NEGOTIATING WITH THE FDA featuring CARRIE BRITTON

Good morning!

Hey? Good morning. I'm promoting you.

Thanks.

Trying to ghost.

Arlen. Good morning.

Hello!

Britain.

Look at my video works today.

Yeah, it does.

That's a good thing.

Arlen, where is your backdrop.

It's in Summit, Colorado Summit County, Colorado, in some.

Are you up there, Erlyn?

We have a place up there. I'm not there now, but this is this is a view out my front window. It's pretty lucky.

I was. Gonna say, it's been warm last couple of days. It's a fast snow melt.

Yeah, it's kind. Well, you know, it's sort of the I know it's the rain. It's the mud season, but it's gets much better than it it, I mean, we're at 9,700 feet. So it snows a lot.

We're supposed to get 31 inches after what? Sunday, I think after the 80 degrees, we're supposed to get here today and tomorrow. Yeah.

Alright!

Another trough that's coming through.

That's that's Colorado.

Yeah.

As you can see, Faison is also looking out his window. He's somewhere in somewhere in space.

Hi! Everyone! Good morning!

It remind us, are you in Pakistan.

Yeah.

What time is it? There.

It's 8 pm. Here right now.

Well, what better to do on a Friday night? That's what I always say. Michelle Mitchell could actually be anywhere in the world as well.

Where are you today? Last week was Paris this week.

I'm home. I got home 2 30 this morning.

So you're ready for bed.

No, I have 2 weeks of laundry.

Oh! Good gracious!

And they can wait.

Heading.

Introduce yourself. Ms. Moon.

What?

Asking our new friend to introduce herself.

Hi! I'm Julie Moon.

What do you do? Where do you live?

I am in Eastern Pennsylvania, about an hour west of Philadelphia, in Lancaster County, Eastern Standard time, and I am the head of Bd. For our Med tech and biopharma divisions here at global regulatory writing and consulting. So I have a growth goal for 2025 to start up FDA pre-market services for our medical Device Division. We're very heavy in the post-market space. very heavy, EU, but we don't do any 510 K. Or Pma work, a few of us, me being one of them. But now I'm in Bd. Have written, supported some 510 ks. In the past and just trying to get some strategic partners, and just become even more informed, so that I can help train this team internally and get that going for us.

Yay, you made a whole bunch of new friends today. Welcome.

Thank you.

Olby. I haven't seen you in a long time. What's going on.

I'm so glad you didn't kick me out.

You're always welcome.

You're always on my mind every Friday, and I think I'm gonna join.

Always on my mind. You were always on my.

You are doing such a great work, Joe, so I have to show up once in a while when I can thank you. I appreciate this.

Daniel, I'm promoting you to panelists so you can be seen and heard. But you didn't answer me, Goldie. Where what's going on. I haven't seen you in a long time. You must.

last time. Remember, I presented the brilliant Founders network. So there was a lot of work on that front back end preparing planning, building infrastructure, plus my regulatory affairs, consulting Job, plus my wisdom, waves webinars that goes on. So it's just like overwhelming. And it's just like my daughter got married in November. That was another thing.

Yeah, nice.

So yeah, it's just too many things happening.

Do you like your new son-in-law?

No.

He's he's he's such a. It's genuinely happy. Guy. It's like, Wow, yeah, I'm impressed.

Darren, thank you. I got your money this morning. I'm glad you're joining us in 4 weeks.

I need to be there.

And Daniel welcome back.

It's good to be back appreciate the invitation.

Yeah, every week. boy, we have a real international group today. Lucas, calling in from the Netherlands, is on, is in Pakistan. Eddie is calling in from Great Britain. Yuha is calling in from Finland.

So before we get started, I just got off the phone with Bill Moss, who is the CEO of 3, aware? And he's gonna be joining us at 10 x along with Bradley Bostic, who's gonna be one of the speakers? And Bill is probably gonna be leading a workshop. I spent an hour on the phone with him. It was fascinating. So fascinating. Yeah. And you know, it's it's all around ehr patient networks, real world evidence. And they're really having a profound impact on the industry. And their their platform is just taking off. I got so much from talking to him.

but what was really great was at the end. He said, I asked him, you know why he wants to come to 10 x. And he said, you know, we are our core. Philosophy is innovation through collaboration with thought leaders. and it is through the collaboration of thought leaders bringing the right people together in the room, having the right discussions, and not about being the person who says, Oh, hey! We're going to do it this way. So he really has the right kind of mindset go coming into this. And I'm just absolutely ecstatic that they're gonna be there. And oh, and he's gonna be speaking on may the second on this program.

Yeah, I put the hotel link there. If you are remotely considering coming, I suggest you click on that today and book a room you can always cancel up until the day before. No penalty whatsoever. I think today is the last day to book at the group rate. So if you haven't done that yet. These 2.

That's awesome.

Yes.

So. Now, I'm going to introduce today's speaker. Carrie Britton, who is lovely in a number of ways. Gotten to know her a bit over the last 2 years, really and through conferences and and through Linkedin and she has. She's a dentist by training and has a tenured record in medical device regulatory, and she's been working collaboratively with the FDA to get products to market and

complied. You know, compliance and audits, and pmas, and and de novo and breakthrough, and every everything that you can think of. And so I thought, who better to talk to us about negotiating with the FDA, whether it's a 4, 83, or what have you than than she and Daniel? I'm glad you're here, because and and everyone else. you know, show of hands who who has a lot of experience in in working collaboratively with the FDA to get products through.

On it. Hands up, Goldie! David.

We are in the process.

Okay, so, like.

Often basically.

Yeah, you're you're touching on a very important topic. So obviously, I'm sure we can help you with some input.

