Making Your Informational Meetings with FDA Valuable & Worthwhile

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.

Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. 

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Some highlights of this episode include:

• Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.

• Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.

• Being prepared for informational meetings is beneficial. Rehearse ahead of time and identify pain points according to the FDA.

• During the informational meeting, pay close attention to what questions the FDA asks as well as address its feedback and suggestions.

• Some companies do not have or make time and resources available for anything not required, such as informational meetings. However, time and money can be saved in the future by addressing FDA concerns/issues.

• The FDA is more inclined to attend informational meetings than other meetings because they like learning about new products and technologies.

Links:

FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Isabella Schmitt

Isabella Schmitt on LinkedIn

Proxima CRO

M1 MedTech

Inventing Tomorrow Podcast

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from isabella schmitt:

“With FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.” 

“It’s never too early for a pre-sub, but sometimes it is if you don’t actually have the information that you need to support the questions that you’re asking.”

“To find them valuable, you need to conduct them in a way that creates the value.”

“They like to attend informational meetings because we’re not really asking anything of them and they just get to be nerds again and geek out over the technology.”

“If you have a complex product, I would plan to do an informational meeting before pre-subs, just to talk about the product and get FDA to understand it foundationally.”

Transcription:

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.

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast, my name is Etienne Nichols, I'm the co- host of the podcast, with me today is John Speer, founder of Greenlight Guru, as well as Isabelle Schmidt. We're excited to have her. She is the director of regulatory affairs at Proxima and the principal at Inwood Medtech. In addition to this, she's also working on a podcast of her own, which we encourage you to check out, we'll put the link in the show notes. She's a very busy person, so we're glad to have her with us today. Isabella, you there with us?

Isabella Schmidt: I am here at this time, so I hope you can hear me just so for everybody's knowledge, we try to do this three times and my internet keeps failing.

Etienne Nichols: Well, it gives me a chance to get my part down, so I'm okay with it.

Jon Speer: Yeah, and Isabella crosstalk.

Isabella Schmidt: I think I've got a lot of practice now.

Jon Speer: Isabella, you mentioned M1 Med Tech, and this is new to me. I'm actually looking at your LinkedIn page, what is M1 Med Tech?

Isabella Schmidt: So M1 is an accelerator. So we have started an accelerator, it's going to be more focused on giving the companies the skillsets that they need to advance. So a little bit different take than a lot of accelerators, they're not all valuable, but a lot of them focus primarily on networking with a light education component. This one's going to be a heavy education component, so the companies will go through workshops and learn how to do the things that they need to do in order to be a successful company, to truly accelerate them forward in their development.

Jon Speer: Okay, cool. Well, I'm excited to hear more about that as things progress, so keep us posted.

Isabella Schmidt: Yeah, I will.

Etienne Nichols: Today we were going to be talking about informational meetings. I know we'd mentioned how busy you are. You want to just go ahead and jump in and we start the conversation?

Isabella Schmidt: Start my rant?

Etienne Nichols: Yeah, let's hear it.

Isabella Schmidt: So informational meetings, what to say about them. So basically what I wanted to talk about today was that a lot of people have questioned the necessity or the value of informational meetings and I think that informational meetings can be very valuable in a certain context and in a certain situation. So I guess to start, we'll talk about what they are. So informational meetings are a type of QSA with FDA, they are basically a situation in which you meet with FDA to present your technology and how it could be used and FDA is really in a listening mode. So they're there to basically learn from you as opposed to a pre- sub, where you're going and you're asking them questions and they respond to those questions. So it's less, Hey, FDA, you give something to me than a pre- sub is, it's more that your relationship building with FDA. So I think in a lot of ways, people think that, that has limited value because you're not getting direct answers to questions and things like that but with FDA the relationship building for informational meetings is a huge component and anything relation know with FDA is valuable and important. That's not really the only reason that informational meetings can be valuable, I think it's all in how they're conducted and what you try to get out of the meeting because it's not like you go to the meeting and FDA just sits there silent the whole time and it's super awkward and you're just presenting and they're like stone faced. You can't see them because you're on the phone but if you were in person that's just their stone faced. It's more like a discussion with them and it's a more open type of discussion than you typically have in pre- sub's. So I'll stop my rant for a second and see if you have anything to say or add or anything.

