Behind the Scenes: How BioSimulation is Transforming Cardiac Device Testing

Joe Mullings (00:08):

Peter Herman joining us from Resolution Medical Today, Steve and I are going to get a chance to chat with him and the real unique proposition they have at Resolution and love some of the tools they’re incorporating that are, I think groundbreaking and required in the med tech industry. So Peter, thanks for joining Steve, myself.

Peter Herman (00:25):

Thanks for having me.

Joe Mullings (00:27):

And Steve, you’ve worked quite a bit with Peter, so I’m going to let you lead this and then I’m going to dig in some areas that I think are pretty fascinating with Resolution Medical.

Steve Maxson (00:36):

Yeah, sure. Thanks Joe. Thanks for taking time to be on the podcast, Pete. We’re interested, we want to talk about Lifetech, but before we do that, if you can kind of give us kind of an overview of Resolution medical and then we’ll get into some of the nuts and bolts of some very interesting biosimulation technology.

Peter Herman (00:58):

Sure. Resolution’s been around for about 12 years and we’ve grown pretty steadily. Started out with a couple of founders—Steve Schmidt and Sean Patterson. A lot of us came from more of the larger CDMOs and we really started Resolution to be a different experience for customers. And in that time we’ve now grown to about 220 people. We’ve got both a large development function as well as a growing manufacturing function. And we’re a bit unique in the space in that our developments business is actually larger than our manufacturing business, mostly due to the complexity of the devices that we develop. Got about 40 active programs at any given time. Some of those are development and launched into manufacturing. Some of those start with process development and bypass product development and go right to manufacturing. And what we’ll be talking about today is a capability that we use to enhance both sides of our business, both the product development and the product launch side of the business.

Steve Maxson (02:09):

Excellent. Now, this LifeTec, before we get into some of the nuts and bolts, it’s very exciting. Can you talk a little bit about the acquisition? I think that happened in 2022, right? Give us a little background on LifeTec.

Peter Herman (02:22):

It did, and in fairness, I’ve been here about a year and a half, so I’m recanting some of this from the legacy of the organization. LifeTec was acquired in 2022 and was really acquired to support the product development side of our business. At the time, we had been experiencing a large amount of bench testing for our structural heart and heart failure products, and we were going through a significant amount of animal testing. And it not only was slow and expensive, but as an ethical part of it, we would like to try to minimize the impacts to the animals where we can. And as a result, we developed a relationship with LifeTec, both because some of their customers came to us and we had some customers that we took to them. And we really felt that that was the best available BioSim platform on the market. And at the same time, LifeTec was looking for a US presence.

(03:17):

And so there’s a confluence of too many benefits not to proceed and not to pursue that. And as a result, we completed that acquisition as you said in 2022. You now have cath labs in both Netherlands and the U.S., our U.S. facility, and it’s helped to grow, not just speed the development and aid the physician training of completed devices, but it’s also really helped grow our engineering staff. They have such an ease of access to real tissue and real hemodynamics and real behaviors of hearts in many different ways. And it just really builds a strong, it really strengthens the biomedical engineer’s knowledge and it helps them understand the physiology as well as, and this might sound abnormal, but we also do limbs. And so sometimes we’ll walk in the cath lab and we’ll see a leg on there and we’re profusing a leg for lower limb devices and therapies. So it’s really been a great addition to our business from a technical standpoint and from a speed standpoint.

Joe Mullings (04:32):

Peter got a question for you on that. When we talk about BioSim, so there’s a lot of gradients in that type of area. And when you talk about, let’s just stick on the coronary for right now, are these live models, are these sort of polymer models or tissue models? Give us a little more around that.

Peter Herman (04:53):

Sure. No, these are actual cadavers. We use both porcine hearts and human hearts. We have a number of those cardiac models that we can use, but they’re actual live or actual tissue. Some of it’s live tissue. And I get to our physio heart systems, that’s in a different category by itself. But whether it’s vascular models, like I mentioned, lower limbs, those are actual cadaver tissues. And we have a proprietary tissue treatment process where we can keep a heart viable and realistically compliant and behaviorally similar to that, which is in the body for up to nine days. And so it’s really, it’s not necessarily well understood that that’s part of the systems, but treating the hearts is as important as the system itself.

