Digital evidence generation: Simulation-driven design for medical devices

Generating objective evidence that a medical device is safe and effective is a central effort in medical device development. Multi-physics simulation can play a leading role in generating digital evidence of device performance and safety — of individual components, of subsystems or of entire systems — often before experimental evidence can be obtained and in situations where it would be impossible or difficult to do so in vivo or in bench tests.

Underlying technologies are becoming more complex, treatments more personalized and the regulatory landscape more stringent. Multi-physics simulation and testing is a key enabling technology to help address each of these challenges.

Benefits for large and small companies, across application areas

Multi-physics simulation is a great equalizer, providing large and small companies the ability to gain insight and fundamental understanding into the performance and key parameters of the devices they design and build.

Whether the applications are in orthopedics, diagnostics, laboratory equipment, cardiovascular and neurological, surgical equipment, robotics, prosthetics, exoskeletons or others, the use of simulation translates to:

• Reduced reliance on costly physical prototypes
• Increased speed through the regulatory process
• Patients gaining access to innovative devices sooner
• Reduced likelihood of recalls

This whitepaper illustrates how today’s simulation solutions provide medical device developers with the tools to realistically model individual components, subsystems or entire devices, all of which leads to increased speed to market and profitability for device developers, while maximizing safety and effectiveness throughout the device lifecycle.

Impact at every stage of the device lifecycle

The ability to simulate device performance (digital evidence generation) is valuable in every stage of the device lifecycle:

• In the early design stages, simulation can explore the design space and guide the selection of designs while identifying critical design parameters.
• In the regulatory approval phase, credible, validated simulations can be used to generate evidence of safety and efficacy that become part of regulatory submissions and can reduce the size and/or scope of clinical trials (“In Silico Trials”).
• In the manufacturing stage, simulation can help guide trade-off decisions that must be made when questions arise during manufacturing.
• In the post-market phase, simulation can help determine the root causes of issues reported by customers using the device.