Table 2

Summary of stakeholders, stakeholder types, roles in and effect of objective performance criteria (OPC) generation

Stakeholder typesRole and effect of OPC generationNumber
Engaged stakeholders
Registry representativeRegistries collect the real-world data needed to generate OPC. Registry representatives can leverage the OPC to generate feedback reports to clinicians and patients on the performance of devices to inform future decision making.2
Health system representativeHealth system representatives collect data on the use and performance of devices within their health system. This data can be used to create OPC and inform clinicians within the health system on the performance of devices to inform future clinical decision making.3
ClinicianClinicians aid in the generation of real-world data needed to appropriately evaluate the medical devices. Clinicians may disseminate the findings of the OPC to their patients in order to inform joint clinician and patient decision making.3
Patient and patient caregiverPatients and patient caregivers provide input on meaningful endpoints needed for OPC creation. Patients are the primary users of devices and are most affected by devices brought onto the market using OPC. Furthermore, OPC may be used to aid in decision making with regard to treatment.5
Device manufacturerDevice manufactures are the primary suppliers of devices. The manufacturers use the created OPCs as a comparison when seeking approval for devices seeking approval. The OPC may be useful in terms of post-market studies required by regulatory bodies.3
Device regulatory application decision-makerRegulatory decision-makers may use the created OPCs in their evaluation of a marketing application and can leverage OPC to identify devices that may be considered for removal from the market following approval.3
Data coordinatorData coordinators link and house the real-world data needed for OPC generation. Data coordinators identify data sources that can be leveraged to comprehensively evaluate medical devices and identified meaningful endpoints.3
Data analystData analysts generate real-world evidence from real-world data. They employ appropriate statistical methods to analyse data and create robust OPC.3
Data informaticianData informaticians aid in the collection of data elements needed for the generation of OPC. They aid in establishing the infrastructure for the linkage and harmonization of the needed data sources to generate OPC for clinically meaningful endpoints.2
Payer/health technology assessment bodyPayers and health technology bodies use OPC for reimbursement decision-making and value assessment. These decisions may affect which medical devices clinician and patient access to medical devices.7
Advisory committee
AcademiaConduct studies using robust methods for the creation of OPC3
Government -regulatory bodyProvide input to the development of and use the created OPCs (1) to aid in the determination of safety and efficacy of a device seeking approval and enhancement of postmarket surveillance; (2) to augment the tools available to registries and CRNs; and (3) to promote the application of the tool in other clinical areas.1
Registry representativeProvide data used to create OPC2
ClinicianUse OPC for clinical decision making2