In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode.
Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.
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Some of the highlights of this episode include:
- How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timeline
- Who this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.
- Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.
Links:
- Shawnnah Monterrey on LinkedIn
- BeanStock Ventures – 3P510k
- Etienne Nichols on LinkedIn
- Greenlight Guru software
- FDAs 3P510k page
Transcript
Etienne Nichols
00:00:48.140 - 00:02:14.340
Hey everyone, welcome back. My name is Etienne Nichols. I'm the host of today's episode and today with me is Shawn, Shawna Monterey.
Am I saying your last name correctly?
Shawnnah Monterrey
00:02:14.580 - 00:02:18.020
That is correct. You did hold ours, but I'm not going to make you do that.
Etienne Nichols
00:02:18.180 - 00:02:31.600
Okay. Oh yeah. You know, that's one thing that I really struggle with. My mom tried to teach me the different languages with my name, like Etienne.
But anyway, great to have you on the show from BeanStock Ventures. I'll just go ahead and let you introduce yourself a little bit and what you do.
Shawnnah Monterrey
00:02:32.080 - 00:02:56.400
Sure, sure. Shana Monterey, as CEO of BeanStock Ventures, about 20 years plus experience in software medical device development. Right.
So, I've been there in the very beginning doing instrument software and then having experience with clearing AI device in the early 2000s. And so, we have quite a bit of expertise in understanding the regulation, the origin of everything, the importance of it.
Etienne Nichols
00:02:56.400 - 00:03:50.330
As well as very cool. And also, I'll just throw in one other thing that Shawnnah, I really appreciate your flexibility in so many different things.
She did a webinar for us a while back. I don't know, this is maybe a year ago. And I had a seed of an idea in my head. I wanted to do an ask me anything session.
And right before the webinar started, I said, Shawnnah, would you be willing to do this? She's like, I think so. And so, the very following week I think it was, we did an AMA and ask me anything session on her webinar topic.
And so, you were the first of that group and I really appreciate your flexibility. So, GL, glad to have you on the podcast today. So, what we want to talk about though is the 3P510k.
Now this is something that I really was kind of excited when this prop popped up because I've very only seen this, I don't know, peripherally, third-party review 510(k). But maybe I'll let you just explain what it is and why we even want to be talking about this today.
Shawnnah Monterrey
00:03:50.810 - 00:04:42.570
Sure. So, it's amazing to know that it's been around since the 90s and it's an amazing program, but highly under. Under underutilized it unfortunately.
So basically, what it is that FDA credits third-party reviewers to help with their backlog if they identify 510(k)s. The more known 510(k)s lower risk. And then with the accredited persons, you can go through them directly as opposed to going through the FDA.
So, we get trained, right. We have special qualifications that we have to be certified with and then we have to recertify every three years.
The intent of the program really is to fast track. Right.
To provide an alternate pathway so that you don't get stuck into the 510(k) and to kind of offload FDA's plate so FDA can focus on the more critical devices.
Etienne Nichols
00:04:44.650 - 00:05:32.640
That's a great rundown. I appreciate you throwing that. Just explaining that. So, on the FDA website, I have it pulled up on my computer.
The 510(k) Third Party Review Program kind of gives an overview of how this works. And just like you said, it's.
I want you to kind of fill in the gaps of my knowledge too because it's interesting that they have a little timeline infographic. I Mean a mini-infographic, I guess.
So, you send that 510(k) to that third-party organization, they actually review it, tell the FDA what they think the FDA should do, and then the FDA goes back to that third-party reviewer, and it comes back to the actual submitter. So, is this more efficient than going straight to the, to the FDA or what are the benefits of doing, going this pathway?
Shawnnah Monterrey
00:05:33.440 - 00:06:34.630
The benefits are that many of the third-party review organizations will guarantee a review date. Right. Lock in your date of when you're going to submit and then guarantee turnaround time.
The caveat is depending on how well your submission is done, that's going to determine the performance and the timeline. And that's true with just submitting directly to the FDA. Right.
So, the better your submission and the more responsive the company is, the faster you'll get it through and approved by addressing FDA's questions or a third-party review's question. The thing that's unique about it is that because the company can kind of guarantee the timeline, we know what our Q is.
We have a really small Q compared to the FDA and we have subject matter expertise lined up. Is that FDA? Once we give our response to the FDA, they guarantee us 30 days. That's a guarantee that they hold by.
