International Comparison of Qualification Process for Medical Product Development Tools.

Area of Science:

• Medical product development
• Regulatory science
• Tool qualification

Background:

• Advancements in medical product science necessitate updated evaluation tools.
• Regulatory bodies in the US, Europe, and Japan are qualifying these tools.
• Different policy approaches exist for tool guidance: Guidance of Guidances (GoG) in the US/EU vs. non-GoG in Japan.

Purpose of the Study:

• To compare the effectiveness of GoG and non-GoG policies in medical product evaluation tool qualification.
• To analyze the lifecycle of development tools, including pre- and post-qualification stages.

Main Methods:

• An analytical framework for the tool development lifecycle was constructed.
• Japanese cases (non-GoG) were compared with Western cases (GoG) as controls.
• The progress of tool qualification and the composition of deliverables were analyzed.

Main Results:

• GoG policies, with defined processes and clear sponsor involvement, facilitate smoother tool qualification.
• GoG policies tend to result in a consistent composition of deliverables.
• Non-GoG policies, while supporting R&D, lack defined tool guidance processes.

Conclusions:

• Defined processes and clear involvement methods under GoG policies enhance tool qualification efficiency.
• GoG policies contribute to standardized deliverables.
• A potential challenge with GoG-only policies is the integration of upstream R&D support tools.