#404: MedTech 101: What You Need to Know About the Medical Device Industry

Chris Rush: 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: Is your design history file. Scattered across the company, Greenlight Guru's product development workspace threads requirements, tests and clinical outcomes into an unbreakable chain. Inspectors and auditors nod and move on. Experience that kind of calm@www.greenlight.guru.

hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode, and with me today is Sarah Adams, medical device Guru here at Greenlight Guru.

How are you doing, Sarah?

Sara Adams: Doing well today.

Etienne Nichols: And Chris Rush, who is a solutions engineer also from Greenlight Guru. How are you, Chris?

Chris Rush: Hey, Etienne. I'm doing well. How are you?

Etienne Nichols: Good. This is an episode that's. Yeah, I said this last week, different than every other episode, but I, I, this one really is. I feel like going to be unique because I want to talk about the medical device industry in general.

I have gotten a lot of people in my network, an influx of professionals into the medical device industry who don't know anything about the industry. And so I brought you two together because I know you've been in the industry for a long time.

And I want to make sure that we cover all the nuances, or at least as many as we can about the industry and just make this kind of like a primer, if that's the right word, just a 101 course on the medical device industry.

So I'll open up to see what thoughts you have first, and then we can kind of jump in.

And we're going to have to be aggressive because we do have three people. So this is going to be rough.

Sara Adams: But we got lots to cover, too. I mean, I'll jump in. I get questions all the time. I like, like what, how, what is this? It is a little confusing, right?

Etienne Nichols: Yeah. Well, maybe, maybe the way to start is to talk about what is a medical device.

Sara Adams: A toothbrush, lots of things.

Chris Rush: Tongue depressor to a pacemaker.

Etienne Nichols: Yeah.

And what's interesting, when I think about what is a medical device, my brain automatically goes to talk to through what the FDA would call it. You know, it's an instrument, an apparatus, an implement, a machine.

All these different things that's used to diagnose, prevent or, or mitigate the disease or physical disease. But what it comes down to is the labeling, ultimately. And would you guys agree?

How, how would you. Because a tongue depressor is a piece of wood until it's used to diagnose something using, you know, pushing the tongue down and so on. So what we say about it really makes a difference about a product in general.

Sara Adams: I agree with that.

Chris Rush: Go ahead, Sarah.

Sara Adams: No, Chris, you jump in.

Chris Rush: I, I agree with that as well. Yeah, I think the intended use, you know, what it's, what it's really being used for is, is really what makes it a medical device.

Even on the software side, something that's, you know, passively tracking things just kind of for informational purposes versus it's just informing a health decision. And you see kind of software companies starting with informative and then they transition to we want to inform, you know, medical decisions and all of a sudden you've got something that requires a lot more than the more passive approach.

Sara Adams: Yeah, I just, I'll just add I've, and this is like a real big rabbit hole that we don't have to go far down. But I have met, there are companies that I've met where it's like, I, it doesn't really matter what you're claiming on the label, it's still a medical device.

Right. Like, there's just sometimes where there, there are companies that don't see themselves as medical devices when in fact they, they, they are. So I don't know, it's a slippery slope from that perspective.

I agree with you. From it depends, you know, what you're really comes onto a label and what you're in in a lot of these cases.

Etienne Nichols: Well, that's a good point. And you know, maybe let's talk about that just briefly because I, I think if, if you just purely interpret what I said about the label claims from a medical device professional, what we automatically think is, okay, what's your indications for use statement or what are your,

in your intended use and then your indications for you statement underneath that. And as a medical device professional, that's where my brain goes. But at the same time, if you back up the fda, I mean, I'm just using the fda,

we can kind of infer what's what the, the EU might think or Brazil and Visa Health Canada. But, but think about the fda. They care about not just what you say in your indications for use, but what any kind of claims you make on your website.

Sara Adams: Marketing.

Etienne Nichols: Yeah, yeah, the marketing side.

And so maybe that's, you know, I've really struggled with how to, how to tackle this to really be comprehensive, but maybe the roles themselves might be worth talking about within a medical device company.

And it's one of the reasons I wanted you, Sarah, to represent quality and maybe you can partially represent regulatory and we can talk about the differences. And then. And then Chris, from the clinical side and wouldn't want to jump in or volunteer to start.

We're each going to have to represent two. I'll be product development and marketing, having never worked in marketing but worked very closely with marketing. So. Yeah.

Chris, what about you want to start?

Chris Rush: Sure, why not? Yeah. From the clinical side, you know, typically clinical is focused on gathering data on devices. And of course there's always hopefully a scientific purpose to gathering data on devices.

But to your point, you know, what can go on a website, what can go in a picture in front of your device or with your device, sometimes there is some input from marketing as to, you know, how they kind of wish to market it and can there be clinical data to support those types of marketing claims?

So it definitely comes into the picture on the clinical side, even for what, what you'd think of as being pretty standard scientific investigation. There is some kind of future facing marketing in the back of, of their minds.

Oftentimes I'd say, yeah, what about quality?

Sara Adams: Yeah, I, I think quality's main focus is to. I don't know, I. Let me back up. So quality and regulatory bleed over a lot of times. So while you've got them separated as different Personas, I would say a lot of times they may be managed by the same people or the same department,

depending on how big it is. You know what we're talking about. Quality is really charged and directed with implementing processes and procedures and following processes and procedures to keep us compliant to what the regulation says.

So quality may hold, you know, depending on where we are, are in the, in the life cycle. Like if we are at just developing, quality is going to be there to write the procedures and to help our suppliers be approved and make sure that we've got the right checks and balances in place for what is required.

Etienne Nichols: When I think about quality versus regulatory, one of the examples I like to use, or analogies, I guess, is like defense versus offense. And I'm going to say this, that's a good example.

What you think, like, I like it. Quality's defense, you know, they're getting. If the FDA comes in, they're going to defend everything we've done to this point. But regulatory, their job is to take the ball and run with it to this agency, that agency and get it across the finish line.

Sara Adams: Yeah, I didn't really talk about regulatory. If we talk about regulatory, I See them as like hey we need to get.

