

[00:30:26] Ken Riordan: Um, yeah, there are some areas like that, the FDA obviously has their pre market review team, but they have a whole post market team as well that is constantly looking at complaints and, trying to review literature and clinical data to find these safety signals that might be emerging to say devices in this area, we're starting to see an increase in these kind of failures or these sort of complaints and getting that back down to the review team so that they can start to ensure that new submissions that are coming in, or if there's a submission in progress or whatever it may be, is getting the necessary attention that it needs with that and then also, in the same vein of your question here is that part of the benefit of the review team here is you're looking at similar devices. So you can start to see and track and keep note of areas that may be of issue. So when I was there, there were some sponsors who seemed to misunderstand, misinterpret some of the biocompatibility requirements. And so they would do some portion of the testing that is listed in, FDA's guidance to ISO 10993, but not all of it, and they would try to rationalize it, but it's there, it's spelled out pretty clearly, do this. So it was communicated amongst the reviewers, unless there is some extreme circumstance with some very solid rationale, if a company comes in without all the biocompatibility testing, it's unlikely that it's going to be okay, we list these tests, the standard to list these tests for specific reasons.

It's not just to go spend a hundred thousand dollars at some lab, it's to make sure that all these different responses that can happen in the body are not going to cause the harm.

[00:32:25] Pat Kothe: Well, you mentioned guidance, and we're gonna, we're gonna shift this conversation to talk about some guidances that came out in September of 2023, that,are relative to the 510K process. But before we do... The word guidance is a very interesting term when it comes to regulatory. What is a guidance?

[00:32:50] Ken Riordan: Uh, yeah, it is interesting. I think it does hold some of its natural meaning of the word guidance. My interpretation is that it's FDA's attempt to put out a document on how to best navigate some specific aspect of the regulation. Instead of just putting out, whatever it is, the FD& C Act, and having you try to guess what the best way to do it, FDA is trying to succinctly spell out what they expect to see, how to best go about creating the data and organizing it for your submissions, or how to go about collecting that data in the most efficient and, I don't know if safe is the right word, but

[00:33:36] Pat Kothe: Expected.

[00:33:38] Ken Riordan: Yeah, expected way.

[00:33:40] Pat Kothe: That does not mean that this is exactly what you need to do and you get your product cleared, approved through the agency. It also does not mean that this is a Absolutely, this is what you have to do, because as you mentioned, justification, happens and,what's best for one type of device may not be best for another.

So this word guidance is really an interesting term because yeah, it is what the expectation is. But it's not the requirement.

[00:34:16] Ken Riordan: Exactly. Yeah. especially on the requirements interpretation of that word, sometimes. I think FDA specifically says it in the intro to every guidance that this is just something to consider and we are not going to hold you to this. But it's best practice to make sure that you're addressing those things in there.

[00:34:40] Pat Kothe: a lot of time on those guidances. They are there for a reason. Think about the things that are in there. You don't have to make every point very clear in your submission, but think about it as you're designing your device and creating your submissions.

So I just gave you my interpretation of guidance and from an industry standpoint, what, how I think about guidances. Inside the agency, is that how people think about guidances, or do they think of more as requirements?

[00:35:11] Ken Riordan: Um, I think that it is a shared view of it. So when you first come in, when I was in my first few weeks, month, whatever it was, I would say I thought of it more of it as a requirement. I'd open up a submission, I'd open up the guidances, almost one for one, but you start to learn what you were just saying, that they're not there to be, this, I need all of these things in here, they're there to guide you through what you should consider.

So it's not a requirement, but it is reviewed, it is considered throughout the review process, at FDA.

[00:35:50] Pat Kothe: So let's, let's talk about the guidances that, were recently come out relative to 510K. Can you explain to us why these were put out, and where we are with,with these guidances?

