Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. 

Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and services, such as tests, masks, and ventilators.

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Some highlights of this episode include:

• EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies.
• The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be legally marketed.
• Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources.
• FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response by the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated.
• Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public?
• Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time.
• FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events. 
• EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs?

Links:

Erica Loring

FDA - Emergency Use Authorization (EUA)

FDA - Personal Protective Equipment (PPE)

FDA - 510(k) Submission Process

FDA - Premarket Approval (PMA)

FDA - De Novo Classification Request

ISO 13485 Standard

CFR Part 820 - Quality System (QS) Regulation

Meet a Guru: Erica Loring

2021 State of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable Quotes from this episode:

“There’s been a huge influx of EUA applications, ranging from things like ventilators to masks to IVD and lab developed tests.” Jon Speer

“There’s money to be made, a lot of money to be made with these PPE gowns, gloves, masks, ventilators, along with the IVDs.” Erica Loring

“Their (FDA) review periods on other products are getting slowed down. They’re concerned and it’s fairly validated that the quality of the reviewing is also going down, not only with the EUAs but the 510(k)s because their resources are so limited.” Erica Loring

“It’s pretty well-known that a 510(k) is supposed to take 90 days from the point of submission to clearance with the agency.” Jon Speer

Transcript:

Announcer: Welcome to the Global Medical Device Podcast, 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.

Jon Speer: All right, as we're recording this episode of the Global Medical Device Podcast, yeah, we're still in a global pandemic regarding COVID- 19. And here in the United States, there's this thing known as the Emergency Use Authorization that has become, I guess, for lack of a better term popular these days for things like mask and ventilators and IVDs and other types of tests and situations. There's a lot of good that comes from this, from an EUA perspective and the responsiveness of companies to deliver products and services to help address the situation, but there's some side effects of this as well. On this episode of the Global Medical Device Podcast, Erica Loring, a medical device guru at Greenlight Guru, and I chat about some of the good, the bad, the pros, the cons, the impact that EUA has been having on the medical device industry. So, enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast, this is your host and founder at Greenlight Guru, Jon Speer. Joining me today is one of our medical device gurus, Erica Loring. Erica, welcome.

Erica Loring: Hey, Jon, thank you. I'm excited about today's talk.

Jon Speer: Absolutely. So folks, let me tee it up a little bit for you, and then we'll dive right in. We're in a, well, continue to be in an interesting time in the world with COVID- 19 and pandemic and all of those sorts of things. And there was this regulatory pathway, it wasn't new, but started to emerge and become more well- known as a result of COVID-19 known as the Emergency Use Authorization or EUA. Erica has been studying, I guess, this topic and observing and consuming information about things that are happening in this space. So, I thought we would dive into this a little bit and talk about some pros and cons, some of the good, maybe some of the could be better scenarios. So, Erica, I guess I'll let you start the conversation. There's been a huge influx of EUA applications ranging from things like ventilators to mask to IVD and lab developed tests. What effect has this had in general on FDA?

Erica Loring: Yeah, so, I mean, I could sit here and probably talk to you all day about it, because I think... A little bit about my background briefly, if no one listened into the last podcast. But, I've been a regulatory professional for 10, 12 years now, 15 years industry experience with quality, but in between my time this year, I've been doing a lot of consulting for firms for PPE, mask, IVD, things of that nature. So I actually put through a couple EUAs myself and some 510Ks for masks and so on. And so, I have a little bit of experience with this new thing. These companies come to me and think I'm some expert EUA, but I don't really think there is an expert EUA, because it's new the whole pandemic. And I mean, the EUA like you said, isn't new, but we haven't had to experience that yet. So the FDA, I think there's three tiers that we're going to see effect, and we're going to see effects of this EUA at the FDA level. You're going to see the effect at ... It's going to reach companies and it's going to reach the consumer. The FDA, it's government funded, they have a limited amount of resources as well and they've just been hit really hard with such a huge influx of companies trying to get in not only their 510Ks as well, because there's money to be made, a lot of money to be made with these PPE gowns, gloves, masks, ventilators, along with the IVDs. And the FDA is just scrambling to fill people and move people around to allocate them into these EUA reviews and also the 510Ks that also apply to this emergency as well. So we're seeing... I read somewhere the other day that they were approving one IVD test, In Vitro Diagnostic test for COVID a day, which is insane. It is insane.

