How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training.

Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic devices and the unique relationship these devices have to medical devices in terms of industry best practices and tools that manufacturers can use to produce high quality products that are safe and effective for end users.

 

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Some highlights of this episode include:

  • IVDs are different from medical devices and therefore treated differently. The difference between IVDs and medical devices is the way performance is proven.
  • Read the FDA and EU regulations for medical devices and IVDs because changes are immense for the classification of devices. 
  • The amount of growth for IVD startups is driven by the up cropping of contract manufacturers. There’s a lot more bringing it to market with less resources.
  • The pandemic has been good for the medical device industry and for bringing products from concept to fruition and through regulatory approvals quickly.
  • Don’t reinvent the wheel. Focus on your technology and seek advice from quality professionals to achieve efficiency and effectiveness.
  • Or, make space for the FDA to move in for months for an inspection and audit. Do the right thing and know what the right thing is. Keep your audit manageable.
  • Perform quarterly quality fire drills with a robust internal quality audit program to prepare ahead of time. Review inventory, complaints, deviations, and more to be current on compliance. 
  • Big Mistakes and Common Challenges: Starting design control and risk management too late. It doesn’t take that much effort to document work.

 

Links:

Joanne LeBrun on LinkedIn

MDC Associates

FDA - Medical Devices

European Union Medical Device Regulation (EU MDR)

EU IVDR

ISO 13485 Quality Management for Medical Devices

Abbott Laboratories

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Joanne Lebrun:

“The difference between IVDs and medical devices is the way that you can prove performance.”

“The quality systems are similar, but if you’re a medical device person and you’re headed into an IVD situation, do keep in mind that it is quite different and the rules for IVDs are just a little bit more forgiving than in a medical device arena.”

“There’s a lot more bringing it to market with less resources to be able to use some of those contractors.”

“The pandemic, while it’s been very hard on a lot of people and I don’t certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast.”


Transcript:

Announcer: Welcome to The Global Medical Device podcast, where today's brightest minds in the medical industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: Okay, this is an exciting episode. I get to talk with Joanne Lebrun with MDC Associates. You'll find out really quickly, she's got some really intense, exciting, positive energy. She's got a lot of expertise in IVD, and so she and I had a chance to chat a little bit about IVD and the relationship to med device as well as the importance of quality management system and things like design control, so enjoy this episode of The Global Medical Device podcast. Hello, and welcome to The Global Medical Device podcast. Well, that on struggled to come out. I guess I need to drink some more coffee, but anyway, Global Medical Device podcast, now with video. Yeah, that's right, folks, you've been listening to The Global Medical Device podcast maybe for years. We recently added video, so if you're running down the beach with your earbud in listening on a computer and get it on screen, you can see my lovely face and the face of our guests as well. And joining me today is Joanne Lebrun with MDC Associates. So Joanne, welcome.

Joanne Lebrun: Thank you. Happy to be here.

Jon Speer: Absolutely. So I'll start with a short story. So my partner team and Greenlight Guru, they said, " You've got to talk to Joanne, she's the IVD guru." And I'm like, " All right, tell me more." So we're going to talk about IVDs today. Is that okay with you?

Joanne Lebrun: Absolutely.

Jon Speer: All right, so specifically, let's start to dive into, I guess, what an IVD company should be doing from a quality management perspective because I think this is confusing in some respects, just that term, IVD. In the US, it seems like it's handled a little bit differently than my outside the US, so maybe that's a good place to start. So how do you see this as the same and different from med device?

Joanne Lebrun: Yeah, absolutely. So IVDs are definitely different, and in fact, they are treated differently in the United States as well, at least in Europe and I'd say in Canada as well, and the difference between IVDs and medical devices is the way that you can prove performance. In medical device- land, there's a lot of clinical evaluation and clinical performance studies that need to be done and the regulators around the world recognize that that's not always possible for IVDs. The nature of an IVD is the in vitro part, which means you're testing outside the body, and so that's what in vitro means. And so, we're testing all of the things that could potentially come out of our bodies to be able to tell us what's in our bodies, and so everybody recognizes that that is quite different. There's no implants that have to happen, there's no pharmaceuticals that need to be taken, and instead, you can get leftover specimens from laboratories and test them, and it's just a little bit less complicated to be able to, number one, consider performance, and number two, define how things work and in the way that they work. So they are treated a little bit differently. There's a lot less emphasis, I would say, unless you're a sterile in vitro diagnostic device, there's a lot less emphasis on that sterility and contamination possibilities, and things like that that medical devices would have. So the quality systems are similar but if you're a medical device person and you're headed into an IVD situation, do keep in mind that it is quite different, and the rules for IVDs are just a little bit more forgiving than in a medical device arena. We talk about that a lot, I talk with a lot of medical device people who are into the IVD arena now and those adjustments are a little bit difficult to take and the scrutiny that's paid on medical device companies sometimes isn't there for IVDs just because it's not critical to the device itself. However, all of the quality system stuff is exactly the same.