Joe Mullings (05:48):

That’s got to be fascinating for the engineers. I know we were chatting before we went on and it’s got to be attractive to be working as an engineer and being able to go right into a lab and ideate and sort of tinker at the same time with whether it’s process, materials, designs, what have you. So share a little bit about that experience for your engineers.

Peter Herman (06:11):

I think it’s a great experience. I’m an engineer myself and really there’s nothing like seeing an actual valve or heart tissue visually actuate and perform over a sustained period of time or through different disease states. We can select hearts with specific disease states, it takes a while to do that sometimes, but to be able to have access to that in combination with the number of programs and devices that an engineer’s working on here… there are some vocations and some jobs for engineers where you may work on two or three or four devices throughout your career. We have 40 active programs at any given time and both in active implants as well as delivery systems and implants. And so the access to the variation and the scope of the products is in combination with BioSim, I think is really a tremendous opportunity for engineers.

Steve Maxson (07:12):

This podcast is timely because for me personally, a couple of weeks ago, I’m involved in a team that’s developing a novel coronary device and had the opportunity to go up to Flagstaff, Arizona and test this device against predicate devices and look at track, force, pushability, torque… and you mentioned about anatomical models like those, there’s a place for that. And the animal studies, I think as you mentioned, I think the FDA is putting some guidance on reducing the use of animals in medical device studies. So this BioSimulator is real exciting. Can you talk about some of the different platforms? You talked a little bit about structural heart, but there’s a couple of different platforms I believe that you offer.

Peter Herman (08:03):

We do. And when I talk about platforms, those are the platforms as we have them today. LifeTec is also a source of continual innovation and technology development. So we’re not sitting still with cardiac simulators and valve simulators and more structural heart items. We’re also looking at other organs. We’re looking at nerve stimulation and a better way of mapping and testing nerve stimulation. But what we have today is basically three of our main systems. One is a cardiac BioSimulators, and we have that in our lab in Eindhoven, Netherlands and also here in Minneapolis, Minnesota. But those systems are also for sale for two customers. They’re relatively portable and easy to put up. They come in two big, large boxes. We take them to some of our shows like TCT and demonstrate live pulsing hearts at TCT. There’s nothing better to grab people’s attention than a beating heart on your table. But that uses a closed loop mechanical actuation of human porcine or ovine hearts that have been specially treated, as I said, and they maintain physiological accurate properties, and we use a clear fluid. So we have visualization and multiple, basically any place you want to see clear video representation of the performance of the heart of the device, it’s really incredible visualization and it’s sustained long enough; you’re not working against the clock. You can come back the next day and do the same thing.

(09:52):

You can iterate in-house. Sometimes we’ll do a lab in the morning, take the devices out, we’ll make some tweaks, and for before lunch we’ll do another iteration with another heart. So it allows for very quick iterations, some of the more subjective parts of developing a system. So that’s our cardiac BioSimulator system. We also have a heart valve testing system, which is a bench level testing system for testing the hydrodynamic performance of valves, stand-alone implants prior to going into our cardiac BioSimulator. And then lastly, we have our physio heart system, which is a more time-sensitive system because we actually have to get a fresh porcine heart, perfuse it with blood, and we get the heart beating on its own. And we can continually perfuse that on the table in the system for up to eight hours, get full EKG recordings, pressures, flows, we can test multiple types of products including EP, active implants, IPGs, heart failure… It’s a more complicated system and you have to be on your toes because you have to get the heart, you have to get it there, and you have to get it in place. Right now, that’s only available in the Netherlands. We’re in the process of bringing that over to the U.S. and we expect to have that over here in the first quarter of next year.

Joe Mullings (11:18):

Do you have imaging technologies also in house there that would emulate those in a cath lab? So if I’m working on delivering a mechanism or a valve or whatever it is to the heart, do you have the same type of simulation there where I can see that in a CT scanner or ultrasound or fluoroscopy?

