Alex Shaw with Archimedic

Alex Shaw Graphic

Industrial Talk is onsite at MD&M West and talking to Alexander “Alex” Shaw, CEO at Archimedic about “Medtech design, regulatory and go-to-market strategies”.

Overview

Archimedic’s discussion focused on helping medical-device founders move ideas from concept through design, FDA regulatory approval, and commercialization.

Core Approach

  • Alex explained that Archimedic supports three connected areas: design, regulatory strategy, and go-to-market planning.
  • Most product failures occur because commercialization is not defined early enough; Alex estimated 70% fail for go-to-market reasons, compared with 20% for regulatory issues and 10% for design.

Examples And Outlook

  • Active Protective successfully developed a wearable fall-detection airbag belt, but had to shift from a consumer product strategy to a regulated medical-device pathway to generate clinical evidence.
  • A smart pill case worked technically but failed commercially because insurers could not support the infrastructure needed to assemble individualized blister packs.
  • Open question: Can medical-device startups regain sufficient venture-capital and grant funding to sustain early-stage innovation?

Outline

Event And Company Context

  • Alex discussed Archimedic at MDNM West and described the event’s growth following the pandemic.

Alex’s Background

  • Background in biochemistry and drug development consulting.
  • Later moved into medical devices because of similarities in FDA regulation and development processes.
  • Became CEO of Archimedic approximately one and a half years ago.

Medical Device Development

  • Archimedic helps clients advance ideas through design, regulatory approval, and commercialization.
  • Early attention to market demand is emphasized before committing heavily to design and development.

Case Studies

  • Active Protective: wearable airbag belt for nursing-home residents; ultimately required clinical evidence and FDA approval.
  • Smart pill case: technically feasible, but the insurance-based commercial model was not viable.

Market Outlook

  • Early-stage medical-device companies have faced weak venture-capital and grant funding.
  • Alex expects renewed funding could support additional innovation and patient benefits.

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ALEX SHAW'S CONTACT INFORMATION:

Personal LinkedIn: https://www.linkedin.com/in/m-alexander-shaw-3a7076a/

Company LinkedIn:  https://www.linkedin.com/company/archimedicdevice/

Company Website: https://www.archimedic.com/

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Industrial Talk is onsite at MD&M West and talking to Alexander "Alex" Shaw, CEO at Archimedic about "Medtech design, regulatory and go-to-market strategies". Archimedic’s discussion focused on helping medical-device founders move ideas from concept through design, FDA regulatory approval, and commercialization.
Transcript

SUMMARY KEYWORDS

Medical devices, Archimedic, Alex Shaw, Product design, Regulatory pathway, Market strategy, Clinical evidence, Medtech innovation, Startup phase, Venture capital, Drug development, Commercialization, Patient lives, Business models, Industry trends

00:00

Hey! This episode of Industrial Talk is proudly brought to you by MD&M West and the incredible News and Brews team. MD&M West delivered big med tech, automation, packaging, plastics, and design. All came together under one roof. The innovation, the energy, the conversation-it was everything that makes this industry extraordinary. I was on the floor capturing the stories, the breakthroughs, and the leaders who are shaping the future. Thanks for tuning in and celebrating the people driving industrial innovation. Industrial Talk, powered by MD&M West and the News and Brews team.

00:47

Welcome to the Industrial Talk podcast with Scott Mackenzie. Scott is a passionate industry professional dedicated to transferring cutting-edge, industry-focused innovations and trends while highlighting the men and women who keep the world moving. So put on your hard hat, grab your work boots, and let's go! All

01:05

right, once again, welcome to Industrial Talk. Thank you very much for joining and your continued support of this platform. This platform that celebrates industry professionals all around the world. You are bold, brave. You dare greatly. You're solving problems each and every day. You're making the world a better place. That's why we celebrate you, and that's why you are the heroes in this story. We are with News and Brews. We are broadcasting from MD&M West, and it is an incredible event. You need to be a part of this. It's brought to you by those wonderful people at Informa, and it is. I'm just telling you. I'm looking out, and I see just people looking for solutions, the innovation, the technology, all here. And if you're not here, you're missing out. You're not hanging out with the cool kids, and you need to be a part of the cool kids. So put this on your calendar. Next year, you will not be disappointed. And the reason you will not be disappointed, you'll be able to meet people like Alexander Shaw, CEO. Archimedics is the company. I didn't put an S in there. Archimedic, no S. Just said.com. There it is, Archimedic, and we're going to be talking about well, Archimedic and see what kind of problems they they are solving. So let's get cracking. Yeah, Alexander, welcome.