Jon Speer: Okay, so it's more on the product where the nuances and the differences and the contrasts are and not so much so on the QMS.

Joanne Lebrun: Exactly. However, as you're putting your operations together, and if you're doing manufacturing, which not everybody is doing these days, there's a lot of contracting going on these days, but if you're doing manufacturing, again, cleanliness, clean rooms, and all that sort of stuff, little bit less emphasis in the operations stuff, but the basic tenets of quality systems, the 30 to 35 procedures that you need and that's not a real scientific number, that's just a guess in my head.

Jon Speer: Right.

Joanne Lebrun: But the 30 to 35 documents that you need to describe your quality system, and then control and have all of those controls in place are basically the same. You follow different regulations, the IVD world works with a different set of reviewers and people at FDA, but the compliance people are the same, so the same people who are auditing medical device people are auditing in vitro diagnostics. And the regulation that you would adhere to in the EU are different as well. There's the medical device regulations, which, I'm sorry, all of you medical device people, that is upon us, but the IVD has an extra year maybe, we'll see how that goes. The moment is now, so it is what it is, but we do have an extra year to be able to get ready in the IVD world because-

Jon Speer: And people like you and I, we read regulations, I don't want to say for fun, but we don't mind reading regulations. Maybe you do it for fun, but when you read through, and I do encourage folks, if you're in this space, you should go read the regulations, especially, but when you read the EU MDR versus the IVDR, I guess my take- home from that is it's a very similar message but what I interpret is... I guess I perceived it as newer or there's been less information or not as much guidance, and so the IVDR is much, much beefier as far as the details maybe than an MDR.

Joanne Lebrun: The changes are immense, yeah. And so, my team and I just went through and it was not fun but it was okay, we went through literally reading, word for word, out loud because you don't really internalize it unless it's said out loud because usually I'm thinking about I've got to buy some bread, and I've got to go out and walk the dog, while I'm still reading all of the words of the regulation because they're incredibly, sorry everybody, boring and dry.

Jon Speer: Yeah.

Joanne Lebrun: But we read them out loud and we compared them, medical device directive to in vitro directive, regulation, sorry guys, so that we would know the difference there and there are some significant differences, there also are very many similarities, and the original IVDD was built from the MDD, with that performance thing considered. So the regs really are basically the same- ish, we'd have to talk about it, but you're right, the differences that have come up between the IVDD to the IVDR is way more extreme than the MDD to the MDR, particularly in classification of devices.

Jon Speer: Yeah.

Joanne Lebrun: In the IVDD, it was these, those, and everything else, and everything else was considered self- declared which was great for the device companies but problematic to the state of the art and the state of healthcare in the EU, so that's why they made that change difference. Now, it's these, those, some other little things that are self- declared, and all the rest now are not.

Jon Speer: Right.

Joanne Lebrun: And that's really the big difference. I'm happy to talk to anybody about those differences and what to do about it, but we're in the process of doing some really deep dive analysis to make sure that we understand the difference, but it is the same stuff. And the quality system requirements, and the risk management requirements, and the design control requirements, all in quality systems, of course, are pretty much the same as device company to device company.

Jon Speer: Right. But the seat that I'm in at Greenlight, a lot of times I'm seeing, well, where is the ball moving, where are the new opportunities within this space? And one of the things that I've heard is that with IVDR, that this will cast a net over a lot more companies, regulate a lot more companies than have ever been regulated before.

Joanne Lebrun: Yeah.

Jon Speer: And that goes back to your earlier point about classification, and at the same time, it seems like there's a huge amount of growth in startups in the IVD space, so what is driving that, do you think?

Joanne Lebrun: Oh, man. I really do think that the up- cropping of contract manufacturers is helping a lot because we've gone past the days of, I want to make a device, I need to make the device. I need to do the software, I need to make the instrument and the startup needs to do all of that themselves, whereas these days, there's a lot more virtual.

Jon Speer: Right.

