Question-based development of high-risk medical devices: A proposal for a structured design and review process

Area of Science:

• Medical Device Regulation
• Clinical Evidence Generation
• Regulatory Compliance

Background:

• European Medical Device Regulation (MDR) introduces stricter requirements for medical device manufacturers.
• Higher risk classifications necessitate more extensive data and a greater emphasis on safety.
• Clinical evidence is mandatory for implantable and Class III devices, but study design requirements are broadly defined.

Purpose of the Study:

• Introduce a structured framework for clinical development of high-risk medical devices.
• Adapt the question-based development framework from pharmaceuticals for medical devices.
• Provide a clear methodology for defining and verifying device requirements.

Main Methods:

• Utilized the question-based development framework, commonly used in pharmaceutical development.
• Applied the framework to a novel implantable haemodialysis device as a case study.
• Defined device requirements and criteria through a target product profile.
• Integrated five general questions from the framework into the medical device design phase.

Main Results:

• Developed a clear overview of requirements and methodologies for clinical development.
• Provided guidance for development organizations to optimize routes and mitigate risks.
• Enabled early identification of projects likely to fail, minimizing resource expenditure.

Conclusions:

• The framework facilitates communication between manufacturers, regulators, and clinicians.
• Highlights 'known unknowns' for post-market surveillance and future research.
• Supports efficient and compliant clinical development pathways for high-risk medical devices.