Medical product development is similar to that of other industries with some key differences due to regulatory considerations.

Key Considerations

Design Controls for FDA/ISO dictate the required activities and documentation that may not be necessary (but are often good practice) in other industries.

Creating and maintaining a Design History File /Technical File is required and ultimately one the largest deliverables.

Project and product definitions are very important to success. Defining clear and verifiable design inputs and outputs is necessary.

Design reviews with key stakeholders are required at major phases.

Risk analysis should begin early and be revisited frequently during the project. Design and Process FMEAs are required actions to mitigate risks.

Part and process verification and validation activities (Qualifications, IQ/OQ/PQ) are required to prove design outputs match inputs. Key skills associated with these activities include: design of experiments, statistical analysis, and technical writing.