And we've done submissions before and they've held to that, to that date. And so, you're getting a guaranteed timeline from the FDA of 30 days.
Etienne Nichols
00:06:35.030 - 00:06:43.640
Okay, so you have a. So, you, as that third-party reviewer, you give a timeline when you'll be done and then The FDA is 30 days after that.
Shawnnah Monterrey
00:06:43.640 - 00:06:44.600
Yes. Yeah.
Etienne Nichols
00:06:44.760 - 00:07:03.240
Wow. Okay. Yeah, that does seem like a huge advantage.
And I saw, just looking at the database of third-party review organizations, there are nine companies and so you are one of nine companies. Is that correct? Okay. Huh. So why would you say, you said it's underutilized. Why do you think that is?
Shawnnah Monterrey
00:07:03.800 - 00:08:28.320
I think marketing, I think raising awareness is important. People just don't know it exists.
So, we did a webinar recently and the team had an idea after I had visited the FDA to kind of do a little mini commercial. And usually, I don't do that. I just kind of present on some sort of topic.
And we found out that people were very interested in the topic and not aware that it existed, even large organizations. And I'm finding more, the more inquiries we get, the most inquiries we get is actually from startups.
And I think because startups are trying to figure out, you know, they're digging in themselves and they're trying to figure out what's most cost effective for them.
And I think they kind of hear from word of mouth with their peers, but from, you know, larger organizations, I think they're used to the standard flow of submission. Right. And so, they generally have everything, they're trained, they know what's changed.
But this, like I mentioned, this program has been around for quite a long time and people just don't know about it. We did approach FDA and had a conversation with them recently.
Actually, a couple months ago we went on site, all the third-party reviewers got an invitation to attend a workshop and most of us were there. And the main concern was getting more third-party applicants. And the feedback from FDA is a marketing issue and FDA is not going to market.
Right, sure.
Etienne Nichols
00:08:28.320 - 00:08:30.400
Yeah, that makes sense. Okay.
Shawnnah Monterrey
00:08:30.640 - 00:08:44.620
The gap, that's basically what they're perceiving is the gap we're going to find out.
We're spending a lot of time, you know, with this podcast and other activities that we're doing, partnering with third-party reviews to kind of get the word out. So, we'll see if, if that's actually the case.
Etienne Nichols
00:08:45.180 - 00:09:03.340
Yeah, that's great. So, when I looked at the 510(k) or the 3P510k program on the FDA website, there are some exceptions. So, it's not just for any 510(k). Is that accurate?
Can you walk me through some of the, some of the exceptions and the reasoning behind some of that?
Shawnnah Monterrey
00:09:03.740 - 00:09:13.150
Sure, sure. So out of all the product codes eligible for 510(k), about 50% are allocated to the third-party review program.
Etienne Nichols
00:09:13.470 - 00:09:14.030
Okay.
Shawnnah Monterrey
00:09:14.190 - 00:10:23.060
Of those 50%, only about 2% are actually going through third-party review. So, it's significantly underutilized. Right.
That's a really low number compared to what capacity we have in terms of availability and also qualification. The idea is when FDA does the allocation, they review the list periodically. Right. So, they do update the list.
They haven't made an update for about a year at least, that's my understanding. But when they make, they do it based on product risk. Right.
So products that are more standard known, et cetera, like let's say maybe an endoscope or EKG recorder, things like that, that they deem low risk, they would then allocate to the program because it's known, there's a known pathway, there's a lot of predicates, a lot of examples. So, the review process and showing substantial equivalency is pretty straightforward.
When we get an application in though, we do consult with the FDA, even if it's part of the list to consult with Them to see if there's any special thing, specialties or any nuances that need to be considered that may make the submission a little bit trickier.
Etienne Nichols
00:10:23.700 - 00:10:57.230
Okay, so. Okay, that makes sense. And you actually kind of touched on something that I'm curious about.
You said you actually do consult with the FDA when you have one, that maybe it's outside the realm. So, what, how does this look from a submitter standpoint?
If I want to submit directly to the FDA, I think my, my reasoning might be, well, I want to have a Q-Sub, I want to be able to talk to the FDA one on one. Are there advantages or disadvantages to that? How does that work with this, with this program?
Shawnnah Monterrey
00:10:57.870 - 00:11:32.170
Okay, so we still consult with the FDA regardless. Right. So, applicant that comes in, then we have a consultation meeting with the, with the FDA. So, we do engage with FDA throughout.