Joanne Lebrun: We're talking to each other, I'm in my house, you're in your house, so things are definitely globalizing, some from pandemic and just by nature, and so there's a lot more bringing it to market with less resources to be able to use some of those contractors. I think the other thing too is that now that there has been so much molecular science happening and so much definition of the genome, and so much sequencing where you can identify that this snip of this sequence means this, that there's a lot more opportunity for the really smart people in this world to bring a product to fruition even if they don't have all of the infrastructure to be a corporation. So I think there's a lot of opportunity out there and I think there's a lot of flexibility for a lot of the really smart people to be able to bring stuff to be, which is very exciting. And I think, really, the pandemic, while it's been very hard on a lot of people, and I don't certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast, depending on who's listening, but it really is setting a stage for, we can react and, yes, we can follow variants and we can be so flexible that a variant can crop up, and of course we're all familiar with COVID variants, or if you're not, watch the news, but a variant can crop up and the FDA or the regulators can say, " You need to react to this variant," literally in the news and here it is. So I think that really says a lot about our industry. Unfortunately, our industry is moving at light speed at the moment, light speed.

Jon Speer: Well, light speed, and then that's going to be the next area I wanted to delve into. The industry is moving at light speed but the ability to regulate is not.

Joanne Lebrun: No, no. They're doing their best, it's a big machine. Startups are a little machine and we all know, small companies are more nimble, right? There's less people, there's less-

Jon Speer: People go zipping in and out and we're on this... Regulations is this giant oil tanker.

Joanne Lebrun: Barge, right.

Jon Speer: It's going to take forever.

Joanne Lebrun: Exactly, but it's got a lot of power and it definitely can't turn on a dime. It takes a big turning radius to get that happening, you're absolutely right. But I do have the fortunate position to talk to a lot of regulators on a day- to- day basis. I talk to a lot of notified bodies, I talk to a lot of reviewers, I talk to the FDA a lot, and they're trying so it's not that they're sitting back and just enjoying the sun on this big barge, but they're feeding coal into that engine as quickly as they can, they just understand that everything is really big and takes time. And if it didn't, that would be a problem as well, because how dare a government agency be so reactive? So they're damned if they do, damned if they don't and I do feel their pain. I really think that they're doing a great job and I think that the task put to them for the last 12 months has been, in my opinion, would have been near impossible and they're doing it.

Jon Speer: Yeah, that's true.

Joanne Lebrun: Everybody knows, even who aren't in our industry, what PCR, at least the three letters, they may not know what it stands for or what the implications are, but they understand molecular, and they understand PCR. We are a household name and no one ever... I used to have to describe what I did by, " Well, you know when you go to the hospital and you get your blood drawn, and then they give you test results after that?"

Jon Speer: Right.

Joanne Lebrun: "Okay. We do that." But that's the very basics of what we do. No offense to the clinical chemistry people out there, there's a lot going on in that arena, but it's definitely we are getting some attention and there's a lot of pressure to be able to keep up with that attention. And obviously, everybody wants to be tested, everybody wants to be vaccinated, and in order to test, I'm not leaving those medical device people out there, there's stuff there that has to come through too.

Jon Speer: For sure.

Joanne Lebrun: The swab manufacturers, bless their hearts, because they're doing the very best that they can do with what they've got. Mask manufacturers, the glove manufacturers, the face shield manufacturers, there's a lot of pressure, and as we all know, and I'll try to keep my language clean, but the supply chain is jacked and has been for the last 12 months and that's been really tricky too. Not just in toilet paper, the toilet paper thing has evened out a little bit, thank God.

Jon Speer: Yeah, I found some crosstalk, we're in good shape here.

Joanne Lebrun: Right.

Jon Speer: We're good.

Joanne Lebrun: But even appliances, even things that aren't medical.

Jon Speer: Building materials, appliances.

Joanne Lebrun: Brutal.

Jon Speer: Things that used to, oh, I'll just go to the big box store because I need a new microwave. There might not be any there. That's crazy.

Joanne Lebrun: It's insane, yeah, it's insane. So we're finding the same thing in the device industry and really trying to navigate what's going on with that.

Jon Speer: Yeah.

Joanne Lebrun: So do the best you can to be able to get your product designed the way it should and do all the things you've got to do, and get your operations together and get your quality systems together and get your resources there and get your contractors there and control your contractors the way they need to because you do need to control your contractors-

Jon Speer: Right.

Joanne Lebrun: ...as critical suppliers, so please don't ignore that, but get all that together, and then you're like, " Okay, place an order."

Jon Speer: Oh.

Joanne Lebrun: All right, we're not going to get that order. So that sometimes will cut you at the knees too. So yeah, we're really seeing a lot of challenges but it's making us more nimble. What doesn't kill us makes us stronger, right, and so I think that's really starting to happen and we're really trying to get up, get moving, and do it fast, and the beauty of using something that, just to get to quality systems, not starting from a blank piece of paper, is huge in this industry.

