#400: The State of the Medical Device Industry

Etienne Nichols: 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.

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hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. Today I want to talk to you about our medical device industry report. With me, to kind of give almost, I guess, be my sounding board, is Sarah Adams, a medical device guru here at Greenlight Guru.

Sarah, how are you doing today?

Sara Adams: I'm doing well. Always exciting and a pleasure.

Etienne Nichols: Yes, I always appreciate you coming on. Even if I have to twist your arm to come on the podcast. People love hearing your voice and I always enjoy getting to have conversation with you on the industry.

Sara Adams: Behind the scenes is Etienne has to twist my arm into doing podcasts.

Etienne Nichols: But we don't have to tell people that they could. They know you love the industry, so that's good enough.

Sara Adams: I think I do. I love the industry. I love helping the industry. So I'm excited to dive into today's topic.

ng about is Greenlight Guru's: 2025

to help companies understand: 2020

This, this industry report is something we do every year at Greenlight Guru and we, we try to interview as many as we can. This year we interviewed or surveyed 536 quality, product development, clinical and regulatory and leadership professionals in the medical device industry.

s during October, November of: 2024

And I don't know what we could talk about all the different things that have changed and we'll touch on that. But Sarah, what are, what, what's top of mind for you right now as you kind of go through this?

Sara Adams: Well, I think even with the October, November time frame, there were some, there were lots of uncertainties about what was going to happen in general. So I think that like we should consider that as we look at these two, while lots has changed since then, there were lots of conversations about what could change and obviously lots of opinions at that point in time too.

Etienne Nichols: Yeah. And just to lay our cards on the table, you know, the things that have changed between now and then, the US has had a change in presidential administration which has changed quite a bit of its approach to different things, including the Health and Human Services,

ration FTA early this year in: 2025

So I don't know that it will change any of this report more than solidify some of the things that we've learned. I don't know what your thoughts.

Sara Adams: No, I completely agree with you on that.

Etienne Nichols: But let's start kind of the top line when I looked at this report and by the way, if you're interested in getting the full report, we'll put a link in the show notes, we'll try to maybe direct where you can look at this and download it.

ted to continue its growth in: 2025

billion in, in: 2030

It's good to see that favorable rise.

You work with medical device companies every day. Sarah,

what have you seen as far as a boots on the ground approach? Are there things that really stand out to you? I don't know how many companies you work with at a time, but I.

Sara Adams: Work with lots of companies at a time. It varies, it's different. I work with all of our customers here at Greenlight, so that includes pre market, post market and everything in between.

I Think what stands out, you know, for this number and maybe this is a little more personal than it is my day to day at green light. I have aging parents.

They're not going to listen to this podcast, but they might. But either way, I have aging parents. And so I think like what I see in my day to day is a lot of really smart people who are looking to disrupt the health, I'll say industry in really big ways for that aging population.

So like my parents are, are boomers. We'll just call them that. And there's a reason that that's what that generation is called. There's just a lot of them. And so when you get really smart people who are looking to disrupt, disrupt that industry and bring cutting edge, life changing devices to market.

Yeah, we are. I'm not surprised that we're on the up and up as far as sales and the industry numbers.

Etienne Nichols: I'm glad you brought that up. That's a really good point. Next week I'm planning to go to the LSI USA at Dana Point, California and I'll be interviewing a few Family Office investors.

And this is something that is relatively new to me. It's not, that's not new by any means, but it seems to be more and more prevalent that Family offices are the ones funding a lot of the medical device companies out there.

In fact, one of the companies that I interviewed in Portugal at another event, they managed to bring their medical device fully to. Well, I was just shy of being on the market and they were purchased by a strategic, they were fully funded through Family Office, which is kind of,

it was unusual to me to hear that, but that's, and it makes sense with the, the aging population and the amount of businesses that are owned by that generation,

it's that money has to go somewhere and a lot of it is philanthropic, philanthropic driven. So I think that's really interesting that you pointed that out.

Okay, let's get into a little bit of.

I don't some of the things that I, that stood out to me in the report and I, I would welcome you to interrupt or, or challenge any of the things that I say, but some of the things that really stood out to me were the amount of new hires that was being halted.

So large companies,

nt and their, their hiring in: 2025

About 41% said they were reducing headcount.

Analysts at KPMG were They kind of explained this by saying the medical device sector is facing challenges such as healthcare budget restrictions, new reimbursement regimes that are impacting margins and disruption from new players entering the market.

So that sounds kind of counter to what we were saying earlier about increased sales, increased, increased market presence. Why are they reducing headcount? And course, some of this may be speculation, but I was curious if you had any thoughts on this before we kind of get too far.

Sara Adams: I think everything I have on this subject is speculation. Right. So I mean, I again, I go back to October, November, there were a lot of unknowns. There was definitely a new president coming in in America.

Who knows, you know, at that point in time which one it was going to be. So there was room for,

you know, economic change, that economic policy that was going to change. And so I think like, there's some hesitancy or there was some hesitancy likely when this report completed, not when it was compiled, but when we surveyed just of unknowns of like, I don't know what that is going to look like as we step into the new year and,

and the new,

just the new scene as far as politics is concerned. And obviously we're not here to talk about politics today, but I think like there was just some uncertainty that even with rising numbers, like how do we, how do we navigate this?

