Designing Electronic Medical Devices That Actually Reach Production

Mmm.

So, Fra if you can upgrade him.

Promote. Okay, it's rejoining right now.

Okay. Well, I still want to do a presentation on the intricacies of, Contract engineering and contract manufacturing. So… I don't hope he will, He will take all the good parts for me.

There's a lot of detail there.

Yeah. Hi, Andre.

Good day.

Hello, everyone.

Hey, Andre.

Share the screen if it's panelists like this.

again?

Can you share the screen if you're focused like this? Let me make sure that everything gets good. Okay, it's… Sweet.

Does that work?

No, try… okay, yeah, Yes.

Perfect.

Thank you so much.

So… While we're… while we're warming up. And, Andre, thank you for sharing your… your slides. You know… been playing with the format, been playing with the conversations. So when we started this thing, when I took over from Joe, it was a really small group. The group has grown exponentially, and I think one of the… one of the most valuable things that we have in this group is, the ability to sort of crowdsource the information. So rather than being one person handing out information to a room full of students, it becomes a collaborative exercise in building a discussion

that moves the topic forward, for all players in the industry. So, for example, you know, many regulatory people may only have a glancing familiarity with design for manufacture. So, it doesn't mean that they don't have anything to add to the conversation. It means that they are coming at this from a completely different perspective. Having 100 perspectives in the room.

Hi, Rick!

leads to a much richer conversation than a conversation between 3 or 4 people. So, my hope is that as this platform continues to evolve, and as these discussions continue to evolve. we will, create more and more opportunities to become less death by PowerPoint, or infomercial, or, the… you know, we've all been subjected to webinars that were painful. And so, our goal here is less painful webinars, right? And a community that people look forward to belonging to, people look forward to contributing to, and people feel valued within that community. And not just because they were the speaker.

Because we have a limited number of speaker slots throughout the year. And… So that means that we become more selective rather than less selective about the topics, and one thing that I worked with Andre on, and I hope he'd forgive me for For saying this, but was to incorporate some polls into the… presentation itself. And… I think that the best way to do this is to use the chat function, but one thing that I would like everyone to do, before we get started today, is to…

Show some love to the article that was published yesterday on MedTech Leading Voice. And to… Take a moment to compose A statement about why you're joining, what you're hoping to get out of today's call… And even if you just write, I'm just here to listen, that's fine. You know, you don't need to come up with a profound statement. But, what I'm… what I'm hoping to do is that we can Drive people to,

develop this conversation more. Can your electronic device actually be built? You know, and that's what we're here to discuss today. So, I'm gonna put in the two announcements about the MLV webinars. And I'm gonna say that MLV webinars are different from the Friday calls. They're, intended to draw a larger audience. They're not as interactive. They do tend to lean more into educational content than a conversation, and… but there is room for Q&A, so those are expert-driven events that, by the way, are for sale, and we're having a sale in the month of August, because what I want to do is I want to fill up my, calendar and my bank account

For the rest of the year, and I'm not shy about saying that, because I, like many of you, am an entrepreneur, am running a small business, and… You know, have… a legitimate need to feed my family and all of my children, and… and employees. So, with that in mind, if you would like to, if you would like to know about the sale that I'm running at the moment, you may just, send a message to, Francesco, who's on the call. Or me, privately, and I will follow up with you at some point.

Now, with that said, hello everyone, and welcome to Friday in Focus. I'm very excited about today's topic. Oh, yeah, the two upcoming events are, Beyond the Protocol, which is a Human Factors webinar, with experts, from Claramid and former Medtronic. Employee who's going to medical school, and because she's left the company, going to medical school, you're gonna get a really unique perspective. from her on, the human factors challenges, and that sort of thing that… that she's seen. And, you know, what's really interesting is, you know, the fact that people are still choosing to go to medical school. And so,

with… and then the other one, is when enrollment stops, and this is with Daniela Carrera from Donavan Life Science. Daniela is brilliant. She's a… you know, been doing, clinical implementation, clinical trials, studies in Europe, and, and the U.S. for, a long time, and has seen everything that can go wrong. And this is as much a diagnostic webinar as anything else, but I think that it'll be eye-opening for many of you. I encourage you to enroll, I'll put the links in. For those two webinars. Done with the infomercial. I'm gonna turn it over to Andre. I'm excited about this, and I want everyone, everyone, even if you don't feel qualified.

to, put a comment in the chat, say who you are, and join the conversation today. It's enough wallflowerism, okay? Thanks. Andre. Hit it.

Okay, Sean, I'll share my screen. Even though it's a PowerPoint, and you don't like death by PowerPoint, but… Hope you can see that.

In a minute.

So, as I know Sean brought up, yes, a lot of regulatory people on here, but you want to have the confidence that once you got a device through all the regulatory requirements, that it's going to be produced and be able to be out on the market and be reliable. And that's really where this all comes to play. So… It's not moving… there we go. So yeah, like we said, we want this to be interactive, so let's have a… let's have our first question right up front. So, can you tell me which of these you may have lived through? First one, a working prototype that couldn't be built at volume. Maybe a component that went obsolete in the middle of a project.