Is approval like the right word here? I need to take the ball. See I can't get the football out of my mind now. I need to take the ball to the right people so that they can give me the approval clearance.

I wish I had a different word here than the FDA speak but so they can give me the okay to, to start marketing this device, to start selling this device to individuals.

How they hold some additional aspects in a like cyclical life cycle of the, of the product itself but more focused on getting, getting the ball across the line so we can start defending what we've put in place.

Right?

Etienne Nichols: Yeah. And I'll just kind of try to round out some of these, these different people that we're talking about. So I separate kind of like you said, quality, regulatory. They may be managed by the same people.

They oftentimes have different roles, different hats they put on. Sometimes in some companies the same person,

I do that similarly with, with regulatory or not regulatory with R and D and product development and oftentimes they're under the same umbrella depending on the size of the company.

I've worked for Fortune 500 companies, I've worked for startup, you know and they, it, it just depends on your resource ability. But an R and D, you almost look at those guys as man, they're just, that's what every engineer wants to be.

They're the jocks because they just you know, wild west they go. They're wrong, they couldn't care less. You know they just do their thing. They've got an engineering notebook but other than that, you know, nothing's on paper.

And then once they get to a point, a viable product or prototype, they hand it off to product development and it's their job to implement design controls, risk management and you know, design transfer, et cetera.

And we can talk about what all that is in a minute but it's really fine tuning that medical device to where now you have done all of your tolerance stack ups.

You have a legitimized product essentially and but, but yeah feel free to throw any color commentary if you have any or disagree even you know what are yalls thoughts?

Chris Rush: Yeah and just in terms of some. Sometimes it's the same person wearing different hats. We talk to teams all the time that are, maybe they're a quality person and they've done quality compliance for career and they're at a smaller company and they need to start doing some clinical activities and a lot of times they're learning the same thing.

They're they're learning kind of a new, a new muscle to start flexing. And to your point, Etienne, I worked for a large, privately held device company and they had a dedicated clinical team.

They actually had an internal CRO, which is a clinical research organization.

And oftentimes the CROs are external. You know, they're essentially contracts contracted by the manufacturer to do their clinical trials. But a lot of teams are kind of finding themselves in the gray space of doing some of those clinical activities themselves,

contracting some of it out to CROs. And then you have large companies where they have their own entire internal CRO that does all of it internally. So they have an entire clinical team.

Etienne Nichols: This is going to scare some people out there, but I've actually written studies for animal studies, not, not human studies, but as a project manager for product development, I wrote some of our animal studies.

So it's, it, it, it does, it's just across the board, you know, what you need to do for these different things and just to, to throw a few more Personas out there.

Marketing was one that I thought of and then the other one might be project management just because they cover a lot of different grounds. I guess that was my final role before I came to greenlight guru.

But the marketing position is an interesting one for med medical device companies because of their interfacing with doctors and interfacing with, with all of those things. And they have to understand from a regulatory aspect, if there's, you've got the upstream marketing and the downstream marketing, the upstream being, we're going to figure out what problem to solve.

Take that back to the engineers with our specific marketing claims we want to have. But then there's the downstream marketing where they say, okay, now we're going to go out and market this and we have to make sure that our sales guys aren't doing any kind of kickbacks or anything like that so that they don't go to jail.

We have to make sure that we're not claiming things inappropriately so that the FDA doesn't come to a, you know,

lots of different things that could happen. So it's an interesting aspect. A lot of times I might run into people who say, well, marketing's marketing. Well, yes, but actually there's a certain amount of regulatory experience that's required in the medical device industry as well.

Sara Adams: So I don't think anybody will say marketing is marketing when the FDA shows up and they ask to see all the printed material. Yes, that has happened before. Right. Like they,

they get to review it with a fine tooth Comb.

Etienne Nichols: Yeah. And we won't mention making sure your company. Well,

I am fascinated by the level of scrutiny that's required. Like if one of your company employees thumbs up an off label use, like a doctor says, I just used this and it was great.

And an employee thumbs up that post on any social media that could be you making a false claim.

Sara Adams: This is, this is probably not a Today conversation, but I have been in a few discussions lately about influencers, like on social media. And how do you handle that from a marketing perspective?

I am using a medical device. I'm telling you how wonderful it is. I have nothing to do with the company at all. And I'm making claims. How does that work?

Right. Like, and I don't have a good answer for you, but I've had many a heated discussion lately about, about influencers.

Etienne Nichols: Well, it goes back to the First Amendment which, you know, you can have.

Sara Adams: An opinion on your, on your own.

Etienne Nichols: We don't have to talk about that.

I do have an opinion, but we'll leave that alone. I think the point, the overarching point of everything we've mentioned though already, because everything has this medical device regulatory aspect.

Sara Adams: Yeah.

Etienne Nichols: That's really what you have to think about when you think about the medical device industry is that regular, it is regulated and it is heavily regulated. So maybe we could start there with the regulatory landscape and talk about that.

Thoughts.

Sara Adams: Sounds good to me.

Etienne Nichols: Okay. I keep saying started, but I guess we've started five times. So we're just going to continue and we're going to go a little bit deeper.

Sara Adams: Yeah.

Etienne Nichols: When I think about medical device regulations, there's several regulatory bodies that we can talk about and I already threw a few names out there the FDA makes. I think most people are familiar with the emdr.

Then you start getting to things like Health Canada.

Brazil is an visa, I believe, and Australia is TGA Therapeutic Goods. And then you have Japan and a few others that are kind of the larger players. But every one of these regulatory bodies have different requirements slightly.

Some are very similar.

And if you want to market in those regions, you need to take your device and make sure that they meet all of those government requirements. But what am I leaving out?

What and what's important? Anything come to mind for either of you regarding either of these?

Sara Adams: I think you hit the big wins. I'll just say there's a ton of regulations under, you know, each of those. Like you could not know all of them. Right. Like there's just a bunch of them.

Etienne Nichols: Yeah.

So let's, let's Focus in. I think we can probably get most of what we need from thinking about the fda, which is what I'm most comfortable with. And we can.

If people have questions about other agencies, we can talk about that. But one of the things I think about. Okay, with the fda, you already mentioned you have to know you're a medical device.