You know, speaking freely about what has transpired, I think maybe that there was some wisdom in that of like, hey, let's just kind of wait and see what happens. I think a lot of people were waiting to see what happened.

I won't take us too far into the HHS conversation unless you're ready for it. But just as far as that's concerned, like not knowing what those timelines are going to look like.

Right. It would be not good if you have a whole lot of people there doing the work and you can't get any of it through the fda.

Etienne Nichols: Yeah, no, I think, I think that's very. A relevant conversation. There are multiple things at play if you think about just the purely regulatory agency that was impacted by staffing cuts, tariffs,

kind of disrupting supply chain to a certain degree.

etting an email in late night: 2019

Wish I still had those emails. I think shutting down indefinitely. I thought my project is toast if this is, if this is true.

Sara Adams: I Got to tell you, I remember. So I was in manufacturing at that point, and I remember all of the engineers at our facility, not me, but all the engineers laughing and joking and talking about beer because it was called the coronavirus at that point.

And so this is not by any means an endorsement, but that was the joke going around. So, yeah, I hear that it was. It was a different season, for sure.

Etienne Nichols: Yeah. And so if, if, if there are supply chain disruptions, again, whether it's through taxation or. Or other things that could definitely have an impact on some of those aspects. And as far as growth,

the. The other side of this, that I.

ears ago. It was mid December: 2020

So we were in the pandemic. We had some vaccines. There were people who I worked with at the beginning of my time at Greenlight and customers who completely had to pivot their device because of cost constraints.

Like a chip that used to be since was now astronomically more expensive. And so, yeah, like, just that piece, with everything that's happening right now, the unknowns of what that supply chain is going to look like could drastically change what companies are developing.

Etienne Nichols: And so to me, when I think about what you're saying, particularly supply chain, I think the best supply chain companies understand this, but with medical device companies, you almost have to think about the traceability from an economic perspective.

All these parts are going into my medical device. Where are they coming from? How are they going to be impacted? That. That makes a big difference.

Sara Adams: I always say. And if anybody's ever heard me on the podcast, you've heard me laugh about my husband, but he works in sourcing. He's the director of sourcing for a company here in Memphis.

It is not a medical device company. And so, yes, I am the quality nerd. Again, you've probably heard me say this if you've listened to me on the podcast, but I am the one that's like, are they an approved supplier?

You can't buy from them if they're not an approved supplier. I think MedTech hears that. I know there are other regulated industries that hear it differently as well, but for us, it's not just as easy as, oh, I can't get my part from Amazon, which I won't start my soapbox about why Amazon should not be your approved supplier,

but now I've got to find someone different. So it's not just like, oh, I can get it cheaper at this supplier, there's a whole list of requirements that Medtech has to manage and, and follow.

Etienne Nichols: And I may be getting a little ahead of ourselves too. But if we talk about supply chain, if I skip. Because it's kind of towards the end of the report, 11 of the responders on this survey says, said their current supply chain management program was excellent.

So that's okay. That's. That's kind of a.

Sara Adams: It's good.

Etienne Nichols: It's a tricky way to word it. Only 11 said it's excellent. That you could say, well, okay, 89 that it said it's.

Sara Adams: There are less.

Etienne Nichols: Some are still good. 43% though, just called it average. So that's, that's kind of, you know, something to think about as you are building out your supply chain processes. Consider how that is impacting your company.

Sara Adams: And I, we could spend a lot of time here. I've met a lot of people in what I do who don't understand supply chain or who may let me back up, may very well understand supply chain, don't understand what it takes to have a supplier approved or what that does to their timelines.

So, like I will. There are people that I meet with that have done all of their prototyping and everything they've got, they're ready to go. And now we need to build a qms.

That's not the right time to build a QMS in my opinion. Right. We should have already taken some steps. One of those things is suppliers. And so I'm not as surprised by the 80, you know, you could say 89% that aren't.

That are less than excellent. Just because there's a lot. I meet a lot of people who just don't have an understanding of what that requires and what it takes and what it means.

When you say we have to have a approved supplier. And I know this, I know I want to back up. I know this is. The report is more about supply chain management.

I hear that as approved suppliers and making sure we've got the approvals in place to be able to meet the demands that we, that, that we need.

Etienne Nichols: Yeah. It's one of the interesting things about the medical device industry. Every leader in the medical device industry that I talk to about, one of the questions I nearly always ask is what do you think sets apart the medical device industry from others?

And they always tell me the regulation.

So you think about.

Sara Adams: What do you mean by that?

Etienne Nichols: Well, yeah, and you know, you could go, okay, upstream of that. Really, what are we talking about? It's. It's the safety, patient safety and there's the regulation that makes it sort of enforces that, but that applies and it has downstream effects to everything.

Supply chain management. Now you have a specific way of doing it, marketing, you have a specific way to do ad promo and and.

Sara Adams: So on that you have to follow. Right. And for somebody who maybe didn't start in the med device industry and started in in an unregulated space, it looks a lot different.

Etienne Nichols: Yeah. And if you're interested in learning more about the medical device industry as a newbie, we are doing a podcast episode on that next week. So stay tuned for that one.

