In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the complexities of FDA submissions for medical devices.
Ellie sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS).
Listeners are guided through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Ellie's expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.
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Some of the highlights of this episode include:
- Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.
- Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.
- Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.
- The importance of understanding and managing FDA review timelines, including potential pauses and extensions.
- How utilizing eSTAR helps identify documentation gaps and assess submission readiness.
- How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.
- The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors.
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Memorable quote:
"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie Reynolds
Transcript
Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. Today. With me is Ellie Reynolds from Proxima Clinical Research. She is the Associate Director of Quality Assurance and Regulatory Affairs.
I'm really excited to have you on the show, Ellie. I'll kind of give you the mic to see if you want to introduce yourself a little bit, maybe give a quick origin story if you like.
Yeah, sure.
Ellie Reynolds: Excited to be here. Like you mentioned, I'm the Associate Director of Regulatory Affairs at Proxima. I've been with the company for three years now and have really enjoyed working with the startups and the variety of companies and devices that we get to help through their FDA processes.
I have a background in bioengineering and a focus in global medical innovation, so getting to be in this ecosystem and a part of the startup culture has been really rewarding in seeing these devices make their way through the FDA processes.
Etienne Nichols: Fantastic. Yeah, I love that background, especially the focus on innovation. That's really cool. Maybe we can get to that a little bit later on and what exactly that means. But the topic that we kind of talked about talking about today was successfully planning your FDA submissions.
So, I think this is a topic that it feels sometimes like an ever-moving target. Maybe not necessarily. Maybe we get a little bit distracted by the global affairs and that's changing regulatory, but maybe we could talk through some of the specific established pathways to plan your FDA submissions.
And maybe a good place to start would be what are the different types of submissions in your mind as you go through this?
Ellie Reynolds: Right, so there's the market submissions that each device has to go through to actually be able to make it onto the market and sell your device.
Those are the 510(k), which people are very familiar for class two devices that have a substantially equivalent predicate, there's a de novo submission. So, if you're moderate risk, you don't have a clear predicate. That's sort of the 510(k) equivalent for novel devices that don't have something to call substantially equivalent. And then the PMA. Or pre-market approval is for those class three devices, and it's the more robust submission that requires clinical data.
And for those higher risk devices, those are all the ones that get you onto the market. But there are a lot of prior interactions and early interactions you can have with FDA through something called Q-Submissions.
And those are meetings or different requests to talk to FDA about what those future market submissions might be like. So, they're pre submission meetings and breakthrough device designation requests and Sprint discussions are the ones we most commonly work with.
But there's a variety of different kinds that you may have on your journey to get to that ultimate market always.
Etienne Nichols: I think I knew this at one point. Q-Sub. Is that Q stand for questions or do you know?
Ellie Reynolds: I don't know that FDA defined it. I've never seen it. I like that, but I don't think it's actually special.
Etienne Nichols: I think it actually might be like the section of a paragraph. I need to look that up. Okay. For the audience. I'm going to make a note to myself to look that up because I always question myself, what's the queue? Making note?
Ellie Reynolds: Yeah, report back. I haven't looked it up either.
Etienne Nichols: So, when we look at these different submissions, do you have a general timeline? I know averages.
It's kind of like it applies to the whole thing, but it doesn't apply to any one device. But what are the average timelines in your mind when you think, okay, class three PMA. It's probably going to take this amount of time from the time I submit to the time here. What are your thoughts, or do you have a general timeline for these different pathways?
Ellie Reynolds: Yeah, so FDA has set the review timelines that they're allowed to take for MDUFA. So those are prespecified. And the longer the timeline for, the higher the risk of the device.
So, it's 180 days for PMA, 90 days for 510(k), for example. But that doesn't include anytime you're put on hold. And so, after a certain amount of time, again, depends on the submission and the review team, they may submit or give you a letter that has deficiencies.
They put your file on hold, and that means their review clock stops. So, although you may only have 90 days of FDA review, you have up to six months to respond to that deficiency letter.
And depending on the nature of the deficiencies, it may take you that entire time. So that adds in a significant amount of time that's not pre specified and is up to the sponsor on how they're going to get through that period.
So, I think that's something that's often forgotten or neglected is that the FDA piece, they have the ability to pause that and to give you back your file and then take care of it, and then their timeline starts again.