Carrie.

Yeah. Hi, I'm Carrie. I don't like to talk about myself, which is probably why Shawn tried to extrapolate a lot of information out of me so. But like you said I'm a recovering dentist. I did it for a bit, and didn't like it much, so I got out of the mouth, so to say, and into doing devices. And that's a lot more fun for me. doing clinical trials and stuff. My 1st experience. I don't know if Arlen ever met him, but was with Dr. Bob Christiansen with Tmj. Implants, and I don't know if any of you have ever had any experience with that gentleman, but he sued the FDA probably 3 or 4 times.

Anybody know Dr. Bob Christensen.

I'm very familiar, I mean.

Are you okay? Well, I worked with him. That was my 1st experience out of out of the mouth, but in the mouth, but into industry with him. And let's just say I got to know the FDA very well, and how to not deal with the FDA. Let's say and my 1st experience was a cease and desist order with them, and they came in with let's see 3 huge rider trucks and 15 men with AR guns and it was sorry, Nelly, you about spit coffee and they came in. I'm like he's over there, and they took him away, and let us all go home with our car keys, driver's license, and our house keys, and that was about it, and they took everything in the place, and it was basically for a

He refused to report Mdrs. And at that time my girlfriend, Maureen Mooney, who, I'm sure she I invited her to come. She refuses to talk about this to this day, but she was being charged $10,000 for each Mdr. That they did. She did not report for his temporomandibular joints at that point. In time.

For the for the slow kids in the room. What is an Mdr.

Mdr. For the Us. Side not to be confused is medical device reportable events, not the.

Okay.

Yeah. So this was back in, I want to say 1999, Dr. Bob, I'm going to call him infamously. Dr. Bob started selling temporal mandibular joints. Reconstruction of the joint. Back in 1964. He was a oral surgeon who invented quote unquote. I should have brought some over here but the Fossa eminences and the temporal mandibular, or, you know, to replace people who had. You know. Tmj quote unquote, everybody has a Tmj. But disorders of the jaw.

And so most of these patients, you know, grind or do their joints. But most of them have other issues. I can say as well, so they never quite go away. But these patients, you know, will continue to have issues with their jaws. And they, you know if you replace them. You know they're going to continue to have dysfunctions of the jaw. And they he continued to say that it wasn't his his joint, but, as most of you know. if you have a a reportable event, your your device caused or contributed, therefore you still are, are at liberty, or you must still report if your device caused or contributed to the event. Right? So you you have to report. He refused to report. So everyone there was 22 events that he refused to report

And so the director of Regulatory at that point I was doing the marketing and teaching docs how to place. These, these. these devices, as well as still working on the Pmas, and doing the investigational ides and hdes and all these at that point. But she was charged $10,000 for each of these events. So she was 2, you know, quarter of a million dollars for somebody who wasn't even planning on. That is a bit of a hiccup as well as him. He had a he claimed, I think, bankruptcy. At that point. He was in jail for about a week. but it was that was my 1st breakthrough on how not to deal with the FDA. So

FDA got to know me at that point. I think I'm not necessarily known as somebody to who to call, but I do get called a lot on a lot of events for whistleblowers. I also called by them in the Doj for the Theranos case. I was also called in on another case for another client of mine. I worked at a Urgo for 9 years, where I ended up helping clear about 150 devices through the EU and the Us. So they know my name at the FDA, and who to work with, and who to work for. So they'll call me on clients that they've seen my name come through on submissions and stuff, so they'll ask me, what do you know about this? And if the Doj calls me, I'm going to.

I'll ask them. Do I need an attorney, and they'll genuinely say no. But there was another case that just recently went through as well. So they'll call me on not necessarily whistleblower cases, but I'll tell them what they need to know, because I'll tell them the truth right? I don't know. Where did you go, Michelle? If you've been involved in any of these cases, too. But you tell them what they need to know right? And so I'm sure this last individual with Why can't I think of the name in this company, but she just got 6 years from the from the Doj. So the Sec. Sec. Trial hasn't even been gone through yet where she was charging it was stemwave. So she got charged. She was charging $18,000 for these neuro stem implants that were being placed in your

spine, where they weren't even active. And so that was for 10 years worth of implants. So per patient she was getting $18,000 per implant being implanted in there. And so it's quite a few implants. She only got 6 years from the Doj, though. and so it took about 5 years to try on that case. Go ahead, Michelle.

Somebody that was banned from the industry by the FDA for like 15 years, and and then they seized the company and all of his assets and shut it down, and then he just moved from Colorado to to Arizona. and he started a new company. He had one of his cronies that was helping do all the bad stuff at the other company. But he did. That guy wasn't banned from the FDA. So he put that guy up as the CEO of the new company, but behind the scenes he still owned everything. and then he got almost got Tucson shut down again, and Mexico he had almost got 2 facilities, 2 more facilities shut down and seized before I at 28

took a job there. What, Michelle? That's how I know.

Yeah, what Michelle is referring to is the infamous FDA department list that once you go through some criminal type, proceeding where you are accused of fraud or engaging in illegal activities. Then you are placed on that list. and it depends on the crime you could be placed for a number of years, or permanently. which would not allow you to do any business with any regulated products.

How many companies are on the list? Is it a big list.

It's a pretty large list.

Is that it's public is public. What do you have to Google to find that.

Yeah, just do. When you go to the FDA website, just do department list, and you should be able to pick it up. If not, we can always send you a link.

Yeah. Whole new series of Linkedin posts for me for a long time. Sorry.

Arlen, your question should be good.

