Tackling Today's Biggest Regulatory Challenges

What's up maybe work with Fra while I'm on this call to do something about the video, because the whole lips moving and words not come it. It looks really really bad. Just replace those with static image video up landing page. And then we put it out. No, just just replace the video on those slides where I'm in there with a still picture of me or something else. But don't have the video because the video does not work.

Anything other than that is fine. You can have a fucking chicken in there for all I care. Thank you. Bye. Good morning.

Chicken sounds good.

Did you hear me?

Yeah, yeah, it was funny. I I think I was the only one, and it wasn't recorded.

No, there were 6 other people that heard it. Okay, thanks.

And you were swearing, Sean, you'd have to pay to the swear jar.

Right.

You're gonna get flagged. You're gonna get flagged by chat. Gpt.

Oh no!

Yeah. Well, Chat Gpt has a number of problems with things that I say, Adam, you're backlit. and then.

You said, you know. Thanks for uploading whenever you do it. That latest weeks, chapter or sessions.

Is doing it, and she's supposed to have it done by today. So.

Share it once it's uploaded.

I will send a link.

So before the call. I was listening to the a little bit of the highlights for 10 x. And I was listening to some of Arlen's comments.

-Oh! What was your response?

About the dating risk, dating response of the matching services I see. And and what are your thoughts about that? I thought it was interesting.

Oh, I mean interesting is a kind word. Do you have anything a little more critical or supportive?

I haven't used them either way. I'm not a physician. I'm a consultant, so.

Right? Right? Yeah, it really had to do with how the consultants industry people engage with end users.

And my very, very 1st client was a physician that I worked with for several years in Santa Barbara.

2828 years ago.

Long time, ago.

What? What was the device? Was it a device or something else?

Yeah, it was a device that was a treadmill that took the cardiovascular indications and tried to help support the patient to help improve their and basically improve their symptoms. Thanks for.

Sorry. I'm just trying to let everybody in at the moment. Wow, so while I'm letting everybody in. I'm gonna start introducing today's speaker, Adam, and Are you unmuted, Adam?

Yeah, yeah, if you can understand my accent, you'll be able to hear me.

I think we can.

Good.

to panelists. More. And so where did we meet team? Prc, correct.

Correct and Malaga and team prrc, and then we bumped into each other really super randomly, in the airport. Like after it, and you will just, I think your flight was delayed. Oh, I know you are. You are very unhappy about that and that's how we met.

I tend to get very unhappy about delayed flights. Yeah, that's 1 of my my things.

That was, that was, that's the story. Pretty much. Last year Prc. Malaga.

Right? So we had a nice chat at the airport. And tell us about your background.

Yeah. So my background is pretty much all, all medical device, quality and regulatory. I started my career working in vitro diagnostics with Thermo, fisher, scientific and the anatomical pathology division. As a quality engineer. You know, just kind of really, really super basic being told. Go and audit this, and that was it. And you know, really kind of 1345, that's it. Before this was before. Eu ivdr all of that kind of stuff, you know, so like the good old days. So that was my beginning. And then after that, I had a few years at Thermo Fisher scientific. And then I moved to work for Stryker.

Working in the orthopedic division of striker predominantly on their mergers and acquisitions, team and remediation team? So basically, I was kind of on the team to go and sort out what Striker wanted to buy which often wasn't that clean? So you know, I would go and do the assessment first, st from the kind of Qa perspective. So see the Qms. Look at the technical documentation and give a report to the the mergers and acquisitions team of striker to say I wouldn't buy, or I would buy with certain caveats. And then from there I've kind of started my consultancy business, and I've just been darting around industry ever since. Working on a variety of devices, pacemakers, you know, implantables, orthopaedics, contact lenses, lots of devices as well as lots of Ivds as well. So you know, I've kind of had a nice.

you know, a nice kind of spread of devices that I've worked on. You know there's easily over 200 now must be so I don't know about anyone else on this call, but I really struggle how to show what I've worked on, and a Cv. You know, like, on 2 pages I don't know how to do it. So yeah, that's pretty much me. It's been all you know. And right now I work. I do a lot of kind of contract work for notified bodies and certification bodies. As an auditor, you know. Assessing conformance against, you know, relevant whatever kind of regulation or standard that I'm kind of asked to assess so I've got a good. I've had a good view of being the auditor.

Spent most of my life, probably, like everyone else here being audited. But having both of the the kind of hats and wearing both of those hats is really, I think, made me a better professional you know, because I kinda I really know what auditors are looking for now. And the reviews, you know, tech doc reviews because I do it a lot, you know, so that's probably up till the current day.

So tell us a little bit what it's like to work for a large manufacturer, because a lot of people here have not worked for large manufacturers directly. Yeah.

