Von der Entwicklung zur Fertigung: Eine globale Partnerschaft

Dieses Transkript wurde KI-gestützt erstellt und redaktionell überarbeitet. Abweichungen vom gesprochenen Wort sind möglich.

[00:00] Bryant Grigsby: „You can actually hand off work overnight. I’ve done that a few times, where we’ve had a team working in the US at the end of the day, they pass it off to, at the time, Eastern Europe, and then they pass it off to India. So we were able to work three shifts in one day and cut the timeline by a third. Setting it up right takes a lot of work, but once you’ve got it going, it can really pay off for customers who need speed above anything.“

[00:30] (Intro): „Welcome to MedTech Unfiltered, the Corscience podcast where we talk about the real challenges of developing and improving complex medical devices.“

[00:43] Andras: „Hello, and welcome back to MedTech Unfiltered. Today, I’m your host, my name is Andras. And today we have two of our guests from PDV MedTech, Nick Hulme and Bryant Grigsby. Welcome. Thanks.“

[01:00] Nick Hulme: „It’s a pleasure to be here.“

[01:02] Andras: „Pleasure to have you here. So the reason that you guys are here is because today we signed an important partnership between the two companies. Is that correct?“

[01:13] Bryant Grigsby: „Yep, yeah. It’s our first strategic partnership that PDV MedTech has signed. So we’re very excited about that. Woo, that sounds good.“

[01:22] Andras: „So what is the origin of this partnership? What was the thought behind this? How did we find each other? How did you guys find each other?“

[01:31] Bryant Grigsby: „So if we think back about our history, and it’s probably pretty similar to Corscience, we’re very customer focused. Everybody says they’re customer focused, but we’re very customer focused. We want to make sure that in our ecosystem, we can make all the introductions, provide all the services that basically any MedTech entrepreneur can take their idea and get it out on the market. Whether it’s successful or not, that the market’s gonna say that. But we want to make sure that there aren’t technical or service roadblocks in it. And so over the last 25 years of doing this, we see all these different holes that our customers struggle with. And one of them is in some of the electromechanical space, especially today with everything moving into more smart sensing, AI based. And you have a long history at Corscience of doing that type of development. We’ve been working in Silicon Valley for, like I said, 25 years. And so when we met at Medica and then later at MD&M, it just seemed like there was a natural synergy right off the bat. And it didn’t take very long, at Medica for us, or at MD&M for us, to go: we need to formalize this partnership. And they’re very happy about it. Nick, what’s your take?“

[03:00] Nick Hulme: „I would just add, along the same lines of being able to support customers more effectively, there’s just a proximity factor that can become a hurdle. Because there’s a lot of good medical device ecosystem in Europe, a lot of good startups that have funding and they’re developing products. And a lot of what we offer as a manufacturer is useful to them, and we can support them in the development of their device from a manufacturing perspective. But just working with engineers in California when you’re based in Germany is a challenge, because you want to be there to see the prototypes, right? You want to be on the same time zone so you can have a regular meeting cadence. And that’s just challenging. And so something that Bryant and I have been discussing for the last couple of years is how can we have a presence in Europe to support the startups while they’re still working on the product development, and then provide a seamless transition so that when they’re commercializing in the United States, then they have a US partner to build up their production line.“

[04:15] Andras: „Absolutely, I 100% agree. And from our point of view, this is why this partnership would also make sense since we wanna expand in the United States and we need a strong partner in the United States, and looks like with PDV MedTech and with the INDO-MIM Group, we really found it. Now a little bit more towards what we do and what we’re good at. As far as I understand it, you guys have the expertise more in Class I, Class II medical devices, some experience also in Class III. And from our point of view, what we really do is critical devices. So it would be Class IIb and Class III. So I see that synergy also in this area.“

[05:08] Nick Hulme: „Yeah, and our experience is fairly wide reaching as far as the type of device and the therapeutic area, the classification of the device. We’re fairly agnostic in that sense, but our expertise is in manufacturing. And so getting involved in the development of a Class III complex implant or energy delivery system, we can work with experts that bring defined product requirements to turn it into something that you can manufacture, that you can get through the FDA or the MDR, and then put on shelves and scale up. But from a Corscience perspective, working on that core IP with them being a partner, and actually defining those product requirements, in those types of respects, I think that that’s where a collaboration with Corscience is going to be very beneficial for those customers.“

[06:14] Andras: „I 100% agree. On a personal level, I’m also very excited to collaborate with you guys. Coincidentally, both companies are 25 years old. Coincidentally, both of those companies are full of athletes. Coincidentally, both of those companies have a wide array of expertise, both in software and hardware engineering. Yet we are a bit more focused in core technologies. Our core technologies are cardiovascular and patient monitoring, emergency related devices. Like I said, Class III and some Class II medical devices. Now, working also in different time zones is, as you mentioned, Nick, very challenging. I know you guys have manufacturing facilities in Mexico, India and…“

