The medical device industry has traditionally relied on a combination of bench testing, animal testing, and clinical trials to guide the development and evaluation of medical devices. Indeed, regulatory agencies around the globe have established their approval processes around these three sources of evidence.
In the mid to late 2000’s, it became clear that our industry was increasing their reliance on computational modeling to help bring new (and better) products to market at lower cost and in less time. Device companies naturally wanted to use this new form of “digital” evidence as part of the regulatory review process. However, regulators were hesitant to base their decisions on the results of a computational model without having assurance that the model was rigorously validated for each application. This introduced significant strain and uncertainty in existing regulatory approval processes, both in the United States and globally.
Recognizing this, the US FDA’s Center for Devices and Radiological Health established computer modeling as a regulatory science priority in 2011. The level of outreach and industry collaboration by the FDA over the past 8 years has been quite broad in scope, ranging from a mock submission on incorporating virtual patients in clinical trials to the development of a virtual family for electromagnetic safety testing to work on virtual imaging for the evaluation of new breast cancer imaging modalities.
And while these are wonderful and impressive examples of the power of simulation to address some of the major challenges facing the medical device industry, underpinning all of them is the need to be able to establish the credibility of a computational model for regulatory decision-making. This is why the FDA partnered with industry and ASME to develop a clear and predictable regulatory pathway for computational models as part of device submissions.
So with all the pieces in place, the next challenge is to socialize this new opportunity to the broader community. And that is why I am attending Visualize MED: Modeling the Future of Medicine, which takes place on October 22nd in Minneapolis, Minnesota. This meeting will include a mix of presentations and panel discussions from industry leaders on how modeling and simulation is transforming the healthcare industry. Topics will range from best practices when collaborating with the FDA and global regulatory bodies to the acceptance of digital evidence and software as a medical device. There will also be a panel session reviewing the digital revolution that is transforming the dental industry, and a demonstration of a VR system where collaborators can break through the boundaries of different geographies and computer systems and collaborate wherever there is an internet connection.
Computational modeling is revolutionizing the medical device industry. New opportunities and solutions are being realized every day. Visualize MED is the place to learn more about the rapidly changing future of modeling. I hope to see you there!
About Marc Horner, Principal Engineer, Healthcare Applications, ANSYS, Inc.
Dr. Marc Horner is a principal engineer leading technical initiatives for the healthcare industry at ANSYS, Inc. Marc joined ANSYS after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME V&V40 Sub-Committee and Chair of the AAPS Process Modeling and Simulation Focus Group (PMSFG). Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
ASME (the American Society of Mechanical Engineers) is a not-for-profit technical membership organization that enables collaboration, knowledge sharing, career enrichment, and skills development across all engineering disciplines, toward a goal of helping the global engineering community develop solutions to benefit lives and livelihoods. Founded in 1880 by a small group of leading industrialists, ASME includes more than 100,000 members in 140+ countries. In the healthcare area, our activities include standards development, conferences, webinars, and learning and development opportunities.
Want to enhance your ability to harness computational modeling to increase patient safety, improve outcomes, and decrease product development timelines? Come to ASME’s Visualize MED: Modeling the Future of Medicine, to learn and network. Learn more at https://go.asme.org/VisualizeMED.