Jon Speer: Yeah.

Joanne Lebrun: Please, people, don't start with a blank piece of paper, use Greenlight Guru.

Jon Speer: Don't reinvent the wheel.

Joanne Lebrun: Use us, use somebody.

Jon Speer: Right.

Joanne Lebrun: Steal somebody's quality system. I didn't say that out loud but I did. But use something that doesn't make you start with a blank piece of paper, reading the regulations and translating what is in legal speak to what's usable.

Jon Speer: Yeah.

Joanne Lebrun: You're just wasting your time, and so contact the likes of me, anybody, whoever. You have great templates in your system as well. At least use something to be able to identify an approach to get it to happen, because now is not the time to be figuring it out for yourself. And so, we've been doing a lot of that, of just start with this. Make your company what you want to make your company, and I love the fact that everybody wants to be unique, but if there's quality professionals listening to this, we all know there's only so many ways you can do training. There's only so many ways you can do document control.

Jon Speer: Right.

Joanne Lebrun: Not that it's boring and I am definitely a quality systems geek, big time, but there's really only so many ways you can accomplish that and accomplish it with some efficiency and effectiveness. Again, now is not the time to run things around and burden yourself with committees and that sort of thing to keep things going.

Jon Speer: I think that's key. I want you, as an entrepreneur, you, not necessarily Joanne, but you, listener, to be able to be focusing on your technology.

Joanne Lebrun: Yes.

Jon Speer: Don't reinvent something that doesn't need it. To your point, there's a finite number of ways to address a quality system, and people have done this before who have expertise in interpreting those regulations, especially if you are a startup, regardless of med device or IVD, focus on your technology. That's what we want from you and, of course, we want it to be safe and effective, and this is what a quality system can do for you, but call Joanne.

Joanne Lebrun: Yeah.

Jon Speer: Call Greenlight Guru, whatever the case may be.

Joanne Lebrun: And what are the tricks of the trade? We know the tricks of the trade. We know not only the shortcuts but I envision it as-

Jon Speer: Straight path. We know the straight path.

Joanne Lebrun: Yes. If I need to go to the store, I'm not going to blaze my own trail through all of my neighbors' backyards. I'm going to take the streets that have already been paved for me.

Jon Speer: Right.

Joanne Lebrun: And I'm going to drive by the rules of the road because that's what's been set up for me, whether I think 20 miles an hour is an appropriate speed limit is a different story.

Jon Speer: Right.

Joanne Lebrun: But still, I'm going to stop, and people who know me are probably laughing because I'm not really a rule follower on the road, but anyway, I do use that analogy a lot, so stop laughing at me, but that's how I think of it. We don't have to blaze our own trail, and maybe while things are relaxed and we want to be explorers and all that sort of thing, it makes sense to blaze our own trail but if there's a trail, I'm going to follow it just because I know it's cleared and I know that there's no bugs, and it's been walked before and it got me there. And so, everybody just wants to get to that finish line, they don't want to struggle to be able to get there.

Jon Speer: Yeah.

Joanne Lebrun: But you're right, we don't know the technology, and I try to stress with all of my clients, I don't know what you do, and so all I want to do is describe what you've crosstalk.

Jon Speer: I'm not going to go try to figure it out.

Joanne Lebrun: At all.

Jon Speer: That's why you do what you do.

Joanne Lebrun: Yeah.

Jon Speer: Let me do what I do. Let's figure out how to blend, right?

Joanne Lebrun: Exactly, and all I want to do is write and control what you do.

Jon Speer: Right.

Joanne Lebrun: Not pin you into a corner and say, " You can only do it on Tuesday with a blue shirt on," that's just insane, right?

Jon Speer: Got it.

Joanne Lebrun: So I want to open up your possibilities, but also make sure that when the FDA walks in, and note I do say, when the FDA walks in, not if the FDA walks in.

Jon Speer: Because they will.

Joanne Lebrun: Because they will. They're going to get to it, they haven't been anywhere in a year, we've had a nice little respite, as far as that goes, everybody, clean house because the FDA is not coming right now unless you have problems but I guarantee you, when things start opening up, here comes the FDA because they've got to make up for lost time, and they're going to be doing a lot of inspections and you want to be ready and you don't... Early in my career we would talk about, well, let's just see what happens in the audit, and then we'll adjust. Please don't take that tack, please don't. Figure it out before you get there and make sure you have your house in order before somebody shows up and expects it to be in order, because the forgiveness is way harder that way than if you just-

Jon Speer: Right.