So, it is ultimately up to the sponsor how long they spend on that. But again, it could be very lengthy deficiencies where you're using that full six months to address their questions.
Etienne Nichols: So, a more organized company is going to get through a lot faster.
Ellie Reynolds: Essentially, yeah, we would hope. It does depend if you're missing a significant amount of data that they were looking for or a test method that you neglected to perform, and then you have to go out either find a testing house or find a way to perform that yourself.
That can take a considerable amount of time, especially with lead times associated with different laboratories. So, some of it is in control. Ideally, the more organized you are, the better you're able to execute on the questions and the changes they're requesting. But sometimes it is out of your hands as well.
Etienne Nichols: That's a good point. So, I know RTA the refuse to accept that's due to just the admin administrative side typos different things like that. So maybe that speaks to the organization, but the actual content to what you're speaking, absolutely.
That makes 100%. Okay. So, there's both of those things working in tandem. Obviously, you need a robust all of the content laid out, but you also need it in a way that's easy to understand.
The organization is helpful, but not everything. I'm with you on that. Okay, that's really good. So, when we look at these different types of submissions, what are some of the considerations for each one?
They're slightly different.
Can we speak to maybe some of the main considerations?
I don't want to ask too many questions on top of each other, but why would I want to go for one over the other? Denovo versus 510k versus PMA.
Ellie Reynolds: Yeah, unfortunately, that second question is ultimately out of your hand.
Etienne Nichols: Let's binge that.
Ellie Reynolds: A lot of times the sponsors will not have control over that. Depending on your device type, there are Ed cases that may be between de novo or PMA, and there's advantages to each.
But generally, you don't get to pick and choose what pathway that you are on unless there's grayer area between 510(k) and de novo, because those are both class two devices. But if there's not necessarily a selection between like a 510(k) or PMA, it would have to be a very unique situation to get there. But in terms of considerations for each submission type for 510(k), the obvious question is the predicate of establishing your substantial equivalents of knowing what you have to demonstrate to be able to convince FDA of that and all of these key submissions, you have an impact.
So, if you've talked to FDA about their agreement to your predicate of any considerations they have of your particular device type, de novo predicate is not in question. So, it's more about the special controls that you're going to establish of the testing that you need to demonstrate to FDA, whether that includes clinical testing or not, to demonstrate the risk level and the benefit and risk profile of the device to get through that submission type. EMA, as I mentioned prior, is the most complex submission considerations for that.
One is whether you're able to take a modular approach in which you kind of submit different bits and pieces to FDA, or if it's going to go the traditional route in which all of it goes to FDA at one time. There's pros and cons to each it's whether your timelines really allow for the modular one, in that you have different packets of data available to give to your review team over a longer period of time.
And so that's the main consideration how to submit that one in terms of the content of that submission. Obviously, your clinical evidence is a huge piece of that, of making sure you have your entire study report, all of the data necessaries brought to you to review from that regard, and then telling the story over the entirety of the submission, because you have so many different elements you have an audit to prepare for as well.
It's a lot more moving pieces involved in that one-off making sure all of your ducks are in a row when you begin to approach FDA, whichever approach that may be.
Etienne Nichols: So, I wonder if you'd be willing to do just kind of a crazy exercise with me. Let's just pretend I'm a company; I have an idea.
Or maybe I'm a new regulatory affairs manager who I've been working through some of the things that we're working on, getting our UDI together, getting all these different aspects, making sure our test reports are pulled together, and now I'm ready to submit to the FDA.
Where would you recommend, I start? And let's just assume I have a class two medical device. We'll just take that. Would I go to eSTAR and start just plowing through that PDF, or kind of walk me through the process?
Ellie Reynolds: Yeah. So, starting with eSTAR is not a bad idea because it allows you to see which sections are going to ultimately apply to your device and the type of documentation that's necessary to even consider that administratively complete.
So, if you have software in your device, you get to that section and it's requiring a hazard analysis and an SRF and all these elements that you're not ready yet, there's a clear gap for you to start addressing.
Similarly, whether electrical safety and EMC testing is going to be applicable. You have your usability things pulled together. The eSTAR does provide a very nice outline to your point of being able to see what you have filled and where your gaps are.
