MedTech Mindset Podcast: Clinical Evidence Insights with Joe Popowicz

MedTech Mindset Podcast
Thought Leadership

November 01, 2018

MedTech Mindset Podcast: Clinical Evidence Insights with Joe Popowicz

"Hospital Value Analysis Committees want to know what the clinical benefit is so, in a lot of cases, you may have a clear regulatory pathway that says, 'No clinical evidence is required.' But that doesn't necessarily mean that you wouldn't want to collect clinical evidence to differentiate your product from someone else's."

EPISODE 3 - Joe Popowicz and Emergent Clinical Consulting

In this episode, clinical study expert Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech. 

They cover pre/postmarket data needs, regulatory pathways, Value Analysis Committees, Significant Risk vs. Nonsignificant Risk, Institutional Review Boards, and more. 

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Joe Popowicz
Principal Consultant
joepopowicz@emegentclinical.com
www.emergentclinical.com


 

Episode Transcript

Eric Sugalski: Hi Joe. Thanks for joining us this morning. Glad you could be part of this.

Joe Popowicz: Absolutely. Thanks for having me.

Eric:     Yeah. Joe, to kick things off, why don't you tell us a little bit about Emergent Clinical. When did you start the company? What was the need in the market that drove you to start this business?

Joe:     Sure. Emergent Clinical's been in business now for coming on six years. The whole focus was to optimize the clinical trial process for diagnostic and device companies. So we started this as a small company to act as an extension to these teams, really helping them guide the clinical pathway.

I was doing a lot of speaking at conferences back in 2013, and I realized there was a need for us to start providing some clinical advice to companies because it was one of those areas where they'd spend a lot of time on regulatory feedback or product development, but clinical wasn't always an area that they were having internal capabilities. Because they would need some trial work or some advice, and then it would go away.

So I gave it a shot in 2013 to start helping clients and six years later we've been steadily moving our way through this process.

Eric:     Good for you. Are you working primarily with startup companies or academic centers? What's the typical profile?

Joe:     Most device and diagnostic companies in the space are small to midsize of less than 50 employees. And that represents about 75% of our business. About a quarter of the business is the larger medical device companies as well that might need some process development work or [inaudible 00:01:30] help so we help them to go through that as well.

Eric:     Okay, great. A lot of our listeners are trying to bring a new medical technology to the market. It might be spinning out of a lab or it might be a spinoff of a larger established company, but there is something new and novel that they're looking to develop, and the clinical factors are important for them to be thinking about at the beginning stage.

I thought the way that we could structure this conversation is by setting up two examples of different medical devices sort of generically that we could walk through from a clinical study standpoint.

And the first one that I wanted to talk about was a new surgical device. So let's say that I am with a startup company, and I'm developing a new laparoscopic surgical device that has some improvements over the existing devices in the market. And I've gotten some feedback from regulatory consultants that this is a pretty clear 510(K). So in my head, I'm thinking that this product, 510(K), I don't need any clinical studies, right? It's just a straight approval process. What's your take there?

Joe:     It definitely depends. It's great you've mentioned about having good regulatory advice because I think that's one of the keys for any startup company is to understand what your regulatory pathway is and what's going to happen moving forward. That said, the market definitely has shifted over the past few years in that you'll have value analysis committees who wanna look at products that come into ORs, and they wanna know what the clinical benefit is, so in a lot of cases you may have a clear regulatory pathway that says, "No clinical evidence is required," but that doesn't necessarily mean that you wouldn't wanna collect some clinical evidence to differentiate your product from someone else's.

So in a lot of cases, we look at it from could you develop a postmarket strategy at that early phase to say we're going to collect some evidence against another product once there's clearance to then say, "We are better in a certain area or we have an economic benefit," so we really wanna work with companies to ensure that we have a clear value proposition for them as they get to commercialization.

There are also some though the regulatory guidance may come through and say, "You will need some clinical evidence." There are 510(K)s with clinical where depending on that product classification, you would have to collect some evidence premarket to then show that this product should be cleared for use.

Eric:     So just to clarify for me. When we're talking about the regulatory approval process, that 510(K) approval, everything before that, the premarket clinical studies, you're saying that during those premarket studies there may be cases for a 510(K) when you do need to collect some clinical data before getting that approval.

Joe:     Yes, absolutely.