And whether you say you are or say you aren't, it really is up to the fda. They're going to determine that. In fact, you can go look at warning letters, which maybe I'm getting ahead of myself, but let's just go step through that.

If the fda, as they purview the landscape out, you know, whether they are cruising Amazon or just googling things, if they find a. What they consider to be a product that is making a medical device claim, they may reach out and say, hey, you're a medical device.

And there's a tier that they could go through. They could be a wellness device. It could be a Class 1 medical device. It could be a Class 2 or a Class 3 medical device.

There's this there. What am I saying? Class. Class two, Class three. Yeah,

there. And those are all based on risk, levels of risk.

Thoughts.

I feel like I'm teaching a class.

Sara Adams: I mean, I like that you're teaching a class. I'll just listen.

Chris Rush: I was giggling here. You know, the FDA could be browsing the Internet, find a class one, two. Hopefully they're never finding a class three device.

Etienne Nichols: Oh my God.

Chris Rush: On the Internet that they have not heard of.

Sara Adams: I don't know. I have some stories, Chris. Anyway, keep going.

Etienne Nichols: Actually, you know, that's worth. So there's a couple things that come to mind. We. Do you actually talk about that finding a Class 3 medical device,

the FDA, the, the food and Drug Administration actually has different arms or branches. The one I focus on is the cdrh, the center for Devices and Radiological Health. And why did they put that rh.

ncy schmancy shoe shop in the: 1950

I want to say it was maybe, maybe a little bit before then you put your foot in here and get an X ray and to look at your bones and then they would sell you your special shoe.

Well, in the meantime, everybody within like a 10 or 15 foot radius was getting, you know, X ray radiation. Right. And, and so that was a problem. The government realized that this is a real problem.

e equivalent is. Back then in: 1950

Maybe they went in to get a shoe upgrade and they realized this is not good.

Sara Adams: Okay, yeah, fun story. They actually have those. I don't think it's radiological health, but they do. You can go into a shoe store now and do that. Like we did it the other day with my daughter and I was like, this is completely why the FDA regulations came about, because of this,

escribed, putting my child in: 2025

But yeah, I'm going to step us back for just a second because I think it's important. I know you were going to talk about the branches of the fda. There are different classifications of devices.

We have been kind of chatting through those and it may go without saying, I don't know who's listening to this class one, you know, things like a toothbrush. I made that joke at the beginning.

That's where my brain goes. When you say, what's a medical device? I think of a toothbrush because I didn't for the longest time know that was a medical device. If you have little kids, medicine droppers, like what we scoop out the Tylenol with, that is technically a medical device.

So class one, class two being more risk. And then class three, when Chris says, like, hopefully you're not perusing the Internet and discover a Class 3 device that, that people didn't know was a Class 3 medical device.

Continuing going up in. In risk. And I'll just add, that's not the same. When we look at different diff. Like I.

My brain is forgetting EU mdr. Those classifications look different, though. Mildly the same, right? When we talk about varying levels.

Etienne Nichols: Yeah, yeah. And I mean there, there's slight differences there, but overall, when you think about the different classes or tiers of a medical device, I think you have to go to risk management.

y're talking about either ISO: 14971

which is don't mean to get too far, but that's driven from the automotive industry, which has been very helpful, and we could talk about the differences at some point, maybe.

Sara Adams: Yeah, okay. For sure.

Etienne Nichols: All right. I need more questions because usually I interview, but you take the questions away and I know.

Sara Adams: Then you just educate. Right. Well, I'll jump in, though, because you were talking about cdrh. So, Etienne, what are some of the other divisions of the fda?

Etienne Nichols: So the two main ones that I think of, because they are tangentially related and could be ones that you eventually interact with if you're a medical device, particularly if you're a combination product.

I'll talk about what that is. Is CBER C B E R, which is the center for Biologic Evaluation.

Sara Adams: I don't know. I just call it CBER all the time.

Etienne Nichols: CBER and cder, Cedar, the Center for Drug Evaluation and Research. So those are two where. If you're a biologic or if you are a drug, those are the branches that you will interface with to try to get your drug or your biologic cleared or approved for use in the United States.

If you are a medical device and you have, let's say, a syringe, a special new syringe, and you want to put a drug in it, depending on the. The mode of action, how it helps the patient, you may.

You may have to submit to cber, you may have to admit to. To a cdrh. And that's based on the pmoa, which is primary mode of action for that combination product.

Any thoughts?

Sara Adams: I got more questions for you.

Etienne Nichols: All right, well, go ahead. Interview, I guess.

Sara Adams: I mean, I'll interview. I'll interview you. That way you don't feel like you're talking the whole time, but. Okay, Chris can. Chris can jump in too, for sure. I get a lot of questions about, like, I get glazed over and actually, I'll specify.

I. It's not just companies that I work with at Greenlight, friends who I went to college with. I did a call a couple weeks ago with a friend who is in academia, and they're like, I don't understand how I get that approval.

Like, what,

what. And so we talked a lot about classifications. And of course, like, my friend couldn't tell me everything that he's doing because it's proprietary on his side. So, like, well, think of us like this.

So that I'm showing him, like, how. Look up what classification you should pursue. I. You. We've touched on that a little bit, but, like, the approval process, how does that work?

I think that's valuable to, to speak into here. How can I get to market?

Etienne Nichols: There's, there's different ways we could start this conversation and I'm going to have to throw the, the mic over to you here in a second Chris to talk about the clinical side of these and the, and the type of evidence you'll need to get your medical device to market.

But I think a good starting place for some companies might be ear and I'm people I'm going to have to duck people throw stuff at they might keystar is what the FDA has.

It's an acronym for the electronic submissions template and resource and it's actually an interactive PDF. And when you think interactive doesn't mean it's fun, it's just comprehensive and you can go in and if you say class two and I do this it populates new sections of the PDF and you keep going through and I for the most part you might be able to get pretty far along without medical device knowledge just going through that PDF to determine

what it is that you need.

But at some point you may get stuck and what I would recommend is actually reaching out to the FTA and putting together,

putting together a list of questions that you want to talk to them about in a pre submission or a Q submission. They call it a Q sub and but it's really just before I'm not ready to submit yet but I still have questions I want to know.

