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Question-based development of high-risk medical devices: A proposal for a structured design and review process.
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  • Nicholas White,
  • Joric Oude Vrielink,
  • Koen van der Bogt,
  • Adam Cohen (EMA-commentaries only),
  • Joris Rotmans,
  • Tim Horeman
Nicholas White
Delft University of Technology

Corresponding Author:n.a.white@tudelft.nl

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Joric Oude Vrielink
Leiden University Medical Center
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Koen van der Bogt
Leiden University Medical Center
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Adam Cohen (EMA-commentaries only)
Centre for Human Drug Research
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Joris Rotmans
Leiden University Medical Center
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Tim Horeman
Delft University of Technology
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Abstract

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 also 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. A structured approach to determining the requirements for the clinical development of high-risk medical devices is introduced, utilising 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. This can then be used to define specific questions to be answered during clinical development, based upon 5 general questions as specified by the question-based framework. The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organisations will be guided to the optimal route, also to abandon projects destined for failure in an early stage to minimise development risks. Moreover, the framework facilitates communication with funding agencies, regulators and clinicians, while highlighting remaining “known unknowns” that are to be answered in the post-market phase after sufficient benefit has been established relative to the risks.
05 Aug 2022Submitted to British Journal of Clinical Pharmacology
08 Aug 2022Submission Checks Completed
08 Aug 2022Assigned to Editor
11 Aug 2022Reviewer(s) Assigned
02 Oct 2022Review(s) Completed, Editorial Evaluation Pending
08 Oct 2022Editorial Decision: Revise Major
25 Nov 20221st Revision Received
26 Nov 2022Submission Checks Completed
26 Nov 2022Assigned to Editor
26 Nov 2022Review(s) Completed, Editorial Evaluation Pending
26 Nov 2022Reviewer(s) Assigned