Computational modeling has been touted as a tool that could revolutionize the orthopedic device industry as we know it by speeding up the development and regulatory decision-making process. A new standard, and FDA’s recent reiteration that computational modeling & simulation (CM&S) remains a priority, are indications that orthopedic device professionals should look to understand and leverage its benefits.
Physical testing in labs (e.g. bench tests), as well as human and animal testing, provide valuable insights; however, the financial burden and lengthy timelines for developing, testing and trialing each new device can significantly hinder the process. The American Society of Mechanical Engineers (ASME) V&V40 standard, Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices, could push the trend to adopt and advance computational modeling.
At OMTEC 2019, Payman Afshari, Ph.D., Senior Principal Engineer at DePuy Synthes Spine shared his experience in establishing the credibility of computational modules for product design and development purposes, as well as the V&V40 standard.
Per Dr. Afshari, CM&S provides more efficient and less costly ways to test and review medical devices. The new standard will help companies answer critical questions about new devices and shift variables more efficiently. For example, companies can build models of devices and the body’s systems and run simulations of how the device will perform when deployed. They can quickly adjust variables to model different scenarios, making it possible to run through a large number of possibilities in a relatively short time and find the optimal result.
V&V40's standard builds on the foundation of other widely-adopted ASME standards for computational (predictive) modeling techniques and performance simulation that have helped to streamline the development of several new technologies.
Adding to the credibility of the V&V40 standard is FDA’s collaboration in its creation.
FDA believes that standardized CM&S techniques will aid in the design, testing and regulatory review of medical devices that will ultimately lead to a more efficient and lower-cost way of evaluating devices throughout their total product lifecycle, said Tina Morrison, Ph.D., Deputy Director of the Division of Applied Mechanics of FDA and Chair of the agency’s Modeling and Simulation Working Group.
In August, FDA’s Center for Devices and Radiological Health updated its regulatory science priorities, naming computational modeling technologies to support regulatory decision making as one of its 10 foci. FDA’s objectives include:
- Establish infrastructure for tracking simulation usage within regulatory submissions and create a database of submitted computational models
- Identify device areas in which experimental test data is difficult to obtain, and then focus development efforts within those areas
- Develop benchmarks and examples of credible models using ASME’s V&V40
- Establish appraisal metrics for companies to certify their simulation practices
While the new standard and FDA backing are a big step for CM&S tools, challenges remain.
For one thing, companies and regulatory bodies will have questions about the quantitative characterization of predictive capabilities for both computational and real-world models, said Dr. Afshari. Also, it will take time to standardize models and procedural norms. Can these processes be owned or patented? Will all companies be able to use new processes? How will companies be confident that they can trust the data they get from their models as much as they trust real-world data?
As the device manufacturing and regulatory communities strive to answer these questions more thoroughly in the next few years, many companies may be more likely to shift away from traditional testing methods and toward CM&S. These processes will likely become more commonplace and accepted by regulatory bodies, and could eventually improve the lives of patients faster and more efficiently.
Image courtesy of Smith & Nephew
Kim Snell is an ORTHOWORLD contributor.