Okay, let's move on a little bit. There were a few other things I thought were interesting. One of them was one of the questions we asked was about their key objectives for the year.

So what are your, what are you really planning and focusing on for companies with products on the market? These are commercial companies. One of the most cited priorities was implementing and upgrading quality systems and processes.

And this was mentioned by 44% of those with products on the market. Now we kind of differentiate from commercial medical device companies and those who don't have medical device medical devices on the market yet those pre commercial companies, they had a different objective.

Those are kind of focused on fundraising above all else, closely followed by clinical trials. We'll get to that. But if we talk about this, 44 these companies who 44% of the commercial companies mentioned implementing and upgrading quality systems and processes.

I know this is something you see every day. What are your talk to me a little bit about this.

Sara Adams: The quality nerd in me, the quality nerd in the room who has heard more times than I can count about quality being a non revenue generating department loves this. Right. I love that at least 44% of customers that are not of customers of industry that we surveyed say we're going to upgrade,

upgrade, update some of these because like the bottom line is these are what help bring safe and effective devices to market. And if I think about the patient, right. I, I'm going back to the boomer parents.

They're top of mind, right. There are devices that are, that they are going to be using that closely impact my family. And, and this is my parents. I've got coworkers and friends that have spouses and children that are more, you know, more directly impacted by devices.

So if we, and again I think this goes back to the human part of this. We are all at some point going to use a device of some sort. I'm preaching to the choir.

So they Say, because I know Etienne's in that same boat.

We want safe products. How do we get safe products? We. I know that some see it just as a piece of paper and a procedure that we may or may not follow.

But the bottom line is the more that we instill this quality mindset, I call it this quality mindset of like this is just the way that we operate. Right. And less of the tribal knowledge, the better, safer our family members are going to be or even ourselves.

Right. I think we all are. Are. We don't need it until we actually need it. Right. So I love this. I think that a key objective should be upgrading those quality systems and processes.

You know, I see that as documenting better procedures as going in, but it's also creating better process that eliminate errors or identify errors easier.

Etienne Nichols: Yeah. And if we kind of, if we're able to look at a more of a 10,000 foot view of this. If we talk about those who may be reducing headcount or maybe not trying to scale up, but they are focusing on these other.

I mean they,

I'm not going to say they go hand in hand, but they're complimentary.

Sara Adams: I do.

Etienne Nichols: In that if you have a more streamlined process, it could be less headcount that's needed. You know, I mean it just depends on the type of product you're building.

Sara Adams: But certainly going to be cost saving from the perspective of recalls, adverse events, things that are preventable by putting some of these things in place. But yeah, I agree with you.

If we have better streamlined processes that could coincide with the. And I'm certainly not saying like, hey, streamline your processes so you can lay all your people off. Right. But if we're fighting, if we're fighting to break into an industry or make a difference in an industry and obviously there are business implications to that.

To your point, if we have more streamlined processes, we can do that with potentially less people.

How about this? We'll just say this. You can. You don't have. If we're not redo. If we are not. I didn't think this through. Well, if you are not having to investigate kappas or document recalls and do those things.

There you go. That's less work for less people.

Etienne Nichols: Yeah. You know, I, when I think of the. About a medical device company, I think of it as a kind of a three legged stool. There are three things that have to happen in order for a medical device to.

And I might have mixed this same time.

Sara Adams: Right, right. It's not like at the same time. We can't just have two legs. You have mentioned this before, so I'll let you tell everybody else.

Etienne Nichols: Oh, yeah, well, so medical device, they are specific. And there's other industries you talk about, pharma, biotech, et cetera, that are similar, but medical device industry, we have to be legal.

And I kind of lumped that in with the regulatory agency, particularly in the U.S. i mean, FDA is a federal agency, so we're talking about legal regulatory processes. But you also have to be ethical.

And that goes back to the patient safety. And you may say, well, if I'm legal, I'm safe, right?

Sara Adams: Not necessarily, not necessarily.

Etienne Nichols: And it goes, you know, it's one of our age old things that we've said in the past, compliance versus quality.

Sara Adams: I know. Do you see, you know, the picture that just popped into my head, Etienne? It's the toilet paper roll, right? Like it's the toilet paper roll. And for those who haven't seen it, Etienne posted this a long time ago.

But it's the, my kids putting it on top of the, you know, toilet or next to it versus actually putting it on the, on the toilet paper holder, right?

Etienne Nichols: Yeah, we had an empty toilet paper. I remember walking, there was an empty roll and then they just set it on top of that and there's a, like.

Sara Adams: So that would be compliance, right? Compliance would be, hey, we have toilet paper to take care of our needs. And then the quality piece would be doing it the proceduralized way.

I don't know, they're probably going to. People going to argue us on that one. But hopefully the visual, that's true.

Etienne Nichols: And then that third, because I know some people are like, okay, what's the third? The third is profitability. Money is the air companies breathe. And we don't always like to talk about that in the medical device industry, but they have to be profitable.

Sara Adams: And so I, I will say on the quality side, you know, I, I told somebody last week, like the FDA does not care what it cost you to make it. They just don't.

They don't care if it's a penny, they don't care if it's a million dollars. They are not judging you on that piece. But to your point, it's still a leg of the stool that businesses have to consider because it does matter if it's a penny versus a large amount.

