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Kevin Dempsey, Tecan - Realizing and Delivering MedTech Innovations | LSI Europe '24

Tecan’s purpose is to improve people’s lives and health. We do that by empowering customers to scale healthcare innovation globally, from life science to the clinic. Together, we are shaping a brighter, healthier future, for patients across the world.
Speakers
Kevin Dempsey
Kevin Dempsey
Sr. Director, Technology Development Group, Emphysys, Tecan

Kevin Dempsey 00:02
My name is Kevin Dempsey, and I represent Emphasis. We're a Boston, US-based technology development company. We're part of the Tecan group, which is a Swiss multinational. Today, before we do the important business of introducing you to some great new innovators, I want to talk to you about your choices when it comes to system design.

Typically, when you're designing a medical device, it's highly complex, involving many subsystems: electrical, mechanical, software, etc. You have a choice: you can take a holistic, full system design approach, or you can take a subsystem-by-subsystem approach. There are some drawbacks to a subsystem-by-subsystem approach. The main ones are that when you finally integrate the subsystems, you can encounter inconsistencies. These could be mechanical, electrical, or software-related. Siloed development generally leads to missed opportunities, and if you design the subsystems independently from each other, you might miss some growth opportunities or future product platform opportunities.

To mitigate these risks, we recommend that you take a system-level approach because, in our experience, the advantage of that is that you have a more integrated, efficient, reliable, and innovative medical device. A very practical example of why that's beneficial is to think about building a house. You're not going to build the foundation, walls, and roof and then come back to do the electrics and plumbing. That would add cost because you'd have to route out all of the channels for those, and you'd end up with a suboptimal design. You might have to put plumbing where it wasn't supposed to be, and you'd have to run a lot of cables to get around obstacles in the design. Ultimately, you might not be able to provide the experience that the homeowner wants because you'll have suboptimal subsystems, which leads to a suboptimal full system.

Similarly, in a medical device, when you have the electrical, mechanical, and software all working together, you get synergies that can provide opportunities and identify risks down the road. This is a favored approach. The big issue with the subsystem design approach is risk mitigation. In our experience, we can do full system design or subsystem design for embedded systems, particularly around electronics for energy devices. However, when we go to do integration later on, a lot of reliability issues can arise in the field. When you take a subsystem approach, you do extensive testing on that subsystem in a very controlled environment. But when you integrate that device and put it out into the field, where it's used by many different users with various use cases and environments, many reliability issues can pop up that would have been spotted much earlier if each of the subsystems had been designed together.

I think it's no surprise to anyone in the room here that having a single medical product is difficult. Having a platform is better. You might have a single medical device idea, but when the various functions come together, the mechanical engineers might say, "In the future, we'd like to develop a few different versions of this handpiece to provide a more comprehensive solution to the clinician." The electronic and software engineers can respond, "Why don't we pre-position for that now by adding more software computing power? We might be able to include video imaging in later generation products." The electrical engineers might be able to incorporate variable power and frequency to offer a whole suite of products.

Again, it's no surprise to the industry leaders in this room that having a team that communicates effectively every day—a multifunctional team—is going to be better than having sub-teams working independently and communicating, at best, once a week.

In conclusion, I know it's not always possible, but where feasible, try to bring in all the functions as early in your product design as possible. You'll achieve a much better design. Just in the last 40 seconds, let me mention what we do. We provide technology development as a service, based in Boston, as I mentioned. We focus on fundamental science and engineering. We have industry-leading console multiphysics simulation and labs where we can iterate physical hardware, test it against the models, and deliver working prototypes for energy-based medical devices in a matter of months, not years.

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