Hi, Carrie, my question, my question is with artificial intelligence. Software is a medical device embedded software. Blah, blah, blah blah should artificial intelligence products be regulated like medical devices, and given the fact that they constantly change, should there be adverse events, reporting mechanisms in place for artificial intelligence platforms.

Oh, there is, and there are I had my midlife crisis and I got my whatever at Johns Hopkins, and they made me do software as a medical device, and my tenure at sterling medical devices was all on software. And there is a whole new realm of software as a medical device and artificial intelligence, and there was a there was a warning letter that just went out to a Colorado company on Artificial Intelligence. A lot of companies are writing. There is one product code for artificial intelligence that a lot of companies are using where it's a was down classified in the 21st century cures act as a class. One device where they're saying their artificial intelligence is a class. One device. I wonder if I could pull up that warning letter.

And there's.

Yeah, I'm sorry. I understand that there's over a thousand cleared software as a medical device platforms by the FDA. My, my question, maybe I didn't make it clear was given that there's drift. Given that there's change. When you apply a different test population. it constantly changes. So how is there an adverse events reporting mechanism when you're using these things. Maybe you said it, but I just didn't understand it.

It depends on the intended use. It depends on the risk. It depends on what the patient population is, and it depends on what it's being used for it depends on the algorithm as well. So I mean the the dreaded. It depends regulatory answer there. But you know, software is based on the risk. So there's class one class, 2 class threes. There's a lot of drift on these clear devices, and what these softwares are doing. So a lot of these devices that have been cleared years ago. If they're continually taking the software and continually updating their software, there's drift in what the intended uses. And there's drift in what that algorithm is doing. And so unless they're doing

you know, as that software changes. And unless they're doing the you know, looking at what that software and what it's doing affecting to that software upstream and downstream, that software is not doing the same thing as what it was intended to doing when it was originally cleared. and the FDA knows that I mean, people are doing agile approaches where they're not writing down. You have to document according to the FDA. And if it's not documented, it didn't happen. And when when software engineers which I've worked with so many of them. They don't document. They go into these Agile's, you know, and they don't write it down. They're just they're just doing these test cases.

and they're just doing it. And it works. And it goes. They're not looking at what it's doing downstream to the actual intended use. And what this software does today isn't what it was doing 12 years ago when they got it here. Here, cleared as a software. So in these AI situations, where they're doing, you know, you know it's what it does this week is not at all what it did last week. and so, if it's static, or if it's.

Additional features being added into the software.

Pardon.

What was that? Fasan.

Are you talking about added features into the software? Which is why it's like changing the intended use.

Anything. I mean, it can be anything that these what these software companies are doing to it. And then there's then there's that gray gray feature that they're doing for these clinical features where it's not necessarily software for medical intended use. And then there's clinical that a lot of these companies were doing that they, the FDA, went through and were giving warning letters to for clinical indications where they were. They down classified it as a class one, but they were kind of riding that gray gray, you know.

Area.

Days where it was a. It was a it. They were saying it wasn't a medical device, but then, in reality it was a medical device.

A couple of things that maybe I can supplement with one is, there's a difference between the software manufacturer and the medical device manufacturer. So it is important to understand that when the software manufacturer makes changes to the software, they they are expected required to notify the medical device manufacturer, because that is going to have an impact on the ability of that medical device to do the work that it's intended to be done. And then it is the responsibility of the medical device manufacturer to evaluate that change and to determine whether or not that change is substantial enough to change the let's call it. Let's call the critical quality attributes or critical performance attributes of the medical device. So

it is correct that things evolve and change. However, they have to be analyzed. It's not any different from what happens with any typical medical device where companies change from one supplier to another, or they change one material class to another. and some of these changes may seem to be small, but they actually can be very significant. So in the end it all comes down to do. You have a change control system in place that does that type of evaluation and the extent to which, then, you need to notify the FDA about those changes.

What about notifying the the person who bought the software? So if you're a hospital or a a medical practice. and you bought this AI quote solution. And it goes through all this rigmarole that you're describing. Is there such a thing as a product? Recall? And secondly, if something like sepsis, we all know the story of people telling us the wrong thing about predictive analytics for sepsis. It didn't work. So is there a product recall? And secondly, who gets notified.

So there are.

When the yeah, when these things drift.

So there are FDA driven product recalls which are class one, class 2, class 3 recalls, one being the highest for that. And then there are market recalls where the company will do it. You don't want the FDA to do a product. Recall. Those are bad done. A few of those. And then you don't really want to do a market driven recall because the FDA is going to look at that and say, Well, is there something else going on, and they will look at any market. Correction is usually what the company is going to call it when they do a software driven. Recall. Dexcom just had a class. One recall that they had to do for their software, driven AI for their readers on the

for a a. 1. c. Readers, wasn't it? I did.

I think I think you're right. Glucose, monitoring devices.

Yeah for their glucose readers for a 1 c, right? Wasn't it for them? Yeah, they just had a class. One recall that they had to do for their AI reader. So that was an FDA driven, was it FDA or their company? Did I think, Dexcom recall that? So you will see a Marlin that they do a market recall in the hospital for it.

So I have a question, how do predetermined change control plans? Come into this and memo to file so.

Yeah.

So I understand that you can do a memo to file for minor changes, and that they've done like 60 pccps to date. The FDA has cleared like 60 of them, or something like that. And so, you know, these are new mechanisms that are in place primarily for software as a medical device I don't know. That's an.

New thing, and the FDA doesn't necessarily know what they know what they're doing with them now, in my opinion that that so with the 21st Century Cures Act. All of a sudden software became part of the definition. Right? So now the FDA, as now, it's a regulation. FDA now puts guidances in place that you now need to follow, because that's faster than putting it in as a regulation which is a law. So now the FDA developed this new digital group that now is trying to put everything into practice which Lord knows what's going on with the FDA now. But they let out that whole digital group go now. They hired them all back.