We request documents from FDA so we have the same access and information the FDA would have, providing we have that conversation with the FDA and ask for that information. Right. So that's available to us. So that's I guess going to depend on reviewer to reviewer.
But going back into like maybe specifically the Q-Sub, you can still do a Q-Sub and go through a third-party review organization.
Etienne Nichols
00:11:32.730 - 00:11:33.290
Okay.
Shawnnah Monterrey
00:11:33.530 - 00:12:13.260
To communicate with your third-party reviewer though, that you did a Q-Sub and you should include your Q-Sub documentation as part of your submission to the third-party review organization. We will ask for it. Right. If you've had it. But we're not going to ask specifically.
Generally, we don't ask specifically for Q-Sub, but we will ask, have you had any interaction prior to us with the FDA and if so, what was it? And so, one thing to keep in mind is that the Q-Sub is binding. So, if you get feedback that's undesirable, let's say from the FDA, that's binding.
You can't skirt through by going through a third-party. Right. We will find out. Yeah, adhere to it as well. It is binding for us as well.
Etienne Nichols
00:12:13.500 - 00:12:33.340
Sure, that makes sense. So being one of nine companies, it's obviously kind of a rarefied era, it would seem.
I know the medical device industry isn't huge, but what does it take to become a third-party reviewer? What did you, being one of those nine, what did you have to go through to become one of those?
Shawnnah Monterrey
00:12:33.820 - 00:14:29.000
Yeah. So, I would say to start like we didn't think we would get approval. Right. We saw the advertisement go out. Right.
Where they're opening it up every so often for new review organizations. Right. So, it's A period of time where they'll open it up for that's when we have to reapply and then they allow new applicants to come in.
One aspect of the qualification is training and real-world experience. Right.
So, the expectation is that we have done submissions before of similar complexity and we have that domain and technical expertise to do the substantial equivalency review.
The other aspect of it is being involved in audit capabilities or roles previously, which includes either an FDA audit or some other type of regulatory structured audit. Right. Having that level of expertise in house as well and then being able to discern what we know and what we don't know.
And when we have to actually extend a hand out either to the FDA to ask very specific questions or to provide very specific input into what we're recommending and why to get feedback from the FDA, like knowing when to do that and also knowing when to source other subject matter expertise. So, I'll give you an example. Like when we do the submission, if we don't have expertise in house, we make sure that we source that.
And so, for bio, we had a biocompatibility need with one of the submissions. We didn't try to pretend we're experts or onboard to it. Right. We definitely didn't have the expertise or skill set.
And so, we were able to bring in a consultant that actually wrote was part of the authoring team of the actual guidance.
And so, because we have industry connections and relationships, we are able to tap into very high-end subject matter expertise to really help facilitate the review.
Etienne Nichols
00:14:29.560 - 00:14:54.840
Okay. There's also a guidance document on the 3P510k. I don't know if they call it that per se in the guidance third-party review for the 510(k) program.
What are some, is this something that you recommend a company would look at before submitting to an organization such as yours? Or, or is this something more along the lines for the actual organizations that are doing the review?
Shawnnah Monterrey
00:14:55.240 - 00:15:07.800
It's for the review organization.
I mean, if someone wants to understand how the process works or to qualify, you know, that's fine, but it kind of defeats the purpose because we've already been accredited through the FDA.
Etienne Nichols
00:15:08.130 - 00:15:08.370
Sure.
Shawnnah Monterrey
00:15:08.370 - 00:15:37.830
Right. So, it's assuming maybe the FDA, you're not trusting what they actually did as part of the accreditation. Right.
So those are the requirements to be accredited. We do have to get training, and we do have to, we do get audited. There's quite a bit of stuff that happens.
And so, we're not trained and audited like we would be for a medical device manufacturer.
But there is quite a bit of rigor there around the process to make sure we're doing what FDA expects us to do and we're delivering high quality output to them.
Etienne Nichols
00:15:37.830 - 00:15:38.310
Okay.
Shawnnah Monterrey
00:15:38.310 - 00:15:49.150
They do score us.
There's a ranking system, so I don't know if you want to talk about that, but there's other aspects that can be looked into to determine who the best third-party review organization might be for you for your company.
Etienne Nichols
00:15:49.390 - 00:15:51.790
Yeah, let's talk about the ranking system. How does that work?
