What Are the First Steps to Take a Medical Device Prototype to Get Regulatory Clearance?
One of the most exciting moments for medical device developers is when their idea is brought to life through a prototype. After the first initial prototype, engineers will keep iterating the design and developing new prototypes. Because of the iterations in prototypes, this phase of medical device development is typically the longest. Prototypes can look like computer-assisted designs that will show a rotating image of the finished device or 3-D printed models, which are physical products that typically cannot perform functions. Once the engineers get closer to the final design, they will start building actual working units as prototypes and start testing the product.
User Needs and Design Inputs
Each iteration of a prototype is a good thing and essential to medical device development. With each new version of the device, the engineers are meeting more of the user’s needs and design inputs. User needs and design inputs are all of the device requirements for performance and safety. These requirements are defined prior to prototype development and guide all future iterations of the prototypes. Engineers will informally test prototypes to see if they are meeting user needs and medical device design inputs. Once engineers feel confident in a prototype’s ability to meet user needs and design inputs, then they will go into formal verification and validation testing.
Verification and Validation Testing
Verification and validation testing refer to a suite of testing that challenges the device to ensure the device performs as intended and reduced risks. The engineers will develop formal protocols with statistically significant sample sizes, defined acceptance criteria, and formal procedures for testing. The test cases in each protocol are designed to verify and validate that all user needs and design inputs are met. Verification and validation testing include bench testing, animal testing, and even human clinical trials. If defined as a user need or design input, verification and validation testing can include biocompatibility testing, sterilization testing, transit testing. If all acceptance criteria are met, the engineers can conclude that medical devices will meet user needs.
The bulk of any regulatory dossier will be the verification and validation test reports. Regulators want to review these reports to ensure all user needs and design inputs were tested, the test methods are acceptable, and the sample size is statistically driven. Engineers and medical device manufacturers should be careful about when they begin to formally start the verification and validation testing. Regulators are interested in reviewing test reports for the final finished medical device. It is important that all verification and validation testing is performed on the final finished medical device. The verification and validation testing are what will bring a prototype to a complete medical device with regulatory clearance.
No matter what stage of product development you are in, DeviceLab is here to help. DeviceLab has a specialized team of engineers and consultants who can answer your questions from prototype development, informal testing, or formal verification and validation. Contact DeviceLab today to schedule a consultation and learn more about our services.