So now they're all back trying to get everything back in place. Right? So we now have a digital group, and they're trying to get all these regulations. Then we put this whole new AI regulation back in place, or you know, they put a new thing in legislation which there's a piece of it that has to do with the digital health and the and part of medical devices. So we have all of that. Where now the FDA is still trying to figure out what's going on with that software as a medical device. And and it's moving faster than what we can even put into regulation. So they're all still trying to figure it out.

They want you to develop software I don't know have. When's the last time you guys have done an e-star for software as a medical device, I just submitted one a couple weeks ago. There is a lot of stuff you have to put in your e-star. When's the when's the last time you guys have submitted one Michelle or Nelly.

Too bad Jose isn't on the line.

I know I talk is gonna be phenomenal because there's so much stuff you have to do for cyber security you have to put in, how are you gonna update.

Cyber security, and all.

The link I just shared. It's 8 years old. But for those of you who know Joseph Gulfo. He did a great talk at 10 x. Thank you.

You have to do so much, trace.

Fantastic.

Yeah. they have this new thing you have to do called penetration testing, which is a pain in the buttocks. And so I'm regulatory. I'm I tend to have verbal vomit. So engineers don't necessarily understand what I'm saying when I talk, because, you know, they're all bullet points, and that's where Jose is fabulous because he could do the engineering speak so there's a difference. There's a whole whole bunch of paperwork, though, and if you go through the Eastar. You have to add in all these documents that don't aren't just the spom. The spom is the software bill of materials. But there's all kinds of other documents that have to go in there, including penetration testing. When I was at Sterling before that whole debacle

talk about that later. But the there are very few people that are certified in penetration testing which goes through your software and make sure that nobody can penetrate, penetrate. Hence penetration testing your software break into it and break in, you know. Make sure that it's basically bulletproof. That's not to say that next week one of these kiddos, because they actually hire these 12 year old little whippersnappers who can break into your software, and. you know, break into it. And you know, figure out how to break it all down, and that's what happened to when I don't know how long ago it was. But Cheney's

pacemaker. They broke into it and shut it down, and that's how this whole thing started with. He had a not medtronic, but bots and scientific pacemaker, and they were able to turn it off, somebody broke into it. Turn it off. So that's when all this started with this pacemaker to break it off.

We did the penetration testing with our cycler. So it's an apt cycle. So it's not only just about the software, it's about the hardware as well. So even if you're like, let's say, software is bulletproof, someone can still, like attach some pins to the board and read data from the RAM and like Tamper with it. So we had to go down to that physical table as well.

And they want to know what kind of testing you're doing upfront in your in your e-star testing. And so you know, you have to tell them. This is how we're doing it. And this is what we do. So they want to know for the lifetime of your product. This is what we're planning on doing. And that's where your Ppcp is coming in and what you're planning on doing for your product in 3 months. And so when you have a product that you're submitting with your light. For as software, as software, as a medical device or software in a medical device, this is what we're doing. This is how we plan on doing it. So if you submitted one to the FDA, you now have this software as a medical device, when you make a change to your software as a medical device, you have to go through this whole

checklist. And then, if you have software in your medical device. Now there's this other set of 5 questions which I'm sure they're going to change this guidance. But you also have to do this memo to file and put it in your design history file. As to this is what we also have looked through. And have we made any changes to this which include cyber security penetration, testing lifecycle management and go through the 63. You know the Iec lifecycle management, risk management and risk is the new 4 letter word with the FDA. You have to go through all of this, which includes Arlen, your favorite word, favorite thing to do with respect to all of this usability testing.

Hence usability testing. Can we break it.

So tell us for a moment. So we have a lot of regulatory people on the call, you know the world is shifting very, very quickly, thanks to AI. Thanks to all these things, you know, and as a seasoned, regulatory, professional, and seasoned dealing with the FDA, how do we prepare for these changes around software as a medical device software and a medical device, cybersecurity. All of all of these things that are going to make a regulatory affairs person essential to the company are going to. You know. I talk about the universities training people for the job market of 5 years ago. You know.

the idea of bringing manufacturing jobs back to the Us. You know. preparing for the past. We need to be preparing for the future. We look to countries like China that are preparing their workforce for the future. So how do we prepare regulatory professionals for the future? And I'd like to, you know. Open this up to anyone and everyone on the call. But, Carrie, you go first.st

Well, come. listen to Jose. I think he's gonna offer a lot of insight on training for software as a medical device. I mean, you have to. You have to stay current with professionals who actually are doing it currently every day you have to stay current with the FDA's current guidance is, they don't know necessarily what they're doing. I find it frustrating, Michelle. I think you probably can too like with the FDA. I just submitted a submission. I don't know how many submissions I've submitted with the FDA, where I mean they're I have a submission you have to use like I said. You know the current documents. You're introducing a a device that's been using every other part of the body. I'm using it with a new indication, with a new

part of the body. And this this division is like, well, we've we don't have an indication for use in this part of the body. Therefore we're it. We're going to give you an Nse. And I'm like it's used in every other part of the body of the body. That's why we're introducing it to this part of the body. It's safe, and they're like, well, you know, it's not in the body. Therefore we're not going to do it now. In the old days I was able to clear it. No problem now they're saying, well, now, we're not gonna do it. So now now I have to negotiate with them, and that's why they are. They'll right away. Now give you an Nse, and I'm like, no. So now I have to negotiate with them and say, it's.

I know I don't know, you know. It's.

Easy. So we do the step, or we do the breakthrough designation.

Exactly.

So we have to not not.

Accept it.