Jon Speer: Question that comes to mind is, just hearing in that short rant that you offered, it seems like an informational meeting is less about a specific product or technology. Did I hear you correctly on that?

Isabella Schmidt: It can be about a specific product or technology or it could be about a suite of products. Typically when you do an informational meeting it's at an early stage and I'd say typically it is probably like 95% of the time, you're too early for a pre- sub or you haven't really quite honed in on what maybe you have a platform of technology you haven't honed in on the specific indications. You want to have a conversation with them about that. So it can be about a suite of products, it can be about a specific product, but it's typically at an earlier stage and it's really to get in front of the FDA so usually if companies come to me, but they're too early for pre- sub, if they want to start having a relationship with FDA, they want to engage or have some sort of interaction with FDA, I'll recommend an informational meeting and getting into pre-sub, just tangentially for a second. A lot of times we, as in the collective consulting community will say, oh, it's never too early for a pre- sub but sometimes it is. If you don't actually have the information that you need to support the questions that you're asking, and then you could be leading FDA astray and in their assumptions about your product or if you're not really getting useful feedback from them. Or as with an informational meeting, you can be a little bit broader because it's really more of a conversation than them specifically answering your questions. So they come at it a bit more open than they do in a pre- sub where they defensive is not the right term, but where they are defending their position a bit more because they're giving you basically written feedback to answers that you can then say, well, you said this at some point. So informational meanings are truly more valuable and they're valuable if you're at a later stage, if you want to talk about a suite of products or if you are having relationship issues with FDA at some point where they're not really understanding for some reason what you're presenting to them to sort of reset so that you don't just keep going back to them and asking questions about a product that they don't truly understand. So it can help to reframe the relationship and make sure that you're on the same page about what you're talking about, insanity, doing the same thing over and over again. So if you've had two pre-subs and they're not getting it, maybe try a new tactic. So those are the ways that I find them valuable, but also I would say that to find them valuable, you need to conduct them in a way that creates the value. So you're in control of all of the meetings with FDA, it's your time with them and they'll say that to you, regardless of what type of meeting it is, but pre- subs is really focused on, Hey, here are the questions that I've asked you and here's the clarification I need based on your answers. That's what the need are. Informational meetings, like I said, it's a bit more open and so typically what they'll do, they'll have a host, like a slew of people come to them, they're the most well attended meetings I've been to. So some folks also say FDA doesn't like them, I have not had that experience, it seems like they truly enjoy them. So that's one case of it. They will ask you questions to clarify any misunderstandings that they may have and then they'll also leave it open for a dialogue and for you to ask them questions back.

Etienne Nichols: So the people who attend those meetings, are any of them going to be the same people you'll be talking with later on during your submission? You talked about that building relationship, how does that work?

Isabella Schmidt: So the forever answer to everything is it depends. The consultants say that all the time in business school, they say it depends to everything, but it depends a little bit on the fact that right now there's a lot of flux going on at FDA. Since the pandemic, I think with every industry and every workplace right now, there's a lot of resignation and new people coming in and so there's that whole great resignation thing going on and that has affected the FDAs, so they have a lot of new reviewers coming in, hopefully that level's out but typically yes, you would say, about the same group. It's been less flux with subject matter experts than it has been with reviewers, so nowadays we're seeing lots of new reviewers, whereas the subject matter experts are somewhat consistent. There's been a little bit of flux with them as well, but not quite as. So you would say yeah, at an informational meeting, they'll bring in the reviewers, they'll bring in subject matter experts and the people on that call specifically the subject matter experts will ask you questions or make suggestions to you based on upon their area of expertise. So that's the ways in which you can get feedback from them that is truly meaningful to support a pre- sub down the line because you can figure out what their specific interests are and where maybe their pain points lie based upon what they're telling you, kind of reading between the lines of the conversation that you're having with them during that informational meeting.