A device that, didn't make it through electrical safety or EMC testing. Unit cost that didn't make sense, because there's just no way it could be built for the business that you wanted to do. Or E, all of the above. So if you want to throw that into the chat… You can throw a… you could just put a letter in, that'll be fine.

I see, I see a lot of E's.

Good, good.

I love the and I would rather not talk about it part. That's hilarious. Okay, so while the poll is running. I'll keep an eye on that. You can move forward.

Okay.

And I'll keep track of the, of the chat.

Okay, and we do have a second question. So, where are you sitting right now on a project? is the, are you at A, early in the design, you got a working prototype, you're in the process of going to production, or you're in production and unfortunately have to fix things. And… maybe all of the above, and that's… that's kind of where I am, advising on all of the above. So, Sean, do you have any… any specifics there on the chat? Oh, you're muted, Sean.

Sorry, I muted myself so there wouldn't be any feedback. We got… we got the full gamut on… on both of the polls. Okay. It's really, We have… we have a diverse… group of people. Okay. And, They have a broad range of experience, and there are a lot of E's in the first one.

Okay, good. Well, then that plays into the rest of my slides here, so that works out great. So, and let's keep it interactive, like Sean said, this is a give and take, and if you have any questions or comments, just jump in whenever you think it's appropriate. So, let's take a look at some real things that happened, and you know, after my many years in the business, we've seen lots of things, but I picked out just 3 quick ones, just so you could see. So, the first one here you see, this is a company that really loved the microprocessor that they incorporated into their design. And when they were getting ready to go to market, they found out that it was going to go obsolete or be replaced about 9 months into their production.

So here you see where they're trying to wire in a new microprocessor to take over, and you just see here the whole spaghetti that was necessary to make the change to get that a new microprocessor. So this was a big change because of an obsolete part. The middle one here is more related to the safety testing, where The circuit board, now you take a look at these two components, the circuit board really didn't have the clearance that was required, and so therefore you had to shunt in some bypasses in order to be able to pass 60601 or EMC. And this one over here is just a matter that The board itself didn't have the… there were a number of areas that shorted out a product, sorry, shorted out a component, that is. And so, again, they had to put in some shunt wiring to be able to avoid that, that, you know, that caused… what caused that shorting.

So these are just real examples that came after we opened up a device and looked inside and saw what was there.

Hey, Andre, is there any way that you can put this in presentation mode?

Let's see…

I think that if you go to… Yeah, just two from current slide.

Current slide. Any better?

Beautiful.

Okay, great.

Thank you. Sorry, someone asked.

Yeah, no problem, no problem.

Passed and answered.

Good, good. We, we, we aim to please. So, here's… a real example of something that actually did happen. Now, of course, I'm not saying the name of the product, and not giving you any details of the customer or anything, but this was a real product, that real process that we had to go through, and what it can affect you. So, we were brought a therapeutic ultrasound device that was going to be used… the indication was for treatment of inflammatory joint conditions, and they wanted to launch it once they got production going, so they came to us for contract manufacturing. And, a review of the device.

And when we did the review, and here's a common problem, they based the entire design off of a single board, single board computer, which we call an SBC. You know, that's a problem, because you're relying on a computer that was designed by somebody that May not be reliable for long-term use. the manufacturer of that single-board computer might put some revisions in that changes your testing and your EMC and so forth. And it may not be suitable when you go into volume, because, you know what, you're making 10 or 20 or 50, a single board computer's cost may be okay, but you start to go into the thousands, and it's not worthwhile.

So what, what happened? We actually had to do a redesign. where we made an actual replacement board. We had to make our own computer, a custom board replacement for that single board computer. But what that did to the project… of course, it was important for the long-term health of the project. But it set them back, and this is actual, a little over $183,000 in redesigned costs, and they lost about 7 months In their original, their original launch date. So, what could have presented this? If they would have came to us, or a company that would look at it up front. There would have been, on this one specifically, to say not to use that single-board computer.

Okay, so again, making it interactive. What's the latest stage surprise you've seen on a device program? If you want to just put a comment in the chat. And Sean can tell me what comes up in there. But have you had any surprises that were out there during the VICE program?

Andre, this is… this is Elisabeth. I just have a quick question about your earlier, items. So, I'm… I'm a regulatory and standards and quality consultant, so, the other thing that… that came to mind for me when you mentioned that single computer aspect. Obviously, that makes it non-manufacturable or meet good manufacturing practices, but it also, I would suspect, would have addressed a serviceability potential risk, as well as, is because if you have something as a single line replaceable unit. It's more costly to the end customer to have to replace that if it… if it has a single point failure, versus if you have potentially 3, 4, 5,

whatever separate printed circuit boards that you might be able to just, have those, those items as a, a much cheaper and much easier repair, and replacement. Is that something that you're also considering when you're looking at some of these things?

100%. In fact, you can even go deeper than that, because sometimes a failure may just be a single component that might be a few cents, instead of a whole… one of a circuit board. But yeah, that's why you want to have a unit designed specifically for the use, because then you could do The tracking and tracing back to where the failure is, and like you… like you pointed out, it's maybe just a single board, or even a single component, so you're absolutely correct about that. Great, that's what we like to see. Good input, thank you. So, we have any comments on this one, Sean?