02:19

Well, thank you. Yeah,

02:20

I'm all, I'm all giddy. I can't wait for this coming. I really can. You having a good show? Oh, hold it, hold it, hold it, hold it, hold it. I'm gonna, I'm gonna make a correction here. Of course, you go by the, you go by Alex, and I'm calling it Alexander. It's probably your mother would call you that, right, Alexander? But I'll call you Alex. There you go. Chia having a good show. We

02:43

are having a good show. Yes, thank you.

02:45

How long have you been coming to the show?

02:46

So this is actually around our second year. So, and it's it's been worthwhile. So we came back. Dean said it's good. Do you think

02:54

it's it's growing?

02:56

I think it has grown. I think I think many shows obviously went down through the pandemic, had had some issues, and even before that, a lot of attendance at a lot of shit was going down. This one, for some reason, seems to be bouncing back pretty nicely after the pandemic. Though a lot of others are not, but this one seems yeah,

03:10

it's it's it's gargantuan.

03:13

Yeah,

03:13

yeah. You you look at the site map, you're like, what the? And you know what's always fascinates me because I'm going to have this conversation with Informa, is the coordination of it.

03:29

Yeah, well, a lot of movies. I don't know.

03:31

I guarantee you, things would fall through the cracks if it was me.

03:36

But it's not. That's good, right? Yeah,

03:38

no, it's not. It just blows my mind. It's that that that they can do it, and they do it with such skills and abilities. All right, let's talk a little bit about Alex. Give us a little background, Alex, on who you are.

03:52

in that world. Grew that for:

04:34

non-competes have a tendency to do that. Yeah,

04:36

huh? So, and the way I got around that was sort of moving one industry to the left or the right, whatever, into medical devices. So it's it's an industry that's very similar to drug development. It's regulated by the FDA. Sort of a lot of the same processes, just different words, different nomenclature you have to use. But it's it's it's a lot of similarities between those two. So I felt very comfortable in it and found. A company that needed some leadership, Archimedic, and came into that in a leadership role as CEO about a year and a half ago, and have been here ever since.

05:08

Well, yeah, it's a segue. Archimedics, what problems are you solving? What what what are you seeing?

05:16

So many of our clients are trying to get ideas for medical devices out of their head, through the development process, and then into the marketplace, and so that's the problem that we're trying to solve. There's a lot of things that are involved in that. We feel or we think about medical device development in sort of three segments or pathways: design, which is what everyone kind of thinks about when they think about medical device design. They think about the guy over the CAD station making pretty drawings, and we and we do a lot of that. However, we think that there are two other components that are just as important as design. The second one is regulatory, so you need to have yeah pathway through the FDA in order to get a market approval.

05:57

Yeah,

05:58

and then the third is go to market, so you need to find a way to commercialize that product. You know, and what is true is that most people, when they're starting a company, think a whole lot about that D part, the design, and they sort of say, "I'll worry about regulatory later, and I'll really worry about go to market later. When it's kind of the backwards approach, to be honest. So, what is true is that of all the products that fail in getting to market, probably only 10% of those fail because of design reasons. Right, you can design just about anything you want to if you just give enough time and enough and enough money.

06:29

Yeah.

06:30

Another 20% probably fail because of regulatory, just there wasn't a pathway or something you know screwy happened in that process. But honestly, most 70% of products fail because there's not a good go-to-market strategy.