Etienne Nichols: All right. That makes a lot of sense. So when you're talking about these different meetings that you can compare them to the other types of meetings, so let's talk about the informational meeting, how do you use that? You kind of gave some different benefits of doing it, how do you get that benefit? What are some tips and tricks you recommend?

Isabella Schmidt: So going to the meeting prepared always is beneficial. So usually rehearsing what you're going to present to FDA beforehand and having an idea of the pain points that they may have with what you're presenting so that you could effectively answer any of the questions that they may have for you during the meeting. So fast forward to the point where you're engaging, because you don't have a set agenda specifically for this right, there aren't questions they're specifically going to talk about. During the meeting, pay close attention to the things that FDA brings up as suggestions or the questions that they have. So suppose you have a novel biomaterial and one of the subject matter experts is asking a lot of questions about, let's say it's a novel bioresorbable material, so suppose that the subject matter expert is asking lots of questions about the duration of the product before it resolves. So you can basically assess from that, that that's going to be something that they're going to want to have information about in the future. So you may not have that answer now, but when you're going to talk to them compatibility or mal testing, or whatever, you should know, that's probably something that they're going to want to have you address. I've also heard them say things, which I think probably we know this, but it's good for companies to hear this as well. They'll say things about, okay remember for biocompatibility it's based upon the entire finished product, not the individual component, so you can't say, oh, my individual component is biocompatible, you have to take the full product processing all of that into consideration. So understanding that type of feedback that they give you during those meetings and applying that to future pre- subs and future submissions is beneficial. So that's a way you can get actual answers to things from an informational meeting without asking them specific questions.

Jon Speer: I think I heard you say that during informational meetings that you get written documented response from FDA, did I hear that correctly?

Isabella Schmidt: So in an information meeting, you don't get a written documented response, it's just the conversation with FDA, for a pre- sub you get a written documented response. What you will get out of the meeting that is documented is meeting minutes at the end of the meeting, not at the end of the meeting, but you'll get meeting minutes that you generate same as a pre- sub that summarizes the discussion during the meeting. So if you have a conversation about the bioresorbable nature of your material or biocompatibility, you can document that in the meeting minutes, and then you can use that in the future as part of your regulatory history or to guide what you suggest for biocompatibility testing or animal testing in the future. You can say, okay we had this discussion and during this discussion, these things were discussed and here's what was said and we took that into account by applying these certain things in this study design.

Etienne Nichols: So really it's more like an off the books discussion with the FDA kind of a thing in their mind, is that accurate?

Isabella Schmidt: Well, it ends up on the books with the meeting minutes but it's a bit less on the books than a pre- sub is because they're not already answering your specific question.

Etienne Nichols: Okay. Go get John and I straightened out in a minute here.

Jon Speer: The information you get from FDA is still non- binding, I would assume maybe that's what we're going for.

Isabella Schmidt: Yes. I mean, as always it's non- binding and non- binding to you, probably even more so, because it assumed that you're at an early stage, so if you go and you present them something and you said it's a bioresorbable material, and then you're like, oh man, they were really obsessed with the duration of this maybe now it's not bioresorbable. I don't know how you would do that, but say you did, then they won't say, oh, well you said it was bioresorbable before and so now you must keep it bioresorbable throughout the entire duration of the life cycle of this product. In your final five time K or PMA or whatever it must be bioresorbable. So you're not bound in that way, the same way you're not really bound in pre- subs, but you should address if you said something and then you go and present something totally different to them, what the changes were.