I'm pretty sure I'm a class 2. I want to make sure you agree with me FDA this is how we plan to go through our clinical investigation and I want to make sure you're happy with that and this, these are the claims that we will make whether there are indications for use and so on.

But Chris help fill in some of the gaps. What are you thinking?

Chris Rush: Yeah, clinical stuff usually comes in after a lot of the kind of initial submission materials are compiled and everything like that.

Generally clinical data is going to be required for Class 3 every time.

Class 2 it varies Class 1 typically not Class 2 it can be FDA required to collect clinical data on a device. It also can be a choice by the manufacturer to collect data or marketing purposes differentiation wanting to understand their device and how it compares to other devices.

I think like vascular catheters like that's like a Class 2 device, you don't have to get clinical data on that but if it's a specialty, if it's a special, you know, catheter that's doing something that the company thinks is unique and clinical data can support that Sometimes they'll, they'll capture data for that.

Sara Adams: I, I'm the girl in the room, so I'm jumping in like you're red. Correct me, Chris, but like your red light therapy laser, I clearly want to sell my device to women.

And so I want to make claims about what that can do. That's when I need to make that clinical piece happen.

Chris Rush: Yeah, yeah. So like you have to have data to support a clinical claim, essentially.

Sara Adams: Right.

Chris Rush: If it's, if it's a me too device, if it's, you know, truly very similar, if you can support that your device does the same as something else, you might not need clinical data.

But if you're trying to differentiate it.

Sara Adams: You want to say you're the best in the market. Right.

Chris Rush: If you say you can do better than these, you better be able to support that with clinical data, essentially.

Etienne Nichols: And there's a couple things here that I think are worth mentioning because when I think about what we're talking about, it's easy for me to say, okay, we're talking about market access or market entry versus regulatory submission.

But you have to make sure that you understand what the conversations we're having. So if we just purely are basing everything we're doing or requiring our company to do off of the regulation, you may not get that clinical investigation, but you want to make money at some point.

And I mentioned this last week to Sarah when we were talking about the three legs. And I hate to bring it up again, but I can't help it. The three legs of a medical device company, you have the legal and the regulatory aspect.

And that's what we usually differentiate the medical device industry for, because it's pretty heavy burden. But then you also have the ethical considerations.

It's okay to go above and beyond what the standard says and make your device especially safe. But then the third aspect is that actually making money in the market being economically viable.

And so if maybe you, only maybe you don't need that clinical investigation for just your submission, it may be worth it to get it so that a clinician says, wow, that really is good.

I see your data here is supporting your claims and not just the technological equivalence.

Chris Rush: And an additional thing I should, I want to mention in, in the EU, in the EU, they do require, even for Class 2 devices, you have to collect ongoing data for your device.

And that could be something as simple as a survey, a physician reporting cases. It could be relatively subjective. It's not as high rigor as like a, you know, class three investigation would be.

But in eu, that's pretty commonly required. So it's a little different over there.

Etienne Nichols: Yeah.

Chris Rush: Will that, will that happen in the us Maybe, Probably. I would say so. It's a little different over there as well.

Etienne Nichols: Yeah. It's hard to say how the US is going to change right now and maybe that's not a conversation worth getting into in this conversation. But let's talk about maybe some of the standards that.

The numbers that automatically come to your mind when you think about medical devices. Because I think that's a good place for people to have a little bit of knowledge. What immediately comes to my mind is.

Sara Adams: I don't know if it's the same as mine or not. Let's.

Etienne Nichols: Sarah, why don't you now see if we're all the same. Sarah, why don't you throw yours out?

Sara Adams:: 1345

Etienne Nichols: Okay, great.

Sara Adams: But I'm the quality loser in the room, so.

Etienne Nichols: Not a loser for me. Quality in the room.

Chris Rush: ISO: 14155

Etienne Nichols: Okay. And: 14155

Sara Adams: Yeah.

Chris Rush: It's essentially good clinical practice for medical device clinical investigations. And that's an ISO standard. So it's not legally binding, but it's. It's what everybody should follow, really.

we should have done that. ISO: 1345

Sara Adams: Quality management system.

Etienne Nichols: System standard for medical devices.

Sara Adams: For medical devices.

e FDA is harmonizing with ISO: 1345

so it is going to become regulation soonish. Yeah.

The numbers that come to my mind are very similar. I would have brought up both of those in this conversation, but particularly 21 CFR part 820 comes to mind. That's the QSR for medical.

For FDA quality system regulation.

Sara Adams: I'm going to jump in because while it does come to mind, it is changing, like you said. And so I think if you're new to the med device industry,

I would start looking at: 1345

hris brought this up, was ISO: 42971

Sara Adams: Yeah. That's the last one I was going to offer too.

Etienne Nichols: Yeah. And the product development engineer in me Thinks about that quite a bit as well.

Those are the numbers to look into if you're a. If those are the key compliance standards I would recommend companies look at.

There are Others of course,: 62304

Chris Rush: Pimpa for clinical studies.

Even like part 11, you know, signatures, a lot of electronic signatures these days. Part 11 comes into pretty much all of our worlds I'd say. Any audit trails? Electronic signatures.

Etienne Nichols: That's a good call out 21 CFR part 11.

Sara Adams: You brought up something earlier Etienne, which was FMEA. And I would say FMEA is not bad in and of itself but I would certainly steer people towards 14, 9, 7 1.

If you have never done risk management before.

Etienne Nichols: Yeah. And I don't want to go too far down that trail. At some point we'll have to talk about that.

It's kind. I would equate it FMEA as a very good engineering tool similar to cad. You could actually draw up your device on paper if you wanted to and design it all on paper.

Or you could use 3D CAD. You're going to be. Have a better product if you use 3D CAD. Your tolerance stack ups are going to be more accurate, et cetera.

compliant you have to use ISO: 14971

Okay, really good call outs.

Let's talk about some of the regulatory pathways in the US because we mentioned all these different classes. If you're a wellness device, what do you have to do?

Sara Adams: Not claim to be a medical device. No, I'm kidding. That was a joke.

Etienne Nichols: Yeah. Don't, don't act like you're a medical device. Yeah, we'll just leave it at that.