Etienne Nichols: Yeah, okay, but so that's commercial companies, they're focused on that quality and that is encouraging to see, depending on what the motivation is. You know, it's hard to read into that.

Exactly. When we talk about pre Commercial companies that don't have that medical device on the market yet and that's in the medical device.

I'm curious what your, your experience is with this. I've worked for companies that you walk in, you feel like you are at a full blown manufacturing facility, yet they don't have a single product on the market and they've been in business for 10 years.

Sara Adams: I, yeah, I think sometimes when you see those or from what I've seen, you know, they may have a different industry that they've been serving and so now they're like, hey, we do all of these things.

Let's take this to a different market or a different regulated space. Right. So I think of like the additive manufacturers and I think of the wellness industry, like where I've got something that I've been serving as a wellness device and now I actually want to make claims so I need to pursue this medical device.

I, that's not everybody, but that's what I think of when you talk about those that, you know, look like they've been in business for 10 years and they've never sold a medical device.

Etienne Nichols: Right. And, and that is a, that is a, probably a large chunk of them. There are some. And one of the things that's interesting to think about is some are purely medical device and just are taking a while to get to market.

And I have somewhere, let me see if I can find it the time it takes to get to market because I think that's worth mentioning,

see if I can find it real quick.

Sara Adams: So I have mine pulled up and I'm at an advantage because I can control F in mine.

Etienne Nichols: I have old school.

Sara Adams: Oh no, that's not the right one.

Etienne Nichols: Yeah. Page seven. I think we talk about the different times it takes to, to get a Class 1, Class 2 or Class 3 medical device market.

Sara Adams: Yes, there it is.

Etienne Nichols: All right, what have you got?

Sara Adams: 3.7 years for class 2 device, 6.6 years for class 3, 4.

See. But for those who have been through the process, that timeline is shorter. 2.7 for a class two device and 4.6 for a class three, four.

Etienne Nichols: Yeah. And that's kind of a long time waiting to make your first sale, obviously. Five, six years to make a first sale.

So this statistic makes a lot of sense when you think about pre commercial companies focus on that fundraising and clinical investigations. 54% focused on those clinical trials.

Sara Adams: Yep.

Etienne Nichols: So different, different complexity that they're focused on, but.

Sara Adams: Still the bottom line, they, they have to be able to raise money to be able to do all the things that they need to do to get a medical device to market.

It is not typically a cheap process to get a device to market to prove that, you know, there's viability there and then to do all the verification and validating that needs to happen just from a design and development.

I'm speaking more into your wheelhouse in that remark, but just from what I've seen from customers, from companies that I get to work with.

Etienne Nichols: Yeah. And you know, the regular.

There was something I always used to put in my project plans when I was building out a project plan for a medical device timeline and that was to compile the DHF and usually put three, at least three weeks.

There are tools now, I mean greenlight guru being one of them, that auto compiles that dhf. So now you've got a different, you could got to put a different buffer in there, project managers.

But there's always something that will potentially slow your project down.

And if we talk about if kind of move on to the regulatory landscape and some of the different things that are that we're facing, I do think that we probably have a more complex regulatory environment than we ever have before.

But I'd welcome any disagreement. If those of you out there who disagree, I'd love to hear it. Please feel free to find me on LinkedIn, voice your dissent. But what are you thinking, Sarah?

Sara Adams: I mean, I agree with you. I think it's a different regulatory landscape based on what we just talked about at the beginning of this call and kind of tiptoed around a little bit.

There's just a lot of unknowns right now. And if I,

if I,

you know, there's, it's not all public. So we don't know who is not reviewing at the FDA anymore. I'll say it that way.

We just don't know. There's just a lot of unknowns. So when we talk about,

you know, you're you. I don't know if your question is more directed at a specific thing, but my mind goes to like qmsr, that's projected for February of next year.

in February. So I realize ISO: 13485

And then it's kind of met with like also I don't know what's going to happen with that. Just I hope nothing happens with that personally, but I don't know what's going to happen with that.

And that's just me as a regular everyday American making that statement. Right. And so the point being like there's just a lot of unknowns. There's a lot of unknowns and regulatory submissions and what the timeline, time frame is going to be for that, if there's going to be anything that we see that changes or you know,

if we, if it all operates as we think it is going to. Right.

Etienne Nichols: Well, and I'm glad you brought up qmsr. That is one of the things that we mentioned in here. We talked about companies level of preparedness for both fda, QMSR and umdr.

And to me they don't seem comparable. They're completely different animals.

Sara Adams: Two separate things, Right?

Etienne Nichols: Yeah. But at the same time it's worth mentioning it looks like only 43% of companies that sell products on the US market consider themselves highly prepared for QMS as opposed to how many?

Sara Adams: 25%. Is that the.

Etienne Nichols: Yeah. For Eumdr. So it's considerably lower. But it's still, it surprises me that it's as low as it is except for when you consider the EUMDR landscape. And it seems medical device companies have a tendency to wait till the last minute when these complexities arise or regulatory changes come up.