Good. Yeah, so super slow. You know, I think is the 1st thing like, everything moves slowly. You know, you can basically say anything will take a year plus 2 years, you know, kind of on top of that. I think the one thing I really noticed was your role as a kind of Qara profession was very, very structured. When you're a large manufacturer versus if you're in a startup, they basically say we need a tech file. And you're saying, Okay, who does? Who do I have for biological evaluation? And they point at you. And then you say, who do? I have for clinical, and they point at you, and then they say. Do I have for risk and the point of view? You know, versus large manufacturers, you know. I think

there's 1 manufacturer I was working with just finished with them recently, and they had a regulatory team of like 45 people. It's the biggest regulatory team I've ever seen. And they were going for EU, Mdr. And it was this massive, massive thing. And I remember I was like this device is not novel. It's not novel, it's essentially it was nothing really special about this device. They were just transitioning from, you know, Mdd. To Mdr. But I was looking at this to say, Why is this such a big program? For you know a handful of devices? And why does the staff need to be so big and whereas I got clearance on a similar type of device, you know, not novel with 2 people.

you know, and like half the time, you know. So I think there's a law. I'm not sure if you know it called Parkinson's law. Which is, I don't know how well coined as or how true actually is. But I like the principle which is basically that work expands to fill the time, you know. So you give yourself a year to do it, you know. Probably do it in a year. Give yourself 10 days to do it, and you'll probably do it in 10 days. My experience very recently is manufacturers really suffer as a result of that type of phenomenon, you know. You know, people still call EU, Mdr. The new Mdr. It's like, not new at all, you know. It's super old. So yeah, that's my experience. Is like, I think

anyone going into Qa. I would say, start with a startup, because if you start with a large manufacturer, you're kind of spoiled in that sense, you know, and I felt it when I went to a startup after it. I was like, Oh, I'm like I need to do everything here, you know, but it really taught me how to connect everything together, you know from it taught me how to connect, how risk and design when integrated. You know why risk management needs to be that 1st thing done. You know. But yeah, I had a very privileged job when I was working at thermal. It's very. It was very chilled relative to kind of being that startup.

So Adam is the 1st speaker in the New Friday in focus series. We're rebranding the thing and gonna make an announcement shortly. And about medtech leading voice exchange, which is a new platform. But not can do that yet. What I wanted to talk about for a second is, 1st of all, the topic for today is the biggest tackling, the biggest challenges in medtech regulatory. So what I would like all of you to do is to put in your number one challenge into the chat and to say what you think the biggest regulatory challenge is, and then we're going to

part of the new format is to use the chat more robustly than we've done in the past. And because I think that makes it more interactive. And yeah, that's that's part of the thing. and then we wanna introduce some new features. Tbd, like the idea of having a product demo for 5 min, or a fast round for 5 min or a startup. Come on for 5 min during each one of the calls so that it's not just all lecture. And we're trying to make these calls more interactive, but also to expand the audience from, you know, 30 people to 130 people. So that we have a larger, more dynamic

group. And I might, you know, ask you guys to help promote that part and parcel to that. If you want to be a speaker, you should reach out to me and and let me, and let me know that you would like to get on the calendar because we plan on building out an editorial calendar and promoting these things more than a week in advance. The way that the calls are structured right now, as webinars restricts that capability. But by switching over to meetings and having the same login and password every week. Then you'll all be able to log in with the same user id and password every single week. To the call and

That will be a slight, a slight format change. So I don't know how many responses we've gotten so far. Trying to answer FDA AI response properly. One person says

Keeping up with all the like weird questions. And like like, that's not what our device does. What are you doing.

Understanding the local regulation and dynamics when entering a new market, not assuming that you'll apply the same formula as your current market. Okay, that's good. Oh.

And Michelle kinda on the kind of Michelle culture and Nelly on kind of budget senior management. you know, as kind of everything, Nelly said, there is pretty much culture at the at the you peel the layers of the onion.

Culture. It's culture. But I I'm literally seeing it right now as we speak. At least half of my clients are like I don't care how long it takes. Here's your budget, but your FDA inspectors telling you you have to do it timely. And so you're they're just. It's like 2 worlds colliding. And so it's like, Oh, we'll do these cuts, and you can talk to it later. And I can tell you, FDA, inspectors are not taking the talk about it later or memos approach acceptable. But yeah, the culture is just you know. it's quality on a shelf. I've got my, I did my quality. I'm done. I don't have to do anything else.

Yep. Starts. Stops. Oh, yeah.

I have had. I've got one client that has paused his Qms. 3 times in 5 years has had 4, 4, 83, and we have 3 right now. We're trying to close, and he tried to pause it again. And I'm like you have, like you're going to get a warning letter. If you do not close these campus.

Yeah, well, yeah, that's pretty. That's pretty crazy. I think. Sean, if if you like, while we're letting some people kind of finalize the answers I I can give. I I thought everyone, because I know predominantly everyone would be on the other side of the of the water. I could maybe give you a little update on what's going on in the Uk. If you like. Just while we're kind of spending a few minutes, kinda everyone's putting their answers in. You know, just a really really quick update, if you like. Just because I've kind of like I've got some things that are coming up, which I would probably like to tell you. So. Does that sound? Okay, Shawn, are you quite.

Hit it!

Yeah, cool. So yeah, so uk, at the moment, really, really, candidly, are still in the process of kind of copying and pasting the EU Ndr and doing the find and replace with the Uk Ndr, so, and the next month and June, basically, we will see the draft uk ndr which will be released for review. And I believe they'll probably you know, as they usually do, they will run a consultation on it, I believe. From everything we've seen in the last 2 or 3 years from the Mhra on the the kind of revision of the Uk legislation. It you know I I make the comments of the Undr. Kind of facetiously. However, that is a real element of it, being serious that you know the the post market surveillance regulations that the the Uk released in January that enter into force. On the 16th of June. So next month. Basically are the provisions of post market surveillance from the Undr

essentially. And then, if we look at everything, the EU or the Uk are releasing. Essentially, there's a lot of conversation from the Uk right now around mutual recognition agreements, compatible regulator countries, reliance and recognition. Essentially so everything that we're seeing at the moment suggests that the Uk are gonna heavily align to the EU Mdr. You know, and I think that's just for all of your clients, or whoever you work for. That's you know. If you've got new devices on the way. There will be some differences, you know. I think the main thing that quick. The question mark around is, I'd love to hear some of your opinions on it is, you know, personally.