Shawnnah Monterrey
00:15:52.670 - 00:16:50.890
So, it's a grading system, but they only start grading once you have done, I believe five or more, look us up. You won't be able to see our grade, but our grade for our submission was A plus. We got the best score.
FDA was actually impressed with our submission saying it was a very complex submission because we pride ourselves on high complexity development. So, it's highly complex but also very well done. Where the FDA didn't have any additional questions. But that's our goal as an organization.
We purposely try to do that because if we go and do the first part of the review and work with our client on a set of questions. Right.
And our client gives us feedback and addresses all those and then we give a recommendation to the FDA, and the FDA comes back with gaps, then I feel personally right, from a business perspective we didn't get enough job. And so how do we do a better job so that we can minimize the back and forth with the FDA? So that 30-day clock is legitimately a 30-day clock.
Etienne Nichols
00:16:51.610 - 00:17:36.590
I love that idea because it's almost as if you already have gotten into the mind of the FDA.
You are, I mean you're representing the FDA to a certain extent, and you can have that back and forth with, with the company and the company is not necessarily going to be as intimidated, especially if it's their first time. I think that's a really fantast program. I mean that's, that's really cool. Do you anticipate. Well, let me see how to phrase this question.
When you make that recommendation to the FDA, you got an A plus and so I think that's fantastic.
I, I just seeing you work, I not surprised are other companies, how likely is it that the FDA would come back to a third-party review and have a difference of opinion on that recommendation to any opinion there?
Shawnnah Monterrey
00:17:36.830 - 00:18:09.770
I don't have any statistics on that, but I knew that I know they do, and I guess I can touch a point. Another topic, a point that we should discuss is feedback around those that have used the Third-party review organization. Yes.
So, we've had customers reach out to us for consulting work and we've mentioned we're a third-party review organization. They're like, yes, we know, that's how we found you.
But what ends up happening is we get feedback on the third-party review and complaints about the program for those that have used it.
Etienne Nichols
00:18:10.010 - 00:18:10.650
Okay.
Shawnnah Monterrey
00:18:10.650 - 00:19:38.940
Main complaint is they perceive the third-party review organization, to your point, as the extension of the FDA. And so, when the review goes through the FDA, they would expect it to pass because they've already dealt with the third-party reviews questions.
And so, they already know what the recommendation is going to be based on those questions. And so there has been cases where the FDA has gone back with very significant findings that cannot be addressed in a reasonable amount of time.
And I'm talking about findings in testing where they have to go back and test findings in the design where they have to go back and remediate the design. Those are significant. And so, when I mentioned what we do as an organization, we're a little bit more expensive actually.
And the reason for that is because we bring in the subject matter expertise to make sure that doesn't happen because we want to guarantee that timeline. And so, if you spend more upfront with someone like us. Right. And again, you can qualify.
The other third-party review organizations, they're all very different in terms of how they actually handle the reviews. We have like, you know, requirements that we all follow. So, it's all the same.
But our pricing model and business model might be a little bit different. And so, our pricing's a little bit, a little bit more and it's not significantly more, it's about 10k more.
But we do pride ourselves in bringing in that subject matter expertise because we don't want to provide a recommendation on something where there's ambiguity.
Etienne Nichols
00:19:39.420 - 00:20:04.200
Okay, now when, when that, let's say, and maybe not your organization, but another third-party, whoever it may be, makes that recommendation, the FDA comes back with those significant findings.
Like you said, is there opportunity for the third-party review organization to push back some and have some discussion to mitigate some of that testing that may have to occur or what are your thoughts there?
Shawnnah Monterrey
00:20:04.360 - 00:21:19.690
Pushback, but there's clarification.
So, let's say I provided a submission to the FDA recommendation to the FDA and I said, you know what, based on this, they've proved substantial equivalency. We recommend that they, they get approval, right?
Let's say FDA comes back and said that's great, but their usability is missing A, B, C and D. And there's a risk here and they didn't appropriately mitigate this potential design flaw in their cyber submission. As a third-party review organization, I can go and look at the submission and clarify with the FDA to say yes, they did, and here's why.
Okay, But I can't necessarily argue with the FDA and say I don't, I don't agree unless I'm able to prove right to say no, I don't think they need validation or usability. Sure, yeah, they don't need to address this risk. And with cyber. Right. Unless I'm able to justify it, just like the organization would. Okay, right.