[00:36:04] Ken Riordan: Yeah, they were released as part of FDA's modernization of the 510K program, which is their attempt to keep this program up to the current view of what the FDA and what the regulations should be doing without becoming overburdensome. The three they released were how to choose a predicate, how to use clinical evidence and data in your 510ks, and then, one of what I think is going to be a series of the evidentiary expectations within certain devices.

And all of these serve the purpose of, think, more succinctly communicating to industry. What the FDA expects to see in a 510K and also how to start to compile it. Again, if you've been doing it for some time, you're a big company, you have a lot of people who are aware of how the process works. These may not be all new to you, but they still shed some good light on the best practice of creating your 510K, choosing your predicate, thinking about what data to include and what tests to do.

[00:37:22] Pat Kothe: Why did they choose these three topics? Is there problems in the, in these three areas or, what was went into the decision on these topics?

[00:37:31] Ken Riordan: I think with the predicate, guidance document, there is a lot of concern or questions with how the 510k program works since it relies on the predicates. And what you're doing is you're saying that this new device I'm creating is just as safe and effective as this old device, but there's this inherent issue of why you creating a new device, it should be different than the old device. And how are you accounting for these differences? So in this predicate guidance, it's giving you things to consider when choosing a predicate. And it's also helping you understand what you might need to look at. in your predicate in terms of real world data that's come out since then. Continuing to review MAW databases and clinical outcomes of this device is important so that you know that it's an appropriate choice and that there aren't safety signals in the clinical environment.

With the clinical evidence one, I think it was just really confusing for sponsors to understand when they needed to use clinical data in 510ks. I think that helped to clarify up what FDA, or more importantly, when FDA expects you to submit clinical data with your 510k submission. And that's both when they don't expect to see it, when you don't need to go out and do the trials, as well as what you think about when you read this guidance is, when am I going to need to go do a clinical trial when I have a class 2 510k device. And then the evidence expectations, um, I think is kind of addressing that first point again of these are the tests for specific device. This is the data for specific device that we expect to see when you submit this. So even if you're doing a 510 K and you're using the predicate device and you look at the summary and these were the tests they did, this is a test that you should do. Make sure you've done them all or you have rationale for why not. Here are some standards that apply to these tests to help you develop your methods and your sample sizes, and it should help to expedite some of the thought process that goes into what you're going to need to do from a regulatory standpoint for your testing.

And then that on the back end can help expedite the review because FDA is going to see what they expect to see or rationale for why it's not there instead of drawing out communication and maybe debate between the sponsor and the agency.

[00:40:14] Pat Kothe: When you read through these guidances, were there any surprises there or were the, these just things that were codified based on, current practices?

[00:40:25] Ken Riordan: I didn't really see any surprises in them. I think a lot of what was put in these guidances has been at least talked about if not practiced since I've been at the agency, especially with choosing a predicate. there wasn't guidance on it. There wasn't much to point to if somebody decided to do something against what the guidance now says.

So it helps to, like you said, codify to communicate it to agency. This is really what we expect to see instead of just a lead reviewer sending an email and saying you chose this predicate. Why? Because normally this is what we expect to see and it helps to put it out there so that people can fully understand it.

But I don't think it's anything that is groundbreaking or new if you've been involved in it for a while. Just, yes. clearly communicating the expectations.

[00:41:25] Pat Kothe: let's talk about the review process of a guidance for a second.

Are these issued guidances? Are we still looking for industry feedback on it? where does the this sit within that process?

[00:41:37] Ken Riordan: yeah, they're draft guidances and that's what the draft guidance is. FDA will get their internal team together. They'll often go out and get some external thought leaders to help them develop it. And then they put out this draft guidance with the intention to get comments from industry because, again, going back to this collaborative mindset.

They don't want to write this big document on here's what you should do and then just slap it on the door of all of these sponsors who are eventually going to try to get devices to market. They want to put it into a list into the document and then say, what do you think? And not all thoughts are going to be valuable or implemented.

