EPISODE 6 – Navigating Regulatory with Monica Ferrante

In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market. 

Monica and Dan discuss:

• FDA risk classifications and how to steer down various regulatory pathways
• How FDA is changing in recent years
• Trends in regulation–are medical devices under-regulated by FDA?
• Formal vs. informal pre-submission meetings with FDA
• How to go about finding trustworthy regulatory support

Episode Transcript

Dan Henrich: Monica, thank you so much for joining me today, really appreciate you coming down. Would you mind introducing yourself and telling us a little bit about your background before we delve into our topic?

Monica Ferrante: Sure. I’m Monica Ferrante. I’ve been doing regulatory affairs for medical devices for, oh, probably more than 30 years, so I’ve been through the evolution. I’ve worked for large companies as well as startup companies and done a fair amount of consulting as well, so I have a pretty good breadth of device types, I guess, if you will.

Dan Henrich: Great, great. What’s your current role?

Monica Ferrante: My current role is Vice President of Regulatory and Quality at Aspire Bariatrics.

Dan Henrich: What type of products are you working on there?

Monica Ferrante: It’s a medical device for weight loss. It was a PMA submission because it’s a novel application of a device, and we were able to get through that process in less than a year and get the product approved and on the market so-

Dan Henrich: Great. Congratulations.

Monica Ferrante: Thank you.

Dan Henrich: That’s great. We already threw out the term PMA here. I think we have quite a variety of folks in our audience who are listening to this. Some of them know just what a PMA is, and they know what constitutes a Class I device or a Class III device, from the FDA’s perspective, and others don’t, so can we just briefly sort of run through what are device classes and what would be an example of kind of the different types of devices that would fall into the different risk classifications at FDA?

Monica Ferrante: Sure. Actually, the FDA started regulating medical devices pre-market in 1976, which may be a long time ago to some people, but not to me. At that time, they went through all of the medical devices that existed at the time, and they classified them. The purpose of classification was to assign a risk criteria and then, based on that risk, they would develop the regulatory pathways for bringing new products to market.

Monica Ferrante: A Class I device is the lowest risk. They are devices that are simple and straightforward. There was good historical data on their use and simple and straightforward to use. An example of a Class I device would be a manual surgical instrument like a scalpel or a hemostat, something like that.

Monica Ferrante: Class II devices are sort of the middle risk, if you will, moderate risk. Back in those days, the intent was, if there was a standard or a standard could be written for that particular product, in other words, the safety aspects and performance aspects were well enough defined that you could write a standard, then they would fall into Class II. That’s how they determined that, that particular classification.

Monica Ferrante: Everything else fell into Class III, which is the highest risk. That was generally intended for new technologies, implants, things like devices that had never been used before or an intended use that hadn’t been thought of for a particular product.

Monica Ferrante: For each of those classifications, there’s a typical but not always guaranteed regulatory pathway. For Class I devices, the FDA, in the past several years, has actually exempted a lot of those devices from any pre-market approval process, although there are a few remaining that would require a submission to the agency. Class II devices typically go through what’s called a pre-market notification process or a 510(k). That process is intended to establish substantial equivalence. Basically, it’s a me-too process. There are already products on the market like a ventilator, or a defibrillator, or a radiant warmer, an incubator, whatever, product that’s already on the market that already has certain features and functionality. In those cases, there are all consensus standards for basic safety and performance, so those types of devices would go through the 510(k) process, and they would receive permission or clearance to market after going through the review process.

Monica Ferrante: For a PMA, since it’s new technology or a new indication for use for a current technology and the risk is considered to be high because you don’t know what the risk is at that point, generally, a clinical study is required, a phase-one study or a pilot study on a small population to determine basic safety, and then a pivotal trial which would provide statistical significance of the claims that you want to make for that particular product.