And so based on our knowledge of the review, if there's a gap because we didn't communicate well from the client, from our review to the FDA, we can bridge that and provide clarification and justification. Right. But if it's something that we missed, like we justify it, then it has to go back to the, the client.
Etienne Nichols
00:21:20.090 - 00:21:52.770
Okay. And you mentioned that each company, maybe they're a little bit more specialized than, than the others.
For one specific thing I looked, I'm just looking at the current list of FDAs recognized 510(k) third-party review organizations. You know, the nine that are there, you can click on each one. And what is that showing me? So, I can see anesthesiology, clinical chemistry.
Are these the things that you, your organization is special like specializes in and is approved for or recommended for? Tell me about that.
Shawnnah Monterrey
00:21:52.850 - 00:22:13.630
So, when we go through our accreditation process, we have to identify the product codes that we want to be able to clear. So that requires a certain level of domain technical expertise. Right. Clinical expertise, et cetera. Okay.
And so, from that perspective, if you go and click on a company, those are the device codes that they're able to clear.
Etienne Nichols
00:22:14.190 - 00:22:14.830
Okay.
Shawnnah Monterrey
00:22:15.150 - 00:23:20.700
So, if it's not on the list, then they're not qualified to do that. And that doesn't mean they can't be qualified or they're ineligible. They just didn't apply for that particular product code.
And so, if you start seeing a trend, you'll see there's the companies that have a lot of PP and either type of product codes or like really simple surgical devices. I say simple because I mean from a technical complexity. Right.
Like a knife or surgical knife or something like that versus a very complex electromechanical software device. You can see a split there. Us as an organization, that's where we need the split.
So, we only do electromechanical devices that have software and software and firmware. We basically say that that's the same thing. And FDA recognizes firmware to be type of software.
And so, anything that's electromechanical with firmware or software is on our list. In general, if there's some that are missing, it's probably we just missed it when we did the sweep to do the accreditation.
But generally, that's how it's done. And you have to get accredited code by code, so you legitimately have to list each one.
Etienne Nichols
00:23:21.020 - 00:23:26.860
Okay. How often do they update the, the list of 3P510k review organizations?
Shawnnah Monterrey
00:23:27.430 - 00:23:38.950
Yeah, I don't know if it's standard, but I know they look at it probably annually, but I don't know if that's guaranteed. I don't think they've updated that list within the last year. Okay.
Etienne Nichols
00:23:39.270 - 00:23:46.790
My understanding, and you mentioned the grading system. Is it possible like if you were to get a failing grade is you kicked out or how does that work?
Shawnnah Monterrey
00:23:47.590 - 00:24:06.810
No, I don't think so. I think it might trigger, it may trigger an audit maybe. Right. Just like if you have a lot of recalls and stuff.
I don't know if that's actually, you know, an indicator of that, but I think it will show that there's an issue and FDA will probably reach out and have a conversation with that third-party review organization.
Etienne Nichols
00:24:07.770 - 00:24:08.890
Yeah. Okay.
Shawnnah Monterrey
00:24:09.050 - 00:24:44.030
Defeating the purpose of the, of the program and the rating system is really there for accountability. Right. So, if you start seeing someone with really low ratings, you might want to question why.
But then again, I want to kind of point out that of the nine organization, there's only two that really have substance in third-party. And the reason being is because they're significantly older, they've been around for a long time, so they have more volume and recurring customers.
And then the other reason is because of visibility with the, with the program. So, the program.
Etienne Nichols
00:24:44.030 - 00:24:44.830
Lack of awareness.
Shawnnah Monterrey
00:24:44.830 - 00:25:15.030
Yeah, yeah, lack of awareness for sure. And so generally like you can imagine, like there's nine. Right. And two of them are predominantly the main reviewers.
Out of the nine, who are you going to pick? You're probably going to pick the one with more traction. Right.
So that ends up being kind of a self-fulfilling prophecy where the other reviewers aren't getting the share of the work. For us, we do get quite a bit of inquiries. So, we're fortunate that way.
I think some of the main things we're seeing with the inquiries is the companies just aren't ready.
Etienne Nichols
00:25:15.270 - 00:25:15.670
Yeah.
Shawnnah Monterrey
00:25:15.670 - 00:25:23.750
And we will not move forward with accepting a deposit if we feel with that initial conversation, they're not ready and we can tell right away.
