By Cheryl Liu, SIMULIA
Physics-based computer modeling tools such as finite element analysis (FEA) and computational fluid dynamics (CFD) are now playing an increasingly important role in the product development process. The regulatory agencies are increasingly recognizing the importance of these tools in virtual prototyping and their ability to look at in vivo conditions that are difficult, sometimes impossible, to replicate on a bench-top. As the FDA has issued guidance documents that provide outline for use of computational tools, it can be expected that the role for simulation in the submission process will continue to grow.
To meet industry demand for more realistic simulation in the development of medical devices, implants, and surgical procedures, SIMULIA is focusing on developing new capabilities and enhancements within the Abaqus Unified FEA product suite – one of the world leading computational software used in medical device industry. The realistic simulation capabilities in Abaqus include complex material models, robust interaction tracking, multiphysics, and high-performance computing, among other powerful features. Such capabilities provide a robust environment for analyzing the physical behavior of mechanical systems in medical devices as well as in interaction with human tissue and bone. While our quality management system is certified under ISO 9001 standard, we also realized the need for validation and verification based on our experience working with other regulated industries including nuclear and automobile. That’s why we are working with standard agencies to develop Abaqus-specific best practices to enable easier adoption for new medical customers.
Our customers are using Abaqus for a broad range of applications, including: the simulation of implanted devices (stents, pacemakers, and heart valves), orthopedics (knees, hip, and shoulder implants), drug delivery systems (syringes, auto-injectors, inhalers), diagnostics and monitoring tools. In all of these applications, the stakes are high for ensuring that the product functions correctly and reliably before being put to use in the patient population. Simulation is playing a key role in investigating the response of these products under realistic loading conditions.
As medical device manufacturers place a stronger emphasis on using realistic simulation during the development process, it is expected that the volume of data, analysis methods, and intellectual property generated from simulation will increase dramatically. Medical companies need to be able to trace the history of their decision-making processes and prepare data for FDA submissions. SIMULIA is leveraging technology from Dassault Systèmes’ new V6 platform and the ENOVIA brand to provide a complete solution for Simulation Lifecycle Management (SLM). SIMULIA SLM maximizes the value of company-generated IP through the capture, re-use, and deployment of simulation best practices for collaborative product development.
With significant advancements in our realistic simulation technology, as well as increasing simulation use within our medical-related customer base, it is clear that our strategy of providing robust nonlinear FEA and multiphysics solutions for the entire range of the medical device development process—plus the tools to manage and secure the resulting IP—is resonating strongly within the industry. It is our goal to meet with our customers regularly to understand industry requirements and deliver solutions that address their product development challenges today and in the future.
Cheryl Liu is the Medical Devices Industry Lead at SIMULIA, a world leader in realistic simulations. Cheryl is interested in helping medical device makers realize the value of realistic simulation in their product design, analysis and regulatory submission. Cheryl holds a PhD degree in orthopedic biomechanics. She has been working with SIMULIA customers in cardiovascular, orthopedics and drug delivery sectors for the past five years.