Monica Ferrante: The timeframes for these submissions, there’s a statutory timeframe. For a 510(k), the FDA has 90 days to review your submission. That’s actual review time. Simpler Class II devices will probably go through in a little bit less or in 90 days. More complicated submissions may take longer, particularly if the agency has to ask you for additional information, but their clock or their target timeframe is 90 days. For a pre-market approval, they have 180 days to review all of the information. There will almost always be a request for additional information in a PMA. A PMA that’s reviewed and approved anywhere between 180 days and one year is actually a really great review time, and it means the submission was well-prepared and all of the information that the FDA needed to make their decision was there.

Dan Henrich: Okay, so a 510(k) is limited to Class II products that have what’s called a predicate. Is that correct?

Monica Ferrante: Yes.

Dan Henrich: What about when you’re dealing with a Class II product that … or something that would be defined as a Class II level of risk or will ultimately be defined as a Class II level of risk but doesn’t have a clear predicate? What does the pathway and the timing look like for that?

Monica Ferrante: Okay, so when there isn’t a predicate device, the product is automatically a Class III and requires a PMA. The FDA, several years ago, introduced a process called the De Novo process, which allows for a submission and, pretty much at the same time, a classification of a new device that has low risk. The De Novo submission may look a lot like a 510(k), but it will probably include clinical data. A De Novo submission review time, statutory review time is 120 days. Again, if you have a lot of information to review or if your clinical study has a lot of data associated with it and there are questions, that timeframe can extend, but the statutory timeframe is 120 days.

Dan Henrich: Okay, and so does that mean that, typically, then … You said when a new device, a device without a clear predicate comes to the FDA, they automatically assign it as a Class III. What would be the motivation for trying to get that class brought down to a Class II? Would it help you get through regulatory faster, or would it just lower the barrier for a competitor to come along and cite your device as a predicate?

Monica Ferrante: Well, it does both.

Dan Henrich: Okay.

Monica Ferrante: Actually, the purpose of a De Novo is that the FDA was receiving PMAs, full 180-day, statistically-significant clinical studies on devices that were extremely low risk. Their thinking is that that is not a good use of their time, the taxpayers’ dollars, or the company’s time and resources.

Dan Henrich: And it’s bad for patients, right?

Monica Ferrante: Yeah, and patients would be able to have access to that technology much sooner, so they created the De Novo process so that it would be a streamlined process where they could review information and be able to give it a classification. It may still end up being a Class III device depending on how things pan out with the review process and what concerns there are remaining with the device. It may not be the physical device itself. It may be the application or the intended use of the device that puts you into Class III, but the benefits of having that classification are several fold. It’s a shorter review time. The burden of proof is usually lessened, in terms of clinical data, and then the follow-on.

Monica Ferrante: A 510(k) submission and a De Novo submission that are approved, if you make changes to the device or if you make tweaks and adjustments to your manufacturing processes and so forth, the FDA addresses those when they come through for their QSR inspections. For a PMA, anything you change, any change to your labeling, any change to your product, any change to your manufacturing processes, you have to submit a supplement and pay the associated fees and get that approved before you can implement it, so it extends every process significantly, not just the initial approval but the ongoing maintenance, if you will, of that product.

Dan Henrich: Okay. Would that be the same process? If your device is approved for a particular patient population and you want, say, to use it … you want it approved for pediatrics or for some other patient population, is that a supplement that you have to submit, or do you have to start the process over again for your new indication?

Monica Ferrante: You generally-

Dan Henrich: Is it an indication? Is that what it is? Yeah.

Monica Ferrante: Yeah. For example, if you have a PMA that’s approved for the adult population and, per your example, you wanted to expand it into a pediatric population, you would have to do a study, and you would have to submit that to the FDA. If it’s the same product, it’s under the auspices of the original PMA, but it’s still a 180-day supplement with all of that additional clinical data and analysis, so it’s effectively doing another PMA to expand that patient population.

Dan Henrich: My guess would be then is when you’re advising young companies who have maybe not brought a medical device to market before, there are different pathways that they may be able to take in terms of who will be … what’s their first application for this device, who’s the intended patient population, and that ties into their overall go-to-market and business strategy, right, if they want to establish a beachhead in a particular area and have some type of revenue stream that that can then support a further study or whatever they need to expand into a larger market?