06:44

That's a pretty common common statement. I mean, it's just not defining the market well enough to say, "Hey, is there going to be a demand for that? Yeah, I mean, it's great in your head. There's a lot of people that have like, "I got a great idea, but

06:58

right, right, right. And so, what many you know designers or many founders, scientific founders, technical founders. Well, I, I have this amazing product. Of course, people are going to buy it, and that's just not true. Nope,

07:09

not even not even close. So, when you when you work with clients, you you pretty much I'm a I'm a person. I want to come to ArcMed. I I have an idea, and you just help me through that journey.

07:27

Yeah, exactly. And achieve

07:28

success.

07:29

Yep. Yeah. And so and we'll help you in all three of those realms: design, regulatory, and go to market. So

07:34

okay, okay, okay. Here back into story world. Give me, and give the listener an idea of a product that went through that process that we don't know about.

07:48

That you don't know about. We

07:50

maybe we know about it. I mean, I I figure in in the world of devices. Yeah. I mean, come on. I probably don't know about it, but it's probably out there. You know that type of thing.

08:00

All right. Well, so I'll give you an example of one that was a success, and an example of one that was not a success.

08:05

Yes, I want that.

08:06

Yeah. So a success. We worked with a company called Active Protective, which is a company sort of based out of Philly. And what they have developed, and what we help them develop, is a basically a wearable belt for people in nursing homes. You know, so that when they fall, it's an airbag and a belt. So when they fall, airbag deploys.

08:26

Now I've seen that. Yeah,

08:27

it's cool.

08:28

Yeah, it is, and it's go ahead. Yeah,

08:31

and so we help them design that. So there's all sorts of sensors that to understand when you're falling. Yeah, yeah, yeah. So we we got them through that process, and that's been a real nice success story, and you know they had some interesting challenges in that. Though they they started that project out thinking it was going to be a consumer product, not a medical device, and you know which was great because it was going to be you know there wasn't going to be any regulatory overhead. It was just they were going to go straight to market, and what they found was that when they went out to their what they thought was going to be their initial customers, which were nursing homes, nursing homes loved the product, but they said, "Well, where's the clinical evidence that this actually helps people from from breaking their hips when they fall? And and Active Protective did not have that at the time. No, they didn't. Yeah, and they and so they needed to generate clinical evidence, and so they ended up having to turn this, what they thought was a consumer device, into a medical device, so they could go through the FDA, run clinical trial, and so while it was a success in the end, and is a fantastic product, it took them a little bit of a circuitous route to go from one sales model, which they thought was right, to this sort of second sales model, which ended up being a medical device, having to be regulated by the FDA. They lost a little bit of time because of that, but in the end, they they just got approved and they're on the market now and they're selling and it's great.

09:50

See, what's interesting is then I think, hey, that's a great idea, and then I can't help but ask the questions: Who's manufacturing that? Because that's all new. Yeah, yeah. It's it's not something that hey just go over here to Acme. They they manufacture things that are similar. That's not the case. It has to be created

10:10

anew. Yeah. So I actually don't know who's who's doing actual manufacturing, but I know that if you want one of these things, you know, you go to ActiveProtective.com. What they're trying they're trying to sell it to nursing homes. Yeah, makes sense. Yeah, and so I'm not sure there's a direct-to-consumer route. Yeah, no, it's just it's just

10:24

amazing that that that that's the case. And it also, once they deploy, like okay, you felt good, you you bounce and it's all good. You're it's like your bubble wrap. That's it. It's a one-shot deal. You got to go get a new one. Yes, that is. You can't just wrap it up and just say, hey, all right, we got another one. Here's another canister. Let me do this. All the device. Oh, that's amazing. Yeah.

10:45

So that's one that succeeded. Yeah. So another one that that really cool, but but didn't end up succeeding, was made a a smart pill case, right? So you have you know, especially you know, there's certain populations, members of the population that have many different pills to take many different times a day, right? And so, a great idea would be if there was something that would just you lay out this tray and in this in this pill box, and you would just get dinged or notified somehow when it was time to take that medication. So

11:18

far, no, no, no.