Joanne Lebrun: ...get yourself in order. And if you're desperately out of order, there are ways to pull yourself in order enough to be able to survive an audit without an inspector being in your facility for months, which has been done, for all of you folks from Abbott, you know what I'm talking about, and other companies. We've been there for weeks and weeks and weeks and weeks, and I would just think that Abbott has the best history in that. It was years ago, decades ago now.

Jon Speer: Yeah.

Joanne Lebrun: But still, it was epic.

Jon Speer: Well, the reality is, you can pick any large company.

Joanne Lebrun: They move in.

Jon Speer: They move in.

Joanne Lebrun: Yeah. They move in.

Jon Speer: I've consulted at places where I'm like, " Oh, well who's in that office," that's FDA's office.

Joanne Lebrun: FDA's. Right.

Jon Speer: What?

Joanne Lebrun: Yeah. So we don't want that to happen and if you're a small company, your resources go towards supporting that inspection so you want your resources-

Jon Speer: And it pulls you away from everything else.

Joanne Lebrun: Totes, nothing gets done.

Jon Speer: No.

Joanne Lebrun: Nothing gets done, so it makes the most sense to try to keep that audit at a nice even keel, make sure that they know you have integrity, and that they know you want to do the right thing and that you know what the right thing is, and that you do that. And we attend a lot of inspections, and I would encourage you quality professionals, bring somebody like us in if that happens. I know you can handle your own audits your own way but there are strategies that we can take to be able to help each other to get through that and keep your audit manageable. Don't let them have their way with you and makes sure that you hold your own. And so, we can help you to do that, not just us, anybody who's been through a lot of audits can help you to do that but the management of an inspection, ISO is exactly the same situation, the management of a quality systems or regulatory inspection is 99% of it is managing how that happens.

Jon Speer: Yeah.

Joanne Lebrun: And so, please do call on somebody if you're thinking, " Wow, we are in danger here." It's not super expensive, it's not super intensive, but somebody can help to be able to do that, so it's coming.

Jon Speer: All right, so let me take a brief pause.

Joanne Lebrun: Okay.

Jon Speer: I want to remind folks, I'm talking with Joanne Lebrun with MDC Associates. Joanne, tell folks a little bit about MDC Associates before we get back to crosstalk.

Joanne Lebrun: Yeah, absolutely. So we're a relatively small company, we've been in business for over 30 years, which is rare for consulting firms, so we're quite proud of that. We have three different things we do. We do quality systems consulting with all the stuff I've been talking about, we do regulatory consulting, getting clearance and CE mark for products, internationally as well. And then, we also have a unique niche which is our implementation training department, so for companies that have relatively small analyzers, not the great big things that need installation, we will do video installation, like what you're watching today, to work with customers of small analyzers that can be implemented in the facility, and we do that through video training and work with the organization to be able to do that. It's a cool program but that's pretty much the of our departments. We've got a lot of people, we've got a lot of expertise. I think we're a joy to work with, we're a no BS kind of a company. I think you can probably tell.

Jon Speer: Yeah.

Joanne Lebrun: Because there's me, but we work really hard and we make sure that we're part of the team and that we take on the workload and work really hard to get you where you need to go, because if you're not a success, we're not a success and that's the bottom line of what we do. So that's us, we're located in Boston, north of Boston. Us, like everybody else, we're branching out a little bit, there as lot of us, obviously, I'm working from home, this is not my office. If it was, it would be posh because I have windows in my office. But I think we do a really good job, and I think we're unique in that we work hard.

Jon Speer: Yeah, for sure. So folks, go check out MDC Associates. You can go to their website: M- D- C- A- S- S- O- C dotcom.

Joanne Lebrun: Yup.

Jon Speer: And IVD expertise galore, so check that out. I want to also remind you, we're taking this brief break about Greenlight Guru. We have the only medical device success platform on the market today. We designed and built this specifically for medical device and I want you to understand that also works for IVD.

Joanne Lebrun: Very, very well.

Jon Speer: Yeah, very, very well, crosstalk. But go check it out, www. greenlight. guru to learn more. Whether you're a startup or an established company, it doesn't really matter, we've designed it with the regulations in mind to help you not have to reinvent the wheel from a quality perspective. You can focus on your process and your technology and let us help you with the compliance and the workflows around design, development, risk, document management, quality events, and so on and so forth, so check that out. And oh yeah, by the way, I forgot to mention the Greenlight Guru academy, have you heard about this? We just launched the Greenlight Guru academy. It is an awesome platform where you can learn about topics within the medical device and IVD industries that you care about. Maybe you want to know a little bit more about the time controls or more about regulatory submissions, well, we're building learning paths for you in the Greenlight Guru academy so go check that out as well. All right, so Joanne, let's get back into the conversation. So you said something a moment ago. FDA will be there and it's not an if, it's a when, and when they do show up or an ISO auditor, to me, that's the wrong time to find out, did I did a good job with my quality system?