Monica Ferrante: Sure.

Dan Henrich: Yeah.

Monica Ferrante: An example of that would be ventilators. A ventilator is a Class II device. You prepare a 510(k) submission, and you get clearance to market, and you bring it to market. There is an application on a ventilator called high frequency or oscillatory ventilation that’s used in premature babies. That application is a PMA application, so in order to have that feature on your ventilator, you have to do the clinical study, and you have to submit it to the FDA and get that PMA approved. That’s kind of an example of a company might want to bring a new ventilator to market, start bringing in the revenue, and use that to fund their study for that oscillatory ventilation claim or feature.

Dan Henrich: Got it. Got it. Okay. That ties in next nicely, I guess, to our next question, which is if you are a new venture, a company that’s, perhaps, forming around the new medical technology that you’re looking to bring to market, how early do you need to begin talking with someone experienced about your regulatory pathway, and how will it tie into your go-to-market plan?

Monica Ferrante: Think it’s really important to start the conversation early. It’ll be a preliminary conversation. There may not be anything from a regulatory perspective that you have to do, but understanding what the device is, what you really want it to do in the market or for your patients, and understanding what the potential regulatory pathway is important. To your point, it may be a product that, if you bring it to market minus one claim, you might be able to get it on the market thru the 510(k) process and give yourself a revenue stream to build out the rest of it. It might be that it’s a PMA from the get-go, or it might be that it’s low enough risk or you can reduce the risk enough, by design, to possibly fit into the De Novo process. Understanding which path you’re headed down and sort of where the lines are, what pushes you over the threshold from a 510(k) into a De Novo or a PMA is important to know so that you can make the right business decisions.

Dan Henrich: I think what we often find with our clients at Smithwise is that their regulatory strategy impacts not just our design process but, really, the market feasibility of their product, and so, very often when we speak with someone who has kind of an exciting new technology, usually I would say they have thought about … they come in and say, “Oh, well this is going to be a 510(k), so it’s no big deal,” but they may have a pretty broad idea of the claims that they’re going to be able to make for their product, and their business model might account for different market segments that are maybe not going to be able to fall under that simple of a process.

Dan Henrich: I think that’s one of the reasons we’re covering this topic now is because there’s a lot of … we see both kind of a dismissive attitude on the part of some medtech entrepreneurs of the regulatory process because people think of the 510(k) pathway as no big deal, and we also see a lot of anxiety on the part of others. Maybe they’re better-informed ones, but they’re a little bit paralyzed by the regulatory process as well, and so it’s great for them to be able to start thinking through these things but, often, we will bring in regulatory support early on in the design process as we’re coaching people through what we call phase zero of product development, so it’s-

Monica Ferrante: That’s good.

Dan Henrich: Yeah. Well, it’s great to have folks like you to call on in those situations. I think a lot of the anxiety that people feel centers around interactions with FDA. I have heard, from a lot of people who have dealt with the FDA very intimately over the course of their careers, that there’s been a big shift in kind of the agency’s approachability, you might say, or there’s been a positive evolution of interactions between industry and the FDA in the past few years. Can you tell me a little bit about the negotiation process and when … How do you know how much information to provide to FDA and when to start that conversation, and are you ever afraid to say too much too early before you have your data together or … you know?

Monica Ferrante: Their process has changed, and it’s actually well documented in a guidance document as far as the meetings that you can ask for versus the submissions, the pre-submissions that you can have them review. The reason for that whole evolution is because having an open-loop system is not beneficial to either side of the equation. I mean if you think you’ve prepared a proper 510(k) or a proper PMA, and you submit it to the agency, and they pick it up and they go, “Oh, my God. Half of what we need is just not here, and it’s because they didn’t know,” maybe it’s a product there’s no guidance document for or something.

Monica Ferrante: It wastes the company’s time and resources, and it wastes the FDA’s time and resources, so they’ve discovered and have been given permission or latitude, if you will, to have this open communication to foster those early conversations so that they can understand, A, where the technology is going, because if industry doesn’t bring it to them, they go out, but they may not get access to knowing what the newest, greatest things are that are going on, and how can you regulate something you know nothing about? So they’ve sort of opened the doors a little bit so that those conversations can happen.