11:19

Yeah. So we're no

11:21

resistance. Go ahead.

11:22

And so the model was that you know, and so we helped them design this thing, and it it also helped measure compliance because when you opened it up and you actually took the pills out, there was an inductive capacitor in the bottom, so it would it would let the doctor know that you had taken your pills that day or or had not taken your pills anyway, right? So it's so so far so good as well. The other really interesting component about this was that you get mailed every week because everyone's going to take different pills, right? Not or different sets of pills, but you would set it up with whoever was generating these blister packs of pills that that set into the tray into the pill box, and so on Sunday nights or whatever, you know, once a week you would get this new pack in the mail. You drop it into your pill box, and then you'd be ready to go for the week. And they would just keep showing up every week. So all that worked technically. It was again.

12:12

I don't see any real pushback. I said it's all doable. The technology there-it just does. It just works. So go ahead.

12:19

So the problem was they just didn't think through who was going to pay for this, right? And so they're well. They actually did think it through. They just it just didn't turn out to go the way they thought it was. What they thought is that insurance companies would be all over this, right? Because it would be a way to ensure compliance. You have fewer, you know, missed doses of various medications. You know, so they. they they thought the thinking was that the insurance company would be very excited about this because it would reduce adverse effects going down the road, and that ended up not being the case. They they were excited about it, you know, the general idea. But what they found is that there was just there was so much sort of infrastructure required around getting all the pills together in a blister pack for each different person because every person's going to have a different set, and they just the insurance companies weren't set up for that, right? And so, in the end, while it was a great idea, great product, and it worked functionally the way it was supposed to, the commercial case did not work out the way they wanted it to.

13:24

So, what do you take that situation? It seems all doable. It's not not something that's like, well, yeah. Then we use rocks from the moon because they're the best. You know, you're not, you know, and have that issue.

13:36

Right. Is it

13:37

is it a product before its time? So in this case, I mean,

13:41

and this happens unfortunately more often than not. Is you know, the company made the wrong bet on the commercial model, and and they ran out of they ran out of funds. You know, it would it would seem like would be kind of an easy bet to kind of re focus pivot to that to a different model where maybe like maybe a CVS buys buys the technology because they have the technology to keep all those pills together, or maybe it's even like a consumer product. I don't know. Depends on how much you want to end up charging for that. So I think there's a case to be made for taking the same exact technology, not changing it really at all. No, but just taking it to market in a different route. So

14:20

yeah, I hate to hear that because when you were telling the story, I'm thinking, oh, okay, oh, that's doable. That's yeah, I know.

14:29

Yeah, no, it's it's isn't it?

14:30

It's the market can be fickle, and and all of a sudden you think you got something, and then all of a sudden there's that one element, and that's a it's a killer. Well, that's just like the death pill,

14:39

and this is how we try and help our clients: is to impress upon them that you really need to think that stuff through before they go, you know, you know, 100% into design. Slap that

14:50

capital in them, ready to go with the money.

14:52

Yeah.

14:53

Well, here's the deal. Where do you see the market sort of going? I mean. Just say, with all of this, this med tech. I'll share this little story with you. So our little granddaughter, she had heart surgery, and it was a a valve, right? So they go in, little thing, little person, little heart. This was just blew my mind. How old was she? I'm just

15:17

curious.

15:17

She was. She went in at eight months.

15:20

Okay. So my daughter had the same surgery, probably. Little towel, yeah, little hole between the two chambers of the heart. It

15:27

was they weren't closing.

15:28

Yeah, right, right, exactly.

15:30

So, what what fascinated me was the fact that okay, they're going in. The scars are already clearing up. It's okay. That's one thing. Wow. The thing is that okay? You got a heart that's a little tiny thing, then you got the little valve that's a little tiny thing, and then they went in and they said, "Okay, we were thinking about having to replace the valve, but they didn't. They didn't have to. They just put a patch on it, right? You're already down. I can't see that. Then they sutured

16:00

it. Ah, crazy, huh?