Etienne Nichols: I've heard John say the more you know, the more you know, so I can definitely see the benefit of this kind of conversation, especially if you're going to be submitting to the FDA, it makes total sense. However, I can see maybe a situation where a company says we're busy, we're just really trying to get this thing knocked out, we're in the trenches of product development, we don't have time for anything that's not required. What would you say to a company like that? What's the benefit and how can you convince them that this is truly beneficial and could potentially save them time and money in the future?

Isabella Schmidt: There's two parts to that. So anything non- required is different than not an informational meeting, so if they're suggesting that they're never going to go to a pre- sub, I would tell them that's a terrible idea. I am currently and have worked on submissions that did not do pre- sub and they require saving if possible lots and lots of CPR. So that is usually not a good idea, not even not usually, it's pretty much like flat out not a good idea. You could say if you're a direct me too, like I'm exactly the same as another product, then maybe you don't need to do a pre- sub, I would still say, why not? But anyway. So not doing your pre- sub is totally different, if you don't have the time or the finances or whatever to do in an informational meeting, or you didn't do one early on. So it's probably if you're earlier on it's of interest, but if you didn't do it, you're at the stage where I do have specific questions, I think it's okay to not do an informational meeting, it's not something like a pre- sub where I would be like, why didn't you do that? But it is beneficial in the sense that if you're early enough on, it will help streamline maybe some concerns that FDA will have that will come up during the pre- sub if you don't preemptively address them, which could reduce the number of supplements that you need for a pre- sub if you're having to do follow- on's to address some of the issues that you missed. Again, it's a good relationship building things, so you're meeting them and discussing things with them before you're going to them and saying, Hey, give the answers to this. Depending on the review team that may or may not be beneficial. So some review teams are really easy to work with just generally speaking, even if the first interaction that you have with them is like a breakthrough designation, they're just super easy to engage with. Then other ones, whether it's just the culture of that specific review team or it's the lack of resources that they may have at that time are a little bit more challenging. Then I would say too, if you have a product that's really complex, it's probably a good idea to talk to them in a more open discussion beforehand, then going directly into, Hey, give me answers to these questions about a clinical protocol, a pivotal study and they've never seen the device before. I think for complex products, it's almost a necessity to bridge any misunderstandings that there may be between FDA and the sponsor company.

Etienne Nichols: Maybe my question actually begs another question, by saying do I have the time or resources or money associated or whatever the case may be? What kind of time commitment is it even and how much is the cost associated with this sort of thing? Would you be able to speak to that?

Isabella Schmidt: Yeah. So all Q- subs from an FDA perspective are free, so you don't have a user fee associated with them. So informational meeting falls under that. So from FDA's perspective, it is free. Same as a pre- sub. Time commit is not huge for an informational meeting because basically what you're going to go in to discuss is a device description, maybe potentially or regulatory pathway. Maybe if you've done like proof of concept testing, you want to cover some of that, but it's not required. It's kind of up to you what you want to include, but a bare minimum, you really want to talk about your device because that's the whole point of the meeting. So it's usually a bit lighter than a pre- sub because you're not having to provide justification for the questions that you're asking, you don't have to provide all the background information for that. So it's a lighter load. If you hire someone else to do it's even lighter load, but then you just have to obviously pay for their consulting fees. From my perspective, I won't lay out definitive costs here, but it is less expensive than a pre- sub and if I'm already familiar with your product, a free sub is less expensive than too. So in that way, it doesn't require a whole bunch of effort from a company's perspective, like a pre- sub does typically, or obviously like a final submission, which requires even more effort. So the more familiar FDA is with your product, it's the same for me. So the more familiar I am, the more familiar FDA is all subsequent submissions and everything they're after are a lot easier.

Jon Speer: You mentioned that the informational meetings are the most widely attended type of meetings by FDA, why do you think that is? Why would they be more inclined to participate in an informational meeting versus a pre- sub or some other type of meeting?