Yes, quite a few. Okay. Let's see, where do I start? Rick says, verification testing Electronic System, complete failure to test. Chris Kelly says, IUV. Let's see… Alexander Henders… Alexander says. Firmware validation and verification were not properly addressed. Chris Kelly… Chris says, company didn't consider validating tools. Danny… Danny says, wearables failing 60601 test. Catherine says, residue from manufacturing process caused, material failure during aging studies. And the list goes on, unsupportability of major smartphone operating system with regard to medical device. Luke says, device late…

which is considered a critical component, which has no UL ROHS Reach at… all taken from, from a sticker webshop. Any, anyway, it goes on.

That's great. It's like, that sounds like an all-of-the-above for what we're talking about, so that's a great point that everybody made. Thank you very much. So, the real question that you gotta lay in before you get into this, and these are… all these 6 questions are important, but let's start with number 1, and it's number one for a reason. And it's really the viability of this product, because you can look at, is there anything like it already on the market? you know. Because if there is, that means somebody already solved the manufacturing and the costing and so forth. So if it exists, that's good. If it doesn't exist.

well, then maybe it's just not feasible. Maybe it just can't go on the market. So, it's not just a blank field to say, okay, our device, you know, is gonna fill this niche. You gotta see whether or not it could work, and you can make a business there where they can make money on that product. So, number one is the important one. Number two is important, and that's related to, can somebody build it from your documentation? Do you have a design history file, a design… a device master record that allows it to be built by anyone, not just the one that you're working with, because If you've got something that only the people you're working with can build, then you still only have a prototype, and you have that staff, so if any of those go wrong, you've got a problem. So the documentation's important.

Number 3, and I mentioned it in one of my examples, do the critical parts have a second source? Or, you know, for example, do you have an alternate for a part? Or do you have, have you checked the lifestyle? Not just, you know, not just maybe with the presentation or what you see in the documentation, but look into it yourself and see what the history is of that kind of a part. Then, a big number is right-sizing the production level. You know, is this something that's gonna be built 20 or 30 a month, $500 a month, or $10,000 a year? And you gotta just see, is… Are you… is the production gonna be right the way it's being designed?

Another one, which we feel is a very big one, is can you do in-process testing? We see a lot of products that only have final QC, and then if you have a problem at final QC, well, now you've got the whole level of production that's lost. So you want to see if there's in-process testing, quality testing during production. And then, at the end, who's responsible for the design? You know, before you go into it, so that you don't have to make any changes to tooling and so forth. So you want to get it right up front.

Can I just ask the audience to expand on number 5? Anybody here? want to comment on, can it be tested in process? I'd like to hear positive examples rather than, the… the worst case. Like, how… how do you… how do you test during You know, the process. Rather… rather than waiting till the end.

Elisabeth has her hand up?

Yeah, Elisabeth.

Yeah, I think, again, it's a… it's a cost-effective aspect, is that if you can, find a failure at incoming inspection, the cost is much cheaper than if you wait until the end. And if you're taking something all the way to the end to test all elements of it, and it fails. There's also the longer process of investigating to determine what is it that failed, because it may not be an obvious, you know, this one circuit board, or this one electrical component. potentially could be multiple. So, you know, there's a balance. You obviously don't want to, you know, have 10,000 in-process, you know, tests

And inspections, but you want to look at where makes the most sense, from a, traceability and, and, and, cost-effective element.

I'm seeing some comments in the chat as well. Test hardware cycles without necessarily having software finalized. You can age mechanical parts offline and then turn them on periodically to gauge performance. Says, I would add, has the product gone through manufacturability reviews with the manufacturing group or contract manufacturer? And so forth.

So, Rick's got his hand up.

Yeah, great. Yeah, we would sometimes use tools like DFMEA to isolate, Blackouts. Where, during a production process, a part could not be, part could not be evaluated. And what we tried to do was avoid building a lot of cost into something that could have been tested a little bit earlier.

Hmm, okay.

Agreed.

So, Andre, you want to move us forward?

Sure. So, you know, let's get into the definition. And the way we see DFM is engineering a product so it can be built efficiently, consistently, and economically. Without giving up quality, safety, or compliance. It's not something for the end. It's a set of decisions made at the beginning that nobody revisits until they are expensive. And that's the definition. You know, you take a look at the… that box that's on the bottom there, it touches every layer of it. Components, the layout of the PCB, signal integrity. thermal and EMC management, enclosures, housings, and pile compatibility, the assembly and automation, supply chain stability, testability, and quality control, and then the final part, unit packaging and shipping considerations.

I just gave these two examples on the right. For those of us that are in electronics, I think the top one may look familiar from years ago, but, you know, when you're putting a prototype together, that's a hand-built prototype with all hand-wired components. And these two things may do the same exact thing, but they're completely different when it comes to manufacturing. And certainly the one up at the top takes hours and hours to put together, and potential errors, and the one at the bottom can be done automatically by machinery, and can be done in minutes instead of hours. I see a couple of hands up.

Leo.

I think Rick was first. Brick, go first.

Oh, Rick, go ahead.