Peter Herman (11:37):

We do—in both labs, we have ultrasound and inter-cardiac endoscopy. We have Fluoro in the U.S. and we’re installing that in Eindhoven right now. We’re upgrading the facility to be able to deal with that. And I think that’s pretty comprehensive for most of our devices where we need MRI or CTs, we have our CBS that we call our cardiac BioSimulator, our CBS system, and it is compatible with CTs and MRIs, and we will bring those to the location. As I said, they’re fairly portable and so we can do those in situ with the customer if we need to.

Joe Mullings (12:22):

Wow, that’s impressive.

Steve Maxson (12:25):

What kind of deliverables do you provide if a customer comes in and you’re performing all these tests on like say the cardiac BioSimulator, are there certain reports or deliverables, visuals, what do you do after all this testing takes place? Or during?

Peter Herman (12:45):

As you can imagine, there’s a range there. It depends if you’re doing the first device or [if] it’s very early testing. It might be just some basic data, some visualization, some actual room, I’ll say video in the room of how the procedure went overall. And that extends all the way then to the complete deliverable or the complete report where we’re dealing with all the images inside and outside the waveforms, flow measurements, device and design recommendations from what we’ve seen on other devices… obviously keeping the customer confidential information confidential and can include physician feedback on the overall procedure, on the risks, on the benefits that maybe weren’t even really contemplated as part of the original device design. So it does vary across that spectrum, but you could expect a very similar report to an animal test.

Joe Mullings (13:51):

A lot of data,

Peter Herman (13:52):

A lot of data!

Joe Mullings (13:54):

Do you get to keep that data? That’s a heck of a honeypot for you. So who owns the data? Do you own it? Does the client own it?

Peter Herman (14:01):

The client owns it.

Joe Mullings (14:02):

So

Peter Herman (14:02):

So clients that for Resolution Medical, that’s one way we’re different from a lot of CDMOs, especially when we get into our manufacturing area. The client has full access to the manufacturing floor process. They can go out on the floor anytime they want. Our processes are not proprietary, they’re the customers. And the data that we have, whether it’s in BioSimulation testing or in development, that’s all the customers. Any IP is also the customer’s.

Joe Mullings (14:30):

Fascinating. And then what about physician training? Before we wrap up, tell us about that. Do you get enough physicians in there to use this? Do they find that [to be a] very powerful tool?

Peter Herman (14:44):

It’s interesting. Sometimes I’ll walk through our lobby and there’ll be four or five KOLs sitting in the lobby and they’ll be sitting there waiting for a customer that is going to use them for either training or for their opinions. But they may not have gone through any of our development or anywhere else in Resolution Medical. We have customers that just buy the lab time for their labs, for their KOLs and for their devices, but we get a fair amount of physician exposure for customers where we are doing the development and the product release. I think that’s an undersold aspect of growing a bioengineering students skillset because now they get to actually deal with physicians and they get to talk with physicians. And there is an ease developed in that dialogue with how physicians think and how things actually go into a patient and how a patient responds. And so in addition to engineers getting exposure to the tissue and the devices themselves in the tissue, they also get exposure to physicians and how they think and what’s important. And it changes the thinking of engineering teams for sure.

Joe Mullings (16:10):

Yeah. Excellent. I love to see the technology rising to the top of the CDMO business and getting pushed out of the mid-cap strategics and the startups who can’t afford it. Love to see the broad development of the CDMO industry at large and those that are sort of leading the way in very unique areas like Resolution Medical is. So certainly Steve and I appreciate your time today and sharing that with us. And I think you’re probably going to have a number of product development engineers that might be in some of the big strategics around you, not even know that what you were doing and leave there and actually go do some real engineering instead of paperwork. So hopefully that works out for you.

Peter Herman (16:53):

We don’t like to actively compete with our customers, but we do. I think we have a pretty open view of whether our engineers go there or their engineers come. What’s important is the development of an engineer’s career and we can’t do that in just one location. So we have a pretty open mind about that for our staff. We hope the OEMs have the same.

Joe Mullings (17:13):

Love that. Love to see that. And Peter, appreciate your time, Steve and I always love these conversations.

Peter Herman (17:20):

Appreciate your guys’ time. Really appreciate the opportunity.

Joe Mullings (17:23):

Thanks Pete.

Peter Herman (17:24):

Okay, thank you.

Joe Mullings (17:25):

I’m Joe Mullings with Steve Maxson one 60 Studios. Be well.