Isabella Schmidt: So they've directly told me why. So they have told me that they like to attend informational meetings because we're not really asking anything of them and they just get to be nerds again and geek out over the technology.

Etienne Nichols: That makes sense, I can see that.

Jon Speer: So really there's no reason not to do that. If you have any questions in your mind regarding your product and as it relates to the FDA, really no reason not to do something like this.

Isabella Schmidt: No, there's no reason to not do it early. A reason that you may not do it in general is if you're already far enough along that you want to do a pre- sub and it would eat up some of your timeline overall for FDA interactions or you need specific answers about something that you wouldn't be able to get through an informational meeting. So say you really want to conduct your animal study in three months and so you need FDA feedback, you wouldn't want to go do an informational meeting before that, because you don't typically submit two types of Q- subs at the same time. So that would be one reason you wouldn't do it. It would be based upon your timelines, but if you're really early and you don't have any specific questions for FDA that you need answered, there's no real reason to not engage with them and introduce the technology to them because you will get valuable information from it. It'll be higher level than a specific question and a pre- sub, but it will give you information and it gets them familiar with your product.

Etienne Nichols: So time duration between Q- subs, is there a typical or expected time between those two?

Isabella Schmidt: Between submitting two different ones or between... I mean you can submit them as soon as the meeting is done back to back, but the timeline, so suppose I'm submitting to packet it today, usually the timeline for review for FDA's perspective, from submission of this one to, I get feedback for pre- sub is about 60 to 75 days, sometimes 90 days. Then you have meeting minutes that take about a month to get finalized. For an informational meeting, the guidance document says 90 days, but they will do them earlier because it doesn't require anything from them really other than to show up for the meeting. So if they have bandwidth to schedule it, they're not like hardlined on it, I think it's 90 days in the guidance document because it's less time sensitive I guess because the company's so early, whereas when you're going to ask them specific questions, usually the company needs feedback in a reasonable timeframe. Not that 90 days is unreasonable, but it's less reasonable than 60. So I think that's why it says that, but you can ask for it a lot earlier and they will give you if resources permitting the meeting earlier than that.

Jon Speer: So Isabelle, I know that obviously since we've been dealing with the pandemic, there's been a huge impact on FDA and specifically FDA resources for a variety of reasons, types of reviews and that sort of thing so much so, that I've even heard recently or it's been actually ongoing for a bit that some branches within FDA have stopped receiving pre- submissions because they don't have the resources to review them. Have you seen or heard anything with respect to informational meetings? I mean a similar type of issue or concern because of the pandemic?

Isabella Schmidt: Yeah, so generally the in vitro diagnostics division has stopped receiving Q- subs period, but they have been a little bit more open to informational meetings, again resource permitting, because it doesn't require a whole lot of review on their end. It's just, here's like this short packet and I don't need any written response from you, you being FDA. So they have been open to that when you ask them on a one off basis, so not just generally submitting it, but if you reach out to them and say, Hey, could I do an informational meeting? They'll say, okay, that should work. That isn't necessarily a hundred percent the case though. I would say by a similar token though, if you've already had interactions with FDA and you're at the point where you really need a pre- sub, in certain cases, they will give written feedback, but no meeting. Take that for what it's worth though because sometimes written feedback with no meeting is not a great idea, depending on the questions that you need to ask. So I think different people would employ different tactics. I would say an informational meeting to me, if you could get one would be better than written feedback with no meeting if it's about critical discussions. The other divisions I haven't had any delays with any of the other divisions, they're still receiving them. There have been some delays based upon resources, not necessarily related to COVID at this point, but for a while they were on what they called COVID deployments and so they would have lower resources than normal because they would send people on deployment. One of them told me that one time and I was like deployment, is he in the military? Then I figured out what they meant and then it was a COVID related FDA review.

Etienne Nichols: So they're almost treating like in the military at this point, so much work to do.