Eric:     Correct. Okay. But then when you get through that approval, there is very likely the scenario where you would need to be doing some comparative studies to look at how this new surgical device performs with respect to the other, the gold standard or the commonly used surgical devices that are for a similar indication.

Joe:     Exactly. And it may not be for claims purposes, but it may be for publication purposes that you could go to a value analysis committee and say, "Look, here is a level X, 1, 2, 3, trial that has been published," to say this is a difference for how the modality of care worked for this particular product. There is a benefit in what you would use for commercialization standpoint to collect some evidence for that product.

Eric:     Got it. So the comparative studies are often for business factors. You wanna be showing that there's a clinical benefit obviously but there's also hospital economic factors that come into play and other things that are gonna matter to the value analysis committees. Is that-

Joe:     Absolutely. And we work with marketing groups even in the postmarket to say, "What do you want this to be working with the end in mind, working backwards," to say, let's develop a trial design that gets you what you need in postmarket so that we can help them get that strategic vision.

Eric:     Right. We talked about value analysis committees. This process of getting a new medical device into the hospital has become fairly complex. Can you help me understand what exactly is a value analysis committee?

Joe:     Each hospital or as this has gone through, more hospitals are relying on an economic assessment of device or diagnostics or products and saying we have limited shelf space, why should we use this product as opposed to the other 15 products that are available in the market? So to that end, they've more formalized this where they have scientists, people with a finance background to look at the products and really get a good assessment of does it make sense to bring in this product versus another product, what are the benefits or risks associated with it, and they have a formal assessment. We've seen that with some of our clients go through the process of having to get product on market saying if I have this hernia mesh, let's say, as opposed to other meshes, why would I use this one versus another one when there are 15 options? And that's where collecting some evidence may differentiate you from some other companies that haven't collected any evidence for their products.

Eric:     Got it. And so back to this example of I've got a surgical device, it's gotten, let's say it's now gotten 510(K) approval, do I just look for the value analysis committee email on the hospital's website and email them? How do I get into the value analysis committee?

Joe:     In that case, most of the sales reps have some inroads to the hospital administration so they're working with their doctors and then they find their inroads. We haven't had a lot of direct experience with going to the hospital administration. We're more on the supporting side of collecting the evidence and helping them through that. But commercial groups typically have some inroads to that.

Eric:     Got it. So it sounds like the commercial groups, the salespeople, they speak with the clinicians and then the clinicians, one or several, may be a champion for a new product to bring it into the value analysis committee in order to get it evaluated.

Joe:     Yes, absolutely.

Eric:     Okay, great. Let's go back to this postmarket concept. We have a new surgical device, it's going up against an existing surgical device. How would you think about the endpoints? What are the endpoints that we would be looking at in that clinical study?

Joe:     So this is where we work with the team as an extension to understand what are the benefits of the product. Why when you started to conceptualize this product did you think this would be better than other ones? And that's really what formulates our idea of what should be a primary, secondary endpoint, however it works. Because in most cases, the engineers, the medical teams, they really understood ... They had a good understanding of why this product was gonna be better than or why we should really commercialize this product. Our job is to kind of translate that portion of what did you envision to what will accentuate that benefit from a clinical standpoint. So primary and secondary endpoints typically revolve around maybe you have less surgical time because it's easier to use. Maybe there should be better outcomes associated with healing or a quicker implementation. There's really a number of different ways and it's really dependent on the product. But we wanna work with the team to understand why did you conceptualize this as a better product, and let's translate that into an endpoint story within the protocol.

Eric:     Got it. I'm still a little nebulous or confused on primary versus secondary endpoints. Back to this surgical device example, give me an example of what you think a primary endpoint would be for this.

Joe:     A primary endpoint for that may be the efficacy of the product. Think of it as primary endpoints are usually built to say we wanna have a claim, and that usually is more in the premarket side than the postmarket side, but each will have an endpoint.

Eric:     Well, let's say that it's a surgical closure device. It's used for closing tissue after say an organ has been removed from a particular area. What would be a primary endpoint in that case?

Joe:     Speed to closure, ease of use. You could see that a surgeon's application, they may have an assessment of it to say how easy was it to use this product. You can have very strict guidances like quality of life assessments but to more qualitative responses to how easy was it easy for me to close as opposed to what I've experienced in the past.

