
Aarno Dietz
Aiheet
The clinician's perspective for generating clinical evidence
From a clinician's viewpoint, generating clinical evidence is a critical step in medical device development, ensuring both safety and efficacy while meeting the needs of real-world clinical practice. Clinicians emphasize the importance of designing studies that reflect practical use cases, incorporating patient-centered outcomes, and addressing unmet clinical needs. Early involvement of clinicians in the development process helps identify relevant endpoints and optimize usability, ensuring the device aligns with workflow efficiency and improves patient outcomes. Collaborative efforts between clinicians, researchers, and industry partners ensure the generated evidence is robust, reproducible, and directly applicable to enhancing patient care. Regulatory requirements primarily focus on standardized data to demonstrate compliance with predefined safety and performance criteria. In contrast, clinicians prioritize evidence that addresses real-world clinical utility, patient outcomes, and integration into clinical workflows. While there is overlap, regulatory evidence may sometimes fall short of addressing practical, patient-centered concerns that clinicians find critical for adoption in everyday practice. Bridging this gap requires collaboration to align study designs, endpoints, and post-market surveillance with both regulatory standards and clinical relevance.