Isabella Schmidt: It is better now than it was late 2020, early 2021 across other divisions but as far as I know, and I've reached out to and talked to a couple of the branch chiefs in the IVD division, nothing has really changed about their acceptance for any Q subs, unless you reach out to them specifically.

Etienne Nichols: We've talked about when to use these informational meetings, how to do them and then why, any other thoughts, suggestions for companies who may be in the position where they're looking to do an informational meeting?

Isabella Schmidt: I would say to get the most value out of the informational meeting, make sure that you have someone who understands the FDA and regulatory a bit, otherwise you may not be able to take and read between the lines or interpret a lot of what they're saying in a way that meaningfully could impact your future submission. So you will get the value of relationship building maybe if you don't go there and kind of see the math, but if you go there and you're structured, you could get the value of relationship building, introducing them to at least an early stage of your technology. But you may not be able to get the value of understanding if they say no biocompatibility needs to be on a finished device, what that truly means and then in your future submission, pre- submission follow on submission of any type, you won't be addressing it in the way that you could, if you understood what that really meant.

Etienne Nichols: That makes a lot of sense. So sometimes we look at these regulatory situations as very mystical almost and they or me being a product development engineer, for example, I'll just give you a quick example. My father- in- law he had an invention he wanted do, he took it to a mechanical engineer and that guy might tell him, well, you need a cross sectional width of X, with so many different things. He's looking at it through his engineering lens, if you don't have any kind of engineering background, it might not make a whole lot of sense. Really what you're saying is when you bring something to the FDA, they're going to be looking at it through a regulatory lens and you have to either have look through that lens or bring someone along who knows that regulatory speak, if you will, is that kind of what you're saying?

Isabella Schmidt: Exactly.

Jon Speer: Like an interpreter right?

Isabella Schmidt: Yeah basically like an interpreter and I'd say that that's true for any of these interactions with FDA, not just informational meetings, sometimes you'll get on a pre- Sub with FDA and a subject matter expert person will start saying something that regulatory director person on FDA side is like, oh, well, no- no, you got to think about it this way. So sometimes if they haven't talked beforehand and someone's kind of going rogue, you'll hear them sort of correcting each other and those types of things can also give you insights on has what perspective so that you can address them broadly moving forward.

Jon Speer: So I believe what I'm about to say is accurate, but certainly Isabella, you can correct me, but I believe that the key component of a pre- submission is that I as the submitter of a pre- submission, need to ask FDA specific questions that I want them to answer. What I think I'm hearing you say about the informational meeting is I don't have questions that I need to ask or even can ask in an informational meeting, is my understanding someone on point?

Isabella Schmidt: Yeah, I would say generally, maybe you do have questions, but you don't have supportive information to get an answer from those questions at this point, so whatever feedback you get from FDA, if you ask the question would be minimally useful or they may just say we don't have enough information to answer your question. I've seen sometimes they've said that not in my submissions obviously, but in ones that I've seen. I've seen them say that and they're only going to talk about the questions that you've asked during a pre- sub, whereas with an informational meeting if you can't provide supportive information for specific questions or you don't have specific questions, you'll have a more open discussion. So I'd say, if you can't ask them specific questions for any reason, whether you have that specific question or not, then don't do a pre- sub do an informational meeting.

Jon Speer: So you can ask questions in an informational meeting, it's just not a prerequisite?

Isabella Schmidt: Yes.

Etienne Nichols: Well, what I was thinking, so to build on your previous question, pre- sub is a very specific question that you may be asking them, so kind of what I'm hearing is maybe an informational meeting. I don't necessarily know exactly what I need to ask yet, but I have a general idea, so I may ask broad questions and that helps me know what to ask in the future, is that right?

Isabella Schmidt: Exactly or what to present in the future. The discussion that you're having with FDA during the informational meeting can guide you to questions that you ask during that meeting. So if they say something like, biocompatibility testing needs to be on the finished product, you can say, what do you mean by finished products? If you don't know that. So it's sort of like negotiation in a way, so you're kind of negotiating more information from them in the context of a discussion.