[07:11] Bryant Grigsby: „…UK and the United States. Yes, we’re in California, Utah, Arizona, Colorado, Texas, Mexico, UK, and two large plants in Bangalore and Chennai.“

[07:29] Andras: „And now you have a development partner in Europe. My experience is that it’s the same as yours. It’s very different to work with a company from California versus a company in Germany, culturally, but also setting meetings is sometimes even a challenge when you’re based in, I don’t know, Eastern Europe, and you’re trying to set up a meeting with a company in California. You have to, basically it’s outside of your work time, no matter when you set the meeting up to. And I see this as a big positive in this relationship that we’re establishing. Project management can be done basically from three different time zones.“

[08:13] Bryant Grigsby: „Yep, yeah. One of the advantages of having global companies is being able to take advantage of the different time zones. So if you’ve got a product that you really need at a very quick pace, having engineering staff around the world, especially a really cohesive team that really breaks through the different cultural barriers and has a strong relationship, you can actually hand off work overnight. I’ve done that a few times, where we’ve had a team working in the US at the end of the day, they pass it off to, at the time it was Eastern Europe, and then they pass it off to India. And so we were able to basically work three shifts in one day and cut it in third. Setting it up right takes a lot of work, but once you’ve got it going, it can really pay off for the customers that need speed over anything.“

[09:08] Andras: „Absolutely, this can fill in many gaps. Shortening project timelines, improving communications. Sometimes it’s not easy to communicate multicultural. We had an episode earlier that compared the German and the American culture to one another. Especially the West Coast, right? So it really helps to form these partnerships and to learn about different styles of working together and effectively communicating to customers. And I do believe a partnership like this will also help bridging this gap, just because of the local presence that we would have on both continents.“

[09:58] Bryant Grigsby: „Yeah, definitely. Also, when you think about different cultures and different regionality, people see the same thing differently. And it doesn’t matter whether you’re talking about art or you’re talking about some engineering. Having fresh eyes with a different perspective eliminates all the assumptions. It’s one of the biggest challenges that we see on early med tech when they go hit the market, is they have all these assumptions about what’s going on with the market. And the whole Silicon Valley mantra was go fast, break things, right? But it’s not really go fast, break things. It’s go fast, get your feedback so you can iterate it, and so that you can get it right, so that the customers, so the end users, get the application that they want. And having a multicultural experience within your team gives you that insight. And so you have less assumptions that you have to try to break up against.“

[10:50] Andras: „Absolutely, absolutely. Another maybe deeper topic that I see here that we might need to discuss is: our technologies, our expertise that we’re bringing together, will not only be innovative in the future, but also it will decrease some costs for future customers, because we have, like we said, different expertise areas. We’re bringing in different expertise from different sites. We have now double of possibilities of bringing projects in building blocks that we acquired, IP that we bring into PDV, PDV IP that we’re bringing into our house. We are able now to bring projects together quickly and more effectively. That’s something I’m very excited about. I’ve just read through your case studies, and wow, you have a wide array of projects that you’ve done, probably a wider array than what we have, because we’re really focusing on a couple of different areas. Maybe could you mention a couple of these projects that you guys have done?“

[12:11] Bryant Grigsby: „Yeah, I’ll talk broadly and then they can go into a couple of specifics. But if you look at how MedTechs evolved in the last 25 years, both in what it took to get it to market, what it took to get a strategic partner, who’s got the distribution channels and how they can actually drive it1, it’s changed massively. And one of the big drivers in it is realistically, it’s where venture capitalists think they’re going to get a return. Everybody knows right now, venture capitalists are focused on AI. So five, 10 years ago, you might’ve had sensors, you might’ve had machine learning as part of your device, but you certainly weren’t calling it AI. And so as a company, sometimes there was a lot of money in spinal implants, sometimes there was a lot of money in oncology, sometimes it really varied depending on where investors thought they could get their best returns. And so you’d have an influx of three or four or five startups that would come in in the technology space and they would stick around for three or four years, five years, and then the next big investment wave would come through. And so that gave us a pretty wide diverse background. So we ended up realizing that we can’t be experts in every technology. We have to go to experts in the technology. We can be experts in taking your idea, figuring out the process, figuring out the design for manufacturability, to get it to market with that diverse background. So if you can hit a couple of different topics.“

[13:44] Nick Hulme: „Yeah, I mean, I kind of mentioned the word device agnostic, and that is why, because over 25 years of business, we’ve just had to evolve with the market. The projects that have come our way, we’ve found a way to be successful in whatever we get the opportunity to work on. And so, it branches from Class III heart implants to wearable sensors, drug delivery catheters, energy delivery systems, like an ablation system. And then, even Class I 510(k) exempt devices, we have some dental products that we manufacture and develop as well. So it’s quite wide reaching, without getting into too much specifics. Anybody that is interested in finding out what our experience in medical devices is can definitely find that on our website.“