I'm not sure what the Ukca mark is doing. At the moment, you know, I well, a lot of people in the Uk are struggling to see why we created a Uk other than for a political reason to have our own mark. Basically, you know, it looked bad after Brexit to leave and still have a ce mark. So the Uk span up the Uk. So at the moment, still not convinced on, you know, on its use at the moment whether it's relevant you know. I I can see a lot depending on how this con consultation goes. You know, I think we may see the Ukca mark kind of used slightly, differently or not used at all by a lot of manufacturers. But yeah, that that's essentially so. The draft legislation is released next month so definitely keep an eye out for that when it comes out. You know, I think it's something that would be really good to have some comments on it from, you know, from people who are different kind of regulatory locations. I think it helps

the today as well. The Uk are extending. They've kind of confirmed the extension of the application. For of the EU assimilated law. I think you've probably seen that going around today, but that applies for tomorrow. So that means that we are essentially keeping that EU law for the next like 5 years. Basically. You know. So that's that's kind of where they are, and then post market surveillance requirements. Will come in to force from June, so people will be assessed against that by the Uk approved bodies. When it comes along. So that's pretty much. That's pretty much it from the Uk, and the really quick update. You know, without going into too much other things that I can see. People are talking around here.

Which we can kind of cover. So I think, Sean, if you like, we can kind of get onto some of these other topics if you like, unless anyone has some kind of questions on the Uk that you would like me to answer while we're on this, or have a discussion on any parts. I'm happy to go like that, if you like. And yes, Michelle, you're correct about the Ukca small paperwork. Yes. So that's why everyone is asking this question of why? The yeah. Hello.

Yes. Can I have a question about particular about Ukca?

Yeah, of course.

So I work for a country manufacturer. They supply into Uk before Brexit everything was fine and under Mdd. Everything was fine, and now, with the same device, we have to do the Mdr. And now we have to do the Ukca. So it's just like even just the hour on the label, the Udi and stuff it took like 2, 3 months for no, I I don't know no benefit to the patients, to the users just work. And also I also work with some EU authorized representatives.

Okay.

So they you know the the con, the the idea right now out there with all those reps, or us agents, or whatever everybody's feeling is that really we spend a lot of time doing busy paperwork. We are not spending enough time and energy to make the device better to provide better quality. So.

Yep.

What! What are your thoughts on that.

You're not alone. That's that is the that is the the norm at the moment, as you know, I I find myself at the moment recommending clients to not go through the process of trying to affix the Ukca mark to the Uk Ndr, because, you know, say, say, we make a medical device today. We'll have to go through that Uk approved body, you know, typical conformity assessment process. and you know, as we see, the Uk is just starting to release everything now. And it's just basically going to copy and paste what's going on in the EU so my view on it is really, I have found myself very much recently, and and the interest of managing my clients budgets and keeping things simple. I've

found myself, which I never thought I would. I found myself kind of sent to clients, maybe go through, maybe go through the EU route 1st and then just leverage the recognition because the Uk are just gonna follow everything that you know, the that the Us are doing, basically, or the Uk kind of thing. That's the way the the or the EU. Sorry. That's the way they're they're looking at. Moving at the moment is really heavy on reliance. So personally. Depending on what your regulatory strategy is. I at the moment, you know. But you said you're a contract manufacturer at the moment.

Well, so well, because I know this is being recorded. So I that's willing to talk about. But then.

Okay.

My-, my question is also, what's the idea behind Mhra and the and the Uk governmental regulatory requirement, like a lot of devices under ce mark class one because the risk assessment and then then when they try to have a Ukca mark, they say, well, we're gonna up classes to class 2. A. So with Class 2 A, you know, you're clinical evaluation reports, your Pm's. Pmcf. And all kind of things, and even some of them that use abilities and just a lot of paperwork. And then so I don't know what's the benefit and what's the reason behind to up class those devices.

Hmm! So the the I'll I will make available. A webinar. By the by, the Mhra, which will, I think you may benefit from Michelle and on that webinar they go through the rationale behind the what, the what they're doing. So the the Uk. I suppose a real fundamental thing that should be said, I suppose, is the Uk. You know everything that happened with the FDA recently, with the resources being really restricted. The Uk Mhra is is is a Compton authority that is not that well resourced? In the grand scheme of you know, and and compared to compared to other competent authorities. So they are. They're moving really quickly, actually, you know, like, and just in a couple of years there's new legislation out, etcetera. So they're moving really fast. But the the

the the problem that that they have is that they need to leverage what everyone else is doing because they cannot spin up a new regulation themselves, you know. So they when the Uk left the EU there was this problem where they were leveraging Mdd. And then, you know. Still, EU Mdd. Uk, Mdr. But what was happening was, they were losing that position, as the you know, the Mhra and the competent authority, and the Uk, because the Uk. you know absolutely it loves itself as being a global leader, you know. So it's still the Uk always will have to be perceived as a global leader. And that it's very political. You know, we know where you are is also the same. You know, in that sense. But with that I think that is a lot of the reason why they're doing it, because they cannot be seen to have a less stringent regulatory program than say, competitor or comparative countries. Basically. But yeah, a lot of it is bringing up to speed. But what should be able to happen is, you should be able to.

you know, eventually think things will become easier. But you should be able to place your device on the EU, and that should also be copy copy and pasted essentially to the Uk. That's what that is what the Uk is really driving towards, because Brexit has left a real kind of open wound after that plaster was ripped off, basically, you know. So the the plan is to essentially try and harmonize to the EU. And so it's painful everything you're doing for the Uk. But I don't think it's gonna change in that sense. Personally.