Etienne Nichols
00:25:24.480 - 00:25:51.760
Yeah, that's good. Any other pros and cons to this program or things that people should really be aware of? I'm, I'm curious if, you know, I'm.
It might go back just to a typical 510(k) submission and the recommendations you would have for any company because essentially, you're submitting a 510(k).
But I guess the question I would have is are there any best practices or common pitfalls you see companies getting into when they, when they go to pursue this program?
Shawnnah Monterrey
00:25:52.960 - 00:25:58.640
Yeah, I would say. And I think this is just generic, I don't think. Well one, let me talk specifically to the program.
Etienne Nichols
00:25:58.720 - 00:25:59.120
Sure.
Shawnnah Monterrey
00:25:59.360 - 00:29:34.210
Specific to the program.
I think it's just vetting the third-party review organizations and then just knowing that in terms of price and process they're going to be very similar. But I think really when you bet your review organization, you want to assess their domain expertise around your product. Right.
And even if they don't have the domain expertise, you want to kind of know enough and have the confidence that they're actually going to go out and source those resources and add them onto the review team so that they can have a high quality review. So, I think that's the most important, you know, availability is, you know, important. Cost might be a meet, be a factor.
But as I mentioned, I think the cost is so in the noise that if that's the factor, like I think those review organizations better be tied. Right. And the reason why I say that is because you want to pick the best review organization for your submission. Right.
And if you're doing it solely on price, you're not really looking at the impact to your business. Right. And the value one review organization would provide to the other. Right.
If they're vanilla and you see them as both being the same, then yeah, just flip a coin and. Right. Or go based on cost or whatnot. But they're pretty comparable in terms of, of in terms of pricing. Right.
And so, one thing we do see is that people coming to us like kind of not serious and shopping around. And so, we, we know that now because we talk to each other and so we're just going to kind of move on.
So, if we kind of anticipate that you're not being very serious and you're shopping around and not ready, then we, you may not get the time, the quality time that you, you need from us or our attention. So that's something to kind of keep in mind. The other thing, and this is Just true with any submission is just being ready, right?
There is a guidance document on what's required for the submission, right? If you don't understand what's required, it's too early to talk to a third-party review organization.
When you're talking to a third-party review organization from a third-party lens, we're not consultants, right? It's just like talking to the FDA. So, we're just going to point you to the guidance, right?
We're not going to give you advice, although most of us do provide consultancy, which is, you know, a bonus when you're looking at the third-party review program. We're not going to be providing you any guidance there. And so, it's really important to make sure that you have the right partner.
Even if it's a third-party review organization that provides consultancy, you have the right regulatory partner. And so, a lot of companies try to, specifically startups, right?
I'm referring mostly to startups, but they try to do the submission on their own and they'll fail miserably.
They'll read the guidance, they'll think they understand it, they'll do the submission on their own, they'll pay the fee and then they won't be able to respond to the questions because the gaps are so huge. And so, it's really important to have someone cross review your submission.
If you don't have an expert cross reviewing your submission as part of your team prior to submission, that will increase your chances of success because they know what to look for.
And so, what you want to do is you want to minimize the back and forth between yourself, the review organization and or the FDA because you're just killing time. And so, you really want to put your best foot forward. It's not a pathway to get a first pass and use it as a filtering process.
And we've gotten feedback before, they're like, oh, we can pay you and you'll do the first review and then we'll know what our gaps are and then we'll go to the FDA and once we hear that, we're like, no, that's not the intent of the program. If you're not ready, we can do an audit, right, as a separate service. But if you're not ready, don't use us as a filter. It's not a good idea.
Etienne Nichols
00:29:34.530 - 00:30:20.680
Yeah, I think that's an important distinction to make.
I appreciate you making that distinction, that you're not, in this instance, you're not operating as a consultant, but a third-party organization may offer that service as well. So that's handy to know and I can see that being a huge advantage if you utilize it that way. But knowing what you're there for is important.
Okay man, I had another question. I just lost it. So that, that makes sense. What are, what about you mentioned startups and doing it for the first time.
Is this beneficial to a regulatory expert who maybe they've got a few submissions under their belt and then they're in a large organization, you know, maybe a mid-level company. How should they be looking at this program?
Shawnnah Monterrey
00:30:22.060 - 00:32:32.260
I would see it as kind of a partnership. Right. So, looking at a third-party review organization that has your domain and leveraging them as a partner. Right.
