Q: Why is Computational Modeling & Simulation (CM&S) critical for medical device companies?
A: Improving device quality, safety, and effectiveness while delivering personalized treatment are key goals within the medical device industry. Novel therapeutic solutions must be developed within tight budgets and time constraints yet be able to meet stringent regulatory scrutiny around the world. Therefore, medical device makers are increasingly using CM&S to improve performance and reduce the need for physical validation of their devices.
Medical devices are also becoming increasingly more complex. For instance, drug delivery devices – say, for diabetes or cancer treatment – have evolved from simple mechanical injectors to sophisticated wearables with onboard sensors to support continuous patient monitoring and adaptive, patient-specific drug delivery. Given the high risk posed by such novel and complex devices, it is critical for device makers to use CM&S to validate their performance in all possible real-world scenarios since doing so physically could be prohibitively expensive and sometimes impossible. This effort requires systems modeling as well as full 3D physics simulations, including structures, fluids, and electromagnetics to ensure that all components are working together perfectly.
Q: What are some challenges in adopting CM&S for medical device development?
A: While CM&S has long proven effective for reducing time and costs of new product development within industries such as Automotive and Aerospace, it remains underutilized in medical device development. This underutilization is due to a few factors.
Regulatory-grade evidence for device safety and efficacy has traditionally relied heavily on physical testing. To replace physical testing with virtual testing, the industry needs well-defined, easy-to-use, and validated modeling and simulation workflows. However, the simulations needed to accurately model and analyze a device in its operating conditions tend to be technically challenging. Typically, simulation experts are needed to perform the simulations and interpret the results. A lack of simulation expertise can restrict the use of CM&S, especially in small to medium-sized companies, which constitute a significant fraction of medical device makers.
In cases where companies have been using CM&S, we often find simulation experts working in discipline-specific silos digitally disconnected from the design process. This means they are using different file formats, different computing systems, and communicating via email or file transfers – all of which are impediments to productivity and quality.
Q: How can development organizations overcome these challenges?
A: Many of our customers are demanding tighter integration between design, simulation, and data management as part of their overall digital transformation strategy. Within Dassault Systèmes, we have answered this need by offering a unified modeling and simulation approach on the 3DEXPERIENCE platform, which we refer to as ‘MODSIM’.
MODSIM provides fully unified, easy-to-use design and simulation capabilities for medical device developers to collaborate and gain early insights into their product performance. Beginning with conceptual designs, designers and engineers can collaborate across work functions on developing a device and its components.
Designers can easily simulate a range of physical domains that influence device performance, including structural analysis of components and assemblies, fluid dynamics of drug delivery mechanisms, and electromagnetic analysis of onboard circuitry and antennas. They can have high confidence in the accuracy of the simulation results since our solutions are powered by our industry-leading technologies, such as Abaqus for structural analysis and the CST Studio Suite for electromagnetic simulation.
Q: Can you explain more about how MODSIM is used?
A: MODSIM builds on the concept of “left shifting” to reduce physical testing later in the process and increase the impact of simulation on engineering and design through standardization, automation and democratization.
As mentioned earlier, the expertise needed to model medical devices under realistic operating conditions often involves very advanced material models and simulation expertise to set up and run the simulation – for instance, the material behavior of shape memory alloys used for stents or the behavior of arterial tissue surrounding them, or the complex constraints to which knee or hip implants are subjected to inside the human body.
With MODSIM, it is possible to standardize and automate the design and simulation processes required for complex simulations using guided and robust virtual testing templates. This enables a few simulation experts to develop best practices and share the validated methods with a much larger group of designers who can then easily evaluate many more design variants in less time.
These workflows can be device, application, or company-specific and made available on the 3DEXPERIENCE cloud platform to the designer team anywhere and anytime. This boost in simulation democratization is where we see the biggest interest in MODSIM from our customers.
Conclusion
Digital continuity and decision traceability are critical within medical device companies for internal quality control, and for regulatory authorities who need to understand what design changes were made, what motivated those changes, when they were made, and what impact they had on other components and systems, and the set of original requirements.
As part of its standard capabilities, MODSIM on the 3DEXPERIENCE platform provides unified design and simulation combined with data management, collaboration, and design decision traceability capabilities. Our customers are leveraging MODSIM to standardize, automate, and democratize design and simulation workflows. As their organizations recognize the benefits of improving efficiency, solving complex engineering challenges, and optimizing the device design earlier in the process, we are seeing momentum building toward enterprise-wide adoption of the MODSIM paradigm.
Ultimately, the MODSIM approach not only improves efficiencies within the development processes, but also helps meet regulatory requirements and improve device quality and effectiveness for patients.
For more information, visit: https://www.3ds.com/industries/life-sciences-healthcare/medical-devices
Connect with Karl on LinkedIn to discover, share, and comment on his views on modeling and simulation in the Life Sciences and Healthcare industry.
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Katie is the Editor of the SIMULIA blog, an expert in engineering and scientific communication, and a strategic digital marketer. Katie has a BA in English and Writing from the University of Rhode Island and a MS in Technical Communication from Northeastern University. She is also a proud SIMULIA advocate, passionate about democratizing simulation for all audiences. Katie is a native Rhode Islander who lives just outside of her favorite city, Providence. She is a true New Englander and loves sharing all the cool things NE has to offer. She enjoys a variety of hobbies including history, astronomy, science/technology, science fiction, true crime, fashion and anything associated with nature and the outdoors. She is also mom to a 5-year old budding engineer and two crazy rescue pups.