Monica Ferrante: It’s important for a company to meet with the FDA once they know enough about their product to have some real questions. Coming in and saying, “Hey, I have this idea. What should I do about it?” you’re going to get a blank stare. Actually, the processes won’t let you do that. If you’re requesting a meeting or you’re doing a pre-submission, the guidance document tells you what information you have to provide to the agency. You have to describe your product. You have to describe what areas you have questions and concerns about and what are those questions so that the meeting or the pre-submission review can be meaningful, so the earlier the better as long as you actually have something to work with.

Dan Henrich: Yeah, yeah. Okay. Do you ever have a client or a situation where the person coming at this from the industry side may be concerned that a pre-submission meeting will lock them into a particular approach that they’re not ready to commit to?

Monica Ferrante: Well, the guidance documents actually describe a formal … and this is generally in the area of clinical studies, a formal pre-IDE meeting. If you request a formal meeting, the information that you have to have to go into the meeting is much more extensive, and you will get concrete, binding information on both sides of the equation. What you are told is binding. What they are told is binding. Nobody really does those meetings. Generally, you want to request an informal meeting, so …

Dan Henrich: Okay, so within an informal meeting, the … I don’t know. Guidance maybe is a bad word to use because it has official connotations-

Monica Ferrante: Yes.

Dan Henrich: … in this area, but the feedback that you get from the agency in an informal meeting is that. It’s informal. It doesn’t bind the agency to look at things in the exact same way when your actual submission comes in. Is that correct?

Monica Ferrante: Right, because what you may be submitting may be different than what you discussed in the meeting. In those meetings, the company is trying to understand some aspect of their product, their submission, and they’re the experts, so they’re there to explain what the product is, what their goals are for the market clearance for the device and for their patient population and so forth. What the FDA’s goal is in that meeting is to say, “Okay. I’m hearing what this is. Here’s what we’re going to need to successfully review that submission when you bring it to us based on the regulations and based on what the market requirements are.” Those are sort of the two sides of the equation. They’re not going to tell you how to do your job or what to do with the product. They’re going to tell you what they need to review it based on what you’ve told them the device is going to do, so-

Dan Henrich: One thing I want to ask you about, Monica, is you mentioned … I think, in your last response, you used the term IDE. Can you tell our listeners what is an IDE and how does it fit into the various regulatory pathways?

Monica Ferrante: Yeah. I apologize for the acronyms. It’s a world of acronyms out there. Actually, I believe one of your other podcasts had to do with clinical studies?

Dan Henrich: Yeah, yeah.

Monica Ferrante: IDE is investigational device exemption. Basically, if you have a product that requires a clinical study to go through the review process at the FDA, you will most likely require an investigational device exemption. It’s a document that you submit to the FDA that describes the clinical study, the patient population sample size, statistical analysis you plan to do, so forth and so on. An approved IDE is required for what’s called a significant risk device. If you have a non-significant-risk device, which would be something like a patient monitoring system that could be monitoring a patient while their normal device is taking care of their health, so a non-significant-risk device, you would still need all of that same documentation, but you wouldn’t need to submit it to FDA and get an approval back prior to starting your study.

Dan Henrich: Okay, so it’s really the approval to use your device within certain clinical study parameters on humans. Is that correct?

Monica Ferrante: Yes and, interestingly enough, the exemption technically is not for the study. It’s technically to allow you to take your unapproved product across state lines.

Dan Henrich: Okay, interstate commerce clause, yeah.

Monica Ferrante: It is [crosstalk 00:24:32]-

Dan Henrich: I remember that from Conlaw, yeah. Okay, so for most 510(k) products, though, where you’re not required to perform a clinical study, you can submit pre-clinical data, right, in terms of showing substantial equivalence? Is that how it works?