Eric:     Got it. So the primary endpoints are directly related to the output of the surgery. You mentioned some of the human factors issues. Does the device result in intuitive use? But then also does it result in a very robust closure or seal if that's what the device is looking to do. Is that an accurate depiction of what common primary endpoints might be?

Joe:     It can. And it can shift. An endpoint is an outcome for the trial, whether it's a primary or a secondary endpoint. It's really a decision by the company of is this trial's focus X. And that's where your primary endpoints would be where you would still look at secondary or tertiary endpoints to say these are other things that are of interest that we would wanna publish on or we would wanna present from a regulatory standpoint. We're also gonna look at this as well.

In the premarket and especially depending on if you need this data associated with a project, there's very clear guidance by products of what you need to show because other devices have done that in the past. In more new devices, let's say De Novo, it may not be as clear and you'd have to have some discussions with FDA potentially to determine what your endpoints may look like.

Eric:     Got it. Got it. So premarket endpoints are really a negotiation with the regulatory agency, whereas postmarket, those endpoints are determined by the company to figure out what is going to be really important for the clinicians that are using the product and the hospitals that are ultimately going to be evaluating the product with respect to other devices that are on the market.

Joe:     Yes.

Eric:     Okay. That's helpful. Let's talk about the size of a trial. Let's stay with the postmarket theme. We have a new surgical device, it's going up against something that's competitive. We believe that this new surgical device can result in a more robust closure process. What does a study look like for that in terms of proving at a postmarket level that we can produce more reliable closures and say reduce infections related to those closures?

Joe:     You hit a nice topic about infections or reduction. Everything is driven based on a success criteria. You'd say our expectation is that this percentage will be successful. In a case of trying to reduce infections, there typically small percentage numbers, single digits, so to show statistically significance in that case you're gonna use thousands and thousands of patients to be able to say we reduced infection rate by 50% from two percent to one percent.

Eric:     Because the infection rate is already so low. If you had a really low incidence rate, that's gonna obviously result in a pretty massive clinical?

Joe:     Yeah. And this is where it's really good to have a great statistician that can work with you on a power analysis because things like that you can see how it'll inflate and adding other criteria might change your success rates. But the important part is to understand what the end game is, so what your endpoint is and the success rate of that to be able to build a good power analysis.

Eric:     Got it. This is I think a really important point because when you're picking your endpoint, you need to also look at what the incidence rate is that you're trying to affect. Because if you're looking at a multi-thousand patient study, that could be beyond what is reasonable from an investment perspective, right?

Joe:     Absolutely.

Eric:     It sounds like when you're looking at your clinical study design, you really need to be trying to identify some endpoints that you can really influence at a significant scale with a relatively small patient population.

Joe:     That's absolutely right. But the one interesting part of it in the post market, you may not be building a study to show statistical significance. You may be showing it to show trending. So in a case like that, you may have hundreds of patients to be able to show we're trending towards that, but we would never be able to run the trial to that magnitude. So we collected evidence to see where did the data trends, not necessary [crosstalk 00:14:25].

Eric:     So when you say trending, what does that mean? Like you haven't hit statistical significance but you're sort of going in that direction?

Joe:     Exactly.

Eric:     Okay.

Joe:     So data trends towards a certain end point, that it's in a positive way or negative way, depending on how the end point is created. But it won't show for a P value or .05. Or it's trended towards that but we would have to power the study to a larger degree.

Eric:     Got it. Great. Okay. That's really helpful. Let's say that we brought the statistician into the process, and she has informed us that the trial should be 200 patients in order to really show significant statistical significance of the study. How do we understand, as an early-stage company, what the magnitude of that cost is going to be from a clinical study at some point?

Joe:     Yeah. There's a number of different ways to look at that. And you can look at just the budget because there's a budget of cost per patient, which is important. That definitely varies depending on the surgical application or the therapeutic application of the trial, certain cost per patients may be as low as $1,500 a patient. There's other applications where surgery and long-term follow up, you could be in the 20 to 30 thousand dollar cost per patient. So it really is dependent on your therapeutic application there. But you can also look at it as how do we play with the levels of number of investigators in the trial and we make it more efficient. So we typically work with clients to say, "Let's do an enrollment projection to see how many sites, doctors' offices you would need to participate in the trial to then get a study done in a certain time frame, to understand the costs of how long a trial would take, how much would it be per patient," things like that so that they have a very clear understanding and can communicate that to investors, management, boards. So they have a really good control of what that clinical cost would really be.