Joanne Lebrun: Absolutely.

Jon Speer: And you said, " Well, give us a call at MDC," and I agree with that. What do people do ahead of time rather than perform the fire drill, so to speak?

Joanne Lebrun: Yes, yeah. We usually call it battle stations, but yeah, absolutely. The best thing to do, and everybody's going to groan at me, but the best thing to do is to have robust internal quality audit program. And a lot of people fluff over those internal quality audits, but if you really take that program seriously, what we end up doing actually, is we break our clients into quarterly audits. Doing one big system audit a year, first of all, is a pain in everybody's butt, and it takes a long time. Second of all, what it does is it gives the quality department this huge laundry list of things they need to fix, and they can't get to it all, and then things get aged, and then they don't address all of their CAPAs at the right time and it really doesn't serve you. So what we end up doing is we break the quality system into quarterly sections so that through the year, quarterly, we're auditing the quality system, and we've broken it up effectively so that you know you're going through your whole quality system all year, so then you have things to take care of throughout the year, and you maybe have a chance of getting those actions done. So then, you have familiarity, you've touched all of those systems through the year, you know where you have challenges. The FDA is not going to give you a lot of notice, folks. It's going to be, at most, five days notice that you can maybe say, " Hey, our CEO is on vacation on Friday, can we do this Monday instead of Friday?" That's about all you get.

Jon Speer: Yeah.

Joanne Lebrun: And really, you don't get a lot of put- off time, and obviously, for ISO, you're scheduling that, so that's a different thing but you do have unannounced audits, so don't forget about those.

Jon Speer: Yeah.

Joanne Lebrun: But the best way to be able to handle that is our battle stations usually are, look at your inventory, make sure you have status on all of your inventory. Look at your CAPA system, are all the CAPAs closed? Have you taken all your actions? Is anything overdue. Same with non- conformances, same with complaints, same with deviations, if you have them. Deviations, I used to want to develop, I was starry- eyed and I thought I had it all going on, I wanted to develop quality systems with no deviations in there. All right, we need those. So my bad if anybody has been working with me for decades, but I think it's really important, but if assign dates, are they up to date? Extend your dates, do with what you've got to do to be able to be current. You're right, when the FDA walks in, that is not the moment you want to open up a CAPA and go, " Oh God, this looks horrible, what are we going to do about this?"

Jon Speer: Or when the FDA calls or ISO says we're scheduling, have your finger on the pulse way before that moment.

Joanne Lebrun: Yeah, yeah. Don't pull an all- nighter the night before. Because if you do, first of all, you're not going to be at your best for the audit, you need to think fast during the audit. So if you spent an all- nighter, you're already setting yourself back.

Jon Speer: Right.

Joanne Lebrun: Been there, done that, we've done plenty of all- nighters before audits, but you don't want to get to that point, so the more robust your quality monitoring system, and the quality monitoring system in my head is, yes, those internal quality audits, for sure, CAPA, NCR, complaints, deviations, management review.

Jon Speer: Right.

Joanne Lebrun: That's not just you've got to get together and talk about... There's actually a lot of value that happens in that management review meeting, and if you can do that, then you have your finger on the pulse, and you know what's going on in your quality system, and you also know how to handle and how to present the things that maybe aren't the best. And so, when somebody asks for something, we all have war rooms and I hate all the acronyms that are all of the things that we have there, but we all call it a war room. And so, you know what you're heading in with but you don't want to put a pile of steaming you know what in front of the FDA without yourself knowing it is a pile of steaming you know what, and how are you going to make that seem like a pile of gold? Or at least, we're already knowing how to sculpt that and know what we're going to do with it. Sorry, gross analogy, but we all have our steaming piles, so you really need to be aware and you really need to be constantly, have a monthly session for yourself, it's a working session where you go through all of your logs and make sure that they're all updated. Just look at it once a month.

Jon Speer: Yeah.

Joanne Lebrun: Walk the floor once a day if you have manufacturing stuff. I'm guilty of staying in my office too long, but if there's a manufacturing floor, please walk that floor at least once a week, at least once a week. Understand what's going on.

Jon Speer: And you get some stuff there, what's the harm, right?

Joanne Lebrun: Right.