But for example, the 10 year old predicate, I think there was a lot of concern over some devices that are like really well understood. And aren't going through a ton of innovation and there might not be an appropriate predicate for your device that was made in the last decade. You might look back 20 years.

And so to have the guidance say don't do that when you don't really have another option was going to be a little overly restrictive for certain device types. And that was a comment that they were able to get from different industry. different companies and industry that helped to reshape it a little bit.

And that's the whole point of this draft and comment period.

[00:43:01] Pat Kothe: In your conversations with other regulatory professionals, are there any areas that you expect some pushback from industry?

[00:43:08] Ken Riordan: There's nothing specifically that I can see. With the clinical data, um, there could be some questions that come up. They talk a lot about this difference of intended use versus difference of indications for use. And I think that's a really confusing differentiation for a lot of people because they sound a lot alike and they are a lot alike.

And so having to say that, my device has a different indications for use than my predicate, but then justify that it's the same intended use and that it's not creating new questions of safety or efficacy and I don't need clinical data, is a little bit confusing. I don't think it's perfectly spelled out in that guidance.

But it's a tough thing to try to perfectly spell out because you don't want to be overly prescriptive on exactly what to do since medical devices is such a broad term and covers so many different types.

[00:44:05] Pat Kothe: The comment period lasts how long until this guidance becomes a... Not, no longer a draft guidance.

[00:44:15] Ken Riordan: I, it varies. Oftentimes you get extensions. I'm not sure what the comment period on this one was. I think that it's at least 90 days, but generally goes further than that.

[00:44:27] Pat Kothe: The word harmonization is used with regulatory things and we've all seen what's happened with CE Mark and the burden that has been placed on many devices, much higher than what it had been previously. How do these new guidances play into the changes that have been made, uh, to, uh, CE Mark for medical devices?

[00:44:53] Ken Riordan: Yeah. that is quite a thing with the UMDR, CE marking requirements at this point. And I'm not sure that there is really a play in that I see. But I do see this balance that needs to occur at FDA because of what's happening in Europe. They come out with this new regulation that is so difficult to meet. There's all these risk classifications. There's all this need for clinical data that wasn't there before. So now it's Time consuming and it's expensive to

[00:45:29] Pat Kothe: device to market.

not only pre submission clinical data, but it's post approval or in market clinical data.

[00:45:38] Ken Riordan: Yeah, exactly your PMCF plans and Reports are being updated all the time. Your CERs are being updated all the time. You are constantly reviewing your device so there's this huge investment that needs to be made now to get it into Europe. And FDA I think is trying to find the right balance of making sure that devices are safe and so finding a way to get that post market data without being overburdenedsome. FDA has their least burdensome principle, which I think is really important because you want to make sure things are safe and effective, but you don't want to stifle innovation and it's such a delicate balance.

And I think with the 510 K modernization, they're trying to strike that balance. Which is a very difficult task.

[00:46:31] Pat Kothe: So let's, talk a little bit about Telos, your company, and you're Regulatory Affairs Project Manager, but what does Telos do, in general? What areas does Telos get involved with?

[00:46:44] Ken Riordan: So we do consulting for medical device and biologics. The word Telos actually means ultimate goal in Greek. So we want to come in and really understand your project and your goals and not just be a solution to a single pain point. Our goal isn't to get you 510k clearance, our goal isn't to get your market adopted or your device adopted by clinicians or be reimbursable.

But it's that whole package so that we can get to that end point of getting your device to market to help patients. And we try right from the beginning to communicate that, to let, people that we may work with know that we've been in your spot before. We empathize with a lot of the struggles and we're here to help you reach that goal.

So we offer, regulatory and quality services, which generally start as high as regulatory strategy. If that's domestic, , helping classify your device, helping with pre submissions and then pre market applications or 510ks. But we're also doing a lot in Europe because of what we just talked about with this changing and complicated landscape that the EU MDR has created.