Etienne Nichols: Okay. That's helpful. Were you going to say something else, John?

Jon Speer: Well, I think just as a general rule and Tanya and I had a guest on recently where we were talking about human factors and the person we had as the guest, she used to work at FDA in the human factors group. Just that opportunity to be able to collaborate or interact with FDA and I think that's one of the huge benefits in our industry today in 2022. It hasn't always been there in this industry and it's not an option in many other markets outside the United States. So I think we're very blessed and fortunate to be able to. inaudible but at least you have that opportunity, I think that's a really great asset.

Isabella Schmidt: It's less available for like drugs and biologics, like Cedar and Seber don't have these types of meetings and sometimes even with a pre-IND for drugs, which would be equivalent to a pre- IDE for devices, they won't have the meeting, they'll just give you written feedback. So you're kind of in the boat of the IBD division in that case. So I think the fact that you even have an option like informational meetings is like, people should feel blessed, especially with also the option to then have follow on pre- subs thoughts and you can have a number of them as long as you're not overdoing it, which that's a whole different discussion in and of itself. I would agree, I think that the fact that you can have these meetings is super valuable and even in the US, it's not always an option for other product types like drugs and biologics.

Etienne Nichols: That's cool. That sounds like a good stopping place for me, John, what do you think?

Jon Speer: Yeah, I agree. I'll have to say that I didn't appreciate the value or some of the nuances of how an informational meeting could be beneficial, but to hear it straight from somebody like Isabella is super helpful because this is what she does for a living and if my regulatory expert is sharing with me that, Hey, there's value in conducting an informational meeting, then I should perk up and listen a little bit I think.

Etienne Nichols: I wasn't going to admit it, but I think she converted me as well, so that's good. Good work, Isabella. We said, you'd get us straightened out in the end, so I think you pulled it off.

Isabella Schmidt: So to be honest, initially I was like an eh, informational meeting person, but then I got converted by having a few of them that actually were really valuable.

Jon Speer: Well, I don't know who's coined with this, but a lot of us at Greenline, we work with a mindset coach and one of the things I've learned from that experience is experiences form your beliefs. So Isabella has had some experiences that have changed her beliefs about informational meetings and I can now piggyback on her belief because she's been there done that, I don't have to necessarily have a negative experience to benefit from the informational meetings. So definitely something I think is worthwhile, I mean, I've been an advocate of pre- subs for a long time, and this is opening my mind up a little bit more about there's even at an earlier time that I can engage. As a company, especially when I'm doing something that has any, I'll say, novelty or uniqueness or if I have a clear cut, I'm just doing a pure me too product then pre- subs, informational meetings, eh, probably not going to be a lot of value. If I have anything that has a slight variation in any way, shape or form from a predicate that's uncertainty and especially if I'm an earlier stage company, a startup company, part of my challenge is to mitigate uncertainty and an informational meeting is a way to help mitigate uncertainty.

Isabella Schmidt: Yeah and I'd say, if you have a complex product, I would plan to an informational meeting before pre- subs, just to talk about the product and get FDA to understand it, at least foundationally in the context of not having to answer a question, because being able to have a discussion about something always clears up miscommunications. You can do a really great job in the packet, but if they're interpreting written word a different way than was intended, that's an opportunity for miscommunication. Whereas if you're having a discussion, you can clarify it on the slide.

Etienne Nichols: Well, thank you, Isabella, this was great. Anytime you can change somebody's mind or inform someone's mind, I think that's an excellent situation to be in. So really appreciate you taking the time to do that today. For those of you listening, you've been listening to The Global Medical Device Podcast powered by Greenlight Guru, the only medical device success platform, specifically designed for medical devices. So we look forward to having you back, but for now, thank you for listening. Thanks guys.

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