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Purpose: To interpret the Medical Device Regulation for occupational therapists in the Netherlands involved in prescribing and manufacturing custom-made assistive devices and to develop a roadmap for implementation., Materials and Methods: Four online iterative co-design workshops were organized under supervision of a senior quality manager to assist in the interpretation of the MDR framework with a focus on custom-made assistive devices; and to assist the implementation by generating guidelines and forms. The workshops for seven participating occupational therapists had an interactive character with Q&A, small and homework assignments, and oral evaluations. Next to occupational therapists, participants with different backgrounds joined such as 3D printing experts, engineers, managers, and researchers., Results: The participants experienced the interpretation of the MDR as informative, but also as complex. Complying with the MDR requires considerable documentation activities that are currently not part of care professionals tasks. This initially raised concerns regarding implementation in daily practice. To facilitate the MDR implementation, forms were created and evaluated for a selected design case together with the participants for future reference. Additionally, instructions were given which forms should be filled out only once per organization, which forms could be reused for similar types of custom-made devices, and which forms should be filled out for each individual custom-made device., Conclusions: This study provides practical guidelines and forms to support occupational therapists in the Netherlands to prescribe and manufacture custom-made medical devices complying with the MDR. It is recommended to involve engineers and/or quality managers in this process.

Introduction: Knee osteoarthritis (OA) is a joint disease, affecting multiple tissues in the joint. Early detection and intervention may delay OA development and avoid total knee arthroplasty. Specific biomarker profiles for early detection and guiding clinical decision-making of OA have not yet been identified. One technique that can contribute to the finding of this 'OA biomarker' is mass spectrometry (MS), which offers the possibility to analyze different molecules in tissues or fluids. Several proteomic, lipidomic, metabolomic and other - omic approaches aim to identify these molecular profiles; however, variation in methods and techniques complicate the finding of promising candidate biomarkers., Areas Covered: In this systematic review, we aim to provide an overview of molecules in knee OA patients. Possible biomarkers in several tissue types of OA and non-OA patients, as well as current limitations and possible future suggestions will be discussed., Expert Opinion: According to this review, we do not believe one specific biomarker will function as predictive molecule for OA. Likely, a group of molecules will give insight in OA development and possible therapeutic targets. For clinical implementation of MS-analysis in clinical decision-making, standardized procedures, large cohort studies and sharing protocols and data is necessary.