Creation of objective performance criteria among medical devices

Laura Elisabeth Gressler; Danica Marinac-Dabic; Susan dosReis; Philip Goodney; C Daniel Mullins; Fadia Shaya

doi:10.1136/bmjsit-2021-000106

Creation of objective performance criteria among medical devices

BMJ Surg Interv Health Technol. 2022 Aug 1;4(1):e000106. doi: 10.1136/bmjsit-2021-000106. eCollection 2022.

Authors

Laura Elisabeth Gressler^{1

2}, Danica Marinac-Dabic², Susan dosReis³, Philip Goodney⁴, C Daniel Mullins³, Fadia Shaya³

Affiliations

¹ Division of Pharmaceutical Evaluation and Policy, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
² Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
³ Department of Pharmaceutical Health Services Research, College of Pharmacy, University of Maryland Baltimore, Baltimore, Maryland, USA.
⁴ Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

Abstract

Objectives: Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key stakeholders on the creation of OPC that may serve as a precursor for a formalized conceptual framework within the USA.

Design: Reflections from key stakeholders and guidance from an advisory committee were captured to gain an understanding of the elements that are crucial to the generation of OPC.

Setting: 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.

Participants: Stakeholders involved in the generation of OPC.

Main outcome measures: Elements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach.

Results: A total of 27 participants were engaged to represent the following contributors: representatives of registries, health systems, health technology assessment bodies, clinicians, device application reviewers, payers, patients, patient representatives, patient caregivers, device manufacturers, data coordinators, data analysts and data informaticians. Consensus was achieved on the five core elements: (1) identification of medical devices, (2) engagement of key stakeholders, (3) selection of data source, (4) performance of appropriate statistical analyses and (5) reporting of findings. The engagement of key stakeholders (38%) was cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) was the most frequently mentioned challenge.

Conclusions: The reflections from the participants identified five elements to be considered when generating an OPC within class III medical devices and may provide the needed foundation for the development of official guidance on OPC generation.

Keywords: active surveillance; consensus; devices; health services research; methodology.