[14:46] Andras: „Great. So that brings me to one of my last questions before we end this episode of the podcast. What can our partners and customers expect from this relationship, from this partnership that we’re entering into? Maybe I will start by answering from my side. Other than what I mentioned earlier, I’m also very excited about your manufacturing capabilities that you will bring into the Corscience doors. And I’m excited to use those capabilities in future projects. That’s probably foremost what I’m excited about. And also just by the fact that knowing that we have a strong US partner on ground, as US is one of our main areas of focus right now as we’re trying to expand there.“

[15:44] Nick Hulme: „I agree. I think that between the two companies, three if you wanna consider PDV and INDO-MIM separate companies, but between Corscience and PDV/INDO-MIM, we can really cover the early stage deep development that Corscience is really focused on, in a few of those therapeutic areas that you center your expertise on. And then the ability to transfer to manufacturing with a variety of options. So that’s something that, while you’re working with your customers, that’s a big value that you can provide, is we have a seamless transition to manufacturing in the United States, to manufacturing in Mexico or India, or whatever combination that we wanna use to meet the customer needs.“ [16:35] Andras: „And it’s their choice.“

[16:36] Nick Hulme: „And it’s their choice, exactly. So we have options that we provide. So if they need a product that is completely manufactured in the United States, then we’ll figure out how to do that, because we have manufacturing in the United States. If they need price, if it’s a price sensitive product that needs a more competitive cost model, then we can do sub assemblies or components in India and final assembly in the United States, or we can do it all in India. We have our clean rooms out there as well. We have certain situations where we’ll do some of the process in California and Texas, and then labor intensive steps in Mexico, and then send products back without the full tariff burden. And so it just brings out a lot of different options. But ultimately it’s what the customer needs. And that’s something that I think that there’s gonna be a full end to end, a true end to end opportunity there. Much agreed.“

[17:36] Bryant Grigsby: „Yeah, what I look at where we are and where we’re gonna go, is going through and looking at the full supply chain, looking at the full development life cycle. And by having INDO-MIM, PDV, and Corscience, as Nick said, we cover a lot of it. We’re one of the leaders in, if not the leader in, metal injection molding, and just gigantic automation capabilities. But there are other areas, there’s certain specialties, that together we’re going to be able to identify and go out and pull together the complete ecosystem. You’ve got regulation in the US, you’ve got regulation in Europe. Oftentimes the regulators, your regulatory consultants there, they don’t know the other markets, and everybody wants to eventually get to both. So how do you overlap that? How do you fill those gaps? And so that’s something I think is gonna be very exciting in the next year or year and a half or so, as we grow this relationship and fill out that full ecosystem.“

[18:39] Andras: „Completely agreed. And even on the regulatory level, both companies are bringing experts onto the table. It’s very exciting. So if there’s a message you wanna send the viewers or listeners right now of this relationship, what would it be?“

[19:00] Nick Hulme: „I would just reiterate what Bryant said at the beginning, which is we want to be able to provide a turnkey solution for our customers. We wanna be able to support a customer. PDV MedTech was founded with the idea of being able to help innovative healthcare solutions reach the market so that they can impact patients. And that’s changed over time. So when we were first founded, usually the way that a product becomes successful is through an acquisition or an IPO. And in order to get to that stage, it didn’t take as much development work, and it didn’t need to go as deep into the process. It just required good IP, maybe some animal, some kind of pre-clinical testing to prove that it would work. And then that might work for an acquisition. Now the market has evolved so that startups are required to go deeper into the process. They need to get through their FDA or MDR clearance. And then they need to actually start their commercial production line and produce product before they can see an acquisition. And so now we’ve evolved to be able to support startups, so that we can kind of guide them through the entire process. And that’s what I think this just expands that. It allows us to be able to support our customers in Europe, support customers that have a need for development support in embedded systems and complex electromechanical devices, and then still be able to provide a full turnkey support.“

[20:45] Bryant Grigsby: „If I could put it into a tagline, it’s what we came up with when we came together with INDO-MIM: building the future of MedTech together. And it’s building MedTech together with your partners, with your customers, so that you can bring these amazing changes to the market.“

[21:05] Andras: „Well, I appreciate you guys coming in here and making the trip to Erlangen, Germany. Hope you’re gonna have a wonderful time here.“

[21:16] Andras: „Looking forward to take the next steps together with PDV MedTech.“

[21:23] Andras: „Definitely. Well, thank you for coming in. Thank you for listening, watching. Stay tuned. Goodbye.“

[21:33] (Outro): „Subscribe to MedTech Unfiltered so you never miss an episode, and find more resources in the Corscience Academy.“