Eric:     Got it. Got it. Okay. So is it fair to say that clinical study that is sponsored by a device company needs to finance the surgical procedure as well as a series of follow-up visits with the patient, typically?

Joe:     So things that are outside of standard of care are definitely part of the trial. So if you have a vote on what would be standard practice ... So let's say I'm adding another product into a surgical procedure, we want to try to stay as close to standard care because the doctors are going to be comfortable with that. We want to ensure that they are comfortable so that there aren't protocol deviations, things of that nature. But costs for the device or diagnostic company are really the things, in addition to what standards of care are. So, typically, our team will work with that group to help them build a site budget. So what will be the costs for the implementation for that patient and really add that into it. So it may be things like data entry because they wouldn't typically enter that data into a database. They would enter it into their electronic health system and that would be the extent of it. Or follow up because it's maybe different than what standard practice is. Anything like that would be a cost to the device of diagnostic company. And you would have to incur that for a trial.

Eric:     Okay. Okay. That's helpful to clarify. So it's not if you're running a clinical study, you're paying for the entire clinical procedure, the entire surgery. It's really just the incremental costs based on the device that you are now introducing into this existing process.

Joe:     Absolutely. That's the ideal situation.

Eric:     Okay. Great, great. Let's talk a little bit about US versus outside US Clinicals. Why would a company want to consider going outside of the US for a clinical study?

Joe:     Historically, speed to market has been one of the areas that device or diagnostic companies have really focused on why they'd go outside of the US for the regulatory pathway.

Eric:     So in that case, the regulatory agencies that are not FDA might have a lower bar, allowing you to perform a clinical procedure earlier. Is that accurate?

Joe:     That's been the perception. I have to say in the recent past, our interactions with FDA, they're interested in making sure innovations come to market first in the US. So the pathways, they've been quicker to review. They've been more collaborative in the process. So that perception should definitely be tested with the FDA. I think if you have good regulatory guidance, they would head you down that direction to say, "Have the discussion early with FDA. Explain the clinical utility of this product, and see if it makes sense to be here domestically," because I think FDA's interested in ensuring more innovation comes to market first in US. So they've really worked with industry to ensure that happens.

Eric:     Got it. Got it. Okay. What about the costs? So we talked about the timing, but is there a significant cost savings to going to South America for a clinical study versus the US?

Joe:     The perception has definitely been there as well, the per patient cost. I think if you look at it in just direct costs, you can make the argument that maybe the cost of the patient in South America might be less than of the cost per patient in the US. But I don't think we're looking at it holistically because there's service costs. There's transport costs.

Eric:     Travel. Right.

Joe:     There's a lot that goes into play. A lot of the companies, especially that we see, the device and diagnostic companies, they're hands on. They want to be there for surgical procedures if that's their type of product. So they're there all the time. They are ensuring that the product is going well. In that case, there's a cost associated with that and having to find a vendor in South American that could execute the trial. It's cost associated. So you have to look at it holistically and then weigh does it make sense. I would argue it's becoming more competitive to be in the US, as a whole, just to ensure that the product comes through. But you have to weigh it out an see what makes sense for your device or [crosstalk 00:20:36].

Eric:     Great. Okay. Excellent. So let's switch gears now. We talked about this surgical device that was a 510(k). I think everything there is pretty clear to me. Let's change over to a different application. Say we have a new diagnostic system. It is a non-invasive diagnostic. It's reading certain health data through the skin. And there's no inherent risk with using the device. There may be some risk with the data that the device is generating, but this is a diagnostic device that is likely, based on regulatory expertise we've received, going to be a De Novo pathway. And we've been talking with some investors about this device, and there's a lot of excitement around it, but there's also a bit of skepticism around the sort of clinical merit, clinical validation. Is this really going to be useful in providing clinicians the data that they need? So in that case, how do you get a study going as early as possible so that you can prove that you've achieved this clinical milestone, you can get the data that you really need?

Joe:     So I'd start with, as we talked about, getting involved early and often. It's the same situation from the regulatory side because there may be the determination of significant risk versus nonsignificant risk. I'd have the conversation, from a regulatory standpoint, to get an understanding of what is this pathway. So whether it's you go the formal regulatory pathway and get a designation through FDA, as an example.