I think if you haven't talked to FDA yet, if you're ready to submit tomorrow, maybe it's worth the risk of submitting and seeing what they say in response to your submission.
But if you do have time, depending on the predicate you're chosen and the substantially equivalent argument you're making, if it feels like there may be holes that your review team could poke in that argument. We definitely recommend approaching FDA in a pre-sub to ask these questions, to see what their thoughts are on your predicate choice and the argument you're making.
So, then you can fill those gaps as well before getting to your submission. And then later down the line, hopefully there's fewer deficiencies and a lower risk of getting an NSE.
Etienne Nichols: Okay, maybe if we could go one layer deeper that I love the detail you gave. That was fantastic. Maybe we go one layer deeper. So now my company has said, okay, we're getting close to our submission, and now I'm taking Ellie's advice.
I'm going to get a pre-sub submission or a Q-Sub. Once we figure out what the queue is for, I'm going to get that Q-Sub meeting on the books and talk to the FDA.
How do I go about doing that? And is there any advice you have as I go through that conversation with the FDA?
Ellie Reynolds: Yeah. So, to submit any kind of Q-Sub, it's a written document that you send into FDA. Now, through the online portal, which is a great jump of FDA into the 21st century.
You submit a document that lays out information about your device, information about the regulatory pathway you've chosen and why.
Discussing of benefit risk, discussion of product development that you've done, if it's applicable. And then a discussion of your testing plans and whether that's bench testing. Sorry, go ahead.
Etienne Nichols: Question about that. So, is there a template or something of all, or is there a bullet template somewhere about what needs to go in for that Q-Submission?
Ellie Reynolds: The Q-Sub guidance does have the general expectations of what your submission needs in order to get past the RTA of the pre sub.
However, it is up to discretion of how much is available for the sponsor. So, if you're approaching really early on, you don't have a lot of product development information, you're more just getting a sense of.
Is 510(k) even possible for me? Am I very likely de novo? You can approach with not as much information? If you're getting down the line and you need agreement on an animal study protocol, for example, then there's a certain level of detail that FDA would expect to be able to give you helpful advice in that regard.
So, the testing section is really where the level of detail varies. For example, you could have human factors questions of I don't know how to execute my human factors study. We have unique considerations. So, the more information you're able to provide to FDA in that regard then allows you to get more helpful kind of you get what you give in this instance, that if you're going to be vague with FDA, they're going to say they can't answer your questions. And as you get closer, you want agreement and understanding that your review team agrees with whatever testing you're doing.
Especially if you're deviating in some way or you're arguing something's not applicable, then it's really important you have their agreement before you got to that 500k or de novo and then get a large deficiency letter because they think you need a bunch more.
Done.
Etienne Nichols: Okay. And we'll link to that pre sub guidance in the show notes. So those of you listening, we'll definitely make sure you can find that. Okay, so once we've gotten into the meeting, what does that look like?
Is it a zoom meeting or just kind of give me some color to that? And then you said the review team a few times, so is that going to be the same people who are reviewing my final submission and maybe give some color just to how that conversation goes?
Ellie Reynolds: So, an important note is that it takes 60 to 75 days for FDA to schedule your precept meeting. So that's something a timeline to consider. It's not that you submit it and you get a call the next week.
It really needs to be built in your timelines on that regard as well.
In terms of the meeting, it is largely zoom. FDA, as of late, is allowing for in person meetings, but they will probably never look the same as that they did before the pandemic.
So, it is zoom. I think that's generally the most efficient way to approach it. The review team that attends is selected based on what division you're in, what your device is doing, and then the particular questions you have.
So, if you have a bunch of animal questions, they will bring in their veterinarian. Or if you have a bunch of BioComp questions, a BioComp expert will be there. It is largely expected that the review team will remain the same for a pre-submission as it is for your market submission.
However, there's a bunch of turnover that's natural and happens in the industry.
People are fiscaling around, and if there's a long period of time between a pre-sub and your market submission, it may be different. It's hard to determine that until you make it to each step.
And then the meeting will be scheduled about two months, two and a half months after you submit, a few days before you get written feedback. So, you pose a list of specific questions in your pre sub.
