Dan Kasprzyk

Dan Kasprzyk on How MSI, IDTE, Catheters Changed Test Methods

Dan Kasprzyk

Daniel J. Kasprzyk

Daniel J. Kasprzyk founded and built Machine Solutions Inc, (MSI) from the ground up and turned it into a successful business that generated over $16 million in revenue when it was acquired. He is  currently the founder, president and CEO of three medical device companies, Poba Medical, Symple Surgical and ExperiENT Medical.

Karim Mounemeine, President of Vivitro Labs, recently had the privilege to interview this experienced entrepreneur and business leader who changed the way catheter and stents are tested, processed, and manufactured in the world.

Karim Dan, I think of the huge impact you had on the industry and especially the number of interventional devices that are tested or processed by MSI equipment to date. You have an impressive track record, and many of our ViVitro customers are currently using some of your systems and the system you have designed. In your eyes, what is the biggest contribution MSI has made to medical device testing and why?

Dan Kasprzyk It’s great to be speaking with you, Karim. We’ve had a chance to work together for years. A lot of people don’t realize the IDTE machine is the foundation of what we created at Machine Solutions. When we laid out our first business plan, there was no sign of stent crimping, balloon folding, marker bent swaging, laminating, or braiding. The list is long. Our pure focus was on aligning test methodology with the interventional catheter world. That was my experience. I was a catheter engineer for 12 years prior to my time at Machine Solutions and always struggled with that foundation between the bench, the pre-clinical work and then the ultimate clinical arena.

Our goal was to come up with a way to quantify the performance characteristics that are inherent in someone’s tactile feel. It’s a really hard thing to do when you’re working with the world’s leading cardiologists and they’re telling you that something’s a little too stiff in one region or they need more flexibility in another region. Our goal with the IDTE was to give some way to quantify when Dr. X says he needs more stiffness on the proximal end, or more flexibility up towards the guidewire, that we could lay out a tracing and quantify that for him in a way that put meaningful numbers behind it. Which is what we tried to do at Machine Solutions. Fortunately, I had a smart engineering partner who was able to develop a floating load cell roller system that mimicked the clinician’s tactile feel so that we were able to measure that retractive force whether in the brain, the cardiovascular or anywhere in the body.

IDTE has a special place in my heart because it was the foundation. People see Machine Solutions and they think of all these cool automated processes to help manufacturing automate and manage their costs. All these other things which are great pieces to have and allowed us to grow the business. But our real foundation for Machine Solutions was device testing -mainly because that was my experience prior to Machine Solutions. It always frustrated me to sit down with a leading cardiologist and try to understand how his tactile feel was not aligning with the device I just put in his hands.

The IDTE really did a good job of putting numbers, curves, tracings, validations, and quantification to what 30 years ago was… I don’t even know if trackability was a word. Trackability was something I think we invented in the catheter industry. And now it’s quantified with things like the IDTE machine that can measure pushability, torqueability, All these catheter functional characteristics are critical to how a device gets deployed or a therapy gets delivered.

Karim I have sold the IDTE and used it at ProtomedLabs and now ViVitro, I completely agree with you. The IDTE redefined the way that the standard described that test. The IDTE is a push-track tester designed to measure trackability and pushability of catheters. The old way was to actually use an [Instron or pull tester. And they do not do a very good job at that. What criteria would you apply today and what challenges did you face when engineering the most used push track tester in the world?

Dan Kasprzyk It’s always a challenge to convince a skilled tactician who is born to use their hands. When they say something feels stiff or feels like it’s not steering, it usually is because their hands are telling their brain, and they’re so skilled and trained at that specific movement, that it’s real. When you put a graph in front of them that shows grams of force versus distance, many times it’s hard for them to extrapolate that to what they’re feeling with their hands. But I think with more practice, even the most skilled technicians will then see the ability of measuring forces at certain distances or certain regions within a tortuous track that there is a number that can be associated with quantifying what their hands tell their brain.

Prior to the IDTE that was our challenge. There were 50 different homegrown methods of measuring catheter performance. And none of them were standardized. They all measured something in a different way. Being able to standardize that and the output that you generate is meaningful when someone is actually feeling this imperfection with their hand. If you can show them data that is exactly what they’re feeling, this peak force right here as you advance into a circumflex artery or a neurovascular procedure, it’s really beneficial and useful. Being able to quantify that on the other side of the equation, the testing required for the regulatory submissions and all that once you get through your preclinical design freeze and validations, it has been a really good tool.

We never thought of it as being earth shattering. It was just taking all this stuff we knew and trying to come up with a standard platform that could then be disseminated to the industry and let the industry use it as a common platform so that when societies or meetings are talking about catheter performance, they could use a standard methodology to compare their notes and understand how their tactile feel may align with their colleagues or their fellows or however the path might go.

Karim The IDTE provides value to relate to clinicians and physicians on how they use catheters because it has a very unique design. The load cell, the way the catheter is mounted on the roller and the load cell, is unique to the IDTE. With that in mind, what tips do you have for engineers that design test equipment? What are the most common mistakes in designing test equipment, like for example the IDTE or anything else as complex as the IDTE?

Dan Kasprzyk One of the challenges was everybody thought you had to have a linear slide where you simulate the doctor’s grip force and then advance and have these six inch sections of motion. Those work just fine but our thought was to design something floating so that as it met any sort of resistance or retracted loads, it would be able to sense them. That’s because it’s on a parallelogram load that sensed it from the angles required to deliver the return or the reactive forces that the device was seeing far down the anatomy, or far down the tortuous path.

Karim What was the challenge behind that? What was the biggest challenge that applies to (the design of) many types of medical device test equipment?