Jon Speer: And you'll see things, anomalies. Those things will stick out to you if you're doing that on a frequent basis.

Joanne Lebrun: Yeah. You've got to be in touch, you've got to do it. And I know we're busy and I know the day- to- day is an awful lot of stuff to do, I get it, and resources are tough, I get it, but you don't want that inspector to be the first person to see it.

Jon Speer: Yeah.

Joanne Lebrun: For sure.

Jon Speer: And again, IVD, I think, because of the dynamic nature of what's happening in the world, and there's a lot more companies that are startups in this space, and you've been working with quite a few of them, what are some of the biggest mistakes? And I guess it doesn't have to be necessarily a startup but what are some of the mistakes or challenges that you've seen on an all too frequent basis with respect to quality system?

Joanne Lebrun: Starting design control too late.

Jon Speer: Yeah.

Joanne Lebrun: Starting risk management too late. Such a big mistake, and it's not as much effort as you think it is.

Jon Speer: Right.

Joanne Lebrun: And I'm not saying, even if you started too late, I'm not saying, this time last year you've got to remember the things you said. Please don't just go back and document that stuff, but there's ways to be able to catch up, but you're not going to remember, and we're all getting older, I literally can't remember what I did yesterday, so we're not going to remember what decisions we made six months from now, in the past, that made an impact on our design, on the way that we did risk management, on the way that we mitigated a risk. And so, if you can document real time and just get everybody in the habit of documenting. For those of you out there in R&D, I apologize but it is true, the other mistake that I see is not tagging your work, and understanding, this document, you open up a file, yeah, sure, your computer's going to tell you when you created that file, but if you've moved it around, you lose that traceability. So who wrote the document? When did you write the document? What were the variables you were trying to control with the data that you came up with? What is the significance of this data? I can't tell you how many times I've looked at a spreadsheet from six months ago, five years ago, I don't even know what this means anymore.

Jon Speer: Right.

Joanne Lebrun: I can't glean anything from it. All that data that you worked so hard to create loses its value.

Jon Speer: Right.

Joanne Lebrun: And it's for nought. So if you can put that extra little information. I always tell my clients, make it so that your grandma can understand it. Your grandma may be a rocket scientist, so sorry for those of you who have incredibly smart grandmas, but make it for me. I'm not a scientist in that regard, so that you can really explain, and I also use a moniker of tell the story. When you're creating documents, it doesn't matter what it is, it really doesn't, tell the story of why you're doing what you're doing, what assumptions you've made, what justifications you may have made, and then what the data means, and explain it to the likes of me, explain it to the likes of my grandma. Maybe I should just pick my grandma.

Jon Speer: Right.

Joanne Lebrun: Explain it to the likes of her so that she can understand the basics of what you're talking about. Then, when we go back five years from then, then we're like, " Oh, I remember what we did in that study, and I remember the conclusions that we drew. Okay, let's not make that mistake again, because here we can see that we had a problem." That, I think, is the message I try to tell everybody and for you software folks too, not just for the reagent rockers out there.

Jon Speer: Well, it's for every medical device company.

Joanne Lebrun: Yeah.

Jon Speer: Reagents, software, even-

Joanne Lebrun: Hardware.

Jon Speer: The mechanical people, hardware.

Joanne Lebrun: Totally. All the same stuff, and the work you do today, you're not going to remember. All right, maybe you guys are young and you're going to remember in a couple of months, good for you, but you're really not going to remember it. You're going to fill your head with so much information between now and the time you go to market, you're not going to be able to recreate. So it really is best if you keep a little diary, a little list, a little something- something, so that you can keep track of, when did your inputs change, when did your risks change?

Jon Speer: Yeah. crosstalk.

Joanne Lebrun: All of that stuff.

Jon Speer: Why did you do it? Who was involved in the decision? Because the other thing I think that people forget about is, at some point in time, you're going to want to bring this product to market, and that product is going to be in the market, and every product that gets into the marketplace will change, something will change. What if you need to make a change from a particular component or a reagent chemistry or something like that? What if the change you're making was something that was done during the development process-

Joanne Lebrun: You already tried it.

Jon Speer: ... thatdidn't go so well?

Joanne Lebrun: Right.

Jon Speer: Wouldn't you wan to have evidence or knowledge of that?

Joanne Lebrun: Yeah.

Jon Speer: Rather than having to find out the hard way? I think a lot of times-

Joanne Lebrun: It's so expensive.

Jon Speer: ...it's good to think about that. At some point, it will go to market so you have to be a little forward- thinking at times.

Joanne Lebrun: You do.