16:01

What

16:02

the? How?

16:03

That's the type of innovation that exists in your business. It's just I didn't know how that. So let's let's talk about the future. What do you what do you see that's sort of tickling your fancy?

16:13

Yeah, I mean tickling my fancy. It's just there's so much uncertainty out there right now. Yeah, in a lot of regards, you know, the medical device field, especially you know, a lot of our business, a lot of Archimedics business, is in the early startup phase, right? Which has taken for the last three or four years a real hit. First from the VC world, which has been sort of stagnant, I guess. Yeah, it has, and then from the sort of the grant world, which kind of had some ups and downs last year as well, you know, and so they've really been having trouble, and I think we're just starting to see a little bit of traction there coming out of really hopefully both of those. Hopefully, I think you know the the HHS just got refunded again or bits and pieces of it again, so so that's good, you know, and then hopefully the VC world is kind of figuring itself out as well. So

17:04

you know, you know what the problem with the VC world? It's reputation. It is. It's just reputation. Everybody's like when they talk about it, and I think there's a role to be played, but it's always a VC. Oh, you know, there's not pretty somebody. Somebody doesn't come in and say, "Yeah, VC, you know, they're they're not sitting there just having a grand old time.

17:25

It's true. It's true. They

17:26

got to change your image.

17:28

Change your

17:28

go VC. Change your image. That's what I want.

17:32

Yeah. So it's interesting. So I'm hoping that in the future, you know, we'll talk about the business part first. Is you know, hopefully the future is for the medical device field, especially the early phased startup field, is good. You know, and then I think we're going to see hopefully a lot of innovation, a lot of really cool and interesting products, which will improve patient patient lives. Which is why we all got into this, right?

17:51

Especially in the medical world, it doesn't doesn't stop. All right, Alex, how do people get a hold of you?

17:59

So LinkedIn is a good way.

18:02

Go to

18:03

dic.com, but I'm stuck in the:

18:11

go to your junk folder. So he's like, I emailed him, but he never responded to me. I'll

18:19

answer eventually.

18:20

All right. that was a great conversation.

18:24

Yeah, thank you.

18:25

Yeah, I love it. All right, we're going to have all the contact information for Alex out on Industrial Talk. I'm looking at his card because I don't want to get it. ArcMedic, A-R-C-H-I-M-E-D-i.com-C is the company. There's a lot going on. He's he's got his hand in a lot of things. ArcMedic, find out more. We're going to have this. You just need to put him in. You just need to reach out to him. All right. Once again, news and brews. We are broadcasting from MD&M West, and we are telling the stories of what all these individuals, such as Alex, out on this industrial talk. We're going to wrap it up on the other side. Stay tuned. We will be right back.

19:03

You're listening to the Industrial Talk Podcast Network.

19:14

Yeah, that was another great conversation. I have great conversations. Industry's fantastic. Alex was fantastic. That was MD&M West. That's as you can tell by the video. We were part of the News and Brews crew, and it was an absolute great event. You need to put this one on your calendar. You get to great meet great people like Alex. Oh yeah, there's so much going on. You got to be excited. You got to just sort of go, "Wow, this is a great time. And you need, you need to be a part of it. There's so much. There's just so much. You just keep listening to Industrial Talk, and you'll find out more and more and more and more. And it's all out there. Alex, reach out to him. All his. Contact information is out on Industrial Talk. Reach out to him, find out more. He's a great guy. You want to connect with him? There is no doubt about that. All right, Industrial Talk is here for you as well. You need to tell your story. You need to inspire that next generation. You have something to contribute to that, and we need more people in the world of medtech. We do. We need more manufacturers in med tech. We just need it, and that's people. That's a people conversation. And you need to tell your stories, just like Alex and others at MD&M West. It's a fantastic opportunity. Tell your story. Be a part of inspiring that next generation. All right. Be bold. Be brave. Dare greatly. I say it all the time. Hang out with Alex, and yes, you will. You will be changing the world. All right. We're going to have another great conversation shortly. So as always, stay tuned.

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