Jon Speer: That's crazy.

Erica Loring: That's a lot. So, their review periods on other products are getting slowed down and they're, I read that they're concerned and it's fairly validated that the quality of their reviewing is also going down, not only with the EUAs but the 510Ks because their resources are so limited and it is important to still meet their timelines, that they set forward the review periods. So the EUA is looked at, it's going to be a quicker, faster to market submission, but they still have to do their due diligence. And it's especially challenging with all the companies coming in from overseas, especially China to get a good quality reviewing. So they're seeing, and I myself have done a couple of EUAs and they're, I mean, they're meaty. It's not completely lack of information, you have to do you're supporting information. You're just not doing your full 510K submission with a predicate device.

Jon Speer: I was going to say, let's unpack some of that.

Erica Loring: Yeah.

Jon Speer: So, there is, FDA publishes their statistics every year about number of pre- submission or actually, I don't know if there's report that or on pre- submission, but they do report the volume of 510Ks and PMAs and De Novos and et cetera, et cetera. And not that it's a flat line, I mean, year over year, the volume of 510Ks and other regulatory submissions do increase. So we've got that trend, if you will, and then you throw in something like EUA and that's been... I mean, I don't know if there's even a statistic on this either, but I just know anecdotally I've talked to so many people that are pursuing EUA. So this is in addition to the normal growth of 510K and other regulatory submissions. Now you're piling on additional regulatory submissions and FDA has a relatively finite number of resources, to your point, but, it's like if you were to prioritize or triaged, do I look at this 510K for something non COVID related or do I look at this EUA that's COVID related, it puts the agency in a precarious situation of sorts.

Erica Loring: Oh absolutely.

Jon Speer: They have to peel people away from some 510Ks that are not COVID related to focus on EUAs. So, they have to reallocate these resources and it's created a lot of challenges. And one other thing I'll throw in to your point about the review time, I mean, it's pretty well known that a 510K is supposed to take 90 days from the point of submission to clearance with the agency. Sometimes there's a little bit of back and forth. And again, these are published statistics, I don't remember the current average, but it's somewhere in the 120 day range, give or take.

Erica Loring: Mm- hmm( affirmative), exactly.

Jon Speer: So, the EUA, I don't remember when it officially went into effect with respect to COVID, but let's call it March, April ish timeframe. And, as we're recording this, it's late October, early November ish. So, that's less than 120 days if my Math is correct or right at the 120 days give or take, depending on when these things went in. So, the fact that the EUA applications are getting through that process very quickly, I mean, of course on one side, you're like, well, it's serving a need, a global pandemic need. And on the other extreme, it's like, yeah, but it's happening so fast.

Erica Loring: It is it's happening so fast, yeah. The FDA tries to put a specific experienced experts on the review teams. Me as a, maybe a person who's done some IVD work, they're probably not going to throw me on to an MRI machine to review. They're going to want to have people who have industry experience reviewing and critiquing these applications, but I don't think that's going to be the situation right now because they're just pulling resources where they can. So, yeah, I think the FDA is definitely feeling the pressure and the strain and that's going to have a trickle effect maybe to the consumer. And I think my brush on that is, they've revised this EUA guidelines a few times since, I believe, I think the first revision I saw was April. So at one point they didn't accept China and now they do accept China, but then they started testing these masks coming in and ventilators coming in, and they weren't meeting the criteria that they claimed in the submission. And now they don't allow China again. And now the ones that do, who are already on Annex A, or is it Annex A or is it ... It is Annex A, which is essentially the list of companies, manufacturers that are allowed or involved in this EUA. So, they're testing and challenging these masks as they arrive in from China. So, and I talked about the IVD tests as well. Those are getting reviewed at record time as well. And, that has a huge variance of accessibility and sensitivity. We saw some sensitivity coming in the very beginning, I don't know, about a 1600 sensitivity level all the way up to 180. So, these tests are not the same and there are hundreds of them. They're getting improved every day, one a day. So the varying level of quality could be a concern or a sensitivity for the consumers as well, just because of the speed of these reviews. So, we're going to see quite the interesting ripple effect across the board.

Jon Speer: Yeah. I mean, and I would say, what I've reviewed is, speaking of quality, it's not that one is good or bad per se, it's really an unknown and nobody knows for sure. One of the things I do appreciate about the traditional regulatory submission processes is the rigor that's expected and required, and the EUA seems to remove some of that rigor. Would you agree?