You say, I want FDA's specific advice on X, Y, and Z, and they will provide a document that has their explicit answers to X, Y, and Z, as well as the review team often includes additional considerations, which are very helpful. They'll say they'll acknowledge you didn't ask about this, but here's some other advice that we may have to offer, which I think is really nice.
Sometimes there's a reason a sponsor didn't ask about something and then FDA still texted it, so it's good to see what they're paying attention to. And then you bring that feedback to the meeting and you're allowed to clarify anything.
If it seems like FDA didn't understand something you said, you can clarify for them and see if that they land on the same page as you. If you disagree with some of their feedback, you can attempt to make an argument for whatever your position might be.
It's not the place to bring up new information. So, say in those two and a half months, you ran a whole new animal study. FEA will acknowledge and listen to you about if you want to present that data.
But ultimately, they're not going to be able to act on that. They really can only act on what they've had the chance to review in your packet. So, it's not necessarily the opportunity to introduce a bunch of new concepts.
And then after that, there's a documentation through meeting minutes where you can just make sure that you're clear on the action items, what FDA stance was on whatever you discussed.
And then that sort of closes that file. When you finish a Q-Sub and before you're in your market submission, they do ask for any interactions you've had before. And so, you document, we talked about this topic, and this is how we are addressing it in this submission. So, say you came to an agreement on a certain type of testing. You want to make sure you spell it out, and you say, see this section or this attachment for how we implemented FDA's feedback.
And then that helps them follow the timeline and the journey of your device, as well as hopefully alleviate any gaps or any issues they may think about pointing out, as long as they know that there's an agreement prior.
Etienne Nichols: Okay, that makes sense. When you go into these meetings, is it safe to say there's one thing or maybe let me back up is there one thing that is a consistent overlook by companies?
Like whether it's specifying your indications for use or going outside some of the intended use? I'm just using that as an example. Is there one thing that you consider be really important, that you really need to get this right, or that you've seen a lot of companies get wrong?
Ellie Reynolds: Yeah, I think it ultimately depends on the questions that you're asking. So, per your example on the intended use, if you're trying to get agreement with your predicate, if it's kind of a stretch, if there's maybe some different questions that could come up about it, then you want to make sure that everything FDA is going to think about that is nailed down.
And so, your intended use is crystal clear. It aligns with the predicate, or you're able to address any gaps in the indications, if there are any, that your technological characteristics are spelled out.
And if any differences exist, you explain and provide a rationale for how there's not new and different questions of safety and effectiveness with that.
Similarly, if you have questions on your testing plans. You can't provide a clinical synopsis and expect FDA to give you agreement to that. You can start and you can acknowledge here's a high-level overview of what we're doing and then it at least starts the conversation.
But say this is your last pre sub before you're going in an IDE. If you're not submitting the full protocol, there's a lot of risk to going into that IDE that FDA is going to agree with how you're about to execute the study.
So, I would say that's generally the biggest issue we see is not being prepared with the level of detail that they need to make the next step in whatever their product development is.
Etienne Nichols: Okay, that makes sense. So, once I get to my final pre-sub meeting,
what does it look like as far as wrapping all those action items up or maybe open-ended questions up that maybe they had for me before I go to my market submission?
What does that look like?
Ellie Reynolds: Yeah, you may have multiple. You may only have one pre-sub. You may not need them if you're a very clear MeToo type device. So, it does depend how many you have.
I would say depending on your relationship with your review team. We have had a lot of reviewers that are open to informal conversations or sending them an email if it's just like one final question.
So that is something that's worth asking for in a pre-sub. If that's the kind of relationship you have with the review team, if it's another huge question of we didn't address this endpoint for whatever clinical data we need for our de novo, then that's somewhat of a different story.
I think it's either worth risking depending on the situation, it's highly variable, but you could submit your de novo and try to make the argument for why what you have is sufficient.
You could be planning in the background on a way to gather the data that you didn't. If there's like a long term follow up to your study, something of that nature expecting that deficiency letter to come or the most conservative approach would be making sure that you're meeting each specification.
FDA is laid out for you before you get to that submission.
Etienne Nichols: Okay, that makes so one of the things that you mentioned there was your relationship with the review team, and I think that's worth emphasizing just a little bit. Can you speak a little bit to how that works?
