Rapid Prototyping and 3D Printing
Once the detail design phase of the medical device design process has been completed, the next step involves the creation of a prototype. A prototype is a full-scale, working version of the design that is produced in limited quantities. It is generally produced through one-off manufacturing processes rather than through cell manufacturing. 3D printing capability makes it possible to produce prototypes more quickly and cost-effectively.
The prototype allows for the verification and validation of the device. Verification is the process of determining whether the specifications of the device have been met by the design process. Each aspect of the design – mechanical, electrical, and software – is tested. Validation, on the other hand, looks at the overall function of the instrument to ensure that its functions meet the needs of the client while conforming to all applicable international standards and FDA regulations. Documentation for each step is produced for the client and to be used in the FDA approval process.
Validation and verification require comprehensive testing. Risk assessment is done in compliance with ISO 14971. Fault tree modeling, failure modes and effects criticality analysis, and other models allow engineers to track any errors to their source components. Electrical safety is validated per IEC 60601, while biocompatibility verification is done to the specifications in ISO 10993. Environmental testing ensures that the device functions under all likely use conditions. Finally, sterility validation is carried out in accordance with ISO 11607 and packaging transit requirements are verified per ASTM and ISTA standards.