And Nsc, you know.

Have them, give us a step.

So.

How do we educate? I mean this issue of how do we educate Reg affairs? People is one thing. How do you educate surgeons. To do this, I mean, given the complexity of all of this and the ever changing nature of it.

Oh, there's Jose!

Surgeon, entrepreneurs, and anybody else that's trying to get an idea to a patient. How do you get them to sort of reg affairs for dummies, or what? What's the way to do that.

I mean, they have to be open. It's really hard to teach. It's really hard to teach old dogs new tricks just same way. It's really hard to teach software engineers to document everything. They have to be open to it. Which again. you know, it's it's sometimes it's just people you have to be able to talk to people, they have to be open to it. I don't know any other way to. It's just teaching. So you have to have people skills all in all. I don't know if anybody else has any other ways to say that. You know surgeons are surgeons. It's it's the difference between Arlen. You know this teaching neurosurgeons versus orthopedic surgeons. They're

different groups of people. So.

My view is this, we have to do this. Well, we are trying to do this in medical school and actually in pre-med. This starts way before you get out there. and it it means culling down the people who have the right mindset to your point. If you don't want to do this, don't do it. Don't waste our time. But if if you're genuinely interested in going down this road and upskilling your competencies, then that's how I think we should do it, and we're trying it, and I would rather spend time on 3 people. Then throw out a safety of a net and say, well, we want anybody to show up, because they're not going to follow through.

Are they.

To read the room, you know.

Arlen. I agree. As because I mean coming from I myself, I'm a dentist, and having no real training of dental school or anything like that, but regulatory is completely foreign. I will say that it's 1 for sure. If somebody wants to learn something, there are plenty of tools in order for you to figure it out, especially with AI and Chat Gpt, you could literally from scratch. Just go and say, Hey. what's going on here? And then they can. You just kind of go through loopholes. So I think, if, like, you said, if there's 3 people and just hone in on them. and then give them the tools in order for them to not so much put everything in their brain, but give them the tools so that they know how to put whatever they want in their brain into their brain. And I think that's

that's the more efficient way of just teaching them how to actually gather the data, then, rather than give them the data.

The other thing I found is, I have a client who hired software engineers who've never done medical device. And so they design the software device and an engineer tried to teach them how they had to be. to how they had to comply with these requirements for medical device. And we we went through like 3 or 4 different people. And the other thing is is finding someone that speaks the same language as that specific person who's already been trained. That has the power persuasion because I can say it to them, or an engineer or project manager. And they're like, Look, I know what I'm doing. I've been doing this for 20 years.

even though I'm getting into medical devices 1st product. You don't know what I don't what I know. And so. But then you get another engineer who's who? All of a sudden that person saying the same thing you're saying, and they're coming back to you. We have to do this now. but I mean it's finding that right partner.

Just just wanted to say something, because this is what I see in the industry all the time. I I think there are basically 3 parties that you have to keep in mind. One is the FDA, and how the FDA interprets the regulation, and Fd is not always right. Most of the time they are. The second is like you, said the engineer, who is the person who probably doesn't understand the regulation. They understand the technical part of developing the software. And then the 3rd person is, let's call it the quality or compliance person within the organization who really understands exactly what the FDA. Expectation is. Sometimes

you have a perfect scenario, perfect storm where you've got somebody from the Fd. Who doesn't know some an engineer who doesn't know, and then somebody from quality and compliance who doesn't know either. And that brings in a lot of complication. And it's part of the problem the industry has sometimes because we overregulate ourselves, because when we don't know, we take a very conservative approach. So I think that the balance is really are the right people with the right level of knowledge, skills and experience doing the job they're supposed to do. And if that's the case, it should be fine. But when that's not the case, there's trouble.

What I found, especially when I was at a mergo is. There's a lot of companies that way, overcomplicate things. They just. There's design procedures that are 500 pages long, and the FDA will come in, and most of those 483 s. Are on companies are not following their procedures, and they'll go to page 57 of your design procedure and say you are not doing number on page 53, line item C, and they'll they'll go to your procedure. And and you know on when you were doing design phase a, or you know, design phase You did not follow design. You know your procedure. and they'll dock you on it. you know. Keep it simple. Keep it to the regulations, and you know, just don't paint yourself in a corner. You know I've I've I was. There was one time this poor lady, this FDA inspector and FDA inspectors are people, too. Everybody's a person, you know. Everybody goes to the bathroom the same way. Everybody eats the same way. You know. People have bad days. This woman called me, or this

manager called me the FDA inspector had this woman in the corner. He was yelling at her. This guy had cut, and it was a Union job, and he had her in the corner was yelling at her, and she basically had a breakdown. She was at Abbott at that point, and I was like Dude. Get go away. You need to go home for the day. Leave her alone, and I mean it was awful. But he ended up having to go back to death duty for that. Whatever. I flew down to Florida and helped him out, you know, helped them out of a whatever those 2 just were, you know piss and vinegar. I don't know what's going on between that FDA inspector and her, but it was, you know, they were not doing well together, obviously in a room, and he needed not to be an FDA inspector anymore. But you know, there's it's

it's just like interviewers, you know. I remember when I was going into dental school. I had the, you know you had the one who's like, what books do you read? The nicest guy in the world, and the other one's like, you know, drills you in the corner. You just it's you just have to. And it like, would you know, we have everything, you know my procedures will read. There's the bullet points for the engineers, there's the novel for the and then there's the flow charts for the visual people. So you just kind of have to. All my presentations will have a bullet point. They'll have the visual, and then there's the, you know. Then there's always the links for the people who need to see it all for themselves in black and white. So it's just

keep it to the facts. Keep it very to the point. It's the same thing when you're answering your 483 s. Response to the FDA, or when you're whenever you're putting it in there. Just keep it very black and white. It's not personal, and it's the same way when you're answering your response to the FDA, you just need to keep it very black and white. They don't need anything personal. It's just keep it clear detailed, organized, you know. It's never a person's fault.