I mean, you really do have a relationship. And the reason I bring that up, because they're people sometimes we look at the FDA as this in the sky entity, but really, you're dealing with people who may have industry experience, maybe not.
Maybe they have mostly a little bit more scientific background. So how do you go about building that relationship and what has been some of your experience there?
Ellie Reynolds: Yeah, I think the frequent submissions does help to automatically build that you're having either it's the same reviewer for your breakthrough designation as it is for your Sprint discussion, as it is for your IDE, and that communication is the relationship is built just on the frequent touch points and communication.
Some review teams, they don't interact the same way as others. I think there's definitely divisions that are more open to collaboration. I think devices that are more complex and showing the willingness to negotiate with FDA also allows for that.
A, because you need more frequent FDA interaction if you're doing a PMA, if you have a high-risk population, a very complex device, you just need more back and forth so that everyone gets on the same page.
But I think also, to your point, they're human. They want to know that there's give and take here and that you're either not shutting down everything that they're saying.
I mean, you can blindly agree to everything. It may make your life difficult, but you could they probably would like that as well, but that you're showing respect for their opinion, that you are working with them on getting to a point where you're all happy and can move forward with the plan.
It ultimately does depend on what the preferences of the reviewers and they each have their own personal approaches, but it is helpful when you're able to have frequent contact with them.
Starting those informal chats, seeing if they're able to respond over email or have a quick call, also helps establish that though there's downfalls to informal interactions as well if they're not on the record, but could help on the relationship front.
Etienne Nichols: Yeah, that makes sense. And I like that you use those two differing maybe ends of the spectrum. You could agree with everything they say, or you could try to stoneball everything they say and neither one is really going to get you where you want to be.
Someone used a phrase once with me. Peacekeepers are the people who avoid conflict in pursuit of just keeping the peace. It's not really what you want. Peacemakers are the people who embrace conflict in pursuit of reconciliation.
And so, I think that kind of describes a little bit what you're talking about. They expect a little bit of confrontation. I mean, there's give and take and so if you're respectful about it, that's ultimately the goal.
Question about that though, if you do a lot of these submissions, maybe I'm my regulatory affairs manager and I've got multiple product lines and I'm doing another submission. Is it possible to get that same review team or is there any kind of oh, they've worked together in the past before, worked really well, can we put them back on it? Is there any option there not formally.
Ellie Reynolds: You can request it in a cover letter, for example, or maybe see if they're available when at the time of your submission. I think ultimately it is a resourcing and a staffing thing on FDA decisions, but I think there is opportunity, especially if it's same versions of the same product or similar related devices.
They'll end up in the same review team regardless.
Etienne Nichols: Right now, that's a good point. Their cover letter.
Do you want to speak to the COVID letter? When does that come about? And what are the things that you typically would put in that so that's.
Ellie Reynolds: Required for all submissions? It's pretty standard form of specifying what this submission is.
Is it a Q-Sub? Is it an IDE? Is it a PMA supplement specifying that, including all of the administrative information about whatever the submission number might be? If it's an amendment, we include just a very brief discussion of the device’s orientation. It's coming from this sponsor. It's intended to do this. This submission is intended to talk about X, Y and Z contact information and signatures and that's about it.
Some information, depending on the submission, some information is required and that's generally spelled out in the guidances of what needs to be in there. But then there's things. I recently had a sponsor that has a grant coming up and they really wanted FDA feedback in time for that grant.
And so, it was very tight on being able to meet that 60-to-75-day timeline. So, we just included in the COVID letter. We're preparing for this grant and would love FDA feedback in time.
If we could receive it by this date, that would be greatly appreciated. And it was scheduled that way. Whether the COVID letter did anything or not, I don't know, but we'll take what we can get.
Etienne Nichols: I've heard some people say that the COVID letter is one of the most important parts of a submission, and the most important part of that is the executive summary, just getting that story out there.
So, whether it's most important or not, I'm sure everybody's going to have a different opinion on that. But that's really good. I like that advice. So, what are some other things that maybe I need to be thinking about as I'm going through this process? I've got my Q-Sub, maybe I'm ready to do my full-on market submission. What are some other things, considerations that I need to be thinking about?