Eric:     So time out for one quick second. Significant versus nonsignificant risk. Are these just interpretations? Are these defined terms? Help me understand a little bit more. What does that mean when a device is classified as significant risk versus nonsignificant.

Joe:     So FDA has a guidance document. I definitely recommend, if you're in that device or diagnostic that could fall into significant risk versus nonsignificant risk, start there. But it's a question of whether there would be some detrimental impact in the long haul from a safety standpoint if something failed for the device. So even if it was maybe not a safety risk from an implant standpoint, but in this case, a diagnostic, if there was a failure for the data to be accurately analyzed, it may be that there is a detriment to the patient because we didn't see some health issue that would have come up earlier than how we'd normally treat or diagnose that case. So there is a pathway that has to be assessed to say there might not be inherent safety risk immediately, but data interpretation may be an issue in the future.

Eric:     Great. This is helpful. So let's say this diagnostic device, it has a number of different sensors on it, but all of these different sensors independently exist. And the clinical can be such that you're using the diagnostic device in a hospital environment, but it's redundant with other data that is being collected with this other instrumentation that already exists. So does that mean that the device is going to be significant risk or nonsignificant risk?

Joe:     So you have to go down the pathway to ensure, and that's where, from a regulatory standpoint, I may not be the best person to go through. However, that seems like the study design that I would implement, saying "We have some data that's collected in this novel way. And we have redundancies in place to make sure that these data match what our standard of care." So you've just basically developed what the design of the trial may look like to ensure the safety in the future from a commercial standpoint.

Eric:     Got it. Got it. Okay. So in that case where you have some redundant devices that are being used, the data that's coming off this novel diagnostic device, the data may not be as likely to be interpreted or relied upon by a physician because there's other sources of data that are being captured simultaneously.

Joe:     Correct.

Eric:     So that is likely to push it into the nonsignificant risk category versus significant risk, with the caveat that there's guidance and regulatory process that needs to be followed here.

Joe:     Absolutely.

Eric:     Okay. Great. So what about significant risk? Let's say that we need to show that this device is going to identify a novel set of health data that does not exist and clinicians are going to be relying on this data. What does that path look like for getting approval to use this device clinically?

Joe:     Yeah. Most devices will fall into a significant risk device, so it sounds scarier than it is. It's more that there is a potential risk associated with patient, so we need to ensure that it is safe and effective. So this is, essentially, an IDE or an investigational device exemption. So that is something that prior to a clearance or approval, depending on the classification of the device, you have assurance from FDA that you can use this device in the premarket to collect the evidence, to prove it's safe and effective for a ultimate commercialization when you send in your application. So that's where a significant risk device, you would be running the trial under an IDE, and then, ultimately, collecting data to get a regulatory approval or appointments.

Eric:     Got it. Okay. So if I'm this startup that is building this new diagnostic device and I know that this is going to be a significant risk trial, do I just go straight to FDA, or what does that process look like for getting that significant risk status and the IDE application rolling?

Joe:     So, typically, you're in that pre-submission process at that point with FDA. And you'll have to have a sense of what the trial would look like and things like that, so they can weigh in on, "Does this application fit?" so that you can be granted the IDE.

As you're going through the process of developing the trial, that's where you would get some sense of, "We have a trial design. Here's what our pre-clinical package looks like. Here's what we've done in the past. And here's how we execute."

Eric:     So IDE. I want to dive into this a little bit more. So Investigational Device Exemption. Is this for significant risk devices only, or is this also for nonsignificant risk devices that label?

Joe:     An investigational device exemption is basically saying, "Because this is not commercially available, we're allowing you to transport this device to different locations because it shouldn't be used in commercial or clinical applications." So it's basically FDA's blessing to move forward.

Eric:     Okay. I want to make sure I'm clear here. So we've got this diagnostic device and we want to do a clinical study. I say that it is nonsignificant risk. That's what I believe. That's what maybe some of the regulatory guidance that we've received believes. So we go to an institutional review board, an IRB, and that's at a hospital, an academic hospital that has an IRB. What happens there? What are the scenarios for the IRBs? Do they basically just pass through the study or, tell me about their decision process.