To help you with your business, to provide a quicker pathway to submission. And so, these organizations generally know how to do a submission, you know, generally I mean to not get back questions is unusual. Right.
So even if you're awesome at what you do, like the reviewer is going to find things, there are going to be gaps there, you're not going to be sure what lens they're looking at it from. Right. Because everyone has a different like angle or like specialty expertise that they're going to tend to dig down on.
And so generally you're going to get responses back. Right. For clarity. And then when that happens, you know, that's fine, that's just part of normal, part of the process.
But I would say for a large organization it really saves time and time to market is really important. Right. And so, you, you see these timelines, especially with large organizations, they understand the FDA timeline. Yeah, right.
The startup, they'll look at the FDA website and be like, oh it's 180 days or whatever it's being claimed and assume that's the case. Right. But it's not the case.
And so, when you're building out a large program and you're doing a launch, you know, whether a big organization does a US launch first or EU. It used to be we used to do EU launches first and then US and now there's a switch because of EU MDR.
When that's being done, they're estimating six to nine months, months of the regulatory part of the process. And so, what that does is actually put stress on the development team because there's six to nine months of kind of unused time.
And if you're strategic enough, you can build in some of the development after the, after the fact while you're getting the approval. But the key thing there is if you make any design changes, you're going to have to make sure it doesn't impact your substantial equivalency.
So, a lot of organizations don't like to do that. They want all development 100% complete before the submission.
So you have this six to nine months of kind of time that you could have used for R&D and so gives you more R&D time basically, if you look at that from that perspective, more R&D time and faster time to market and more predictable time to market.
Etienne Nichols
00:32:33.300 - 00:33:44.790
So, when I first started hearing about this, my immediate thought was this seems like a great program for startups for someone who's never done it for the first time. But that distinction, you said this is not a filter for, you know, just, just getting a first pass.
I almost now my mind is sort of thinking, okay, now I'm a regulatory expert in a big company and I'm used to submitting to the FDA, but why would I go to the third-party review? I'm actually thinking, okay, wait a second, I could go to this third-party review.
And now I have a more concrete deadline or timeline that I can give my project managers that I can give to upper management, and I can limit that uncertainty. The things that are outside my control now I have a little bit more certainty around and that is actually pretty huge.
Having been in project management, I was a PMP, I guess I still am, I think I've maintained it. But anyway, that is huge. Controlling the things that are outside your control is pretty powerful.
So I can see that being a huge boon and even a knowing that and being able to articulate that to management to get the funds needed to maybe just a slightly additional, could be an additional way of getting that, that, that access to this third-party review program as well.
Shawnnah Monterrey
00:33:44.790 - 00:35:54.810
Exactly, exactly. And the third-party review program, like the cost is comparable to the submission cost of the FDA. You do not pay the fees twice.
So, one question that we have is, okay, do we pay you and then we go and pay the FDA, right, the MDUFA fees and no, that's not the case. You pay us instead of paying the FDA and it's comparable.
I think the FDA is what, maybe 20K right now and the third-party review organizations are anywhere from 20, maybe 18K depending on the device type K to 30, 35K. Okay, so I think it's comparable. Obviously if you're a startup and you're pinching pennies, 10k makes a significant difference.
But you have to look at it in terms of the value of time to market. And a lot of startups have a dependency on regulatory clearance for fundraising because A lot of investors deem that as being high risk.
They don't want to invest in a company that they don't understand the complexity or the safety impact or the risk from a regulatory perspective.
So, it's almost like if you're able to get a product cleared, it provides a sense of assurance from your investors like, okay, this hurdle has been achieved, it's going to get cleared. I don't have to worry about that uncertainty because it's been cleared here. Now I can go ahead and make a follow-on investment.
And so, you have to look at it from both perspectives. One, is this, you know, additional funds or fees that I'm going to pay going to unlock investors faster. Right.
If you have pent up investors that express that concern, which they probably will, and then two, is this going to enable me to get to market faster? Right. And for startups, I think, you know, time is money even for large organizations. But large organizations can weather that storm. Right.
If organization has a launch that's six months late, right. Maybe people are not going to get fired and maybe you're still going to get a paycheck. Right. Assuming that it's not that business critical.
But big, large organizations generally have a reasonable buffer.
I've seen products three years late and nobody lost their job and we're still struggling to try to get the product launch on time for like technical complexities and stuff like that. But for a startup, a month could be detrimental. Right. Because of cash flow.