Monica Ferrante: Yes. 510(k)s are me-too, so you’re going to submit performance data to standards to your requirements and so forth. The FDA just came out with a new guidance document called Safety and Performance for 510(k)s where they’re expanding the abbreviated 510(k) process a little bit. That’s to say that you don’t have to take your predicate device and do a comparative bench study anymore. You can do what they’ve actually always allowed you to do in the past, which is do a study against a standard and provide that data, so just an aside.

Dan Henrich: I know there have been recent changes or proposed changes to limit the body of available predicates to a more recent period of time. Is that going to …

Monica Ferrante: That’s kind of part of this same guidance, but what they’re really trying to do is is make sure that you’re comparing yourself to something that’s reasonable in terms of sort of the state of technology. Claiming a predicate device from 1980, depending on what the product is, may or may not be reasonable to do, so they want you to be working on state-of-the-art product to the extent that … You know.

Dan Henrich: Yeah, yeah. Does substantial equivalence then mean that you’re now going to have to demonstrate that your predicate has not just previously been approved by the agency, but it’s sort of predicated off of the standard of care, effectively, or …

Monica Ferrante: What that does is that eases your process. For example, if you have an electromedical device, go back to the ventilator, there’s a performance standard for a ventilator, which tells you about the features and functionalities that all ventilators should have. There’s the 601 standard, which is electrical and mechanical safety, and then EMI standards to make sure that you’re not emitting or susceptible to radio interference. Your submission would have to have test data to all of those requirements, and then your predicate device would be something fairly recent that also has testing to those same standards. The way you get at that is, on the FDA website, you pull up the summary of safety and effectiveness that’s on the website for your predicate device, and you’ll be able to see what testing they did compared to what you’re planning to do, so-

Dan Henrich: Yeah, yeah. Okay. This all sort of ties into a conversation that I’ve been a part of recently if I’m at a cocktail party or just out and about making small talk. Of course, when you meet someone, they ask, “What do you do, and what kind of company is that that you work for?” When I mention that my company designs medical devices, often, they bring up, I’ve found, one of two things. One is there’s a Netflix documentary called The Bleeding Edge, and there was also a Wall Street Journal article published, I think, at the beginning of this year or maybe the very end of last year. Basically, the narrative that these pieces are building is that medical devices are dangerously under-regulated by FDA and that they haven’t been addressed in the same way that drugs have over the past, say, 30 years.

Dan Henrich: There’s been a lot of backlash from industry towards those types of sentiments, and I think the way that a lot of members of the public are seeing it is sort of as a, “Well, who do we believe? Are we going to believe the people who make money from bringing new drugs to market or new devices to market, or are we going to believe the journalists who are documenting this without an agenda?” I wonder if you could just tell us what are your impressions, sort of, of that general sentiment that FDA has been sort of sitting on its heels for quite some time and letting their regulatory system for devices become outdated?

Monica Ferrante: Very interesting question. I get that question a lot. Actually, there is a push in Europe to align medical device regulation much more with the way drugs are regulated. If you look at the overall history of regulation in the United States, I’m talking all the way back to 1906 when it kind of all started. Actually, it started before that, but the evolution has always been the drug industry being regulated and certain things being applied, and then devices did come along afterwards. There’s a pendulum that swings. I think we talked about this a little before we got started.

Dan Henrich: We did, but I want our listeners to hear it too because it was well put.

Monica Ferrante: The regulation pendulum goes from, “Leave us alone. We’re fine. You don’t need to regulate us at all,” to, “Oh, my God. They’re killing the American people. Every single thing that gets done needs to be regulated.” The pendulum swing goes back and forth. It has for the past, well, since 1976. The swings are getting smaller, which is a good thing because it means that we’re honing in on a nice balance between appropriately protecting the public health while appropriately promoting the public health. In fact, the FDA changed their mission statement several years ago to exactly that. It used to be protect the public health, so we need to make sure everything is as safe as it can be no matter how long it takes. It was actually the advent of the AIDS epidemic that caused that philosophy to change, and promoting the public health, making sure that our citizens have access to the best and the greatest medicines and medical devices became part of their mission.