Erica Loring: Yeah, absolutely. I know you do have to perform your testing. So I did a couple of EUAs for masks and you do have to do all the testing that's required, biocompatibility testing, your fluid resistance, all that, filtering, but I don't think it's going to be nearly as challenged as a 510K and you're not sitting here and comparing and contrasting to a product kit. I think I have a couple of clients actually with Greenlight Guru who are putting ventilators and mask through and they're a little bit unique, and they don't know quite where they fit in and what pocket. So it's definitely a new situation and they're going to go through EUA as well. You don't have to fit in a pocket. You can be a little bit of a De Novo, maybe not traditional De Novo, but people are making their own little pathways.

Jon Speer: Well, to your point, I mean, with the EUA, the notion of a predicate is not a firm and fast criteria requirement, right?

Erica Loring: Yeah. Correct. You have to fit on the product codes or you have to fit in the product codes that are allowed or involved in the EUA. Like I said, we have a couple of mask companies that are very creative and I have no doubt of their quality, the ones that we're working with at Greenlight, but it's like they fit into two different categories under respirators and masks. And they're just picking one and going with that. So that would be a little bit different if you're doing a 510K, you're comparing and contrasting in all your predicates, and back and forth with the FDA. Whereas in EUA, you're just like, that's closest to this product code and it's in the EUA, let's just go with that. So it's, yeah, it's interesting.

Jon Speer: I mean, and I guess maybe to the lay person, and I'll offer this and you can say, no, you're thinking about it wrong, or yeah, that's right. But it seems like there is the risk, if you will, I mean, is it... Well, I guess even as I'm about to say it I'm questioning, but I'll say it anyway. It seems like a risk with a mask might be less so or a completely different profile than an IVD test.

Erica Loring: Yeah, yeah. I would say so. I mean, it's tough. If you're claiming that your KN95 or N95 and you're filtering 95% particles, right, that's pretty important. And these masks are getting sold into point of care in hospitals, in surgical units and things like that. And then, there was a huge shortage of supply a few months ago that hospitals could not get the appropriate masks that they typically go through, they have their purchasing catalog that I'm sure they just pick out of. So they were forced to get creative and find masks through third parties and direct suppliers and manufacturers coming in from overseas. So in that case, it's a little bit concerning because, if they're not filtering the 95%, are they being exposed in a hospital setting where they're constantly seeing COVID? That could be a little bit of a concern, but. And then you have your IVDs that false positive, false negatives at this point in time. I mean, false positive isn't that scary, of course it will affect our numbers and our statistics, but the false negatives would be more of a concern, right?

Jon Speer: For sure. I mean, speak a little bit more about, I mean, compare and contrast an IVD test result that's either false positive and false negative, just to give some clarification for those listening who may not be intimately familiar with the pros and cons or the risk of either scenario.

Erica Loring: So, typically a false negative is going to... We do IVD test and you think cancer, and obviously that's going to be delayed care of getting your appropriate drugs and treatment. For COVID, a false negative, there isn't a whole lot going on with point of care. I mean, they're learning some things of antibiotics and other drugs that are helping lessen the symptoms, but you're just going through it. But yeah, false negative, you're going out into the world and spreading this on to who knows how many people. False positive is on the other hand, typically if we're talking something a little more common or serious as cancer, if you get a false positive, what kind of treatment are you going to potentially undergo and mental stress, obviously, you just got told you have cancer, that's pretty scary. So false positive for COVID, sometimes we hear about this, your symptoms, you're asymptomatic. So if you're told you're false positive or positive, and you feel as though you're probably asymptomatic, the worst case scenario is, okay, we're going to stay inside for two weeks, but it's going to affect our numbers and so on and so forth. So, I mean, I would rather get a false positive than a false negative. And those sensitivities are definitely taken into consideration when you do your applications.

Jon Speer: Yeah. Thank you for elaborating on that. The other really interesting thing for me on this whole EUA thing is the volume of companies who have submitted EUA applications who are not, and never have been a medical device company. What are your thoughts about that?

