Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey

Area of Science:

• Medical Device Regulation
• Health Technology Assessment

Background:

• Current medical device approval processes often lack robust evidence requirements for safety and efficacy.
• The Total Product Life Cycle (TPLC) concept is gaining traction but needs a structured framework for evidence generation.
• The IDEAL Framework, developed for surgical procedures, may offer a suitable template but requires adaptation for devices.

Purpose of the Study:

• To modify the IDEAL Framework into an evidence template for TPLC-based medical device regulation.
• To establish a standardized approach for evaluating medical device evidence throughout their lifecycle.

Main Methods:

• A Delphi expert consensus exercise involving 34 specialists was conducted.
• Three rounds of structured questioning with iterative feedback were employed to reach consensus.

Main Results:

• 27 experts participated, agreeing that the IDEAL Framework, with modifications, can serve as an evidence template for TPLC regulation.
• Key modifications include a new Stage 0 for pre-clinical studies, expanded use of registries, and conditional omission of IDEAL stages for successor devices.

Conclusions:

• A standardized TPLC evaluation framework for medical devices is currently lacking.
• Adapting the IDEAL Framework offers a promising solution to improve medical device safety and regulatory evaluation.