Joe:     So at that point, you'd ask an IRB to designate if they believe that it is a nonsignificant risk. So if you believe that you have a nonsignificant risk device, you would go to the institutional review board and say, "We believe that there is a pathway for this to be reviewed through your governing body. Please let us know if you agree that there is no risk associated with the patient, that you can allow this trial to go on without a formal designation from a regulatory panel." So at that point, the IRB will review what the protocol is and the consent documents, things that would be the trial-related materials so that designate, yes, you can move forward with this trial or no, this is significant risk. You need to do this under an IDE. So go back to your regulatory authority and get granted that to move forward with the project.

Eric:     Okay. That's helpful. So what about the level of information that is needed for each of those pathway? And this may be more of a regulatory question, but there's ... If you're going the IDE route with the significant risk status, my understanding is that you need to do a much deeper level of testing, verification work, documentation, versus the amount of testing that you would need to do for a nonsignificant risk device. Is that true? Can you talk about the pros and cons of each of those scenarios?

Joe:     In our experience, whether it's the nonsignificant risk or the significant risk device, both are going to require a fairly large set of data. So in either case, you're still using it on a patient. There's still some application associated with it. So you'd have to ensure that there is no safety issue that it does work to some degree, whether it's NSR or significant risk. So that and it's more about the product class and what level of evidence you would collect, whether it's preclinically or clinically to determine this is a useful product to be available on the market.

Eric:     Okay. Okay, great. Now, one of the key pieces of information that needs to be provided to either the IRB or the regulatory authority is the clinical protocol, right?

Joe:     Yes.

Eric:     Who's writing that clinical protocol? Is that me? One of the engineers on the team or do we need to get Emergent Clinical to help with the clinical protocol? Who exactly is responsible for that?

Joe:     So we typically help clients write the protocol. The way we envision it is it's a two-fold process. There's a medical application to it, as well as the operational aspect. So we typically work interchangeably with the device company because they have a great understanding of the medical application, but we understand the clinical ops portion, so together we'll help build the framework, all the required elements for it, the things that will help them get to the finish line sooner without multiple iterations with the institutional review board or the regulatory authority, things that would be expected to be seen in that process, but we rely heavily, because it has to be a collaborative effort.

Eric:     Got it. So in a realistic scenario though, when should that clinical protocol start? Does drafting that clinical protocol begin after the design is complete? Should it happen before the design is complete? What's the timeline look like there?

Joe:     We've worked with clients very early on to build synopses. So a very simple outline of what the inclusion, exclusion criteria would be for patient selection. So the things that you would want someone to have or not to have in the trial, the endpoints that we discussed before, a simple power analysis, things like that that give a sense that you have an understanding of what the trial will look like. That happens very early in some cases and that's important whether it's you're raising capital, you're having conversations from a regulatory standpoint, you're looking for strategic partners, it really conveys that you have an understanding of what the pathway looks like and what you're going to do to execute a trial. The more formal protocol should be closer to execution because things will change, you'll learn more things as you go through, you don't need the 70-page, full protocol early on. But to have a handle on the synopsis as early as you can I think is valuable to companies.

Eric:     Got it. Okay. That's great. So I've heard of some companies taking the route of an IRB within an academic institution and then other companies taking more of the for-profit IRB pathway, like a Western IRB or one of those for-profit IRBs. Talk a little bit about the differences, the trade-offs associated with both of those pathways.

Joe:     Sure. Institutions select what IRB they will have review their products, or projects, excuse me. So in a case of a large academic institution, historically they have their own institutional review boards and the institutional review boards processes to ensure that this is an ethically sound protocol, the patient's rights and safety are maintained in the project through informed consent process, there's no issues with the design of the trial scientifically, so it's important that they're really the patient's advocate in ensuring that this project is worthwhile and ethically sound. So larger institutions historically utilize their own boards. Lately, they've been more inclined to work with commercial institutional review boards like Western IRB and their multitude out there. The pros and cons typically, an institutional review board that has a commercial application tends to be faster to review and give some process associated with it. So you'll have a Western IRB that will provide a review cycle within a week in some cases and give you a decision where, historically, some of the larger academic institutional review boards have taken months. They don't meet as often, they are trying. So I think things are changing. You have to assess on a case by case basis, what the institution you're working with, what their IRB looks like from a review cycle, how quickly they turn it around, things like that, because it will play into the ultimate timeline of the application.