Erica Loring: That one is near and dear to my heart, because I've been in IVD companies who go from Research Use Only, RUO to IVD, and that's falling under the 21 CFR 820s and it's complying with ISO 13485 and usually it's a pretty big ramp up. You have to put together your quality management system, you have to make sure you have the appropriate resources. You're doing tech transfers, manufacturing transfers, scaling up. And that's not a quick thing, but these companies are thinking, let's throw in our EUA submission so we can get these sales. A lot of them already probably have sales pending in EUA, lined up. A lot of my companies I consulted for did. So they're really pushing to get this through. But what does that look like for the companies who are going essentially zero to 60? Zero to 120? It is a challenge of, do you have the right resources? What's your manufacturing capabilities? What's the quality going to look like when you're pushing out millions, millions of masks or hundreds of thousands of tests? Do you have the right personnel with the right experience? Do you have enough personnel? So I had consulted for an IVD company. They actually wanted to hire me on as their regulatory director. And going in, I realized, I want to be a regulatory director. I would be a regulatory director, a quality director, operations director. I would be incoming receiving. I would be QA, I would be QC. These companies don't really understand the resources that are important.

Jon Speer: Yeah. Well, and if you read the latest EUA guidance and I don't remember, so forgive me if it's quite this explicit, but if you read it, it gives the impression that some of the 820 quality management system requirements, the regulations, some of those are lifted or it's being allowed for companies to be a little bit more lax on that. And that's a head- scratcher for me. I mean, part of me gets it because it's like, okay, well, if there's truly this huge need, then obviously we need to figure out what obstacles can be removed. But at the same time, to your earlier points, it's like, well, how do we know the quality of these products and these tests, et cetera? And that's what a quality system is intended to do is, is to put the proper processes and checks and provisions in place to ensure that the product that's being manufactured and delivered to those who need it is the highest quality and the safest most effective it can possibly be. So, it's this-

Erica Loring: crosstalk.

Jon Speer: Yeah. It's like this weird thing. And it's concerning in some regard or in many regards, actually.

Erica Loring: Mm- hmm(affirmative), it is, it is. Yeah, like you said, it's not required for them to have a registered medical device facility, and it's not required for them to have ISO 13485. They're encouraged to follow CGMPs, Current Good Manufacturing Practices, but there's no one checking, there's no auditors that are going to see, okay, well, yeah, your facility passes, it meets these criteria. We've done an audit. Uh-uh ( negative), it's not. You're swearing, you're putting your little signature that you're going to follow these guidelines, but there's no way you can put a full quality management system in place. The company I had consulted for and they wanted to hire me, they didn't even know what a CAPA was. They didn't have-

Jon Speer: Oh my.

Erica Loring: Yeah. They didn't even know design controls at all, zero, at all. They didn't know that existed. Yeah, there's definitely concerns and they're growing, they're outgrowing what their capabilities are and which is-

Jon Speer: Sorry to cut you off there, but something, I mean, even though there may be some more lax criteria with respect to a quality management system, I've also know that there is an expectation that one should be doing proper design and development design controls. You should have provisions in place from a CAPA perspective. These are not things that should be viewed as optional. So that is super alarming to know that companies that are entering into this aren't following best practices from a design control perspective and they're not equipped or set up from a process perspective to be able to handle potential post- market challenges and quality events. That is concerning.

Erica Loring: It is, it is. And I don't want to sit here and say, no test is trustworthy. It's definitely not the point. We have a lot of the bigger companies too, the Roche, BD, Becton, Dickinson. What's the other one here in San Diego? Fisher. They're all putting... I'm guessing their products, they're not cutting corners. I'm sure there's a lot on the market that's very trustworthy. That there's great quality. I think, yeah, there's just a small room for concern with the EUA and all prospects from FDA consumers and these companies. But yeah, yeah, it's a trying time right now and it's going to be interesting to see the long- term effect of this.