Sara Adams: Don't claim things.

Etienne Nichols: Stop claiming that you could cure cancer.

Sara Adams: I mean, you know, like for people who don't know what we mean, we say wellness device. You think the things that you wear on your wrist. We will not say brands or anything like that.

You can't claim that you, I don't know, can predict pregnancy. I'm giving a radical example there. You can't claim that and continue to be wellness device.

Etienne Nichols: Yeah. So class one, this is one that's interesting to me is so you're a low level, not, not high risk. You're that toothbrush.

What are some of the requirements there? I'm going to turn this into the Interview at this point.

Sara Adams: Oh, I don't want to be interviewed. I liked interviewing you. Well, you don't. There are some, and I'm purely going FDA at this point. There are some design control exclusions, I would say, for class one, so you don't have to have those.

There are. And gosh, I'm not, I'm mincing my words. There are some Class 1 devices that do require design controls and those are spelled out for you within the qsr.

Yeah, but by and large you don't have to.

Etienne Nichols: I think that's a good way to put it. So class one medical device, as the company would need to have the establishment listing registration just so that you're on the FDA's radar.

And then other than that. Yeah, like you said that 21 CFR Part 820.30 has that list of. And one might be like surgical drapes or a surgical glove. Those require design controls.

But if it's not a surgical glove, it's just a glove in general. It's, you know, it doesn't require design controls. Maybe, you know, let's go ahead and finish the pathways class two, class three, and then we'll talk about what design controls are.

Because I feel, I, I feel bad that we've alluded to them without defining them.

So. Okay. Class two, class two medical device. It's a moderate risk. Chris, do you wanna, you wanna elucidate or do you.

Chris Rush: I can try. Sarah's probably better at this than I am, I think.

Sara Adams: I think you dive in.

Chris Rush: Yeah, sure. Class two,

higher risk than class one. I always think things that are not implanted, like a urinary catheter, vascular catheter, needles, syringes, those sorts of things.

Sarah, I'm gonna let you take it from there though, because I, I look at more of the clinical side, to be frank.

Sara Adams: No, I think Etienne, you can hop in too. I. Class two different types is that. I. I guess like I automatically think of pathways to market. So 510k is what comes to mind.

And maybe we shouldn't talk about design controls here at TIA, but you know, again, like a 510k would be a pathway to get. I, I don't know, you probably know the statistics at hand.

Like most Class 2 devices take a 510k route. It's certainly the quickest pathway to market where you can claim.

I'm not going to have the exact verbiage, but you can claim likeness to a predicate device or something that is already been approved and cleared by the fda.

Etienne Nichols: Substantial Equivalence, essentially.

Sara Adams: There we go. Thank you.

Etienne Nichols: Yeah, we have the same, the same technological features and we have added no new risks to the medical device that we are, that is our predicate. And so the 510 process, it's a good point.

You,

you are, you have to follow design controls, you have to have those in place. And then I guess if we go to class three.

Well, before we do that, let's just mention the de novo pathway as well. So a medical device that's novel, it's unique, you have no predicate, but you also don't feel like you're high risk.

You can make that claim and to the fda and if they agree, then you could pursue a de novo pathway, which is a novel pathway. And then, and then finally you have the Class 3, which is the highest risk medical device in the U.S.

and that, that requires that same establishment, registration from, you know, your company. One thing I'll throw out there is actually, I'll get to that in a second. But you have those design controls that you have to in place and they're also going to be special controls that are in place.

So those may be controls that you as a company and FDA kind of work out. What are those going to be? Is it going to be certain clinical testing, is it going to be certain all the different special controls that you put in place, that you start helping put together a product code and blaze your path to market?

A few things real quick about this is there's something called mdufa, which is the Medical Device User Fee Agreement. We're at number five, I think right now.

t's supposed to go up through: 2027

I want to say it's something like 20,000 something dollars.

Go ahead.

Sara Adams: No, that's. I was gonna. No, I thought you were going timelines wise. So like 112 days for a 510k. I only know that because we talked about it last week.

Etienne Nichols: And what do you mean by timeline? Go ahead.

Sara Adams: Timeline to get approved by the FDA for your 510k to get approved.

Etienne Nichols: Yeah. So what that means is I've gone through the estar, I have my submission and I've given it to the FDA. They have 112 days to approve that now.

Sara Adams: Yeah, and I should. There's a caveat I shouldn't have like it doesn't just mean we're going to approve it. Right. They may ask for more information but they're going to give us that and.

Etienne Nichols: They stop the clock when they ask. So it's. Yeah. So it could take a lot longer. Depends on how quickly you are getting the average day.

Sara Adams: The average timeline is 112 days and they publish that.

Etienne Nichols: So it's public record and that's actually a really positive thing. In the EU right now there's been a bottleneck of, there's a lack of notified bodies. So you get in line, you wait, you may be a year.

But from, from getting certain things done, there's no guarantee, whereas up and well is supposed to guarantee this, you know, this timeline to, to get you to, to market quicker.

And so I wanted to mention one thing about that because there is a cost. It's and, and you can look that up on that. I don't have the numbers off the top of my head, but it's something like 25.

That 25k raising my price now because I'm nervous that I'm getting it wrong. Class three is a little bit higher and it's called a PMA which is a pre, pre market approval and it is somewhere in the $300,000 range.

But if you're a first time Class 3 medical device manufacturer, you can get that waived. So you can, it's kind of an encourage. Yes, please innovate in the Class 3 space.

We want those high risk devices to.

Chris Rush: Market and the PMAs, they usually for Class 3 devices they require what's called an IDE, an investigational device exemption. So they kind of go hand in hand. Pma, ide, they usually are kind of joined at the hip if you will.

And the IDE is essentially the IDE investigational device exemption essentially allows you to use that device in a clinical investigation and you need that in order to proceed with an, with a clinical investigation for class three.

And then just a slight like jargon note, 510k, those are clearances.

Etienne Nichols: Yeah.

Chris Rush: Class three devices are, are approved. So it's, it's a minor little difference that you kind of pick up over the years in the regulatory world. But 510k, it's kind of, you kind of think like an open door, someone's at the door checking your wristband and you're cleared to go in 5 class 3 like an PMA that is a closed lock door and you need approval to go through it.