Sara Adams: I think too, like, and I don't know if this is the case or not, but I'm thinking back in my time in industry,

we,

we moved to a change with ISO: 13485

There was a cutoff date. Right. You can't certify everybody to the new version on the same date. If we're a notified body, that, that kind of shuffles over three years research versus surveillance audits.

And so we were kind of like thrust into doing that earlier. Right. So if we had answered, I know this survey had happened then and we had answered how we felt in that respect, we would have been super prepared because we were forced to be.

No one is really forcing. I mean, yes, it's legal. Yes. February, when it goes into effect, we have to comply to comply with it. But it is not, there's no forcing function.

No one's being forced early. Right. Like the FDA is not going to knock on your door tomorrow and be like, hey, are you ready for this? Because you know, you got 11 more months.

I can't count 11 more months. To get ready for this. I think there's a lot of unknowns there too of just like how, like, okay, I have an FDA inspector who previously could not look at my management review and my internal audit and now they can.

What's that going to look like? I don't know.

And so I think that's one side. The other place that my mind goes on qs, qmsr. And I am looking at the phrasing of how we phrase this question. So I don't know if this is.

es on the market that are ISO: 13485

ike I, the, the transition to: 2016

cluded for me, if I am an ISO: 13485

the.

It feels less like a big jump. Right.

Etienne Nichols: And one of the things that I would say, if there are companies out there who are on the fence trying to side this, oh well, emdr. But it keeps getting pushed back.

Let me just say the FDA is not going to do.

Sara Adams: Not getting pushed back. I don't think, I don't think it is.

Etienne Nichols: I cannot imagine. And I'd love to be wrong. Maybe. I don't know. I don't know how I feel about that. I would love to imagine.

Well, I'm just going to say I can't see the FDA saying, okay, you guys didn't meet the deadline, we'll push it back a year. That's going to happen. Happen.

Sara Adams: I think barring a global pandemic or, you know, like there are some things that I could push it back that, like just. Because historically we've seen that happen. Right. Like so unrelated but related.

Etienne, do you have a real ID yet? Because I don't. I gotta go get one of those. It's actually gonna happen in May. Right? Again, unrelated to the med tech, but, but just from a government perspective, I do think there are some things that could land it getting pushed back,

but I don't, I think this is imminent. I'll also add, because it's on my LinkedIn and socials, I Have said, I think since I got into the med tech industry,

the first day, I don't know, the first week, it was like, yeah, yeah, ISO and FDA might come together and, and this might be a thing. So it was such a long process that for me, I always said, it'll happen when pigs fly.

I didn't pay attention. I've said that to you on a podcast before and, you know, I don't know, like a year and a half ago it was like, hey, actually, I think this thing is going to come to fruition, so we should start paying attention.

Etienne Nichols: Yeah, yeah. So don't expect the FDA to just kind of sweep it under the rug for a while or ignore it. It's coming law.

Sara Adams: It's law. Right, right.

Etienne Nichols: And there's. There's several things like that. You know, there's a couple other things that are just. Maybe they've kind of flown under the radar. But both the US and the Europe have put different pressures on manufacturers, for example, to provide advance notice of supply chain interruptions.

I actually just wrote an article about this and published it maybe a week ago.

And just for example, for the FDA, they released that guidance on Section 506J of the FT and C Act, which states that manufacturers have to notify the FDA about potential medical device shortages during public health emergencies, even or in advance of a public health emergency.

Which still boggles my mind. I mean, this whole thing, it blew my mind a little bit on the, you know, we can make different arguments and favor of, or, or against.

all the baby, baby formula of: 2022

ecall the formula shortage in: 2022

like conducting expedited reviews and exercising enforcement discretion for certain infant formula requirements. So I thought that's a good example. And I love that she brought that up. Bring me back.

Sara Adams: Right, man, though, my, my brain is going to. Yes, but the FDA caused the shortage, right? I mean, they didn't. They didn't. It wasn't their fault. I'm glad they did. Like, yes, I know, I know I got to be nice.

But at the same time, you know, that, that was, that was part of the issue was. Yeah,

anyway, okay, yeah, that's a good example.

Etienne Nichols: I have kind of dominated as far as picking things out that I wanted to mention. Any of the. Were there anything specific you wanted to mention and talk about?

Sara Adams: Not, not I, not specifically. We've done a good job of kind of hopping over what, what I'm seeing or you know, what I've seen based on, on the people that I'm meeting with.

I'm trying to think if there's anything.

Etienne Nichols: There was a statement I saw on page six, I really liked it said medical device companies in the early stages of development need to prepare for compl.

And that seems like a no brainer, like oh of course. Well what it's sort of getting at if you. And I really encourage you to get the report and actually read about this.

But it talks about the issues pre commercial companies have versus the issues post company. You know commercial companies, they're different. They are different. And one of the statistics is that pre commercial companies say they spend 17 hours per month on reactive remediation activities.

That jump, that Number jumps to 52 hours per month with companies who have products on the market. So preparing for that complexity is important. The way I kind of use my layman's terms is I say you got to dig the well before you're thirsty.

Sara Adams: Yeah, no, I agree with that. I think that's a good analogy for sure.

Etienne Nichols: Another thing that I kind of wanted to mention was going back to the quality management.

Operational excellence is going to have to become a guiding principle because only 26% of professionals said that their quality management was highly collaborative and which indicates that it's primary. You know what is that?