Ellie Reynolds: Yeah, I think your market submission as a whole will be associated with a user fee. I think that's often neglected or just that detail is not looked into. Each submission is associated with a payment that you have to make before that your submission will even make it past Document Control Center.
And they can be very steep. They change yearly, but EMA fees are upwards of $100,000 or sorry, multiple thousand dollars de novo are also upwards of $100,000.
So, they need to be factored in, obviously. However, for startups, there is small business determination. So, if you meet certain thresholds on the sales that you and have achieved, it is all pack space.
That is beyond my purview. But. A sponsor can submit for that. And it does take 60 days; the statute says 60 days to get that answer. It often comes faster, but if FDA agrees that you are a small business, you have significantly reduced user fees.
So, for 510(k), it's on the order of a couple of grand. For de novo, it's on the order of $100,000. So, it's very important to get those in because that is make or break for small companies and it does take a little bit of time to have that.
And that is a critical checkbox that has to be done before your submission even makes it past the administrative wall.
Etienne Nichols: Yeah, that's something I meant to bring up earlier when you mentioned MDUFA. I forgot to define some of our acronyms medical Device user Fee amendments, and I'll put a link in the show notes to that page as well.
I like how transparent, I guess, that the FDA is on this. They have a breakdown, like you said, five, ten k, I just pulled it up. The standard fee, not the small business fee, is about $20,000 for a 510(k).
But like I said, only about 5000 for a small business and then jumping up for de novo to be over 132,000. So that's really interesting. So that is a good point.
We need to be thinking about those things for sure.
As I'm going through, I guess we go back to our eSTAR at this point. Maybe that's the next step.
What are some things that maybe you see some companies leaving out or maybe not doing a very good job of, whether it's justifications or any things like that. What are some things that you see?
Some people could really bolster up what they're doing.
Ellie Reynolds: Yeah, so eSTAR is only applicable to de novo, but they have from our end, been very helpful in sort of providing that outline that we talked about earlier. Fortunately, you can't really leave out a lot because the PDF will not work if you leave out things that are required.
So that definitely helps in establishing of you have to give me this document whether you like it or not, or an excuse of why you don't have it in order to make this PDF go.
So, I think overall we have benefited from it, and it allows the review team to start a quicker review occasionally, and they may go into interactive review and start answering little questions before getting into the substantive review where you get deficiencies in terms of things that are like different tips and tricks for them.
The justifications, I think as long as you're answering the question that is asked for, you don't need to go overkill on it, but don't not answer it.
I think staying within the bounds of what's being asked for is important because they are not always the clearest question.
I think that helps, making sure that you are giving them what they want and then being very clear on your attachment names, you're going to be uploading lots and lots of documents.
It does get very slow occasionally but being able to reference back and forth different parts of your submission because it's best practices to only upload each document in one spot that you want to be able to cross reference across the entire eSTAR.
And so, if you're not using a systematic naming convention, if you're just uploading things that are called like final, final, like FDA feeds all of that. So just putting your best foot forward on the administrative front and being very clear about the connections across the submission and where everything can be found, I think is the most seamless way to attack that submission type.
Etienne Nichols: I love that, and it kind of harkens back to your quality management system and your ability to focus on quality for your revision control and really having a good handle on traceability across all documents, it kind of sounds like to me.
So that's a really good point.
It's one of your first opportunities to really show that, I guess. Not that they're looking for that, but yeah, go ahead.
Ellie Reynolds: Yeah, we found that the clients that have the most put together QMS are the ones that are able to fit into the eSTAR and into the mold that FDA is looking for. I will say know, I know with greenlight, the way the design traceability matrix works doesn't necessarily map one to one with the e star. You can get creative on how to export things of referencing.
So, say you don't have one particular document type because it's buried in a larger document. You can upload something that says, like, see this column of this attachment, for example.
I guess don't freak out if you don't have everything under the same name, you can make it fit to what you have. But I think having a clean QMS allows us to know what you have, allows you to know where to find it, and makes it just like a better picture overall going in.
Etienne Nichols: Fantastic. That makes sense. So, any closing statements? Is there something I forgot to ask or something you'd kind of like to bring up about going back to our original title, successfully planning your FDA submission, what are some other things or are there any other things that you really think people should know or be thinking about?