Okay? So then make a cheat sheet around this.

Yeah. So how would we know when your webinar is available?

So the the the Mhra published a webinar last year. Which I can I can send to Shawn, and he can make it available to this group. It's on Youtube. It's about an hour ish, and they go through the main elements. So they go through technical documentation. Essentially.

I might have seen that I don't. I don't know.

It's it's really worth a watch. And you know. But you can watch that and then see everything that's happening now, and you'll be able to put them together and say, Okay, yeah. But basically that present that webinar they've done basically says we are gonna go. you know, in line with the undr potentially over and above.

Yeah, because the contract manufacturer supply into a few of your very large manufacturers or distributors in the Uk. I'm very familiar. Well, I work with them very closely, and then it was just a lot of paperwork. But yeah.

Yeah.

We have a lot of ground to cover. So let's move on to the right. 1st topic. So while you're thinking of the 1st topic that you want to address. I'm just gonna go ahead and put in the chat. This launch website, and just give you the 30 second overview. So we're we've officially taken over the Friday calls. They're the Friday in focus calls, which is part of a larger platform called medtech, leading voice exchange exchange is a community. It's an online community, and it's built for and with product and service providers like yourselves. Because there was no organization representing product and service providers, wraps.

is for regulatory affairs, professionals advamed is for manufacturers. LSI is for startups. There are no groups for you all. And so me as a marketer have noticed over and over again that you all have one thing in common. Well, 2 things in common that is expertise and a hatred of marketing. So the goal here is to bring you all together to provide an audience and a stage and a platform for you to share your expertise more broadly through publications, through channels, through interaction, and to develop

personal connections with other members in the community as well as with oems and startups. So we're going to be expanding. The Friday calls to include more manufacturers, to include more startups, to include more investors and try to cover all the bases in the ecosystem on a more regular basis. Obviously, it's going to skew towards product and service providers to a certain extent, because you are the members. So what I'm trying to get people to do is to join this community, to make a commitment to it and to

step up. You know, we need community leaders in clinical, in regulatory, in quality, in risk. safety, and and you know the standards, etc. Engineering, cyber security supply chain. You know. All of those things, you know, are going to require resources. You know, but every single one of them is speaking opportunities, publishing opportunities, exposure, opportunities, and the last thing that I'll say before I turn it back over to Adam is support one another. do so vigorously what we saw at 10 x.

Let's carry that energy forward and continue to support one another on Linkedin and to build an actual. You know, it's funny. People say community. And it's like this bogus marketing word. You know, that really doesn't mean anything. We have an opportunity here to build a community of people that can help each other. And when when you do that when everybody is trying to do it alone, they're not likely to succeed. and that's been my experience. But when we come together we we stand a much better chance. So please take a look at the landing page. Don't, don't judge the video too harshly. It was a 1st ever. We'll replace that with a better video moving forward. But,

I'm going to be this. So this is the soft launch. You are the 1st to hear about this, and I hope that you will. Yeah, the link is there. It's illumino courses. mykajabi.com slash mlvexchange slash register. We'll create a shorter version of that, but it is posted in there. So yeah, please show your support. Get involved. Okay, you're not seeing it in the chat. It's literally in the chat. I don't.

There's some app. There's some people who posted after your chat, so.

Okay. So I posted it again.

Just question. So on our old Mdg, will that fee stop being charged? Or how's that gonna work.

Yes, Joe and I are talking about that right now, so that is you can just stop the payment or Yes, that that is no longer going to be actively supported.

I don't. I don't know. We can stop the payment like for me. I signed up just automatic pay in my using my credit card, and then, Joe, just process it. I I don't know how that works, though.

Okay. Well, I'll talk with him. I had a conversation with him about it yesterday, and we'll have another conversation about it and clarify that for everyone next week. That's unfair. So with that in mind, okay, hopefully, you guys can see it. Do you have a coupon code for me? I'm Dutch. Yes, I have a coupon code. I think the coupon code is mlv. 20. Try that

No, that did not work.

No? Okay. Well, I'll have to get that from Dylan later in the call. Nelly, just text. Dylan.

That's what I'm doing right now.

Oh, it might be Mlvx. 20. At any rate. Next topic is sorry, Adam, I apologize for hijacking your call.

It's okay to whatever the feel free. Continue.

So I really liked Jose's question. Which was tying it all together. But maybe we should go with one of the more individual ones before we get to all that. So let's do something like time and resources taking time to work on procedures, handle Kappa's, etc. We're a manufacturer. What do? What would you say to the manufacturer?