So it's just a slight difference in jargon, 510k clearance PMA approval.

Etienne Nichols: I like that illustration.

Sara Adams: I do too. Because you can be like me and just say em both every time I get them mixed up. And so I always am like approval clearance because it goes together.

It doesn't go together. Thanks for highlighting that. Seems a big deal. Many people will comment on that for sure.

Chris Rush: Right?

Etienne Nichols: Yeah.

Sara Adams: I just want to make one point. Class one toothbrush a lot cheaper to bring to market than Class 3. Fill in the blank with whatever novel thing idea that you have.

I'm not going to say any because somebody will steal it at the end and then I don't have. I don't have any ideas anyway. But lots more goes into funding wise,

bringing a Class 3 device to market.

Etienne Nichols: Oh yeah. There's a big regulatory strategy behind each one as well. So I mean, if you want to sell on Amazon, you want to go straight to consumer. Class one makes a lot of sense.

If you want to be a barrier to market and put that moat around your product, Class 3 might make the most sense though.

Sara Adams: I don't. I'm not going too far ahead because I know you want to talk about what post market looks like, but I don't ever recommend you sell on Amazon. That's another soapbox of a story in general.

Just be really cautious with customer feedback. When we get into the post market section about what can transpire on places like Amazon.

Chris Rush: An ominous preview. I like that.

Sara Adams: I know, right? But we also got to get there. So we might have to do a part two of this podcast, you know?

Etienne Nichols: Yeah, that's true. I should have known when I brought you guys on board we could, we could talk for days.

Sara Adams: I know.

Etienne Nichols: Let's talk about the medical device development process so that we can go ahead and hit that design controls and risk management piece when you have a medical device. I mentioned R&D versus product development early on we were talking about some of the different roles and the responsibilities in the industry.

R and D kind of tinkers. They come up with that solution to a certain degree. A prototype. At some point you need to start documenting design controls.

Sara Adams: There are no rules. Right. In R and D. And then all of a sudden we need to have rules.

Etienne Nichols: It probably shouldn't be that way.

Sara Adams: I know, but it, I understand why it is because in R D we need to explore and I don't know, I'm thinking about my kids science projects. Right. Like we need to be able to go out and say, like you need to be able to try all these different materials.

We need to be able to prove viability and so I get it. There's the rule. Lover in me doesn't love it, but at the same time, I get it. We need the two, two legs there.

Etienne Nichols: And you know, rule over aside, there's actually a different problem with it too that I have been on. I've been on the very inside of this problem that is reverse engineering their thought process that got here.

And you might think, okay, well, you've got the thing, you've got the blueprint, whatever. Well, you have to document something called user needs.

So if I were to come up with a design controls matrix, there are five pillars or five columns that it would look like. So user needs would be one column.

That would be the first. We are going to solve this problem. The user needs a device that helps them manage their diabetes or whatever the case may be. And maybe the solution is a continuous glucose monitor, I don't know.

But then you come up with these device inputs or design inputs. Design inputs are okay, we need something to monitor diabetes. So we are going to do this, we are going to look at the blood in this way and then you come up with a design of something that would be your design output as blueprint,

specification, material, specs and so on.

Sara Adams: I'm going to interrupt too, just for people who have no idea. Design inputs. Help me here, Etienne, because this is your, your area. But like ingredients, think ingredients, whereas the outputs are the recipe.

And yes, I like to cook. We can talk sourdough later. But right, like that's a, a way to think of this as well. We're defining what those inputs and those steps are going to be.

Etienne Nichols: Yeah, that's a good. Trying to see if I can modify that slightly.

Sara Adams: Modify it slightly.

Etienne Nichols: I don't know if I can. I don't know if I can. I think that's good. Design inputs are a little bit hard to explain sometimes.

Chris Rush: They'd be like, blood glucose monitor needs to be portable or lightweight. What does that mean? Does that fit in your pocket? It needs to be these dimensions. It needs to be this shape.

It needs to be something you can have on your arm all day. It needs to be low profile. What does that mean? Here's the, you know, cross section, here's how small it needs to be.

That's what I. That's kind of how I think of it.

Etienne Nichols: Yeah, I would. And I would. I. That's a good, good way to look at it. So let's just take one of those. So it needs to be able to be fit on your arm all day.

Might be a user need.

Then you Might need biocompatibility as a design specification needs to. What is all day? You define what all day is, like nine hours, 10 hours. And then you would come up with in your design output, the actual material that is biocompatible.

That could do that.

Chris Rush: Oh, man, I like that. I like that.

Etienne Nichols: And then you would verify and validate the design. So verifying would make sure that we built the device correctly, that we actually can stick this on someone for nine hours a day.

And then the last part, the validating, we'd say all day actually means nine hours. And they might say, no, it actually means 24 hours. So. And you would validate that your design is actually meeting the user needs.

Sara Adams: So five of them, User needs, design inputs, design outputs, verification and validation.

Etienne Nichols: Yeah.

Sara Adams: And those. I'll just speak as the quality nerd. Those are defined in the qsr. So it specifically calls out, you will have these things from a design and development point. I want to take you back because one of the things you were talking about was reverse engineering.

So R and D coming in and like, solving for all of those things and then documenting it. And I see that a lot. I see that a lot from teams that come in and they've done the work and now they've got to go back and document it.

Like, the way the design process works really well is starting with those user needs, like, what are we trying to solve? And a lot of times I see teams that come in where they have not defined those user needs.

They've rushed straight in. I don't know. Etienne, speak to that a little bit.

Etienne Nichols: Yeah, I'll just use a pretty simple one that I think everybody could understand is, let's say R and D made the button red. If they. They have two buttons on this device.

One's red, one's gray. Okay. Then we go through. We say, okay, well, okay, we document this. It's. We don't know why, but the button's red. And we go through. And during usability testing, which might be, you put the device in front of somebody and say, okay, how does this work?

ed, the standard there is IEC: 62366

But that's just one example. So you would go through. And you want to know, why did we choose what. And colors is a simple one. But ergonomics, you know, whose pocket is an 8 pound 12 inch thing going to fit in.

