FDA Opening to Simulation Supported Verification and Validation for Medical Devices

FDA-CDRH-Medical-Devices-SimulationBringing new medical device products to market requires verification and validation (V&V) of the product’s safety and efficacy. V&V is required by the FDA as part of their submission/approval process. The overall product development process is illustrated in the chart below and phases 4 and 5 show where verification is used to prove the device meets the design inputs (requirements) and where validation is used to prove the device’s efficacy. Historically, the V&V processes have required extensive and expensive testing. However, recently, the FDA’s Center for Devices and Radiological Health (CDRH) has issued a guidance document that helps companies uses computational modeling (e.g FEA and CFD) to support the medical device submission/approval process.

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Phases and Controls of Medical Device Development Process, Including Verification and Validation
 The document called, “Reporting of Computational Modeling Studies in Medical Device Submissions”, is a draft guidance document that was issued on January 17th, 2014. The guidance document specifically addresses the use of computation in the following areas for verification and/or validation:

  1. Computational Fluid Dynamics and Mass Transport
  2. Computation Solid Mechanics
  3. Computational Electromagnetics and Optics
  4. Computational Ultrasound
  5. Computational Heat Transfer

The guidance specifically outlines what form reports need to take if a device developer is going to use simulation for V&V.  By following the guidance, a device sponsor can be assured that all the information required by the FDA is included. The FDA can also work with a consistent set of input from various applicants. 

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CFD Simulation of a Drug Delivery System. Used to Verify Uniform Distribution of Drug

Computational Modeling & Simulation, or what we usually call simulation, has always been an ideal tool for reducing the cost of V&V by allowing virtual testing on the computer before physical testing. This reduces the number of iterations on physical testing and avoids the discovery of design problems during testing, which is usually late in the development process and when making changes is the most expensive. But in the past, you had to still conduct the physical testing. With these new guidelines, you may now be able to submit simulation results to reduce the amount of required testing.
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Simulation to Identify Stresses and Loads on Critical Components While Manipulating a Surgical Device

Validation and verification using simulation has been part of the product development process in the aerospace industry for decades and has been very successful in increasing product performance and safety while reducing development costs.  It has proven to be a very effective tool, when applied properly.  Just as with physical testing, it is important that the virtual test be designed to verify and validate specific items in the design, and that the simulation makes the right assumptions and that the results are meaningful and accurate.

PADT is somewhat unique because we have broad experience with product development, various types of computational modeling and simulation, and the process of submission/approval with the FDA. In addition, we are ISO 13485 certified. We can provide the testing that is needed for the V&V process and employ simulation to accelerate and support that testing to help our medical device customers get their products to market faster and with less testing cost.  We can also work with customers to help them understand the proper application of simulation in their product development process while operating within their quality system.