74% seem to think that it's somewhat siloed and that's gonna have to change.

Sara Adams: I mean I think that's a issue that the med device issue. The med device industry has fought forever and it goes back to like ah, we are. I got my own job and I'm gonna stick to that.

And we, we don't see all of the cross collaboration where I, I don't know, I, I could speculate all I a lot but I serving living on the quality side.

People don't like quality people, Etie. And I don't know why you like quality people but it's the rules. It's the reason that in my everyday life I get made fun of by my friends because I like rules.

It's a personal problem. Right. I like the black, I like the white, I don't like the gray. The gray is hard to live in for me, not for everybody. There are Plenty of people who love the gray.

But where I'm going with that is like the operational excellence. It was a battle that I fought the entire time I was in the med device industry. There's this tandem of like we as quality professionals cannot go into the room and say you have to do X because X is a million dollars and we got to make it happen.

Right?

Because there's probably not just one way to do it. Right? And to quote you, we've got this three legged stool that we're trying to balance that the C suite execs are trying to make we do well, right?

I've never seen a stool work real well where one of the legs is longer than the other two. Right. Like we need that, we need this, this operational exc. Excellence that I see.

Like high performing companies have our, that balance of, of what they do well. Like quality comes into the room and I'm speaking from my experience, but quality comes in the room and says, hey, we have this problem that we need to solution together, right?

Not coming in the room with the solution, but here's this problem and here are some ways that we think we could meet it. Having that collective conversation is always going to serve us better, right Than, than me deciding we're going to put this change to our device in effect and that's what we're going to do without having the,

the cross collaborational conversations.

Etienne Nichols: I remember a mentor early in my career, he told me quality can be a police or they can be a partner and part of that is up to you. And so, and I'll just give my imper.

My impression of how FDA puts rules in place because I think sometimes this is helpful because it's, it kind of trickles down to how quality people do their job to an extent as well and how product development, which what I consider myself interact with product quality.

This was helpful for me to understand because sometimes I, I like cut and dried rules so I know the boundaries to work in. I do like that at the same time the FDA doesn't say go 35 miles an hour around this curve.

Sara Adams: You're right.

Etienne Nichols: Those of you who used to drive, you know, I used to ride motorcycles and if I saw a 35 mile per hour curve, I knew I could probably double that.

Sara Adams: Oh, a double that. Come on, Etienne.

Etienne Nichols: There were times when I missed and I.

Sara Adams: But everybody has that limit, right? Everybody has like what that means to them.

Etienne Nichols: But my point is what the FDA, they don't put that 35 mile per hour sign up. What they say is it's a 15 degree curve with a radius of X and it has a coefficient of friction of the wind comes out of the southeast at x miles per hour.

And you have to understand all of that and say okay with the vehicle I'm driving I can make it this fast. If I'm driving a semi, I'm actually going to go 15 miles an hour.

And you have to know what your company is. And I think that is where the comp the true quality professionals shine.

Sara Adams: Yeah. This is your mechanical engineer factor of safety. Right. Like that's what I hear when you say that entirely. That's an inside joke for all the listeners.

Etienne Nichols: Anyway going there, my brother was civil engineer. He said you're. Yeah, I used to work in aerospace and our safety factors were razor thin because of weight distribution. Right. So you really wanted to be on the money and yeah, that's a good.

I'm glad you brought that up.

Sara Adams: The inside joke is because my husband is also a mechanical engineer. Not to bring him back into this. He's going to love that he's brought up multiple times but that you know it's really funny because I'm like the.

But if we have a factor of safety people die in the med device industry. So that's right. But what I, what I wanted to come back to in that is a lot of times when I teach to I have you know, people who are in the pre market customers and they are literally looking at procedures that are with glazed over looks in their eyes.

This is the first time like going back to the like it takes longer when you've never done this before. Right. They're like what on earth does this mean? Do I have to fill in the blank?

Whatever. And as the rule follower in the room I like pulling up the QSR as the example in this in right now to say look, this is what the FDA says.

Do you read in there anywhere where it's. And I don't say it that I don't mean for that to sound passive aggressive but like do you see this explicitly spelled out because it's not there.

Right. A lot of times that is kind of reassuring for teams that haven't done this before. Ones who are quality focused who do have a desire to do it all just say the right way or just with a way that has that quality focus to be able to say like oh there are multiple ways that we could get to the same destination and we need to live inside of of what that says.

I, I challenge. I don't know, maybe we need to ask this next year at the end. But like, I don't think there are many people who have actually read what the FDA spells out for.

There are lots of quality people and regulatory people who have. So let me just speak them into. Because whoever is in that, like they just shouted at the top of their lungs, yes, I have read that, but I do, I think there are a lot of times people who have never done this before that are following blindly almost,

so to speak, where they haven't actually taken a look at what. What that says,

what tells them to do.

Etienne Nichols: Well, if we go on to a little bit further in the report and we're. I think we're close to being able to wrap this up just those who are listening. But one of the things I noticed was only there were about 10% of the respondents of our survey that said their is their company had been issued an FDA Form 483,

which I thought was interesting. That was in the last 24 months I actually have been in a company that was issued a Form 483 multiple. And so it's. It causes a lot of churn and swirling in the company.