Eric:     Got it. So a commercial or a for-profit IRB, do they have specific clinical sites that they use? Or is that up to the sponsor of the trial to determine where the sites are?

Joe:     So the sponsor decides which institutions they're going to use for the trial and then the institutions decide which IRB that they would do or contract, things like that. So it's one of the things we assess as part of our feasibility assessment in who should you work with to execute a trial. It's one of a number of things of how do they review budgets, contracts. There's a whole startup criteria that you have to understand so that you select the right institutions to ultimately execute a project.

Eric:     Okay. But say we went to a Western IRB or a group like that, and is there ... If there's an existing IRB at one of the sites that we would like to use, is there going to be any conflict between the in-house IRB at a large academic institution that is receiving the IRB approval from a group like a for-profit IRB?

Joe:     So the for-profit would review the study as a whole, let's say, and then anybody who subscribes to Western would then allow them to be listed under that approval.

Eric:     Got it.

Joe:     Separately, the local IRBs can run other institutions. Let's say you have five institutions, three can be under Western, two can have their own institutional review boards do the review. So it's a bit of both you can have, and it's dependent on them to decide, do they allow for the Western approval to apply for their institution or do they require that their own local institutional review board is the one that governs the protocol review?

Eric:     Okay, okay. So could be a combination. But what I heard is that sometimes, if you're using a commercial or for-profit IRB, it can be a faster process than going through a large academic IRB?

Joe:     Absolutely.

Eric:     If you're looking to get a trial going very quickly. Are there any downsides to using a for-profit IRB? Is the data not respected as highly or are there other factors that might be considerations?

Joe:     No, I think they just formalize their processes differently than other local institutional review boards. So because it's a commercial entity, they've learned how to ... A customer service group and routing, scheduling technology, so it's more about efficiency as opposed to the quality. The quality is good whether it's the centralized Western IRB or a commercial IRB versus the local IRBs, I think that it's essentially the same quality you'll get, it's just a question of speed.

Eric:     Got it. Okay, great. So we've hit on a lot of topics here. We've gone down the 510(k) path with a surgical device. We've talked about endpoints, primary, secondary, quantified the size of trials, and then we looked at the diagnostic application, more of the De Novo, the premarket process of getting early clinical data. We talked about significant versus nonsignificant risk. This has been great. I've learned a lot here. I have one last question for you. Advice that you have for early stage companies or companies that have new technologies. What advice do you have on how they can get into their clinical study design most efficiently?

Joe:     So we always recommend come early and come often. So the earlier the better. It's great to have conversations with early stage companies, maybe that haven't gotten their round of financing secured at this point, but they have a great idea. We've started conversations four or five yeas ago with companies that are still not to the clinical phase because they are still working with a group like yours to help them with product development and ensuring they have the right application. But there is still value in us having the conversation, because they may get utility out of understanding what the clinical pathway would look like. And I think that goes for most in our industry. I think you have to build a really strong team around you, whether it's product development, regulatory, clinical, to ensure that you have that right structure moving forward, even if it's early, because then you have an understanding of what you need to do, what that pathway looks like, and it will be easier for you to communicate to investors, strategic partners, things like that, as you develop the project. So come early, happy to have the conversation. We love to see technology. We got into this space to ensure that we saw all this cool medical technology come to market. So we love the early stage conversations.

Eric:     Yeah, this is great. So it's a reminder for me, being an engineer and often looking at problems through the lens of an engineering sort of technical side, that when you're bringing a new medical device to the market, it's not all about just "Does the design work? Can we engineer this product really, really well" but there's all these other factors, and I think what you're representing here today, the clinical side is so important to be thinking about really early on in the process. Looking at those endpoints, where exactly are we going, what are we trying to achieve? There's a number of other factors that we're going to get into during other sessions, but this has been really very helpful. We really appreciate you taking the time to chat with us. One last thing, if companies want to find out more about your company or reach out to you directly, how would they go about doing that?

Joe:     Come to our website, emergientclinical.com. There's an information section there, you can reach us, there's all our contact information. I can put my email address in the show notes. We'd be happy to reach out and hear from anybody out there, questions about clinical and just in general. Again, I love to hear about the medical technology that's coming through, so feel free to reach out and we'll start a discussion.

Eric:     Okay. Thanks again, Joe. Really appreciate it.

Joe:     Thank you.

 

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