So the the kind of word that I think is is most relevant to is is risk. I see. So every every single company that I audit. You know I think I every manufacturer has the best will. Everyone has the will, you know. I do not believe that people are like, you know, kind of willingly non-compliant and purposefully putting dangerous products on the market. You know it's just not that. Not like that right? But people have will. And I think. from a quality system perspective, a lot of people have legacy systems with, say, a really good example is, say, your non-conformance procedure, where I see so many fat manufacturers that have, like a Nonconformance procedure which escalates everything to capas, for example, and then they end up totally inundated. So they spend all of the time trying to close Kappa's for things that really don't matter. You know, and without and then they don't get to the actual root cause because they have

a million cap is open for low risk issues. And then I see that really, you know, I think when I said, starts to eat into the quality, the quality, and the regulatory teams day to day, which is to kinda which is to operate the system. But I think also, it's hard to answer this question without mentioning what Michelle said about culture. You know, the quality team should not just be the people that are kind of doing all of that. And that's in in that sense. And I think that is kind of part of the problem. So there's the kind of initial the way the Qms. Is set up that it's not risk based enough.

I do think the Qms. Is certainly from when I started an industry versus now, need to, you know, be a bit like that. Have more of an appetite for risk in that sense. You cannot deal with everything. So you know, I think they need to really focus on how to, you know, Deal, you know. I think it's the phrase my old mentor said to me, I think you know my mentor, Natalie Mcroberts. Everyone here will probably know Natalie, my mentor, from back in the day, you know if everything is a priority, nothing is a priority, is what I was really taught. And I think that is the problem. You know. I think it's really, I see as a consultant you know we can't do everything. Kappa's are the

to me, anyway, are the biggest things the organization is facing. If it's not the a big thing that the organization is facing, it should not be being called a Kappa in that sense, and I think you know the as an auditor again, with my auditor hat on. There's 2 red flags when looking at Kappas. If there's no capas, and if there's a lot of Kappas, you know. They start to make the the kind of alarm bells ring. You say, Okay, is your system not detecting it? Or maybe you're detecting too much. You know. So I'd be saying Maya, on that risk based approach, you know, really go through everything with a fine tooth comb, and you know, I think don't be afraid to be really bold.

you know, and just say, Well, I'm not going to do with that. The and the same way, because we have all of this other more important things to do with.

So one thing that I've done, not my Qms. Is when you've got a nonconformance. Everybody wants to document it, which is reasonable because you. You want to show that. So what we've done in Bqc land is in the Ncr process. We have a manufacturing, we call it Ops, Ncrs and Qms Ncrs, you can document higher Nonconformance, close it out. If you do a small. It's almost like a small Kappa. But it's really it's quick and easy. You're supposed to document it, take the action, sign the record and close it out. And so that way that that's super. So that's like, where okay, the medium to high risks. Go to the Kappa and then you're you're still documenting any corrections that you're making. But you're not escalating everything into Kappa Land.

Yeah, that's that's exactly it.

One of the things I had is I got the pleasure when I got Mdsap. Train God, 15 years ago. Please don't date me. Is. I was the auditor was an ex FDA or an ex non notified body, the auditor and one of the things that he said to me, and it really sticks to me this day he goes. If you have an employee force of 100 people, you should have no more than 2, maybe 10 capas open. That's it. So think about it. If you have 5 people, we think of that ratio. And so that's something I think about. And you know when I'm when I'm taking the risks on Kappa.

So that's that's exactly. That's my say. I give the same feedback, you know. But I think I don't know. I don't know what everyone else's opinion is on. Why we've ended up in this situation with this. you know, we, I think again, it's from that the most charitable interpretation is because everyone's trying to do the right thing. I suppose that's my belief is the way I look at it. But I think a lot of it is being scarred from previous audits or inspections, and and everyone thinks all we need to manage absolutely everything. You know. I think that's where I I see I see a lot in just for yourself, Nelly, as well. I see a lot in audit schedules. Where people try and audit that every year audit schedule looks the same. Try and audit everything every single year. You know it's against what 1345 says. But you know I. I work with clients, and I say to them, create an audit schedule over 3 years.

you know, justify, justify why you're doing things a certain way. you know. Don't be afraid to not audit something, if that if your Qms. Signals are not flagging any concern, you know, if your post market surveillance related to your device is showing that there's nothing going on really high safety profile. Then, you know you can. You can begin to prioritize what you're looking at a little bit more, you know, and I think the I think the key to it is that fundamental risk based system from your nonconformance to Kappa internal audits the way actions are allocated, you know. I think all across the Qms. Needs to be needs a real, a real kind of revision of it. I think 1345 as well as a standard, I think.

could. Maybe it obviously talks about risk. But it doesn't talk about risk, maybe as much as some of the other standards within the Iso and Xsl framework. You know. So I think a revision to 1345 that emphasizes more of a risk based approach, for manufacturers may also help people just make it implicit, you know. So let's a little.

Oh, sorry go ahead!

Can. Can we shift gears a little bit and move to the topic of culture? Now, Michelle Lott had put in culture. I'm not exactly sure what she means by that. Because, you know, every organization has a different culture. But you know what are the biggest challenges anybody have a comment on that Michelle, maybe, or Nelly, or anyone.