Oh, I think my hand was still raised from last time.

Okay.

I'm just… I'm just, listening to… DFM is… DFM is pretty much the center of what I do. Unlike Andre, I've got… my concentration is mechanical, and nearly every project I've done has been to protect the electronics, which are really the heart of the device, and the biggest challenge sometimes is working out how the Electronic DFM interacts with the mechanical DFM in order to reach the most robust, lowest cost, highest production.

Well, let me…

Combination of them.

Yeah, Rick, let me ask you, because that… we see that all the time, is that where the… let's call it the industrial designer gives a device a look. And then you find out the electronics is not gonna fit in that enclosure. I don't know if you've ever come across that.

I've come across all kinds of stuff. I've seen that in purely mechanical devices, too. But I love working with industrial designers, and don't tell anybody this, but I love working with marketing people, too, because they really are… they really have it very much in touch with what needs to be done, with what the customer needs to see. And so my challenge is to figure out a way to make that visually equivalent. But physically possible.

Very good. Now, Leo…

Okay, so a couple things. I see in the list… A lot of really good things. Thrilled to see all that. I'm also looking at… from a… 601 perspective, I don't see labeling, and I don't see, sort of, the regulatory, sort of. wrapped around as well, that I'm concerned about, because I look at, from crittle to grave. When I look at a project from the design aspect and also the standards, how are those considered?

Yeah, that comes into play throughout. You're right, Leo, and certainly the labeling and safety warnings and so forth is certainly a part of it, and that's absolutely part of, you know, putting the IFU together and the actual direct product labeling, so absolutely agree, and I appreciate you bringing that up. Okay, let's move on. So, and then this plays again into what Leo just said, and that is the standards that you're doing. You know, when you're designing a device, maybe a consumer device, that's a lot different, because medical devices have a lot more standards. And of course, now, as of February 2nd, 2026, it's the QMSR and not the QSR. So, which incorporates, of course, the ISO 13485-2016 into the FDA QMSR now, so…

And then, of course, to continue with the ISO requirements for international, and now as well as for the U.S. And Leo pointed out the testing for the 60601 testing. And, of course, now the big focus that's on risk management, and everything related to risk. So… We kind of… this is kind of a terminology that we came up with, and that's the Grade 8 of DFM. And the Grade 8 are things that you need to apply before you look into a design. And for number one, mentioned it in one of the slides before, the photos I had, the creepage and clearance is important. That's, you know, for the PCB layout, so you want to make sure that it's set up properly before that board is finalized.

Number 2 is the component li- reliability… sorry, component availability. And make sure that when you design something, it doesn't have a short end of life. Number 3? Are you able to test it? Can you do validation and verification so that it can be tested in different ways? Number four, do you have a design transfer ability with your design history file and a device master record? It says design master record. It should say Device Master Record, so that any manufacturer can build it. Number 5? maybe you started with a 3D printed enclosure, but can it be molded? Does it have the proper drafting and angles? And, you know, Rick knows about those. So, you know, can it be manufactured through injection molding, or urethane casting, or however you want to get into the production of it?

Number 6. Is it the kind of device that should be made for automated assembly? Or is the amount that you're gonna produce that's something that really just justifies hand assembly? Number 7, can you put in-process testing fixtures there to be able to test it during.

that in-process, as well as the final QC? And then the final area, of course, is the packaging and shipping. And does the carton make the requirements for what you're shipping? Not only the device carton, but maybe you have a bulk package that carries multiple devices.

Okay, I'll stop at this. Sure, go ahead, Sean.

Before we go to Elisabeth and her question, what, you know, their grade 8, those are really effective. What one or two do you see biggest sticking points?

with. Consistently water. Frequently or often. And if anybody wants to put in the chat where they see, problems arising. Or other, you know? Something else. I don't know. What do you think, Andre? Where do you see this going?

Well, you know, I think actually the first two, believe it or not, are the ones that we see mostly. You know, the, the… The 60601 testing reveals problems that you probably could have addressed right up front.

And that…

It causes delays, and you have to retest. And then the component availability. you know, do you have alternates? We sometimes look for even… not just second alternates, but third alternates, and have that right on the bill of material. So this way, if anything happens with one of the components, you've already got a tested and approved alternate that you can plug in. So I think the first two, really, are the biggest ones that we see, Sean.

Awesome, thanks for that clarification. Elisabeth, you had something to say?

Sure. One of the things I noticed is, is I like this list, this was great, thank you, Andre, and I also heard you describe some of the things of different materials that were going to be utilized And one of the things that popped into my head from a regulatory standpoint is things like WE and Ross directives, sustainability, the recycling directives, things like that. What materials can and cannot be utilized in certain, jurisdictions, and, you know, that's one of the things that I know that we've had to, in my role in supporting companies in regulatory, is You know, first off, making sure we understand during the design process what countries they're planning on distributing, so that when the manufacturing decisions are made is, are they going to distribute.

from…

that one factory to all of the countries, or are they going to potentially have multiple factories because of some of those material controls and limitations of distribution? And those go from everything from the materials in the printed circuit boards all the way up to, you know, the packaging and the shipping containers and and all of those kind of things. So I, you know, I applaud that you have these things listed. I just wanted to mention that, because I'm not sure how many people on this call are in the regulatory area, but I know everybody always thinks of the regulatory elements as, you know, the 510K or getting the product approved, but there's a lot of sub-elements of regulatory that need to be considered in those discussions.