Daniel J. Kasprzyk For us, it was just getting that load cell design such that as it was floating in space it was able to measure very minuscule retractive loads that could be meaningful to someone’s fingertips. But we’re not putting sensors on their fingertips. We’re trying to relate the reactive load that the catheter sees as it moves more distal and then use that reactive load to give meaningful design information to a clinician or to a design engineer that now has to work hand in hand with this inventor. Many times, they’re speaking different languages as it relates to quantitatively analyzing certain design features.

It’s gotten way more complex in the last 20 years because of the movement towards steerables and the massive move towards structural heart. It’s not just navigating the neurovascular or cardiovascular anatomy with flexible wires or the deflectable catheter tips. You now have robots that can deliver these devices just as effectively as a skilled interventional cardiologist. But the information from an IDTE could be just as useful to a robot as it is to a skilled clinician. Our goal with that device was quite simply coming up with a standard tool that device engineers could lean on and go to as they’re making quick design iterations and then gather information that’s really meaningful to the design.

I could tell you the countless hours spent fighting over whose methodology was more accurate versus designing a catheter that performed in the anatomy. Everybody’s trying to get a product to market. That’s the goal. So, if we could quantify this testing and use it in an FDA submission or use it to convince the inventor that his tip is designed the way he intended it, then that was the role of the IDTE. And to this day, I think it provides a great tool. It just has so much more functionality because of the markets that it now serves and the markets that didn’t exist 15 years ago.

Karim You’ve introduced a very interesting idea. Today there are more and more requirements around test method validation. Definitely Europe is really strong on that, it’s coming with the FDA, and becomes a huge deal in the medical device industry when it comes to submission.  Test method and measurement uncertainty can offset the outcome of the test itself. Why do you think it’s important to have validated test methods? Why do you think it’s important for submission?

Dan Kasprzyk  I think not only just the selection of the commonality of the test methodology, but the validation of that test methodology, so as engineers, can talk apples to apples as it relates to the device performance characteristics that we’re interested in. The governing bodies can now see this as a meaningful piece of data so that when they’re looking at device approvals and other things within the industry, they’ve got some standard to go to that’s a little bit more advanced than an  Instron and measuring tensile forcesIt is really geared to this subspecialty of interventional medicine and minimally invasive procedures. And it is important for just the time and the cost that goes into the validation of the methodology.

I can remember clearly back in 2000 to spending almost two years in meetings between groups in New Jersey, Miami Lakes, and the Netherlands. Years fighting on track methodology because each one had their own method for creating an unvalidated solution in order to quantify certain things, whether it was deployment or trackability. Two years went by along with two years worth of improvement in product launches worth so many hundreds of millions of dollars to the companies involved. A lot of it is also just engineers proud of their inventions. We want ours to be the standard.

But when you’re in a device company and your goal is launch a product, you should not be fighting for two years over whose test method is more accurate, more reliable, or just a better tool for providing that validated source for the product and then move on because at some point they have to fix what they’re seeing on the bench. If it’s an issue related to any of those functional characteristics of trackability, guidewire movement, torqueability, pushability are all critical. But it was a really, really arduous two-year period. It was pre-Zoom, but we would leave these phone calls and just be worn out because they lost sight of the fact that their end goal was to get this thing on the market. Having validated systems is critical because everybody speaks the same language.

Karim I think you also have the risk of that when everybody is using different test methods, even within the company. Very often a slight change in environment, a slight change in setup leaves completely different results and then suddenly you lose track.

We spoke about the challenge around test method validation. You disclosed that there are more and more complex interventional devices, especially with robots and the robotic aspect. What are the future challenges of the medical device industry from a testing point of view?

Dan Kasprzyk The massive movement towards structural heart as a discipline and the ability to provide standard test methodologies related to whatever it is, whether it’s any one of multiple valves or multiple platforms that get delivered through a balloon expandable or self-expanding or a bioresorbable  platform, there are so many moving parts right now that I think there’s going to continue to be a major press on just standardizing the test language so that we can all test prior to doing hundreds of millions of fatigue cycles on very, very expensive implants or deliverables.

A ton of work can go into just standardizing the test methodology, then getting agreement on how to push these things forward. Because at the end of the day, there’s a patient on the other side of all these devices. And we clearly want to make sure we eliminate devices that are dangerous. And that’s where testing can have a huge impact. Companies that spend 20 years trying to develop a better leaflet and then realize through testing that it’s not as good as an existing leaflet then have to make that hard decision at a 20-year investment to kill a program. It’s sort of the nature of a multinational, multibillion dollar, well-funded R&D programs around the medical device industry.

I think testing has great promise as it relates to making sure that the right devices are put in the patient when they’re on their deathbed or when they need the help. But it’s just as important to make sure that you can test out some of these ideas that just might not have that final design characteristic that is required for this thing to be used by any clinician anywhere in the world. It’s great in their hands because they invented it, they developed it, they know how to deploy it. But I think that’s where a lot of times they lose sight of that. I don’t know if I answered your question.

Karim You did. Definitely you want to shift assessing all the risk at the preclinical stage and avoid devices that are going to somehow make it to the clinical stage, but this risk hasn’t been properly addressed because of test method validation and robust test methods and so on.

Dan, it is truly a privilege to add you to our Cardiovascular Pioneer series. Thank you for your perspective on the medical device industry. It is very interesting, and I wish you great success with the ventures that you have going and especially with Poba Medical.

Dan Kasprzyk Thank you. We’ve found a nice niche and we’re excited to continue to help our customers as they develop lifesaving technology. It’s been a pleasure to chat with you.


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