Monica Ferrante: It’s a scientific process, but the FDA can only evaluate whatever science has put in front of them, and they have to evaluate it based on the regulations, so they try to balance the risk versus the benefit of a particular device. You try, in your clinical studies, to determine what those risks are, and you address those risks as best you can through risk mitigation and design through proper application of the product to the appropriate patient population and so forth, but it is a little bit of an iterative and learning process. It’s never going to be 100% the first time out the door.

Monica Ferrante: I will say that the agency, being science-based, is sort of blind to public sentiment in that regard while they’re doing their assessment. There have been times when people have petitioned the FDA and said, “You should never have approved that medical device,” and it turns out that the people that are making those claims may not understand the number of people that have actually benefited from that therapy and that it’s a small subset that has had the issue. Whenever you read these things in the literature or in various social media or publications or whatever, you kind of have to take the perspective of digging into the detail. What is the context of that particular failure, and how was it responded to?

Monica Ferrante: That way, as the public, you can be better informed and you can understand, oh, the FDA didn’t see that coming. They did address it, and now the product can be safely used in a more limited application, or the FDA actually has had it right all along, and one particular event is being blown up to be a terrible, terrible travesty when, in fact, it was anticipated and understood by both the medical community and the FDA as something that could potentially happen. There’s never any device or even any drug, for that matter, that’s zero risk.

Dan Henrich: Yeah. Well, one of the things I think just very few members of the public appreciate is the number of devices, perfectly good new medical technologies that simply don’t make it to market because of a number of things that derail it from its path. That might be a regulatory problem, or it might be a market problem that, simply, the market can’t justify the cost of developing this device, especially if it’s for a small patient population. One thing that we see, I think we all become aware of things that go wrong and grab top headlines, like superbugs in endoscopes or the vaginal mesh class-action lawsuits and things like that.

Dan Henrich: What we don’t become aware of, I think, as just members of the public, is all the products that do not make it to market because they have encountered some barrier that they just can’t get over for one reason or another. Now, being on the inside of the industry, I’m extremely encouraged when I see FDA take proactive steps to try to lower unnecessary barriers while still ensuring safety and efficacy so that new devices can come to market, particularly for small patient populations where the market … just to make the market case and make something make business sense and attract the investors that it will take to develop the product can be so difficult.

Monica Ferrante: Yeah and, to that end, the agency hasn’t lowered its standards, for example, for pediatric devices and so forth, but they have eliminated user fees and things like that, so they’re doing … within the realm of what they have control of, they’re trying to facilitate the whole humanitarian device exemption, which is the device equivalent of an orphan drug, if you will, where they reduce cost but not necessarily performance thresholds so that companies that have those kinds of technologies have a much better chance of actually bringing their product to market.

Dan Henrich: Right, right. Yeah. I’m not sure if it will be the next podcast we release, but we have an interview coming up with a pediatric device specialist, and I think he and I are going to talk a bit about what are those programs that FDA is instituting to try to compensate for some of the deficiencies in the free market model when it comes to bringing devices to market for underserved populations or for very small patient populations where it’s just difficult to overcome that barrier? They can’t lower the safety or efficacy standards, and we don’t want them to, but how can the FDA or how can the Patent and Trademark Office or how can other government agencies facilitate still navigating those products through the same regulatory pathway in terms of ensuring that they’re safe but lower barriers in terms of the overall cost to bring them to market?

Monica Ferrante: Yeah.

Dan Henrich: Yeah. One other thing, Monica, that I certainly wanted to discuss with you is we talked a little but about how, when you’re evaluating your regulatory strategy, which pathway will you try to steer a device down, at least when you’re first establishing your revenue stream if you’re a medtech entrepreneur? What about the idea of bringing a certain type of product to market which is kind of on the line of whether or not it’s actually a medical device or whether it’s a piece of consumer health technology? Can you talk a little bit about how a company might evaluate whether they want to be regulated as a device and how they would approach that situation?

