OBJECTIVES : Objective Performance Criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of Class III medical devices. This study aimed to capture reflections from key stakeholders on the creation of OPC and develop a conceptual framework for the creation of OPC with general criteria to be applied to Class III medical devices.

METHODS : The conceptual framework was developed through the engagement of key stakeholders and feedback from an advisory committee. A non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions. A phenomenological approach was implemented to summarize and describe stakeholder perspectives regarding the priorities of, experiences with, roles within, and perceived challenges associated with OPC creation. Finally, an advisory committee provided their recommendations and input on the final elements of the framework.

RESULTS : A total of 27 stakeholders were engaged to represent 14 stakeholder types including: representatives of registries, clinicians, device application reviewers, payers, patients, device manufacturers, data coordinators, analysts, and informaticians. Consensus was achieved on the core elements of the framework. Engagement of Key Stakeholders (38%) followed by the Selection of the Data Source (23%) were cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) and reaching stakeholder consensus (25%) were the most frequently mentioned challenges.

CONCLUSIONS : This framework provides a step-wise guide to the generation of an OPC within Class III medical devices. The framework consists of five core elements: (1) Identification of Medical Devices for the Development OPC, (2) Engagement of Key Stakeholders, (3) Selection of Data Source, (4) Performance of Appropriate Statistical Analyses, (5) Reporting of Findings. This framework may provide the needed foundation for organizations, government agencies, and investigators involved in the development of official guidances and OPC generation.