Jon Speer: This is one of the benefits of design controls.

Joanne Lebrun: Absolutely. It's so, so, so important. And shortcutting verification and validation, oh my God, y'all, please stop doing that, because really, here's the deal. What needs to happen is, yes, you need to put your best foot forward to get your clearance, right? Whatever it is, CE mark, your pre- market approval, whatever it is, wherever it is. You need to put your best foot forward, sure, but if your best foot is so far away from what you're going to make every single day, then all you're going to do is have problems in the market.

Jon Speer: Right.

Joanne Lebrun: You're going to have complaints, you're going to have recalls, you're going to be running that stuff around and that's going to take up your resources where you could be making product to sell. So consistency really is important. The FDA, and I'm not going to quote this right, but they say somewhere like 80% of all recalls happen because of poor design control.

Jon Speer: For sure.

Joanne Lebrun: Could be 75, could be 85, I'm not really sure the actual number, for those of you who are geekier than me, but that number is intense. And so, if you cut corners, or if you're out there and you're saying, " Well, but that's an outlier, well, that's an outlier, well, that's an outlier," well, who is going to call that an outlier when we're really using it as a device?

Jon Speer: Right.

Joanne Lebrun: No one. And so, therefore now that's a performance problem as opposed to now an outlier, so you've really got to be careful and we want everything to be the best it can be and there's a lot of pressure to get it out there, I get it, but verification and validation is super, super important and thoroughness in that job is very important, and that's where regulatory folks can really help too because we do know some of the secrets to be able to get there, or at least the efficiencies to be able to get you to the finish line.

Jon Speer: Yeah. Those who know me know that I'm very much a design control and product development nerd. If you know the origins of Greenlight Guru, that was our beachhead, that's where we dove in to try to bring solutions to help with that, and up until that point, even yet still today, a lot people are like, "Ugh. Design control stifles my innovation and my creativity." Well, then you've got the wrong process in place, you've got the wrong tools in place, because that is not the intent.

Joanne Lebrun: Right.

Jon Speer: The other thing that drives me, sorry, I'm getting on a soapbox for a moment, Joanne, I should have warned you, the other thing that drives me crazy, especially here in the US, is somebody's like, " Oh, well, I have a class one device. I don't have to do design controls." You should want to.

Joanne Lebrun: Exactly.

Jon Speer: Because design controls are about demonstrating that your product is designed in a way that shows safety and efficacy, that it works.

Joanne Lebrun: Yeah.

Jon Speer: Why would you not want to do that? That's... All right, stepping off the soapbox.

Joanne Lebrun: And it's going to save you money in the long run. That's the crazy part of it. Yes, it's going to cost you money now, but it's going to save you money in the long run because you don't want to get out in the market and not come through.

Jon Speer: Right.

Joanne Lebrun: That does not want to be your market appearance. Your market appearance-

Jon Speer: Especially if it's your first entry too.

Joanne Lebrun: Totally. You want to be the superstar and yeah, they make a consistent product. Is that exciting? Maybe not. There's not a lot of drama in it, but it's good business and you don't want people to say, " Well, I don't know if I can trust that device, because I don't know, it doesn't work anymore." And you really want to be consistent in the market and that's the only way to do it is to test, test, test, test, test, test, test until you know what's really going on, and manufacture. Manufacture, I'm not going to say that that many times, but you want to make sure that you go through your process enough to prove that it really is robust and you really can continuously make this product, whatever it is, consistently and be honest about it.

Jon Speer: Yeah. Well, Joanne, I'm going to put a pin in this discussion today, but we're going to do it again real soon.

Joanne Lebrun: Cool.

Jon Speer: So folks, help me in thanking and give her applause, send her a note, whatever the case may be, Joanne Lebrun with MDC Associates. Again, M- D- C- A- S- S- O- C dot com.

Joanne Lebrun: That's us.

Jon Speer: Check them out. Thank you so much, Joanne, and thank you so much to all of you who listen to The Global Medical Device podcast, the number one podcast in the industry today. Now with video, new and improved, or whatever the right label might be on that, but check it out, share it with your friends and colleagues and if you need a little bit of help with your quality management system endeavors, design controls, this is what we do at Greenlight Guru for a living. We've got a software platform that's designed specifically for those purposes, so go to www. greenlight. guru and we'd be thrilled to have a conversation with you about your needs and see if we might be able to help.

Joanne Lebrun: It's worth it.

Jon Speer: It's worth it.

Joanne Lebrun: It is

Jon Speer: All right, so until next time, this is your host and founder at Greenlight Guru and you have been listening to The Global Medical Device podcast.


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