Simulation takes mathematics and scientific explanations of phenomena like heat, contact, friction, fatigue, hard impact, and many others and makes it quantifiable to study objectively. These are all phenomena that we humans can perceive through our senses and provide useful insight during clinical trials.
So then why should we simulate?
Computational Modeling & Simulation (CM&S) allows medical device companies to ask specific questions that they are interested in and the conditions that impact their device and patients to ultimately improve patient experience and patient outcome.
Questions like:
- How many cycles of dynamic loading will this knee joint sustain before it cracks? Where will the crack start?
- When this vagus nerve stimulator is implanted into the body to treat seizures, will the battery overheat? How hot will the battery get? Will the patient sustain burns on the inside?
Medical Device companies must articulate exactly how devices will impact patients and predict whether, how, why, and when their devices will fail.
Here are 5 reasons device makers use CM&S today and why you should too.
Reduce Capital Risk of Innovation
Medical Device companies are aggressively increasing their expenditure in R&D with the hopes that the added money will be used to make more reliable devices that stay on market longer. This capital risk of innovation ranges from hundreds of Millions to Billions. With newer technologies such as additive manufacturing being used, using CM&S can help identify whether the design of the device, and the manufacturing process itself is safe enough for commercial production.
Test Wider Spectrum of Conditions
Using CM&S as part of your V&V (Verification and Validation) and R&D process can help augment clinical trials so only the best devices make it to the clinical trials thereby helping to increase the probability of successful trials. With preemptive CM&S testing for a wide spectrum of parameters like patient demographics, unique patient conditions, device anomalies, and failure modes, you can be just that much surer about your device and its reliability.
Acceptance from Regulatory Bodies
The American Society of Mechanical Engineers (ASME) and Food & Drug Administration (FDA) have collaborated to form the ASME V&V 40 sub-committee which sets procedures to standardize verification and validation for computational modeling of medical devices. These guidelines and procedures show exactly how scientific and mathematical evidence must be reported in FDA submissions. The FDA’s involvement in these subcommittees is a huge signal to the market that credible and reliable simulations can be used as part of your submission
Algorithmic and Iterative Control
Medical Device design is a highly iterative process to get the right fit and form as well as meet the necessary safety limits. With CM&S, you can automate the iterative parts of design by engaging your analysts and scientists early on and only designing what you need. This needs-driven design is a bedrock of medical device development processes and can also be the dominant design philosophy if you use CM&S. With CM&S, you are able to leverage simulations such as Monte Carlo and Least-Squared to conclude the correct design parameters for your medical device and make it an integral part of your V&V.
Reduce Reliance on Animal Testing
Over the years the support against conducting animal testing in certain applications has decidedly moved consumers away from companies that rely on animal testing. Furthermore, while the cost of conducting animal testing may not be a growing concern for some medical device companies, if the same goal can be achieved with CM&S, you can capitalize on that capability to conclude results with the same or even higher degree of credibility while also helping your brand.
The Takeaways
One of the biggest defenses for traditional testing is that it has always worked in the past. CM&S does present an infrastructural challenge because you need to have the right experts and specialists who understand the science and mathematics of the phenomenon that poses the question of interest, is a master of the tools, and finally can make the appropriate judgement about how it should be modeled. Once you’ve made that investment in CM&S and when you’re able to use it correctly, you can avoid failures and recalls while also taking steps toward making the right devices to begin with.
To learn more about CM&S in medical device development, sign up for a series of webinars produced by Aventec starting July 30th, 2020.