Monica Ferrante: Well, that’s sort of the very first step of your product idea. Is it a medical device or is it not a medical device or is it something that could bridge? The FDA has established several guidance documents in areas that are of high activity, so apps. Are there apps that should be regulated as a medical device, or should they not? The guidance document addresses that, actually, pretty clearly. Same thing, when does exercise equipment become physical therapy equipment and things like that? They’re trying really hard to provide some framework in terms of when you’ve crossed the line and you really are a medical device.

Monica Ferrante: They actually did that with 23andMe. When they first came out, they were like … they didn’t even think about whether or not they were a medical device. They had no clue, right? Interactions with the FDA and, “Oh, yeah. We sort of cross that line.” They did the submission that they needed to do, actually, through the De Novo process, and now they’re adding functionality. They added a diagnostic for BRCA, so that’s been approved under a De Novo or cleared for market under a De Novo and so forth, so they are expanding on their technology, moving more and more into medical and doing the appropriate regulatory work along with it.

Monica Ferrante: If you’re in an area where you’re not sure if you’re a medical device, that’s a really good time to call the FDA and say, “Hey, this is the product. These are the things that we want to say about it. This is what we want it to do. Is there a line or where is there a line?” That doesn’t prevent you from staying in the commercial world. It just informs you that, when you’ve crossed the line and you’re moving into the medical world, what you’ll need to address.

Dan Henrich: Is coming to market, say, with limited claims as to what your product does, is that a strategy that a company might be able to employ in order to gather the data that they will need to show to FDA, or is that … It sounds like a tricky-

Monica Ferrante: Yeah. Well, I mean it’s-

Dan Henrich: Maybe it’s not a fair question to ask you, but-

Monica Ferrante: You can do that, absolutely. The question becomes how do you gather that data and what are the processes that you need to do that? If you’re testing a product that’s not a medical device but you’re testing potential medical claims, is it an investigational device that you need to follow the regulations for clinical studies and informed consent and so forth? There are a lot of interesting questions there that need to be evaluated, but yeah, it’s all possible. It’s a matter of how you sort of work through it.

Dan Henrich: Yeah, yeah. It sounds, to me, that when you’re dealing with a young medtech venture and they’re just starting to think through a lot of these things, they really need to form a relationship early with a really qualified regulatory consultant, maybe even one that has experience in a particular area. Do you have any recommendations in terms of how people should go about forming those relationships? Should they take multiple meetings at first? What if they don’t feel they have great referral networks? How should they go about finding a regulatory consultant and then determining that that person is trustworthy?

Monica Ferrante: Yeah. There are a lot of ways to do that. There’s an organization called RAPS that is actually regulatory affairs professionals. If you go on their website, they have listings of regulatory people who are actually certified, but obviously, in this age of the internet, you can do your own searches. There are a number of different ways to come across regulatory professionals. I think the main thing, to your point, that you want to have a conversation with that person about, their comfort level with your area or your device type or whatever and your comfort level with them.

Monica Ferrante: I mean, to me, working in this arena with the FDA, it’s about relationships and conversations and the ability to communicate, so finding a person that you can do that with, in terms of the regulatory expertise, if they need to go and research something to figure it out, that’s not necessarily a bad thing. The regulatory environment and landscape changes, so you need someone who can know where to go to figure things out and who to ask and when to ask as much as someone who already has all the expertise in their head. You’re not necessarily always going to find that.

Dan Henrich: Yeah, yeah. Great, great. Well, thank you. I’m sure we could keep talking about this for a really long time.

Monica Ferrante: Oh, yes.

Dan Henrich: I know this is going to be helpful. This has been helpful to me even though I have a little bit of a background in it. I think it’s going to be really helpful to our audience and to folks who are just starting out on that journey to bring their products to market so, Monica, I want to thank you so much for your time.

Monica Ferrante: Oh, thank you. It’s actually something that I love to talk about. I love my work, so-

Dan Henrich: That’s great. That’s great.

Monica Ferrante: It’s always changing.

Dan Henrich: Great. Well, thank you.

Monica Ferrante: Thanks.