Playfully. Let me interject here and say, I'm having a hard time training Rama to just take herself off mute, put on her camera and ask for questions. She keeps writing these long things in the.

Oh, and I don't even have my chat.

The chat so.

Hi! Sorry.

RAM options.

Encourage you to come on camera.

Like making a flow charts. That's exactly what I did, and while working with engineers. But the other thing that I found helpful was just to like explaining them the importance of why we are doing what we are doing like how it will like create value for them down the line, let's say, like, after a year or 2 a new engineer comes in and he tries to like change a feature. and then he'll like once he's about to do that, he will be able to see the history like by that. Let's say that feature is there like. Where? Which requirement did it come from, or like? What hazard is it mitigating? So that was like very helpful in getting the systems implemented.

Now I hear Rama is currently helping a client land a Presa meeting to declassify their medical device and general wellness product while maintain focus, revised, intended use and labeling. What's your experience in negotiating products to transition? Again, it's all about the claims. There is a general wellness product, guidance. You can use that It's you have to word it creatively. You look at the guidance. There's examples at the end. I don't know what the intended uses. I've helped a client, and I don't want to say it, because whenever I say the name on it, I get every single add on every single feature on my

everything, and every one of you will get it as well on every single one of your phones and Instagram and Facebook. So I'm not gonna say the name of the client. But You have to word it, and look how the wording is, and be very creative about the wording and the and the whether it's a wellness product or whether it's a read the intended use. And if it's a physical claim of, you know, to diagnose or help the or cure or mitigate. Yeah, right? Right?

Learn the definition and stay there.

And look at similar devices, and look at the intended uses of similar devices, and stay away from those similar devices intended uses. I can read warning letters. Oh, Touche, yeah.

Because.

Or.

Rama, did you have anything you wanted to add now that you're on camera? Thank you.

Thank you. Yeah. I'm always more of a listener than a speaker. But thank you so much, Carrie, for the clarification. Yeah, the intended uses, and the claims are certainly the focus in line with the general wellness, guidance. But I just thought it might be interesting, you know, in a preset meeting with the FDA. What kind of things could be expected in terms of like a positive result like, for example, would a simple letter confirming that the FDA is in alignment with the proposed, you know, agenda to transition this product into no longer a regulated medical device in terms of like with negotiating with the FDA.

The results of this kind of meeting? What can one expect? Is it simply okay to have the confirmation from FDA? And then that's it.

So for Qceps, the FDA will never confirm or deny. They will just give you quote unquote recommendations, and tell you, if you want the actual recommendation, you know. Confirmation. Submit a 5 13 g. They will always ask, you know, at no more than 5 questions. They will never give you. More than that, I would ask the detail in writing, if you want the actual. But again, it's non determination, you know, it's it's just their recommendations. And Co. With very concrete questions and what you are asking them if you are going with the face to face. Not I mean, they haven't been really doing face to face. But if you are going with a teleconference, let them do most of the talking.

and I would also ask for written feedback as well, because that's where you're going to get most of your really good feedback. But let them do the talking.

Because that's where you're gonna get all of it and don't argue with them. It's more of a collaborative.

Relationship. And if you want specialists in the room, ask for the specialists in the room from the General Wellness group that you're whatever group you're going for for your intended use. But ask for what you want your claims to be, and ask for the exact feedback you want to get from them general questions, because they're not going to give you the feedback.

In the interest of time. I'd like to get to David.

Go ahead!

And I'm gonna ask you a pointed question.

I want to go back to Arlen. But 1st I want to say there is so much wisdom being put on the table for everyone who perhaps has never heard it. So many gems are coming out, Joey. I guess I'd like to see the Transcript come, but I don't think you do that, but it's just wonderful.

That was a trick.

But this.

It was wonderful writing. Follow up articles every.

Oh!

Bye, thank you. If I win. you could make a whole Mdg. Out of any one of the things that Carrie said today.

I know.

Oh, today, this morning.

Yeah. And and I wanted to go back to Arlen. When he he asked the question about How do we train these people, or whatever. I think you have to remember. Mds, you were mentioning an Md. If they're really good, is an inventor, they're inventive. They they push a needle into something or a wire, or, you know, put a heart valve in, and they say I could do it better if I twist and turn and bend this device a little, I'll get the better angle.

House.

You know, and they may have taken the device. Obviously off label use, or they're doing the way they want to do it. And they're invented. So that's just simple devices, hey? What about when we get to the AI devices? It's the wild Wild West, I think.

In Colorado.

Everywhere.

I I would just observe that there's a difference between an invention and an innovation. and there's certainly a difference between an invention and something that has commercializable potential in my world. I'd say about 1% of the people that I deal with. White coats have an entrepreneurial mindset. We don't teach it in school. We don't teach it in residency. We don't teach it in practice. We don't teach it. Period where some of us are trying to change that, including the people on this call. But the fact of the matter is, they don't have an entrepreneurial mindset. That's a big hurdle, and I don't. I agree with you. I mean every I'm an ent surgeon.

We're gadgeteers. We all come up with gadgets and off the you know we do that. And I've had that experience of never getting that product over the goal line, which is part of the reason I'm doing what I'm doing. But I'm trying, we are we? This group is trying to change that. And and it's a long haul. But we need, you know, it takes a village kind of thing.

Yep. Yeah. I agree.

Thanks.