So we will do gap assessments for your current quality system and documentation to MDR. We'll help you create technical files. We will do gap assessments for CERs and we have a team of CER writers. And then also we help with the creation of post market surveillance plans. And PMCF plans and reports as well, because what we were just talking about was it needs to be done.

People haven't really done it right in the past, so not only do you need to start this from scratch, but you want to do it in the most efficient way possible. Because you could just go create a device registry, but that's very expensive. And so helping customers balance meeting the regulation without spending ridiculous amounts of money.

[00:48:54] Pat Kothe: Who's in your sweet spot right now? Is it large companies? Is it startups? Is it mid sized companies? What's the sweet spot for, for, uh, people that you help?

[00:49:03] Ken Riordan: Uh, yes, to all of them. It's whoever needs our services, and I think it can be anyone. Because when you look at smaller companies, you're looking at companies that may not have regulatory divisions. Or may not have the expertise to really understand the landscape that they're going into. So that's where, more of our whole regulatory package can come into play.

We can help create your strategy and execute on that strategy. But sometimes as we build up more to these mid to large companies that do have the capacity or do have the expertise in house, they may not have the capacity, especially with more of the European requirements when it comes to writing CERs.

Or doing this post-market work because it's very time consuming. And so sometimes people will look to not bring somebody in-house just to be CER writer. And that's where we can really help you, understand and not just create the CER, but create a process so that it can continue to go through the life of that device, which is required by eu now

[00:50:13] Pat Kothe: Are there enough people in the regulatory area? Are we staffed appropriately with regulatory professionals? Or are we, as an industry, light in that area?

[00:50:26] Ken Riordan: I think we're getting to being staffed appropriately. Uh, there's probably some, some improvement to still be made, but I would say probably since my time in the industry, you have seen more of an investment from companies into their R and Q departments because they understand or are starting to understand the importance that this plays.

And it's not only the importance of getting your device approved or cleared, but the importance of cost savings that sometimes is a benefit of this, especially with quality, but also with regulatory. If you can do it right the first time, then you save not only all the time of redoing some testing and rewriting the submission, but you save the headache of having to go back to the agency, and you can move on to your next iterative improvement or your next innovative device.

And so, really, staffing appropriately and getting the expertise, either in house or using a Telos to help you understand what needs to be done, I think is important because it has more benefits than just, you know, we cleared FDA, we cleared, we got our CE mark, let's go to the next one, but lasting benefits that can be seen.

[00:51:44] Pat Kothe: So you, you mentioned when we were talking about FDA, you mentioned collaboration and a collaborative approach between industry and FDA. and there are, Some that, do it well, some that don't do it well. I'm assuming the same thing happens when you're a consultant brought in on some of these projects, too.

What is, what does a good customer do that makes it, makes it a good collaboration between Telos and the sponsor?

[00:52:10] Ken Riordan: With any good collaboration, I think it starts with open communication channels. And I think that's something that we do really well here at Telos is integrate ourselves as part of your team, right from the start. It's not like you're going to talk to some high level project manager who's going to try to understand and then pass it down to somebody else.

If you are working with me, I'll be in the meetings and then I will also be doing the work moving there forward. So it's creating and allowing us if you're the client to integrate ourselves into your team so that we can understand, not just the small project we're working on. But again, this big picture.

Because there are efficiencies that can be found in future projects or in this certain device moving forward in other aspects of your company that we can really help you improve at that moment if you allow us to be in the team to become a part of it.

[00:53:10] Pat Kothe: I am not unique at my company with having a lot of industry experience or fully understanding what needs to be done. We have a lot of great professionals here. Good clients, like you said, will take your advice without just hearing it and ignoring it, but they'll try to implement it.

[00:53:28] Ken Riordan: With strategy, especially, we're laying this out there because we think this is best for your device and best for your company, not just because we think it's easy for you or easy for us.