Yeah, thanks, Luzia. The reason I was smiling when you were talking was just last week.

We were… we were brought a product that used a… they had an overmold in their… on their injection molded part, a soft overmold to make it more pliable.

And it actually contained the phthalate, which is restricted in a number of countries, and so then.

the.

The entire thing had to be changed because that flexible material could not be used, so you're right on point with that one. It just happened.

Yeah, I had that exact issue happen recently as well, so…

Okay. We'll move on.

So now we come to another time where we'd like your input.

So…

And you can vote in the chat, which of these 8 hurts your programs the most? A with PCB layout, B, component obsolescence.

see the enclosure, the materials that Elisabeth just talked about, biocompatibility questions.

Test fixtures, yield and work. Or, packaging, shipping, and everything at the end of the product. So if you just put something in.

And we'll see what kind of responses we get on this.

You see anything there, Sean?

Yeah, they're starting to come in. EBB… DCBE due to EPR. So, B, a lot of Bs, a lot of Bs.

Okay.

C, D, B, all of them. So, it's, it's, everything from everything, a lot of B's, A, A's. Yeah, a lot of people are timing in. Thank you, everyone, for your feedback. A, B, and C depends on what stage your product is at. Awesome.

Good. Alright, well then… you know, let's… let's talk a little bit about B. You know, the components… you, you know, gotta source it, you gotta look at the economics, and of course, it's important to have a vendor strategy, you know, as part of your SOP, how you analyze a vendor, whether or not you qualify them on a long-term basis. Then you look at the actual The availability of critical parts.

Most important are microprocessors, because that's really the heart of the operation of the device.

You want to identify alternate sources, I mean, I recommend not only just a second source, but even a third source, because you never know what could happen. And that's why you avoid that potential obsolescence that comes up. And then, with regard to, you know, the assembly, you want to look at the steps.

That are needed for assembly?

whether or not you can panelize the PCBs, because if you could put 10 up.

That's a lot cheaper than making one at a time, so you want to penalize that PCB.

You want to look at the testability of the PCBs before you put it together, as we discussed before. And then, what happens if you have to rework? What are you going to do? And that's why all of this relates to the, you know, to the potential viability and valuation of the device. So, what do teams discover late?

It may not have a lot.

Absolutely.

comment on the last slide, Andre?

You wanna go back, Fluke?

Yep. It's, the long-term availability. Yes. It turns out that, the medical industry and even the, aviation industry is, rather small compared to the automotive industry. Right. So if you wanna… designed for very long term. It's a good strategy to, to hang on to the automotive part. So, if you see a part that's both available in a regular version and an automotive version, the automotive version tends to be available longer. Hmm. Now, there is a slight caveat now that, because of the, like, the second component, shortage we're experiencing now due to AI, is that also for automotive, some, simple hardware

seems to be unavailable. So, if you… if you go to the automotive strategy, you have to be careful to have a good amount of supply to to keep your production running. But over the long term, say, over 5 or 10 years, the automotive parts are better sourced than other parts.

That's a good observation, looking at. I can tell you one of the things that we've had… we've seen in the past where There was a microprocessor that a product was based on, and there was going to be an end of life, and so our customer had just decided they're just going to buy every part they could up front, and they were buying them from resellers and so forth, and They bought tens of thousands of those just to try to delay the timing. But at some point, they still had to face the redesign.

Yeah, you buy some time, yeah.

Yeah, so, but if the automotive has a longer life, that's a very good suggestion, and I think that's… people should look at that, if it's possible, so…

Yeah, and also sometimes you start out with the cheapest component available, but then suppose there's also the same version, but then with an industrial temperature range, or something like that. You can easily get that as a drop-in replacement for your original part.

Right. Good, thanks.

So, I'd like to bring Jose into the conversation at this point, because he just posted something that I think is really important, but I'd also like to say that he's going to be speaking with his partner Muhammad, next week on 510K Cybersecurity Annex one, and all of the components that go along with that. He can clarify that statement. But, to his point about AI, tell us what you said in the chat, Jose.

I just put on there that, we've seen clients running into issues with memory right now, memory chips, because AI is, like, eating up the world of memory right now. And so, components I used to be able to get with a 3-month lead times, like, 2-year lead times, you're seeing things like that, because you've got these gigantic companies who are coming in and buying, just everything. So, and you're seeing that in the valuation of these companies, like. Memory companies have tripled in value in the last year. So, just something to be aware of, but yeah. And as to next week, yeah, we'll be covering kind of all the different security controls and cybersecurity at a little bit of a high level. Should be a fun conversation with Mohamed.

That's all.

You're exactly right, Jose. We had a situation where, before, we used to get things within a couple of weeks, and we just recently looked at one, and they were talking about minimum of 9 months. So you're absolutely correct. Okay. So, you know, of course, this… I'm not going to read this slide, but… all of the things that we've been talking about has a significant valuation to the… to what the product is going to be worth to not only to the company, to investors, and how long is it going to get on the market. It all has a financial risk.

