An interview with Jeff Bischoff

Some months ago we created In Silico Talks, a series of video interviews with scientists , whose aim is to increase awareness around in silico medicine, and accelerate its uptake in the healthcare sector. These video interviews are becoming more and more successful! That’s why we decided to expand the series and include key figures from organizations that are leveraging Modeling & Simulation. Our first guest from the life sciences industry is Jeff Bischoff, Research Director at Zimmer Biomet.

“Zimmer Biomet is a musculoskeletal company that traditionally has made joint reconstruction devices, artificial hips and knees and other medical devices for many, many years. Nowadays, we continue to focus on implants, but also on other aspects of the patient journey, such as rehabilitation, tracking, remote monitoring, and a lot of other technologies that we can bring into musculoskeletal solutions. My team is focused on the biomechanics to support these solutions: we are looking at physical testing of new concepts, new designs, computational simulation, to address all sorts of performance requirements or potential safety concerns. We’re addressing potential manufacturing issues with the production of these implants, and many, many other areas where we can bring in Modeling & Simulation”.

Zimmer Biomet has been using Modeling & Simulation for many years, throughout the total product lifecycle: “Early on, we would use it for supporting concept development, where we would receive a design and use Modeling & Simulation to evaluate that design. The interesting thing is that technologies have improved a lot and our internal appetite for using Modeling & Simulation has increased as well. Today, rather than receiving designs and evaluating them, we’re even bringing in Modeling & Simulation earlier to help define the parameters in which we can safely design and then the assessment really becomes an afterthought, because we know that if we’re in this envelope, it’s going to perform well”.

“For many years, we’ve also used Modeling & Simulation as primarily finite element analysis to support verification of devices. By verification we mean: are they going to be strong enough? Are they going to perform well enough? And we use Modeling & Simulation and physical testing to support those questions. Over the past few years, the impact of Modeling & Simulation to address those issues has increased to the point where nowadays, across the globe, there’s a pretty significant footprint of Modeling & Simulation to support the review and clearance of medical devices. It’s great to design the implants, and to show that they’re going to work and support the regulatory submissions. We’re able to use Modeling & Simulation to help the commercialization efforts. If we made an improvement in some area, relative to a device that maybe we had 10 years ago, or relative to a device that maybe another company has on the market, we’re able to use Modeling & Simulation to really accentuate some of the benefits that we believe we have engineered into the technologies”.

Regulatory aspects are very important when designing and developing medical devices. “We obviously are in a regulated industry, and anything we do to support the development of a device or the verification or validation of the device, we’re always thinking about: can we use the same techniques to directly support the conversations we’re going to have with the regulatory agencies? And we’ve been able to do that. So again, the footprint of Modeling & Simulation in these discussions has been there for quite a while, but it continues to grow over time. And in my experience with regulatory authorities – and this is both internal regulatory authorities, the regulatory folks at my company who are in charge of putting together the submissions, as well as the regulatory authorities outside for whatever country who are governing the clearance of the device in their country – what I have learned is that if we as technical people believe in the quality of the work, and if we have properly challenged ourselves to define and defend the validity of the approach, then we can have those same conversations successfully with regulatory authorities. There may not be the same level of technical detail, because they are looking at other aspects of it. But that’s the bar that is most effective. And again, if we’re able to do that, if we’re asking ourselves, the tough questions, as we’re developing the models, and as we’re deploying the models, we ask those tough questions, and we can answer them with evidence, then, generally speaking, we can have successful conversations with the regulatory authorities as well”.

Modeling & Simulation will continue to grow. “Everyone has known for many, many years that the promise of Modeling & Simulation is a cheaper way to evaluate stuff, whatever that stuff is. And cheap is great, cheap matters. But the other thing that we can really get with Modeling & Simulation is an unprecedented level of insight into how our devices are actually performing. There are no other methodologies that enable us to understand how this particular device may be on this end of the spectrum in terms of material properties, in terms of strength, and how this particular device will perform in this particular patient. What other way can we bring those together? Modeling & Simulation is the way to do it. So, as we continue to try and drive to patient- specific solutions, where that solution is not just the device, but it’s all aspects of the process of the prehab, the surgery, the device selection, the rehab, that whole process, as we continue to try and make that more and more patient-specific, customized to this particular patient, simulation really is the only way to do that with confidence. I think that’s the upside for Modeling & Simulation: we can get answers for all these sorts of things with the level of hardware and software that we have nowadays. It’s no longer a question of whether we can get answers, we will get answers, we can come up with a patient-specific model, a patient-specific plan. To achieve that in practice, we just need to make sure that the answers are correct. So that’s going to continue to be the appropriate limiting factor to the deployment of Modeling & Simulation in these spaces. But we have to be aware that there are some things that we can’t model. We understand the physics well enough and we can demonstrate that there’s some other areas where the level of the computational model isn’t as mature. And there we still need to put in more technical work to bring it up to regulatory grade”.

“There are various experiences that I’ve seen directly, where you dabble with some Modeling & Simulation, you think it’s going to be easy, it’s going to give you a quick answer, and you do it. And those may not be the best answers. And if you don’t look at this with the appropriate level of detail, and really challenge yourself to do it well the first time, then you may end up having a bad experience at the first time. You may come up with a result that isn’t right, that leads you down the path of designing something or redesigning something you didn’t have to redesign, and that’s a bad outcome. It may lead you down the path of using simulation within a regulatory submission. And the regulatory authorities don’t accept it because it’s not a regulatory grade. It’s not the level they want. It’s not written the way they want to see it, and that can set the company back for five years. Then you don’t want to use it again because of that first experience. So my advice would be: look at it. It is a very powerful tool. You can learn things that you cannot learn through other means. But make sure that you give it the proper attention and do it right”.

Finally, what are the main challenges that the medical device market is facing today? “I think one of the challenges which is very relevant to the use of Modeling & Simulation is there really is increasing expectations on gathering clinical evidence. There are a lot of patients that due to anatomical specificities, or curiosities about their activities, are sort of an extreme. And it’s really, really hard or potentially even impossible to get good, compelling clinical data. On those extremes, you know that the smallest patients, the most active patients, if you think about implants, that the smallest implants, or the largest implants, are these combinations that are important for addressing the global population, but necessarily, are on the tails of the distribution? How do we get sufficient clinical evidence to support those sorts of patients, those sorts of challenges? I think that’s a real problem and that’s an area where Modeling & Simulation can really help out”.

“Another challenge is the cost to entry that continues to grow right with the expectations on acquiring clinical evidence, either in advance of a submission or for monitoring. That takes a lot more investment to make really compelling, innovative new products. And the barrier may limit innovation, unintentionally, but that can be a consequence. So I think one of the other opportunities is we can use Modeling & Simulation to enable us to still chase after those truly innovative technologies, while still having a measured approach to the clinical evidence that may be needed to support the clinical use of those technologies”.

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