What's. What I think is. I don't know if this is reassuring or exactly what to call it, but I wrote an article a few years ago on what the top three reasons for 483s were and for several years and I'm.

My guess is it's still the same and it's CAPA design, controls and complaints.

If you're building out your quality management system, those are the three things you just focus on. Nail those. And not that you can't get a 43 for something else.

Sara Adams: But yeah, I tell everybody, like have a process established. Right. Because okay, so I'll back up there. All that data is available. Well, I assume it's still available. It was in December.

That's the last time I checked it. There's a huge. For people like Etienne who love data, who want to be able to extrapolate all those things, you can get a lot of data hilariously or not hilariously.

To prove Etienne's point, you can break that data down by what those. There's this beautiful little graph that gives you the percentages of what the top three or whatever you want to look at are.

You can li limit the date range, right. To say I'm going to look at last year. I'm going to look at the year before last year. It's the same ones over and over again.

And so yeah, like I would, I would challenge if you do those three, then you probably should do training well because that's what the FDA is going to look at next.

Like, oh, I can't tell you the number of times in audits, not even just FDA inspections, but in every supplier audits, customer audits, all of that. If you don't have a finding and you need a finding, you just go look at training because you can probably find something low hanging fruit there.

But again, like I, I as the, I know there are people listening who have set in more FDA rooms than I have, but I've shared this before. There were eight FDA inspections in my time that I sat in.

The FDA is reasonable. They are not, they are there to ensure compliance and patient safety. Right. And so if you have a, an established process that maybe you're not following to the nth degree.

Right. You can open a non conformance or whatever that looks like internally in your system. You probably have something that they're called to identify. Like hey, we identify that this was not recorded properly or we didn't initiate this.

Now if you've never initiated any complaints and you have a procedure, they're still there. That's not going to fly. Right. But they're just like you can do things well and not do them perfect because we are human.

So like that added piece to this again, like I, I would not, I would not, I would not skip the kappa complaint and design controls process.

Etienne Nichols: Yeah.

Sara Adams: Unless you're class one and then maybe that looks different for design controls but.

Etienne Nichols: Well, I want to, I want to kind of close out with a statistic and then maybe an action plan. We have an action plan in the report to some of the results or the control conclusions that we drew from breaking down some of the data.

Because those are really good points. One of the things that I thought was interesting is one of the biggest fears.

Well, when it comes to, well, let's just say purchasing tools for making all of this easier, simpler, more streamlined, collaborative, all the different things is that, well, two primary things.

One is the cost. 69% of companies cited costs and that's a legitimate fear. If you say, okay, well am I going to get a tool and it's actually going to, you know, do something for me.

But then the second one is fears about how long it will take to implement that new solution and they consider that to be one of the significant challenges. I know you onboard quite a bit.

I don't know if you had any things to touch on with when it comes to building out new solutions for your medical device company.

Sara Adams: I so not everybody knows this. I had a, I, I lived in a paper based world for a very long time and I transitioned, I helped transition from paper into an electronic quality management system.

I, you and I have talked a lot about like where those live, how they get there, like what the bottom line for me is.

And I, I don't, I don't want this to come across as reducing people. A lot of times there are teams that are making do with less because they're not getting the headcount.

It's not always about reducing people, it's about not adding people. Right. And so if I've got three of us and we are spinning our wheels because we can't, we're not efficient, we are chasing down people, we are trying to, I mean I physically had you and I have joked about coffee stains,

right Because I'm, I, I give this document away and I would put post it notes on it that say when you sign this return to Sarah Adams desk because it gets lost and people can't, you know, it's like I don't, I've got, I don't have time to go hunt it down.

I've spent too much time in that but, or in explaining that. But what I hear when I see this is don't, don't consider the, or consider the cost of what you're implementing.

Like the tool that's going to drive efficiency. But more than anything that is a reduction in the number of people that you're going to need to do the tool, do the job right.

So you not only become more efficient but you reduce that, that. I don't know just what's the right analogy? Like herding cats seems right, right? Like going round and round the hamster wheel and doing the same thing, the same process.

It's wonderful if you want to like go out and make your processes on, on the manufacturing floor better, your design control processes better. But if you are still herding cats and, and not efficient at, at the, at managing your quality management system.

Yeah I, the, the point being there is that that cost associated can make it where you do need less people to do the work or you don't have to go higher.

Hey guess what? Like you don't have to pay for benefits for a software that, that comes right. You don't have to pay for time off and things like that. The second piece of this that I heard is how long it takes to implement and I think that that kind of depends on,

on you, it depends on what your team is facing on how many people you have and what the day to.

I, I would love, I love the teams that just come in with a mindset of like, you know, what if we all do this and we do it well for two weeks, three weeks, whatever,

we can really get things to a lot better place so that we are more efficient and we do have more time.

There are people like consultants, there are people that can go in and get it, get that piece done so that you can keep doing your day to day responsibility.

It's not as simple as putting a key in the ignition and turning it on. Right. There are some regulatory things that you have to do to be able to state going to an electronic system or we're going to use this new software that helps us be quicker.

At the end of the day. Oh God. Jump in.

Etienne Nichols: Well, I was just gonna say no, go ahead and finish your thought.