Etienne Nichols
00:35:55.050 - 00:36:10.690
Yeah.
And I don't know, I am not arguing with you at all in startup, but I might make the argument now that the larger organizations are feeling a little bit more just due to the economy and hopefully it goes back to that, oh, three years is no big deal. But right now, it might be a big deal.
Shawnnah Monterrey
00:36:10.690 - 00:37:16.950
I agree.
And that's why I was saying typically, yeah, the current landscape we are seeing significant layoffs like just from not meeting timelines, competitiveness. Right. Like that, your competitors getting there faster, quicker. We are seeing that, that pressure and I think the pressure started with COVID right.
That impacted the industry in terms of their ability to withstand. Right. A recession and all this other stuff that's happening because Covid was a long time. It wasn't like a six-month impact. Right.
It was a couple of years impact on even, you know, elective surgery and that and that type of thing. And then the new entrance of digital health is kind of shaking things up.
So, the big medical device manufacturers are behind, you know, everything's on the instrument. They're not leveraging the Cloud, unless they started as a cloud company. Right. And so, there's a sense of kind of catch up. Right.
And this starter, these startup companies are more nimble. Right. So, anything that a large organization can do to be more competitive, get to market faster is definitely going to be a benefit.
Etienne Nichols
00:37:17.190 - 00:37:30.790
Yep, that's, that's a good point. That competitive advantage of getting to market first is pretty big. Anything else?
Any last words you have about this topic or how can people find you? What, what last piece of advice does you have?
Shawnnah Monterrey
00:37:31.830 - 00:37:57.050
They can find us on our website, so www.beanstockventures.com but also on the FDA website.
You can go there, and you look up your product-by-product type and device and product code and then from there you can see the list of third-party review organizations that are qualified for your product. We are listed there. I believe there's a; there's an email on there. Do you happen to have it up? I think it's three.
Etienne Nichols
00:37:58.810 - 00:38:09.150
Let's see here. I just did have it up. So, an email to the.
There, there's a list or an email to each one of the different companies as well as the website contact name and phone number.
Shawnnah Monterrey
00:38:09.470 - 00:38:14.270
Yeah. So, our email is on there as well. And what's the, can you cite the email that's on there?
Etienne Nichols
00:38:14.270 - 00:38:19.470
I think it's 3P510k beanstockventures.com exactly.
Shawnnah Monterrey
00:38:19.470 - 00:39:26.360
So, feel free to email us. We usually respond within 24 hours and so if this is something that's important, you feel free to reach out. We do, like I said, respond.
We meet with every client in person on a call. So, if there's any questions you have around the program, we're more than happy to help. Even if you're not ready, that's fine.
We will still meet with you as I mentioned, but in terms of moving forward with the program from that point on, from once you are aware of how the program actually works with us, then it's really about, you know, if you're ready. I mentioned before, if you're not ready. We do provide services to be ready.
We'll pre review, do an audit and assessment and we can even remediate gaps across the board.
We have templates and training as well specific to software in a medical device and software as a medical device for those that are in digital health.
We do provide templates that'll help satisfy the process and I know Greenlight also has quality management system and processes as well that also satisfy that. So, there's a complimentary there package that you can get to help you with your submission.
Etienne Nichols
00:39:27.070 - 00:39:50.030
Absolutely. Love to. We always love working with BeanStock Ventures and, you know, if there's anything we can do to help anyone out, just let us know.
Really appreciate you bringing awareness to this topic and I'm excited to see how this program will grow in the future. It's been around since the 90s, you know, so, but it's, but it's in that, that slow.
I could see some maybe exponential growth in the next few years with some good marketing. So, we'll do what we can to help.
Shawnnah Monterrey
00:39:50.670 - 00:39:52.640
Thank you much, much appreciated.
Etienne Nichols
00:39:53.350 - 00:40:01.670
All right, thank you so much, Shawnnah. We'll let you get back to the rest of your day. And those of you been listening, you've been listening to the Global Medical Device Podcast.
We will see you all next time. Take care.
Shawnnah Monterrey
00:40:01.910 - 00:40:02.550
Thank you.
Etienne Nichols
00:40:03.670 - 00:40:47.070
Thank you so much for listening. If you enjoyed this episode, reach out and let us know either on LinkedIn or I'd personally love to hear from you via email.
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About the Global Medical Device Podcast:
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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.
