Introduction: The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices. Methods: A structured approach to determining the requirements for the clinical development of high-risk medical devices is introduced, utilizing the question-based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question-based framework. Results: The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks. Conclusion: 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.

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The need for data to study the relationship between fatigued healthcare professionals and performance outcomes is evident, however, it is unclear which methodology is most appropriate to provide these insights. To address this issue, we performed a systematic review of relevant articles by searching the MEDLINE, EMBASE, Cochrane, Web of Science, and CINAHL databases. The literature search identified 2960 unique references, of which 82 were identified eligible. The impact on performance was studied on clinical outcomes, medical simulation, neurocognitive performance, sleep quantification and subjective assessment. In general results on performance are conflicting; impairment, no effect, and improvement were found. This review outlines the various methods currently available for assessing fatigue-impaired performance. The contrasting outcomes can be attributed to three main factors: differences in the operationalisation of fatigue, incomplete control data, and the wide variety in the methods used. We recommend the implementation of a clinically applicable tool that can provide uniform data. Until these data become available, caution should be used when developing regulations that can have implications for physicians, education, manpower planning, and ‒ ultimately ‒ patient care.@en