Hi! Hi! Carrie! Hi! Ed! My question draws out a little bit from from this, because I think all the stuff you've been saying is great, but it also feels like it's a little bit. You know how the the system has been working, and you know my big concern, particularly as a medical device company outside of the Us. Just in the past week. We've now had another layer of complexity. The 1st complexity from the beginning of this new administration is hhs, you know, Leader and Doge. And now we have tariffs on top of that. My question is. what is the prospect from where we sit today for a company outside of the Us. Wanting to bring a device into the Us. Market right now. And what on earth is your best view of what the FDA is going to be able to handle?

Or should we just keep our hands off and go to other markets? For now.

I believe. Well. I'm gonna I'm an optimist. So I'm thinking, from the way it looks since they hired back all the Cdrh group and it looks like most of the damage appears to be. I don't know if most of you can agree with this on the Cber side, that the device side looks like we're might be in good. We might be good. I don't know

But I heard that, like some senior people at FDA, have all left or been forced out.

This is true. most of the senior people. With respect to the division sides on the ode, the device of the office of device, evaluation are all still there. So I have a lot that are in the queue right now for device evaluation. And that's a good thing. So that's I'm optimistic about that. They don't. They don't evaluate my device evaluation. And I'm I'm okay with some of the people that have left with respect to the device with the inspection side. I don't know.

Michelle, or yesterday I attended a webinar from Rqm plus on this very subject, with 2 speakers and They were talking about the the impact and the uncertainty with regard to all this I can. But I was I was thinking about asking that speaker to come on here. Would that be of interest.

I would be really interested.

Good thing.

And again, it's not just for me. They're actually a company I'm working with is looking at bringing their device to, you know, again with, is it? I don't know this week. Today I think this minute it's a 10% tariff, but it might be 20%, Lord knows, and all that.

So the terrorists for bringing them into the Us.

I don't think anybody can say with any.

I don't know about that side.

But the you know I my my sense is that you know I think a company should should move forward with the regulatory approval. I think that the approval process is gonna remain more or less the same, although timelines may, there is some speculation that the timelines might be.

I. We just asked my reviewer, and she said, We're on time for getting your response back. Wow! My response is is due. On April 14, th she said. We're on time for getting a response. But by April 14, th for this step, so.

Here's my recommendation. I mean what we are experiencing now. It's a little bit of change, but but I think that.

Little pissed. Sorry.

But but what I wanted to say is that the FDA, in my opinion. the innovation that we have experienced in the pharmaceutical and medical device industry has probably surpassed a little bit the skills and capabilities that they have been able to be exposed to. So I always say that if they may be 5 to 7 years behind where the industry is. So so I think that that really what's important here is for us in the industry is to really be as smart as we can be in terms of making sure that whatever submissions we make now, especially now that we follow that pattern that you were talking about. Be precise, be keeps things simple, straightforward.

maintain things well documented. Be ready to present things 1st time. Right? So that when when you are speaking with them. you're doing that in a way that they don't have to come back, that they can get it, because a lot of the problems that I see with our industries is that level of complexity that we try to bring, that we think that the more is better when in reality better is more and better meaning. Be precise, be simple, and that's all we have to do, especially at this moment of transition. Where there's a major generational gap between the people who are reviewing submissions today and the people who used to re review them years ago.

and and that learning curve for these new reviewers. It's it's gonna be painful. So we're gonna have to help them.

We have to train them. They're very green.

Yes, absolutely.

Well, one of the things I do at Bushman, Qc. Is, I actually designed my checklist to align with my procedure that aligns my standard. So even if you heaven forbid I wouldn't want you to do this. But even if you didn't read my procedure, if you picked up my form, you're 90% there, you're going to be successful. And the other thing is is writing at. I write my procedures all the 7th grade level and matter of fact, I actually it shocked me. I had an Fd inspection going on, and she picked up one and she goes, wow! This is the most detailed best procedure I've read in a while, and it was actually using Eastar, not Eastart. It was using the Esg system, and she's like, I've never seen one anybody write one? And I thought, Wow, I'm going to take that one and put it in my pocket because I don't think I've ever had an FDA to say that to anybody.

The last FDA lady. She didn't even know what the Esg system was, so that one was amazing to me that she didn't even know what that was, or her registration and listing system is. So they aren't even training within their own system. So that was a little disheartening. But then, again. That's where we get to train the FDA, because they're all green right now.

I think my inspector had had done 10 inspections, and what I find and this is the last 2 inspectors I've dealt with is they have. They have less than a handful of inspections, and they inspect you. Then they take everything back, and then an entire department. Oh, yeah, well, maybe that's.

Maybe that's what Dodge just got rid of, so I don't.

And here's the point. If you don't do it. The way you guys are talking about you're gonna get a very negative reaction. You're gonna get 4, 83. You're gonna get warning letters on stuff that is nonsensical. That makes no technical sense, but because they didn't understand that they're gonna cite you.

They don't think.

They they cause they didn't get it. And now they're upset, and you know what I say. It's my fault. It's our fault that we didn't do the job to really make it clear, simple, and straightforward to them.

But that's because the staff didn't understand it. So it's our job to train the industry.

Yep.

Hey, son, let me let me have you hold off on your comment because we're at the top of the hour, Carrie. A number of people have said in a number of different ways, David, perhaps most eloquently about the value of this call, and how many things and Michelle's like each of these could be a talk unto itself. Having said that There was so much that I would love it if you could take 5 min to field no questions other than this one, and that is. if somebody tunes in for just 5 min. If we make a synopsis of this call, and we make a video? What are the main things you would like someone to take away from this talk.