You know, why did we choose this size for something that, that is supposed to fit in someone's pocket? So knowing and documenting those, those understandings, maybe it's not a person's pocket, maybe we just say fits in a pocket.

There's a pocket next to the bedside table that is consistently that. I don't know, I'm just making something up. Knowing people's,

your mindset and how they got to those decisions is really important. That's why, I mean you've been, you've seen those reverse engineered design controls matrices and I've been involved in trying to, to reverse engineer those.

So yeah, one thing I will say is if you are in a medical device company and you're struggling with that, that document can be a living document. There are certain procedures and processes you have to go through to edit it, but it can't be edited.

Chris Rush: Etienne, I've got a question for you. When it comes to like R and D, they're working fast. They're documenting things in their engineering notebook.

When it comes to like verification validation, this might be an entirely different topic. We don't need to go down here. But verification validation, you know, designing an animal test for that.

How does, how does the R and D kind of development, does that feed into some of that verification validation, testing? And it has to be kind of a different formal process when you get into those verification validation testings.

Etienne Nichols: Yeah, it depends on how the company's set up. Honestly, if R and D is under, is operating in a, I don't know, a quality mindset where they're documenting properly their procedures and they have a change management process so that they have this engineering protocol that was properly signed off.

It's underneath the quality management system. Some of that can be used for supportive evidence.

Oftentimes those early stage R and D animal studies are not,

not the final design. So not really indicative of what you finally have.

Chris Rush: Sure.

Etienne Nichols: That being said, if you want your life to be a little bit easier, making those studies to where and it's, it's usually just a small level of effort, but then you can use that to, to inform how you're going to do future testing.

And I think that's how I would ultimately try to leverage those early, early stage animal studies. Yeah.

Chris Rush: And I, and part of the reason I ask is you, you oftentimes when you hear about clinical trials, you also hear about pre clinical and sometimes people are like, well, what is it?

What exactly is that? And that's, that is kind of the Animal engineering lab testing, which is kind of a different realm, but it's pre clinical. It's before you get to the human trials, but they kind of feed into, you know, those become some of the submission materials in your clinical trials even.

Etienne Nichols: So I'm glad you brought that up because there, I mean there is, there are multiple times when animal studies are. And just using that as an example applicable and, and, and worth doing, they may actually be a part of your clinical investigation.

Your pre clinical, like you're saying. I guess I was thinking we in my background we had did something like a adhesive for a biocompatibility and we were using pigs, a pig study and we did that far before we were under the product development process.

So none of that could really be used justifiably to inform, you know, future moving. I mean you could from an engineering standpoint, but we weren't using it to support our submission by any means.

Sara Adams: Yeah.

Chris Rush: And my understanding of that kind of that whole realm, even like animal testing and it probably depends on the type of animal site, there's regulations surrounding that even. Good, good.

Etienne Nichols: Yeah.

Chris Rush: Good practices for animal studies. And you can't just find some pigs and start work. It's very tightly controlled.

It's not something you can just kind of jump into haphazardly. And even like the engineering side, like the good lab practices for like engineering testing, there's regulation around all that too, which I'm not as familiar with.

But maybe just worth mentioning, adding a little bit more complexity onto the pie here.

Sara Adams: Yeah.

Etienne Nichols: If we were to zoom out because maybe we do need another version at some point.

We talked a little bit about key roles and responsibilities in the industry, what the different, the different ones focus on. We didn't really mention manufacturing and operations, which is unfortunate.

I used to work in manufacturing. I know Sarah has as well. You want to touch on that real quick or.

Sara Adams: Well, yeah, there's multiple avenues there for sure. So manufacturing, I guess like to put it bluntly, like you can't just have these great design controls and have no way to produce it.

Right. And so that's where manufacturing and operations comes in. I did almost mention operations just when we were talking about multiple hats. So some separation between quality and operations. Preferably.

Right. Where we're not all doing those or where one person's not owning all of those areas.

You need some division. But as far as like manufacturing your device there, you can do it in house. You can manage a contract manufacturer which would then become one of your suppliers, which we didn't talk at Length about.

But managing suppliers has all kinds of regulations. You can't just go out and decide, hey, I want Etienne to make this for me. Right.

But as far as manufacturing is concerned, you'll, you have processes and procedures where you take the,

you know, inspection, the, the specifications, you're developing work instructions so that people know what it is that you need them to do as a part of manufacturing that device. I don't know, what am I leaving out?

Etienne Nichols: I think what we left out from this whole episode is inspections and audits.

Sara Adams: Oh, well that, that comes last though. I mean that's kind of a post market. I mean it's not. And it's not completely. It's not completely. We have a great inspection and audits podcast that we could probably share that we've done before.

But yeah, that is a piece of this. And, and I, I hesitate, I'll just tag on. I hesitate to say like, obviously the whole point is to pass an inspection and to pass an audit.

That's not true. Right. Quality is a, and I'm speaking from quality, but a mindset that should be felt throughout the organization and not just by quality or not just because we need to pass an audit.

The driving force, and you and I talked about this last week is the patient and wanting to meet that requirement. But audits and inspections are going to be a part of your life, right?

For it as a part of the medical device industry.

Etienne Nichols: Yeah, absolutely.

If you were to say, just because we kind of are at the end of our time, a piece of advice for a newcomer to the industry. What would you say is a good place to start?

Sara Adams: I could answer this one way and then after we get done, I'll be like, oh, I should have answered it that way. I am going to pick reading. Reading the regulations, so we've named a bunch of them here.

Or finding someone who can help you understand those regulations. You're gonna have to pick a market. Right. You're good because they're all different. Let's say you pick the fda. Right.

Understanding what is required of you is an important place. But then like Etienne, my brain also goes to. You got to know what classification you are. So doing a little understanding of what,

where you fall so that you have a better idea of the path that you're going to be going and embarking down.

Chris Rush: Chris I come from working for a large device company so I think like I had the luxury of having a pretty robust training in house,

but that's not always the case. Luckily nowadays any. Anything that comes up typically regulation wise That I, I don't understand. Number one, the regulation is a great place to start, but it's tough to read them.