I find the biggest challenge with the culture, and it kind of goes. It connects with the Kappa and Cr's internal audits. Manager view is that people don't know what to do. So then they go to Kappa first.st It's like an in. It's like, I don't know how to do this. I want to do the right thing to your, to your point, Adam. So I'm going to go to Kappa instead of having. and it also connects back is, if you have somebody who's only been in a large company, all large companies do is issue Kappas right? Whereas if you've been in a startup, you've had to wear so many hats. You've seen more, and you have more of a sense of where you can take risk, whereas when you're in a large company. You don't have that sense because you're in a very siloed. You have a very structured role.

Yeah, yeah. can. Can I just add on to that as well? I think. With that, Nelly, I think and on Michelle's point about culture, the I I was doing an audit recently on a very, very high risk device. And the. and it was a really large, really large manufacturer and the the front room had like it had like 15 people in the front room, and it was just me doing the audit right? And that was really like it's quite a lot to manage, because I know they had the front room. They had the back room, and it's a lot to as one auditor that's like a lot to manage. And the culture of this organization when I would, my thing is, I always say I audit for conformance, not nonconformance. And I say that in opening meetings, so I always make them aware and say, if I see anything that's a potential non conformance. I will tell you

as I see it, and I'll let you know what I would like to see to see the conformance, you know, for this process, or this objective evidence. and the appetite of this organization towards receiving Nonconformances, legitimate nonconformances that they could raise within their Qms. To stop FDA or notified body, etc. Raising it was they were so against it, and they would. You know the 15 people would fight me tooth and nail, and all I had to do was say, there's a requirement. Here's a lack of evidence. And here's my cited deficiency, you know, because I'm don't raise findings for no reason. But that, I think is a really.

I think that is a really dangerous culture. When I I don't know if you all see it, but I see very regularly as an a quality objective. No nonconformances from audits, no nonconformances on technical fail reviews, etc. I believe they are really dangerous cultural kind of. They're really dangerous from a cultural perspective, because there's always gonna be problems. You know, like the Md Mdr. Is like, you know, it's so huge. For example, Qmsr is coming. It's all you know. You can't not have issues. And I really believe when you see these objectives it's always a bit of a concern for me, because

I know that I'm not that interested in what is actually gonna come out of this audit in that sense. You know, just on that, you know. So I think what you're saying now, in that sense I totally relate to in that sense, you know.

Do you think?

Sorry sean.

You mentioned Comsr is coming. Be afraid, be very afraid, be not afraid. What what's your take on that.

I think people here probably have more of a take on that than me personally, because I you know. But but my take on it is that I think it's a really challenging time for medical device manufacturers. You know, because the Uk is changing things. The EU Ndr and Ivdr. We all kind of got used to that. And now it's officially under a targeted evaluation. And God knows what that's gonna look like when it changes. You know, for example, that really that is really to me a concern. Because everyone is kind of starting to get used to it. Now, Switzerland now has its own Swiss ordinance, which is essentially the Mdr. But yeah, my, my, take on on Qmsr, as essentially, from what I've seen, the field, a lot of people are quite happy about it.

and and the Uk. And the EU. Lots of people are happy about it. My caveat that I need to give them is that you know it will not. The FDA will not accept your Iso. 1345. Certificate, as you know, as they will not do that they are not that content authority, you know, like, I think, unless you've dealt with the FDA, you don't know what they're like. You know. I've the FDA were the 1st competent authority I ever dealt with. I really, you know. So before I dealt with anyone else, it was FDA and I learned so much from them as a regulatory agency. You know I have a lot of respect for them. But yeah, my take on it is that I think we will see a lot of issues as a result of it, not from

manufacturer, not from the FDA per se. But I believe a lot of people will use it inadvertently as a way of thinking. Oh, well, it's reliance on its recognition, but I don't think people understand that it's not quite going to be like that that the FDA will still want to conduct verification with their own eyes. Essentially, you know. So that's my main view on it. That's my main caution to manufacturers. I believe any sort of harmonization is good. But yeah, I think there is risks with it, and I think we I think the FDA will have a lot of hard work in repeating that message to everyone.

Okay. So, moving on to Jose's question, since it was a big, hairy, naughty question, Jose, why don't you come off mute for a moment. And 1st of all, you know glad you're here, because along with Qmsr is the FDA's new approach to cyber security, and is, there is is is the EU taking cyber security as seriously as the United States is at this point. What's the story over there?

Yes, the yeah, they are. Yeah. So the EU, because of like, say, like the AI act and Ndcg have released a lot of documentation on cyber security. With that comes into the issue of kind of artificial intelligence as a medical device as well as software. As a medical device, we have some very novel devices on the market in the EU at the moment that are one device I worked on which is a really really cool device. It integrates a piece of software that integrates into an endoscope that essentially uses artificial intelligence to scan tissue samples and define benign or cancerous, that's cleared, and on the market. Now it's done, you know, so cybersecurity in the Uk is taking and in the EU. Taken really seriously.

Uk is trying to become along with Korea, I suppose. A bit of a leader with AI as a medical device. They're releasing a lot of guidance documents on it. So is Korea really, definitely worth checking out. But I'd say cyber security? We asked. I noticed that there is a lot a lack of competence for it. You know, I think it's still perceived as maybe a bit boring by a lot of people you know about a lot of regulatory people as well. A lot of my good friends think it's super boring, and they're just like, not interested, you know, so, but as taken very seriously by the authorities.

So, Jose, what do you have to say to all that.