Jon Speer: Yeah, for sure. Folks, let me take a brief pause and remind you that I'm talking with Erica Loring. Erica is one of the medical device gurus at Greenlight Guru. And speaking of Greenlight Guru, did you know that the medical device quality management system platform provided by Greenlight Guru is the only medical device quality management system on the market today? It's designed specifically and exclusively for the medical device industry, and our gurus like Erica and the other gurus on the Greenlight Guru team, they are part of the resources that are used to help shape and design and influence that entire platform. Erica has been in the industry for 15 years. I've been in the industry for 22 years. All of our gurus have been in the industry for a long time. And so, that experience, that knowledge, that expertise is influential in shaping this product. And Erica and I are talking about EUA. This is a relevant, timely topic in the industry. All of us keep our fingers on the pulse of what's happening in the world from the medical device industry perspective. And that constant knowledge that keeping our fingers on the pulse, means that the platform that we're providing to you is always up- to- date state- of- the- art, meets your needs as a medical device company. So if you're interested in learning more, how the Greenlight Guru medical device quality management system might be an asset to help your business, I would encourage you to go to www. greenlight. guru. And if you are a one of these companies that's exploring or interested in pursuing EUA, we have expertise on staff for that, and we can help you ensure that you're not cutting corners with design controls and CAPAs and other quality system criteria through this platform. So, go to www. greenlight. guru to learn more, and we'd be happy to have a demo and a conversation with you so that you can learn more about why this is so important to the health of your company. All right. So let's talk a little bit about, and we inaudible a little bit, but the impact that EUA has had on non EUA types of products. I mean, I think I read an article recently that I think it was dr. Shuren at CDRH had made some comment and don't quote me on this, but this is my recollection. I guess you can confirm if you've read something similar, but, that this has had a negative impact on other non EUA devices that have been submitted into the queue. I mean, there's been delays that have been received from FDA and it's pretty well publicized at least for a long period of time. And I suspect there's still some ramifications of this too that clinical trials in a lot of cases had been put on hold indefinitely because a lot of hospitals were sequestering their staff and there weren't resources available and that sort of thing. So what have you seen or heard or observed as far as impact for non EUA products?

Erica Loring: Sure. Yeah. I had been working on a couple of products on the side of 510Ks and submissions that had nothing to do with the EUA, and the turnaround time was definitely lagging. Actually, I'm still waiting to hear. So I started at Greenlight, it was just a few months to go and I think the week before I started, I submitted a 510K. And I think that's why I was like, oh, I need two weeks before I can hop on board because I was wrapping up some 510K stuff. So yeah, that delay, I'm definitely still feeling, I still have my client ping me at least once a week if I've heard any news from the FDA. Not only that, it was really challenging to get some of the biocompatibility testing done, because there's so much biocompatibility testing that are just getting pushed through for gowns, gloves, masks, and any other ventilator situation for not only the EUA, but other inaudible submissions for COVID related products. So, cost went up, turnaround time, quality of how often I could hear about from these labs, there's a few good, big ones and they're at their max capacity. I think we waited 10 weeks or something like that just to get on the timeline of when we can get on test. So, and that's on top of a eight to 10 week turnaround time of completion. So, yeah, the impact is felt all around. Also, I work for a couple of companies who were doing healthcare, beauty, hand sanitizer, shampoos, things like that. I do all the formulating on the side and it was really hard to find bottles, pumps, cups, it was getting down to, they're getting a little desperate of buying a huge box supply of product from, or pumps or cups from China and hoping for the best. So it's just, it's reflected all around.

Jon Speer: Yeah. So, I mean, the supply chain...

Erica Loring: The supply chain is hard, yeah.

Jon Speer: Yeah. I mean, I was, a few months back I was doing some work with a potential EUA product that was a ventilator, we'll just say a low cost ventilator and that was what we experienced. I mean, they were trying to get printed circuit boards and just different sheet metal, I mean, sheet metal and plastic and everything that you can imagine that would go into a product. A lot of those suppliers were quoting lead times that were ridiculous, in half a year in some cases. I was like, this is not good. And that was for an EUA thing, I can't imagine being a company today that's... Because this is the thing, I mean, while the world, I don't want to say stop, but it certainly changed because of this, but at the same time, we all know that this is, we don't know when it's going to end. And we know that it will end at some point in time in the not too distant future. But if I'm a medical device company, I'm in this for the long play, I'm not just worried about the next month or two months. I'm thinking about the entire life cycle of my company and the products and the portfolio that I'm building and all these sorts of things. So as best as possible, I'm trying to maintain and operate business as usual. And now all of a sudden, I can't, because there are delays with FDA, there are delays with biocompatibility tests and there are delays from my supply chain. So, this really is, the downstream effects of this have been very painful, especially for a lot of small businesses, which in the medical device industry, this is a fact that few people realize. Something like 80% of medical device companies have 50 or fewer employees. So those 50 or fewer employee companies are feeling this in a big, big way.