Though I guess general tips for the industry when it comes to navigating regulatory processes like FDA negotiations, is, understand the regulatory landscape. stay current with relevant regulations, standards and guidance documents such as right now, Iso 14, 9, 71 for risk management and the FDA's quality system requirements for 21 Cfr 8, 20, and Iso 13, 4, 85, monitor updates and policies and technological advancements that could impact compliance requirements. 2, plan early and strategically. when you're developing your regulatory strategy early in the product development and process, do it right the 1st time. This includes identifying any potential risks, regulatory pathways and submission timelines

know what markets you're going to go to upfront, so you can plan all of the standards and guidances you need to comply with upfront engage with regulatory bodies early, like pre-submission meetings to gain feedback and clarity on expectations, plan it into for your device. Design again, emphasize risk management, adopt a robust risk management framework, incorporate risk management include the identification of critical tasks, use tools like fmeas to ensure thorough assessment and risk management strategies. Document everything. Again, you've heard it a million times since it's not documented. It never happened. I would maintain clear, detailed, organized

documentation. This includes all test data, clinical evaluations, risk analysis. Usability studies. traceability is key for regulatory success. Document, document, collaborate cross functionally. This includes regulatory quality, assurance. R&D regulatory affairs, all departments. They all. Everybody needs to be aligned cross functionally on objectives to ensure collaborative cohesive approach. Don't forget about regulatory engage with experts, work with regulatory consultants, legal experts. Whenever you need to navigate across complex requirements or develop submission strategies. R&D, don't work in your silos.

Collaborate always test for usability and safety. Don't forget about your usability requirements, conduct, thorough usability, standards and safety tests to identify potential hazards up front and ensure you've dealt with them to ensure compliance and human factors, engineering guidelines. FDA is looking at these upfront. So a lot of times those are a lot of polls that the FDA comes back with now and says, Where's your usability? Studies? Cb, it's another one. Be transparent and responsive, respond to all regulatory questions and deficiencies. Promptly and transparently, and be thorough. Build, trust, and open communication with the FDA and attention to detail.

A lot of times when you do this, you can go through your submissions with without getting a letter. And you can just work with the FDA and hopefully get your approval. Letters click quickly. Leverage data and technology. I like to use real world evidence a lot of times in my submissions so you can get you don't have to do all the clinical studies that they want use data, analytics, digital tools to track compliance. A lot of times in my software as the medical device, I'll use data, truth data. I'll use past data and everything like that. So I don't have to do more clinical studies to enhance decision making through life cycle, product lifecycle. And then

talk for 5 min. I didn't think you would do it without a breath. And then just one more foster quality culture embed a strong culture of quality and compliance throughout your organization.

So sean.

Sure everybody understands maintaining regulatory. There you go.

We need to. We need to replay this at 50% speed.

Was it fast? Did I talk fast.

Also Karen.

Is that doing New York.

You must have. You must have read that. So you have a sheet, or a poster, or something. Please send that so we can publish it.

Cause. I don't know about you people, but.

I heard a lot of words that I could not do, but I wouldn't be able to repeat what you just said. It's just too much.

If not, that's where Shawn's transcription is gonna come into play.

Yes, absolutely true. And for those of you who might be on the fence about coming. Can you imagine just having lunch with Carrie, and talking about what you're working on, because that's.

I just had surgery last week, and my doctor's like we had to give you versed to shut you up. It was pretty funny.

We have meds that will be serving there. Typically, it takes ice cream, but we could spike yours.

That'd be good.

Joe, Joe, let let me say one brief thing about this call and many others because you had a couple of folks here who who aren't regular attendees. And the way I characterize this weekly event is, it's a little bit like going to church. There could be a really good sermon, but you don't know if you don't go. All the time I use this. I tried to get my.

Friend Billy to come. If he would have come, you guys would have had really holy water. He's funny.

Use this philosophy as well when.

Count, to count.

About rationalizing, buying lottery tickets. But that's a different thing.

Harry, can Billy come and join you.

I'm trying to get him. He went to London this week to play with friends. I'm like London, and having pipes of Guinness versus coming to this whatever. But I'm trying to get him to come. He lives in Las Vegas. Billy. Sudden, he wrote. 21 Cfr. 8 30. I'm like, boy that's riveting.

That's a familiar.

But he's actually quite lovely. So.

He's on the tentative list, according to Shawn, so.

Yeah. Yeah. So he lives in Las Vegas. I mean, all we have to do is scoot him over right? That's not that far.

What we need to do is scoot them. We have a number of people in in Orange County that we're also trying to get to scoot about 10 miles away, but sometimes.

Yeah, right.

Get them that last couple of miles. Sean. Take us, take us home and maybe an update on on maybe something that we don't have on the website yet about our in person meeting.

So we keep adding, adding more sessions, adding more workshops. It's this is gonna be an amazing event. Also, I've started doing. Write ups of these calls? In case you didn't see the one from last week. Take a look at that. It's on medtech leading voice. And com. And so that just takes you right to linkedin When I publish these, I would love it if you guys would like comment reshare reshare with comments is better than just repost. So repost with comments. you know, and help us help us spread the word. I think these calls are really valuable. And when there's this kind of collaboration and a lot of smart people get together, that's when good things happen. So with that in mind. I look forward to seeing as many of you as possible at 10 x. And thank you, Joe, as always.

a big, charming host.

Fantastic, call.

Keep that.

Thanks, everybody. I'll see as many of you in person as possible. Chad.

The ice cream.

For ice cream. And I've already got the fun movies picked out. So some really good ones. I even test tested them on my Jennifer, so I'm feeling pretty solid on these.

Good. Thank you.

Everyone bye, for now bye.

Everybody. Bye-bye.

Thanks, Carrie.

Thanks. Bye, guys.

I.