Yeah, I mean, the the gist of my comment was that I know in particular a lot of our clients who are startups, part of what they struggle with, even beyond cybersecurity, is just how to tie everything together. You know, everything's interrelated. There's so many guidance documents. There's so many standards, you know, there's regulations. Of course, there's a different geographies. And so I think the question that you had originally asked is like, What's the biggest challenge. And I think the biggest challenge for for startups in particular is understanding how it all comes together. So you know, we specialize in cybersecurity and software, and even there which is just a subset of most systems unless they're pure software's medical devices.

you know, even just in kind of that subset. There's tons of things to to be familiar with, you know, from 6 to 3 or 4 to SW. 96, and then all the guidance documents and and etc, etc. So yeah, I think that's 1 of the big challenges that companies have. And it's interesting. You know, you mentioned earlier that contrast between large companies and startups, where at a large company, you might have a a team of dedicated people whose specialty is whatever cybersecurity or software you know, compatibility or whatever. Whereas at a startup you're kind of leaning on a single or a few consultants or employees to have to be able to manage it all. But I have to imagine that even at the larger companies you need somebody who does understand it all, even if maybe not at the same level of depth.

But who can go. Wait a minute. That thing you're doing in cybersecurity is impacting usability, you know. And so, or, you know, like we need to get the input from the clinical team. Or we need to, you know, see how it aligns with this new regulation, this different geography. So I think that's just the challenge that there's at least one or 2 players in any team that has to have a very holistic view of how it all comes together.

Yeah, yeah, I I really see that the for for I think just on your on your point. Now, Jose, just to just to go through all. Think the the words kind of risk, usability, design, control everything. I think it all to me. All I was working with the manufacturer yesterday, and it all goes back to that kind of thing of intended use and user needs for me. You know, no user needs no medical device. In my opinion, you know, no user needs no medical device. That's how I look at things. You know. And in that case everything you know needs to come out from there essentially, you know. So your risk, management, plan, and design the other. And that design development plan are those 1st parts for me. In terms of in terms of that's how I piece it all together for manufacturers that I say startups.

you know I do not know how they piece it all together in that sense, you know, without getting a consultant, and I don't believe there is an answer for them. Unfortunately, because it's a minefield, you know.

The problem is, they think there is an answer, and then they get to a month before 5, 10 K. Submission, and then they have to hire somebody like Jose, or, you know, to come in and fix everything.

Yep. Yep.

Carlin? You had a comment question. Maybe.

Yeah, yeah, my question is, I ran into a fellow last night actually, who is a former CIO and a Ciso, and he does cyber security audits for potential acquisitions for a client company. And this gets back to the point that was just made by Adam. So if if you are a relatively unknowledgeable. For example, physician, med tech startup entrepreneur. who really doesn't understand this conversation. If you hire a person on this call a Ra. A regulatory affairs person is that person the appropriately qualified person to do the cyber risk assessment?

Or do you have to hire somebody else to do it?

Good question, so.

Cool, I.

To to me. Risk management is A is A is a team activity? So it should not be. You know. I would be really concerned. If I seen one person doing the full thing. You know, I think the the key would be. If you have a person who understands to say that regulatory risk management framework 14, 9, 7, 1, and being able to facilitate and ensure that that process drives, you know, drives the correct inputs to that as well as the the right outputs, you know, because I I think recently I seen a manufacturer that they had a software as a medical device. There was lots of software of unknown provenance being used within it. And none of that, or the or the interoperability of the device with the hardware that was associated with was on the risk management system. Nowhere. It was nowhere. You know, and that was, and they. But they had a risk management plan. They had a hazard analysis.

They had a risk management report, you know, but it was really lacking and the input of it. So they were. They were subject matter experts. They were experts on the software and what the software was doing. But then I looked at it from that risk management perspective and that holistic view, and said, You're missing lots of stuff here, you know. So I think the key to that would be having that blend approach Arlen, probably on having a good team there that can speak freely. Someone who knows the harmonized standard or the standard you're applying to be able to ensure correct facilitation, and then having the people in the room that are doing the work, you know, like Gemba, essentially because they they know the risks. But you need someone good to kind of pull the risks out of them and put it through the process. Basically. So yeah, I'd say, it's a participative, you know, kind of team based approach for for that, especially in a startup

having the right people.

So Jose has talked to me about this before he, you know you might have a really talented engineering team working in your company. And it's still not necessarily appropriate for them to be doing. The testing, like the fuzz testing, is like not a good use of their time. You know you're paying them way. Too much money to be doing that or some, and there are many components to what is now required by the FDA, and I guess, similarly by by the EU and the Uk. For testing that, I assume that the same is true with biocompatibility. The same is true with, you know, any

area where it's like, yeah. But do you really want, you know, your highest paid employee? Spending their time doing that work or trying to get somebody who is not necessarily skilled in that area is a smart, capable person, is certainly capable of figuring it out to figure something out that one of you on this call has already figured out, you know. And so that becomes a question, you know, for me like, when does it make more sense to outsource. You know certain tasks and to expand the capabilities of the team. As you said. That, you know, risk is is is best done as a team sport.