Erica Loring: Absolutely, yeah. We're seeing a butterfly effects and it's reaching all corners of medical device community and people in general. So, yeah, it's been interesting to be in the thick of this and being involved.

Jon Speer: All right. I guess, to wrap up the conversation today, I mean, we've talked about some of the challenges or the concerns, if you will, from an EUA perspective, we've talked a little bit about the impact on non EUA medical devices. I guess get your crystal ball out if you will, but what happens after we get through this pandemic and the EUA condition is lifted from the agency. What happens to all these products that are on the market that got EUA? What happens next with them?

Erica Loring: I mean, it's expected that once the EUA is lifted, they are going to remove those. These companies will have to remove their product from market if they didn't continue forward with the 510K. So that's going to have a huge effect on companies as well. Are they going to downsize, are they're going to remove their product from market? Is there going to be a grace period where they can submit 510Ks to keep them on market? All my clients that I'd worked with in between Greenlight, I strongly suggested that they continue on with a 510K, just because you're already did all the testing for an EUA. You have to include biocompatibility as well. And I think a lot of companies aren't used to that, but masks would just go through with a 510K if you've already done most of the work. But yeah, I think we're going to an interesting effect. The IVD company I referred to that I did some consulting work for, they put all their eggs in one basket, in the COVID basket. They're thinking they're in it for the next X amount of years and they're just going to rely on COVID tests, but they're one of 200 probably COVID tests at this point. So who knows how this is going to disrupt the market once it's lifted.

Jon Speer: So what advice would you give a company that decided to enter the med device space that wasn't a medical device company who successfully obtained an EUA for their mask or their ventilator, or their IVD, what advice would you give them? What should they be doing now? Because, I think we all know that there is going to be a finite period of time where EUA is allowed in to what we've talked about. At some point in time, I don't know if... It's not going to be tomorrow in all likelihood, but it will be soon where that is lifted and it's not a thing anymore. What advice would you give this EUA company that may be in that scenario?

Erica Loring: Yeah, that's a great question. You'll hear me talk about this up and down and continuously is resources. Find yourself an experienced quality and or a regulatory person to help you develop a quality management system, to help you submit these submissions, whether it's a 510K or the EUA right upfront. But I really, you can't undervalue experienced industry experience. Yeah, just find yourself the right resources. And again, quality and regulatory people have a lot on their plate, more than likely you're going to need more than one of those experienced people, but yeah resources is going to be a huge thing. Invest in understanding what a quality management system is and all the things that come with it, design controls, risk analysis, CAPAs management reviews. Those are all put in place for very good reasons and it's not just to check the boxes. I promise you, your company will do better if you fully invest from the top down in the quality management and resources.

Jon Speer: That's great advice. To wrap this up, one of the things that I would like to throw out an offer is less to the medical device company or the EUA company but more to the consumer, the patient, the human in the United States. And maybe this sounds a little too skeptical, but when my eyes became open to the medical device industry many, many years ago, I would find myself in a hospital or a doctor's office and fascinated by everything that's on the wall or on the counter. I was like, oh, that's a medical device, I wonder who makes that? And, oh, look, that's a product that I was involved with. So, sometimes, I would even, after that visit or whatever, I would go and do my own research, is this a good product? Is this a bad product? So I tried to inform myself as a patient. And then, as my family members and friends, they've had different procedures, I would say, hey, do you know what product they're using? What about this or what about that? And I realized that might be a little weird there, but I would encourage the consumer, the everyday average person to do a little bit of homework. If you're going to go get this test, try to find out then more about it, the integrity of it, the information about it. A lot of this information is in the public domain. So do your homework because you won't have confidence that this product or this test or whatever the case may be is of the highest integrity possible. So that's my words of wisdom for citizens in this country, and frankly, the world to consider. Erica, thank you so much. This is, to your point, we could probably talk for the rest of the day on this.

Erica Loring: Absolutely.

Jon Speer: And I guess we'll continue to keep our finger on the pulse and see how this situation unfolds over the coming weeks and months and maybe we'll follow up on this in a future session. But folks, thank you so much for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry. Continue to spread the word, share this with your friends and colleagues, and I hope you've enjoyed listening to this and the insights of some of our medical device gurus, Erica Loring, Jon Speer. Thank you so much.

Erica Loring: Thank you.

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