Sara Adams: No, at the end of the day, like it, it's,

I guess, I don't know. You finished my thought for me, at the end of the day, it's more valuable than it is frustrating. Right.

Etienne Nichols: Well, the analogy I was thinking of, and before I get into the analogy I was going to mention if people are interested in hearing what Sarah thinks about a quality management system and can you buy it, can you build it?

She has a great episode on the global medical device podcast called can you buy a qms?

And her analogy is with sourdough bread. And I'll leave it at that. Go check out the, the other, go.

Sara Adams: Listen to the other one.

Etienne Nichols: But the analogy I like to use is I, I think medical device companies are waking up to the inefficiencies of document management because having lived in paper based, the **** technology I like is computer aided design and 3D CAD.

Sara Adams: Yeah.

Etienne Nichols: As a mechanical engineer I've used a lot of different types of CAD in my time and I actually worked at a company where we had six different ways of managing our, our blueprints.

We'd have parts come in that I was a refurbishing type engineer. I would evaluate what we had, what could we use, what we. And I would need to go look at the old print.

Sometimes I'd look at it at microfilm, sometimes these were hand drawn.

Sara Adams: Oh wow.

Etienne Nichols: You know, cats had the impressive things and those engineers knew their stuff but they've been outdated. They've been replaced by guys who know 3D CAD. And if you are trying to implement SolidWorks for the first time, it's going to slow you down at first and everybody's going to be frustrated.

But think about it. In the long run, does it make sense to draw things on paper or to draw them in cad? I, you know, in the day and.

Sara Adams: Age that we're living in. Right. Yes.

Etienne Nichols: Okay, let's get to this action plan and I'll, I'm just going to skim over this. I really encourage you all to go check out this report. But the, the action plan.

Would you talk about re. Reality checking your timeline and we talk, talk through the different changes in timeline from a class two, class three perspective. And companies that are, have successfully launched products versus those who don't have any products on the market.

I think it's worth looking at that because to me if I'm owning a company or running a company, what I look at is, okay, that's knowledge. Knowledge behind this can get me faster.

So something to think about. Secondly, bridge the leadership employee divide. There's a, there's a dissonance here between what the leaders think they can accomplish versus what the quality of regulatory development people.

Sara Adams: Yep. The worker bees, if you will.

Etienne Nichols: Yeah, right. And that's, that's pretty big. So I think that's something worth mentioning. The third thing is you can accelerate that performance with the right technology.

And we've already mentioned this, so I'm not going to hit it too much home. But I will say that based on the data we were able to come up with from these 536 companies that use purpose built medical device quality tools are twice as likely to hit their quality targets compared to those using generic solutions.

So that's, that's pretty big. Fourth, it's important that you break down those data silents and your future performance depends on this.

This is incredible to me. Companies that report they are very well equipped to reach quality objectives are six times more likely to say their organization is highly collaborative. Collaboration matters.

Sara Adams: I, I think collaboration matters and like just to add to that, it is a better work environment when there is collaboration and you don't feel siloed. So it's a secondary part of this.

Etienne Nichols: You know, we talk about collaboration. Maybe what it really boils down to is communication. If you talk about any relationship without communication, it will fail.

Sara Adams: And then it really boils down to trust and vulnerability. Right. Like, do I trust this person to be able to walk in the room and be like, this is a bad idea.

This is not what we need to do. Right.

Etienne Nichols: All right, moving on. The fifth, the fifth point in our action plan is to make quality your competitive edge.

Sara Adams: You put this in for me, didn't you Atie?

Etienne Nichols: Hey, this is a mutual this is a mutually right here. Make quality your competitive edge. But what are your thoughts? And I want to hear, I mean.

Sara Adams: I feel like that's what we've discussed this whole time because I'm, I love quality. I think it, it, it can be your competitive edge. Like if not just, not just from a efficiency standpoint in the workforce and, and money and things like that.

Like it's your name on the market. Like how many times have you heard about recalls or advisor warning letters, things like that? Like if that is your brand,

that's not a good thing. I, you know, gosh, I work in the device industry. I shouldn't say this because then I'll get a bunch of LinkedIn messages, but there are devices that I don't want in me, there are brands that I don't want in me.

I don't know if you've heard me tell the story about delivering two babies and being like, and what brand are those stitches? Like because I, you know, there's just some things that you've seen.

So again, I probably have a skewed perspective because I work in the industry. But from a quality is a competitive edge not just in like finances and, and reducing costs and reducing failures, but also like do people actually want your product if you don't have a quality product on the market?

Etienne Nichols: Yeah. And the regulation, if you read the very beginning of 21 CFR part 820, the purpose of the regulation is to produce safe and effective devices.

And the easiest way for me to think about that mattering is to think about it impacting my six week old baby, for example, or whatever else that.

Sara Adams: The patient like directly in your center, in your circle. Right.

Etienne Nichols: And so the very last line of this report, I really like this, or of this point at least, is when quality drives your decisions, regulatory requirements become stepping stones rather than roadblocks.

And I think that's pretty good way to point it.

Sara Adams: You just see things differently, right?

Etienne Nichols: Yeah.

Sara Adams: Agreed.

rofessionals surveyed for our: 2025

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