So there's just tons of resources online. YouTube videos, you know, there's articles written by people from all over the industry including, including Greenlight Guru to start understanding it. I think that's, that's a really good place to start is use online resources, read the regulation if you don't have that internal training in place and you can find some great pay for play trainings online if you're,

if you're needing to do that as well.

Etienne Nichols: Yeah. As far as resources go, Greenlight Guru puts. We put on free webinars monthly and obviously our podcasts, if you're already aware of. So I think that's a great call out there.

Go ahead, Sarah.

Sara Adams: I just was also going to mention there's several definitive guides. Am I saying that right? That Greenlight does. That are a great place to start too. They just do a great job of kind of breaking down.

Like if you truly have no idea where to start. A lot of those guides, they, they're kind of, they may be lengthy, but they really take those regulations that are con.

That may be confusing if you've never seen them and break them down. Obviously if you have more money to spend, there are some great like in person style trainings that are virtual trainings that, that can break it down for you.

Etienne Nichols: Yeah, yeah.

Chris Rush: And a lot of, a lot of people on LinkedIn that are experts in this stuff, they're consultants and they're out there getting information out there associated with their name. So even finding people on LinkedIn that are highly regarded in the industry can be a good place to, you know, make,

make a connection, figure out where they're speaking. Might be a free webinar online, might be at a conference somewhere. So just kind of finding that network, even on LinkedIn can be a good spot.

Etienne, you're all over it. So you're all over LinkedIn. So I changed my answer better than I can.

Sara Adams: My answer is start by reading all of etienne's post on LinkedIn.

Etienne Nichols: It's funny because I actually. Your answer was read regulations and I, I thought what would I say? And I actually wrote a LinkedIn post. I don't know. This is a few.

This is. Okay, it was May of: 2024

Sara Adams: Read regulation. I just, you would be floored by how many people I meet who are trying to bring a med device to market and they have Never read the regulation and it's like, would you, I don't know, I don't have a good example because I'm the, the quality person that's like,

hey, I'm going to install this in my house, I'm going to read the manual and that's not what everybody does but it's going to make it go a lot smoother for you and a lot.

Yeah, I don't know if you know what's required.

Etienne Nichols: It's not as it they are. They can be difficult to understand. I will give you that. If you are bringing a medical device to market you can understand them. Yeah, yeah.

Sara Adams: You gotta have the, the desire and the ability to critically think and, and to, to work through that. I just like there are all kinds of tools. I really hesitate to bring up things like ChatGPT, but you can put it in there and, and you know you're not gonna have the expertise to fact check that.

Grain of salt. But that's. I get that answer often, Etienne. Like hey, I just plugged it in Chat GBT to see what it says. It can be a great starting place.

Right. Or ask it to cite some sources so that you can dive in from there.

Etienne Nichols: Yeah. If you read the regulations though, 21 CFR Part 820 FTAs Quality System Regulation. I don't know how long it's been a while since I printed out. I, I don't want to say it's less than a dozen pages.

Sara Adams: I've never printed it.

Etienne Nichols: What is it, 20 pages? Maybe less.

Sara Adams: Yeah, it's not much.

s: Yeah, I haven't done my so: 1345

So I'll go with that one. Since you said read regulations already, I'll go with this one. Focus on the problem as much if not more than the solution. A lot of times on the solution but you really have to understand the problem you're solving if you want to be able to go through that design controls the risk management and have a strong submission.

Those are important.

Sara Adams: It's like it's not often that you're solving in the med device industry one of your problems. Right. Like I, that probably happens sometimes. Like hey I, I had this life changing experience and now I want to make this device.

But in general like you need to understand the problem that you're aiming to solve and not just solution something.

Etienne Nichols: Yeah, I'll put a solve, I'll put a Link to my, my LinkedIn in, in the show notes if someone wants to see that post, particularly, I don't know.

Sara Adams: But anyway, I. Etienne, were you a product development person who read regulations?

Etienne Nichols: I was.

Sara Adams: Oh, good.

Etienne Nichols: I was and I'll tell you why. We had some certain SOPs that I felt like were too restrictive and I went to quality and they said it's because of regulation. I'm like, oh yeah, bring it on.

I went and proved you wrong. I came back and I said, this is not the regulation. I'm changing this sop.

Oh, and I had the. From then on, I learned a valuable lesson though, and that was friends with quality. We were, we were good. It was good.

Sara Adams: But that is something that happens often. People will put themselves too constrained in a box rather than. And I'm not telling you to be vague, but at the same time, like there are multiple ways to meet regulations.

There's not just one.

Etienne Nichols: And I will say I had the confidence to do that because of the leadership that was there. I actually came up to a question. I had a question about certain. It was one of the part four.

I was a drug delivery combination product guy. So I had a part four question. He said, well, let's look at the pharmacopoeia. I'm like, I never even heard of that word.

He literally brought out a massive, you know, book. And he brought it. He knew exactly where to look. And I thought if he could do that, I ought to be able to do that.

So I started reading his regulation and it was helpful. Made me understand.

Sara Adams: I think it's hard to be a med device person if you don't know, if you have not read the regulations.

Etienne Nichols: Yeah. All right. We're kind of at time. Maybe if those of you listening, if you want to hear more, if we went too crazy and scattered, tell us. I would love any and all feedback.

Send it to my LinkedIn to podcastreenlight guru. I'll check both of those places.

Reach out to Sarah if you loved what she said. Reach out to Chris if you love what he said. If you don't love what they said, reach out to me.

I. I'll take the negative feedback,

Ed.

Sara Adams: She knows how much I love my LinkedIn message box after podcast.

I think we need a part two. I think we need to talk about post market at some point too.

Etienne Nichols: Okay. All right. I'll wait to. To punish you guys. But I know we're kind of at the end here, so thank you so much for listening. We'll let you all get back to the rest of your day and stay tuned for next time.

Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform.

If you've got thoughts or questions, we'd love to hear from you. Email us@podcastreenlight.guru. stay connected for more insights into the future of medtech innovation. And if you're ready to take your product development to the next level, Visit us at www.greenlight.guru.

until next time, keep innovating and improving the quality of life.