[00:53:42] Pat Kothe: Companies or people that are listening to this may have development programs that are underway. They're developing their products, they've got some ideas on what pathway they're going to go regulatory wise. But we've got these new guidances that just came out. So how should people that have development programs in place approach their strategy in light of these new guidances?

[00:54:09] Ken Riordan: I think that hopefully with your development program that's in place, you have started to integrate a regulatory plan throughout it. Because that's going to help you do it the right way as you continue development, but it's going to really show its worth when it comes submission time. So with your regulatory plan in place, you should be looking at standards.

You should be looking at regulations and you should be looking at guidances on some iterative basis to make sure that new releases, new documents coming out aren't impacting your development process. So with these three new ones, if you have a device that is going to be a 510k device, which if you're marketing in the US is probably the case, make sure that you are looking at them, and that if you're at the point where you're choosing a predicate, review how you chose that predicate.

You're going to have to spell it out in the submission anyway, so it's good for you to start early and review why you chose it. Enlist your rationale. Look at the clinical data one and make sure that if you're saying you don't need clinical data, it aligns with what FDA is thinking. And then, again, this evidence, the evidentiary expectations is specific to a spine right now.

if you're not a spine, but it... might not play, but it is important to be aware that at some point they're probably going to release one for your device type, especially if you're a more common device type. So start to look out for it. Maybe compile some information if you have the bandwidth in house on testing that you've seen in predicate so you can be aware when the time comes and you're not, oh no, look at all these changes that we need to make.

Regulations sound boring, but they're really important to, you know, implement throughout your entire process because what we touched on earlier is that they're there to spell out the right way to do it, and it's not just to be burdensome, but it's to make sure that at the end of the day, you're helping the patient in the best way you can.

[00:56:22] Pat Kothe: Demystifying the FDA will help make the relationship between industry and the agency better. I'm really glad Ken was willing to share his experience. And I hope that it opened your eyes. A few of my takeaways.

Ken discussed FDA as being a black box, but we know that isn't the case. It's not just a bureaucracy. This is a real people that are in there that are doing their best to assure safe and effective products are on the market. So, as we know, they're real people, you can start to build that relationship before you submit the product.

So we know that we've had. You know, pathways to talk to FDA prior to submission to get a good feeling. Do a pre sub, uh, for, for your product, get a good understanding so that you're not coming in out of the blue. They know who you are before you even get there. And, and once you submit, you're going to be working with your reviewer. And you can actually pick up the phone and talk to them.

It's not a black box. There's somebody on the other end, that's working your product. So make sure that you establish a good working relationship with them. Because as Ken said, you may work with them sometime again in the future. And that good relationship on both sides is going to help you long-term. And the best thing that you can do is provide good quality work. It's your reputation, build your reputation solidly.

And the next time you go in, it's going to be a much better experience for you.

Secondly, we talked about alignment between FDA and industry on what a guidance is and, you know, industry as a, as their opinion on what guidance is. It's great to hear that FDA views it as the same way. It's not a requirement or it's not a semi requirement. Uh, that, um, that rethink it's, it's a guidance, but they really think of it as requirement.

No, they're, they're thinking about it as a guidance as well. But just remember if you decide to do something that's different than a guidance, make sure that you have proper justification and you've communicated properly.

The last thing was teamwork within the FDA. And I really enjoyed hearing about this.

The mentorship that goes on. Ken referred to time when he came in and people helped to reframe some of his thoughts about the agency, about resources, about regulations, about guidances. And there's great mentorship that he received as a new person coming in. Also collaboration with experts. It's not just one person that you're dealing with.

He talked about veterinarians, statisticians, clinicians, other people that are, that are at his same level. So this collaboration with experts. Uh, really gives me a good feeling about, you know, what's going on with, uh, within the agency as well. And, and the motivation of the people he talked about, all of them being public service oriented and their objective is to help you get through the hurdle of the FDA. Not to be the hurdle.

Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the Mastering Medical Device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the Mastering Medical Device podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind.

 
Patrick Kothe
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