Question-based development of high-risk medical devices: A proposal for a structured design and review process.
Nicholas A WhiteTimo J C Oude VrielinkKoen E A van der BogtAdam A CohenJoris I RotmansTim HoremanPublished in: British journal of clinical pharmacology (2023)
The framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining 'known unknowns' that require answering in the post-market phase after sufficient benefit is established relative to the risks.