If I could like, just take a crack at Arlen's original question. I think I don't think there's anybody in this call that would be willing to say that they're experts at everything that's required. It's just. It's impossible for a single person to be like an expert on sterilization and cyber security and biocompatibility and packaging, and like everything out there. No. So you need kind of a quarterback like somebody who's knows we're going to need to find the right person for 66, 0, 1. And we know, Leo, we're going to need to find the right person for cyber security. And I know, Jose, we're going to need to find the right person for bio comp. And I've got somebody for that. So there's kind of like a good. It's important to have a good quarterback kind of person, but for the individual pieces, just, it requires so much expertise

that you really have to bring a team of experts. And you know, to Sean's earlier point, yeah, it's just it's the climbing, the learning curve that's going to be expensive. So for a company, for example, if they're looking at. Okay, I can have my really smart chemical engineer or something. Figure out biocompatibility, and they're doing it for the 1st time. It's going to be more expensive for you and higher risk than if you find somebody who does this all day long, you know. So I think that's that's the kind of the challenge that I think, particularly with startups, have to come to grips with early. It's like we're going to need a team of people who are experts in these various areas because it's all complicated.

Sounds like a general. It sounds like a general contractor with subs.

Hmm.

And I guess the barrier is money. I mean, you have a you have a startup and you're pitching. This makes total sense. But what's this gonna cost.

Yeah.

You know, I kind of. I kind of equate that to, you know, somebody hires a quality engineer to run the entire quality organization, and in my opinion most colony engineers know the Qms. But they don't live and breathe it, and so they build it from an engineering perspective. Well, the average person is not an engineer. And so I write the procedure from a human perspective of a 7th grader that anybody can use it, whereas a Qa. Engineer will look at it and write it for, hey? I'm an engineer. It needs to work in my brain, so I understand it and speak to it. And so that's the same thing a lot across all the disciplines. It's like I can do risk. But you know what the 1st thing I tell people is, I'm not a risk expert. I can get you started.

But you really need to get a risk expert. I'm not your cybersecurity expert. I've got a template. But you know, you need to get this person started. So you need to find people who are willing to admit what they're good at as well, because a lot of people's consultants are like, I can do everything, and I can provide everything, and that's dangerous. Because then, you know, you're not.

You're gonna get junk out of it, and I've seen it several times over where clients have come back to me after they've been shafted to be one, and that's a nice word. And they've ended up going to ground ending up, dying, because, even though they've come to me and gotten what they need and gotten approved. It's too late. They've lost their funding by then, and that's really sad that that bugs the crap out of me. I'd rather them come to me even a little late. and get approved, and get to market and be successful, than going through that hell that they went through the 1st time.

Yep.

Yeah, yeah. There's an English show.

So as we go into the last 3 min of the call, I wanted to give anybody that's new the opportunity to say hello and say where they're from. I I think there are a few people on this call that I haven't really met before.

Before you do, Shawn. I do want to broadcast out that the coupon code is sean 20. It is Sean 20.

In all caps.

I think it works. I just tried it. It went through and says, process my payment. It worked.

Well, thank you for everyone that's registered. I think this is going to be a really dynamic community to Jose's Point, about the quarterback. I think Mlb. Exchange could be that quarterback in a certain extent that you're giving startups access to a mastermind group of experts where they can really come and get the advice that they want. I think the challenge, as we saw at 10 x. Is getting them to actually avail themselves of the resources available to them, and I think you all are familiar with that as as providers and consultants is, you know, And so I think.

figuring out ways over the next year to expand the reach and the audience. It will be really exciting. yes, there will be a member section where you can communicate amongst yourselves directly. This is the members only section that other people to be public, facing resources and inwardly facing resources, some resources that get shared on Linkedin some resources that don't and all sort of a work in progress. But you know, bear with me, there's no model for this, no fun. No, I should say no highly functioning model for this.

so There was Someone.

There's quite a few questions as well for me, Sean. I think that and hear from earlier. So what I'm gonna do is I can put my Linkedin in the chat if you want. And anyone if there's anything that you didn't feel like, I answered as well, because we were kind of wee bit short on time, then feel free just to ask me. And you know I'd love this kind of stuff. So is that all right, John?

That that is all right. Yes, please do. I apologize to anybody that's having trouble with their camera. Let me see? More remote panelists, more promote panelists, to panelists more promote to panelists. Yes.

Sorry I've been listening.

Me too.

Well, it's nice to have you all here. And I look forward to your feedback, Julia, did you want to say hello to everyone.

Yeah.

Don't call pie. Have a good.

Take care!

Bye. yeah. Now, now it my camera is working. I think I was like in another mode before. Yeah. So, hey, everyone, I'm Julia. I'm currently located in Switzerland, actually. But I will be moving to the Us in few months. So that's why I'm yeah reaching out to this network. And I find it a really cool platform, and I'm I will sure be back here in this discussion around. Yeah. thank you.

And what do you do?

Oh, yeah. So I I work in Med tech since a few years. My background is biochemistry, and I have experience in sterilization and also in yeah. Mdr transition, I was part of. Now. Yeah, here in the company, I work for and I'm in quality management since more than 4 years, also doing a lot of auditing internal and supplier like supplier quality management. So that's like my main topics. I'm working in. Yeah.

Nice to meet you. Welcome to the group. Nice to.

You, too. Thank you.

Would anybody else like to say anything before we drop off this week?

Not for me. No, that just thank you to everyone for kind of listening to me, and taking part so nice to meet you all.

Yes.

Everything here. See you next week.

Bye, everybody!

Bye. Thank you.

So.

Thank you.

No like it.

Hi.

Thank you.