Ellie Reynolds: Yeah, I think the biggest thing is timeline of thinking of all the things that have to impact that, how your testing has to be done to get it to the pre market submission, how you need to vet your testing plans to a certain extent with FDA, and how the Q-Sub takes time.
We just have clients come to us that are like, well, I need market clearance in the next three months. Like, well, given that FDA is going to take 90 days on its own to do that, I think you need to adjust your timeline.
So, it's jacked up, and it's unfortunate how long each thing takes, but it is the reality. So, if you have a date of, I need to be on the market by this date, working backwards and assessing, is that feasible in the first place?
Can FDA even meet that timeline? And ultimately, they're going to be your rate limiting step, and can I get all my testing done? If you have a two-year clinical trial but you're trying to launch in two and a half years, not so sure that that's going to work out.
So, it's just thinking about how many pieces are going into it, because it is not. And I don't think many people do this, but if you're discounting the size and the amount that goes into your submission, it's going to appear as, oh, and then we just go talk to FDA and it's over.
And it's really not everything that you've done to date needs to be clearly communicated in that submission and how you've spoken with them before. Any interactions all have to be logged and accounted for.
So, I would say that's just the biggest thing is being realistic on what these timelines look like and giving wiggle room for yourself and for them as well. So, you can move quickly, but ultimately you can only move so fast when you're dealing with a government agency like.
Etienne Nichols: This, that makes sense. And you talk about the timelines a little bit. So, a lot of companies, they'll have a project manager dedicated to leading the project. I myself was one of those on a combo product.
I got my PMP, and I was leading a combination product. We were trying to submit to multiple different ways, but I found the regulatory affairs people were my closest allies.
I had to really work closely with them. So, you almost have like the project manager is kind of your internal defense, I guess, or internal, and then your regulatory affairs are the external.
They run the ball down the field to the government agency. How do you describe that relationship? Or are there tips you have in working across the aisle with product development or in the trenches with product development?
Even? I don't want to put words in your mouth, but curious what your thoughts are.
Ellie Reynolds: Yeah, I think it's transparency.
You can promise that a product is going to be done in a month when knowing that that's best-case scenario. It's being transparent about like, where's best case, where's worst case and what is most likely, and building off of that and allowing for overlap of those timelines if you can, acknowledging the lead time that's necessary for certain things. Like we talked about with testing labs, if you need your product done. And that's going to take X number of months, maybe starting to talk to your BioComp lab right now, because they're also going to take X number of months before they can get you.
So being conscientious of where things can be stacked and where things ultimately can't be. And being very transparent on that, because you don't want your software being actively coded as you're combining things into your eSTAR.
You can I don't know the quality of that. You can do that, but it just can make it the most seamless process of making sure you hit those checkpoints and do your design reviews as appropriate.
And you're at the point where everyone's comfortably finishing what needs to be done.
Etienne Nichols: Yeah, companies, they're looking for multiple different things. And so, I guess just to kind of add on to what you're saying is to those project managers who may be listening to this, I almost see it as the FDA is another one of your critical suppliers.
I mean, it's not really qualified as a critical supplier, but that is the requirements that you can have to meet needs to be properly input into your timelines. And maybe if I were speaking to regulatory affairs professionals, truly knowing those timelines, not only the FDA timelines, like you said, they have their clock, but it stops when it comes back to you. Now we're impacting the timeline, so we got to think how we want to put that in. So those are really good considerations, I feel like timelines.
We actually did an interview of; I think it was 613 medical device professionals earlier this year about these different things. And it was something around 70, 67% of companies, they missed the timelines by a year, two years. And so that's really something we as an industry need to get better at. I don't know exactly how we're going to do that, but maybe this is one step.
Okay, any other thoughts?
I really appreciate you coming on the show today. Maybe any closing statements? You probably already had a closing statement where people can find you and if they can get a hold of you with more questions.
Ellie Reynolds: Sure, yeah, I guess closing statements, as we say, interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible.
My name is Ellie Reynolds. I can be found on LinkedIn or ellie@proximacro.com would be the other way to reach me.
Etienne Nichols: Rock on. Thank you so much. Really appreciate you coming on the show and those you've been listening you've been listening to the Global Medical Device Podcast and we will see you all next time. Take care.
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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