Right. As I like to say to clients, everybody wants to know one thing, or two things. How do I make more money, and how do I stay out of trouble? And I think that last, that last slide is a roadmap of both of those things.

It always comes down to money, Sean, that's… Alright, so on this slide… What… what would you do? You do your first production run of 500 units, and only 110 work. So what would you do? A, B, C, or D?

Well, we got a D so far. 3Ds. 5Ds. Order 2,000 more. PD. Many Ds.

Well, that is the answer, exactly right. So, I agree with all the D's. So… When do you bring in that manufacturing engineering partner? Not just a contract manufacturer, but an engineering manufacturer, contract manufacturer. Of course, you can do it too early, you know, you really haven't set up what the product's gonna do and what it's gonna be, and so forth, so that might be a little early. The middle one is really the right time. Once you settle in on what the device is supposed to do. You know, you can have a conversation about the manufacturability about it, and speak with people that are knowledgeable in that area, so they can, you know, look at it probably right in one meeting, and tell you what it looks like.

And, of course, we don't have to dwell on what's too late, because if the design has already been set, and the tooling has already been purchased and paid for. that's when it costs a lot of money. You know, you could have to maybe not be able to use the tooling that you have, and have to redo the tooling, or redesign the board, as I mentioned before, with that single board computer, which cost them $183,000 in redesign costs. So you… You want to look at the cheap window, obviously.

So, a lot of… a lot of people on the call have experienced the too-late window, and, to the tune of hundreds of thousands, if not millions of dollars in… in rework. If you've experienced that, you know. Raise your hand, put an emoji, I don't know, do something. Show signs of life. you know… I don't think that there are probably too many people in the too early window. But, you know, hitting… hitting… hitting the… the… the Goldilocks, thing, you know, how often does that happen, you know? And how often, Andre, do you see people coming to you too late?

To… to fix.

Many, many times. That's really… What we see is, almost last resort when they're coming in and they can't get something done, and it has to be changed, so yeah, that's… unfortunately, a lot do come. I can't say that we don't get people on the middle window. We do get people at that time, and that's because they've, they've thought about it, but there are people that come when it's too late, and it's very expensive, and not only money, but in time.

So… If somebody wanted to bring you in, somebody on this call wanted to bring you in as a partner on a project, you know. how should they reach out to you? You know, what's in it for them, you know? And do you have any sort of formal partnership program, at your company? Or, you know, how do you… how do you work with partners? Because one of the things that I've… Tried to communicate to all of you is that the hundred other people on this call are your best source of new business. You know, and the more you get to know each other, and the more you get to trust each other, the more likely it is that you're gonna refer business. So, we're working on a partnership program. If you have feedback for me, just write feedback.

But, you know, if you want to participate, just write participate. If you, want to talk to Andre, just write Andre, you know, and we'll make that connection happen. But, you know, for the time being, you know. How can they get ahold of you?

Yeah, I mean, email, LinkedIn, my email is andre at admtronics.com, my first name at ADMtronics.com. And, you know, as you pointed out, John, we absolutely believe and rely and work on referrals, and we do have an agreement with the, you know, people getting compensated for referral work that we do get, so certainly that we're certainly open to that. Happy to do that. And networking is really where we get most of our clients, from networking, from our past clients that are happy that we… what we've done with them before. Current clients, and then, of course, with consultants that have a real problem that they have to work with. And if we work with them, and we're able to secure that client, we do have a written agreement for the referral.

That's beautiful, that's what I wanted to hear.

Rick had his hand up.

Hi, Rick.

Oh, yeah. Well, you've kind of going there already, but… If you're not sure how soon you're going to need to get somebody in, call them. You know, get… have a conversation with them, spend a half an hour on the phone, see what they do.

Excellent.

And then when you start running into, like, if you were… if you were wanting to figure out, how are we going to make sure that we don't run into these kind of problems with our electrical assemblies? Well, then you give Andre a call and say, hi, we are at this stage. Andre's reply might be, okay, yes, we're also at the NDA stage, let's… let's protect you by making sure that happens, and get that taken care of, but we're at this stage, and when would be the best time to get you involved? He could say, well, you know, right now. But if it's not right now, Andre's not gonna say right now. Correct. On the other hand, it may be… it may be, you know, it sounds to me like you're about 3 weeks from when you would need to be making a phone call to me.

So let's talk about that to make sure I can get involved. And… It's… It's entirely device-dependent, it's entirely, it's entirely schedule-dependent, it's… and there are some special things that come in there, which make it You know, which can really affect that. But the fact is, Andre's been doing this for a long time. And he would have a real good idea of when to bring you in, and he's incentivized to not bring you in too early, because you will figure that out, but he's also incentivized to make sure that He will not bring you in too late, because then it's gonna cost you a lot of money, and and a lot of fixes.

