Challenges to objective performance criteria (OPC) generation identified by stakeholders
| Biggest challenge | Registry representative | Health system representative | Clinician | Patient and Patient caregiver | Device manufacturer | Device application reviewers | Data coordinator | Data analyst | Data informatician | Payer/HTA | Total (n=36)* | Percentage |
| Stakeholder consensus | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 9 | 25 | |||
| Meaningful, accessible, high-quality data source | 2 | 2 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 3 | 17 | 47 |
| Identifying and measuring meaningful outcomes and covariates | 2 | 1 | 1 | 4 | 11 | |||||||
| Identifying medical devices that would benefit from OPC | 1 | 1 | 1 | 3 | 8 | |||||||
| Resources: funding, data sources, patient-centerd stakeholders | 1 | 1 | 2 | 6 | ||||||||
| Disseminating the results correctly | 1 | 1 | 3 |
*Some stakeholders cited more than one challenge; thus, the total number of cited challenges is greater than the number of stakeholders engaged.
HTA, health technology assessment; OPC, objective performance criteria .