Which value aspects are relevant for the evaluation of medical devices? Exploring stakeholders’ views through a Web-Delphi process

Background: Implementation and uptake of health technology assessment for evaluating medical devices require including aspects that different stakeholders consider relevant, beyond cost and effectiveness. However, the involvement of stakeholders in sharing their views still needs to be improved. Objective: This article explores the relevance of distinct value aspects for evaluating different types of medical devices according to stakeholders' views. Methods: Thirty-four value aspects collected through literature review and expert validation were the input for a 2-round Web-Delphi process. In the Web-Delphi, a panel of participants from five stakeholders’ groups (healthcare professionals, buyers and policymakers, academics, industry, and patients and citizens) judged the relevance of each aspect, by assigning a relevance-level (‘Critical’, ‘Fundamental’, ‘Complementary’, or ‘Irrelevant’), for two types of medical devices separately: ‘Implantable’ and ‘In vitro tests based on biomarkers’. Opinions were analysed at the panel and group level, and similarities across devices were identified. Results: One hundred thirty-four participants completed the process. No aspects were considered ‘Irrelevant’, neither for the panel nor for stakeholder groups, in both types of devices. The panel considered effectiveness and safety-related aspects ‘Critical’ (e.g., ‘Adverse events for the patient’), and costs-related aspects ‘Fundamental’ (e.g., ‘Cost of the medical device’). Several additional aspects not included in existing frameworks’ literature, e.g., related to environmental impact and devices’ usage by the healthcare professional, were deemed as relevant by the panel. A moderate to substantial agreement across and within groups was observed. Conclusion: Different stakeholders agree on the relevance of including multiple aspects in medical devices’ evaluation. This study produces key information to inform the development of frameworks for valuing medical devices, and to guide evidence collection.