So true, and a lot of headaches, so you're right, absolutely, Rick, thank you very much. So… When you are working with a contract engineering manufacturer, we kind of went over this already. Of course, you know, you gain a number of things. You can see the list that's there. We talked about the risks already, about redoing it and so forth. And then, how do you protect yourself? You want to have a… proper agreements, you want to have proper control of the IP. You know, we've developed, our company's developed over 30 patents, but our agreement is very straightforward. If we develop a patent, we may be the inventors, but it's automatically assigned to our.

Absolutely.

So they… they own that IP, so you want to have that… you want to have clear documentation. Rick mentioned the NDA up front, and then you want to have the, you know, the manufacturing and the quality agreements set up as well. So that's got to all be done right when you start the relationship with the contract engineering manufacturer. So, what do you look for? Now, you might want to screenshot this, because really, this should be the 9 steps that you look for before you get involved with anybody with respect to Designing and manufacturing your medical device, especially your electronic medical device, or mechanical, with respect to Rick. So, you want to screenshot this page, you ask yourself these nine questions, and candidly, you want to, you know, you want to score anybody on these 9, even us. You know, you want to check us against these nine.

there's related to their experience, their supply chain, they have relationships already. Can they scale this? You know, it's important for a manufacturer to tell you Are they good at producing tens of thousands? 50 a month? Or can they go to millions? And you gotta right-size their scalability. Do they already have all the quality systems set up, especially if they're doing international ISO 1345, and now with the FDA QMSR? Internal testing and validation? Are they financially stable? Do they have engineering depth? You know, for example, in our case, we've got all the disciplines in-house. Excuse me, not outsourced. Mechanical, electrical, software, material sciences are all in-house.

And then, another thing that's important, do you have one person that you want to get to? Is there one project manager, project leader, Becomes your source to contact. Excuse me. So screenshot this, and before you work with somebody, ask these questions. So… We're coming close to the end now, so maybe, is there one thing you want to know about Design for Manufacture? That, wasn't covered or wasn't discussed by everybody else that's on the call during our give and take. If you just put it into the chat, Just, write something in there, and we'll see if there's something that we didn't do. And by the way, if there's something that we didn't get to specifically on the call today, I'm available, you know, on,

this afternoon, by email, on LinkedIn, certainly happy to speak to anybody about it, even if you've got a project you're working on yourself, or you know you have a client that's working, bringing a project forward, no matter what stage it's in, I'm happy to discuss it. But if there's any questions now that I didn't cover on this, you know, please let us know.

So, one question that came up with, somebody that I was working with earlier was… and I think Jose might be able to comment on this better than me, because I'm not really an expert, but it was about cryptography. and securing the device. I think that with manufacturer of electronic devices, there's a window on cryptography, I don't remember if it's 2030 or something like that, but basically, you know, the cryptography is going to become obsolete, and a lot of devices are just too small. Physically too small to accommodate the, The extra…

protection that needs to be created and embedded in the thing. I may be wrong. But I'm just, you know, thinking about things that can go wrong, with, future regulation of… of device security and so forth.

Yeah, I mean, that's definitely a concern, but even closer term on the security side of things, you know, making sure you've got a good partner is really important. Make sure that you think through the provisioning of keys, for example, and how you're loading firmware onto your devices. We had one client in the past who, essentially, somebody got… their firmware. just created a replica of their device, somebody from another country, of course, right? So all of a sudden, they start seeing their… something that looks identical to their medical device flooding the U.S. market at a lower price. And, you know, they were able to trace it back to, essentially, their supply chain, where the board manufacturer, offshore.

Somehow, their firmware got leaked. And then, you know, all of a sudden, this IP that they've created, you know, you don't always have full protection through patents. There's other… things that you don't… can't protect that way, and so… got… their business suffered a lot because of that. So, really, the supply chain security part of things, and then also just making sure that you're… you're thinking through how you're going to provision your keys for encryption, decryption in your medical device and the embedded software. Like, that's a process that has to be done securely as well, because if somebody gets access to those security keys, they can then essentially read

Clear the information that you're sending back and forth. So, yeah, that's a part of cybersecurity that people tend to neglect, is the supply chain side of it, and it can really come back to bite them.

Yeah, good. In fact, we're getting a lot of questions about cybersecurity, which we really never got before, so I know that that's become a hot topic now, and you know, even your testing for the cybersecurity as part of your protocol for testing is important, so you're right, Jose, I appreciate that.

Yeah. I'm kind of curious, Andre, with everything that's happened in the last couple of years around tariffs and, you know, everything with China and everything like that, are you seeing a lot of onshoring happening in medical devices?

Absolutely, we've had it. We're working on a couple right now, people that want to produce in the U.S, because of the concern of tariff that maybe previously got all of their stuff externally. And are looking now to the home source, you know, domestic source, a number of components. They may not be able to do lots of things, you know, certain microprocessors and so forth they can't get internally, but they're trying to bring as much on. So yes, absolutely, we're seeing that more recently.

But it even goes as far as that from Europe, the United States is not a reliable partner anymore, so there's an onshoring from the United States back to Europe.

I only like the term.

It's both ways.

Luke, I only like to talk about the other way, so… Okay.

You're good.

No, I'm just kidding, I'm just kidding, but yes, of course. Elizabeth?

One of the questions that I was just thinking about was, with the change to the QMSR, obviously cybersecurity, as was mentioned, has become a much higher element, both in the products, but also in the manufacturing process. But the other thing that's become obviously very big is risk management, and risk management across the quality management system. So, you know, that's also something, and I know you had it as one of the nine things of the ISO 1345 and all that. But I think one of the gotchas that many, companies are experiencing right now is that they were ISO 13485, which, yes, did talk about risk management across the processes, but for whatever reason.

the QMSR audits, and many of the consultants that are out doing, mock QMSR audits are identifying that companies really did not embrace risk management across their quality management system. They did a great job with 14971 in the product design area, and they were very robust, and so they were very successful in that, but I think that that's something also that companies, when they engage with a manufacturer, whether it be internal or external as a subcontractor, need to make sure that they think about the criticality of certain processes, you know, if it's a specialized process.

you know, things like, you know, sterility, biocompatibility, even wave soldering, you know, hand soldering, things like that. You know, I… my way, way, way back machine, I was in military quality and regulatory as well, and those were all certified training elements, so I think those are things that people want to think about as questions when they're engaging with the person, so it's not just, do they have an ISO certificate, but start to ask some of those next-level down questions.

No, you're right, Elisabeth. In fact, if you look at a failure mode, you should really look at which is important, is if a certain part fails, what is the risk of that part failing? Some may be very little risk, but you might have a, you know, $1 component that could expose the user to significant risk. So you have to look at the failure mode of the individual components as well, so it gets very, very minute at that point.

So, I'd like everybody to drop one thing they learned today onto the, one thing… thing… I'm sorry, I can't type. Still, you learned today. Putting the link in the chat back to the original post about this is, you know, if you found this, helpful and insightful. I'd love your feedback. Please share it publicly. That helps us, helps us grow as a group, makes the group more dynamic. I think the way to think about these events is really your opportunity to come and connect with like-minded people, similar-minded people, people that are fighting the same good fight that you're fighting, but perhaps in a different area. You know, I'm… you know, engage with the people who you see on here. Connect with them on LinkedIn. This is not just about spamming people, but it's about…

actually making valuable connections, you know? So… as we take this group forward and develop it, I think we need to leverage the platforms that exist to help us, and not Just, flood LinkedIn with a whole bunch of meaningless, Stuff. For the sake of visibility. Hopefully this will give you a channel to channel your visibility, to be part of a conversation that means something, that moves us forward. I think that, Andre I, you know, you did a great job. There are many more questions. The chat has been, you know, just going gangbusters today, so I think

If this format works with you, we can incorporate more of this. If you're like, wow, this is, like, a great big pain in the butt, and Sean, you're annoying, then just write annoying. In the chat, you know, I'll get my feelings hurt and probably block you, but, the, no kidding. And, no, seriously, I, I welcome your feedback. And again, just to reiterate, so here's how you contact Andre. Which, andre, are you gonna make the slides available? Can I… can I share them with people?

Sure, sure, no problem.

Okay, so the slides will be sent to all of you, so if you are busy screenshotting, you'll be happy that you're gonna get… you're gonna get a copy of these slides for attending. share them. Help… help Andre help you. And andre, do you have closing thoughts for us?

Yeah, well, just… just reiterating, like I said before, if you've got a project, happy to help, or if you know someone, there's a referral that we… referral program that we have, and we've worked with regulatory consultants before, and done this before. And so, if you need any designing or manufacturing… design for manufacturing, let me know. And if I could close with the next slide, Sean. Because, I think that that top sentence is, that top statement is important. You know, when you innovate and you make a new medical device, or a better medical device, you get the attention of people. But if it's manufacturable, that's where you build a company, and that's where I think this all plays into.

So if you've got something, let me know if I can help you in any way.

Thanks. Yeah, that's a really wise statement. Manufacturing. Manufacturability builds companies. I, as usual, want to thank all of you for your time and attention today. I want to thank all of you who commented and shared. Feel free to write a thing like, hey, I attended a really cool thing today. Share it with one or two people, and that will double the size of the group. Next week. Jose's thing, I don't think the reg page is up yet, but I'll make sure that everyone who was here gets an invite for next week. Think about coming on camera, think about chatting. What are we gonna talk about again, Jose? Oh, right, cybersecurity, yay!

And… Yeah.

I'll have my very colorful British partner. On as well, so it should be fun.

Thanks, Sean Hey, Sean, before we close, I really want to make, you know, I've been… I've been involved with medical devices since before the medical device laws in the United States. It's been a long time. And I have to tell you, Sean, I really appreciate what you're doing with MLVX. This is a great, great way for us to share things. Over the years, I've been involved really from the very beginning, and I think that what you're doing here is very important, and not only a great way for business and so forth, but for learning. So, I want to send you my personal appreciation for your efforts in working on this, so thank you.

Thank you for kind words, and thank you for working with us on the presentation. We're lining up our speakers for, Q4, if you'd like to speak, please reach out to me, we'll have a conversation, we'll frame the topic, we'll figure out, you know, if this is appropriate, and, and who to invite, and… and… and yeah, let's, let's, keep this thing moving forward. Thank you all. I'm gonna… Sign off. Thanks.