An Overview of Stakeholders, Methods, Topics, and Challenges in Participatory Approaches Used in the Development of Medical Devices: A Scoping Review

Abstract

Background: There is a wide variety of participatory approaches to involve stakeholders in the development of medical devices, but there is no comprehensive overview of these approaches. We therefore studied what participatory approaches are used in the development of medical devices as well as the most important characteristics and challenges of these approaches. Methods: We conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 and July 2019. Papers were included if they presented original research featuring any form of stakeholder participation in the development of medical devices. We used The Spectrum of Public Participation to categorise the approach of each paper. Subsequently, we described the characteristics of each approach: the stakeholders involved, data collection methods, and topics addressed. We also identified challenges of the approaches as reported by researchers. Results: 277 papers were included, which could be categorised into three levels of participation: collaboration, involvement, and consultation. Patients and healthcare professionals are frequently engaged in all approaches. The most often used methods are workshops in the collaboration approach papers, and interviews in the involvement and consultation approach papers. Topics addressed in all approaches are: the problem, device requirements, design choices, testing, and procedural aspects of involvement. Reported challenges entail issues related to sampling, analysis, social dynamics, feasibility, and the limited number of topics that can be addressed. Conclusion: Participatory approaches reported in literature can be categorised in three overarching approaches that have comparable methodological characteristics. This suggests that if researchers want to apply a participatory approach it is not necessary to adopt a pre-determined approach, such as ‘participatory action research’. Instead, they can independently determine the degree of participation, stakeholders, methods, topics, and strategies to account for challenges, making sure the participatory approach fits their research question and context.

Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance

“…Currently, both the technology itself and the associated legal frameworks are met with skepticism due to their relatively low adoption rates in the healthcare sector as a whole. To address these challenges, stakeholders involved in the PMS process for medical devices should offer educational resources aimed at sharing the advantages and disadvantages of BCT in the medical device sector [ 71 - 73 ]. This proactive approach can help promote understanding and acceptance of blockchain within the industry.…”

How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study

“…Using five steps outlined in table 2 , FRESCO aims to facilitate a process of collective creativity through structured co-design activities, 17 18 29 39 with involvement of users, developers, and other stakeholders in roles of design partners, informants, or testers. 18 This process is informed throughout by findings from systematic user-centred evaluations (see steps 2–4 in table 2 ).…”

“…Despite burgeoning literature on both user-centred design (and variants, including human-centred design) and co-design, 17 18 22–24 26–30 39 practical guidance for combined use of these methods and principles in the development of clinical practice tools remains limited. In this article, we address this gap.…”

Participatory Methods Used In The Evaluation Of Medical Devices: A Comparison Of Focus groups, Interviews, And A Survey

“…Interviews and focus groups are the most often-used methods in participatory research of medical devices (13). Surveys are chosen because they are also used in qualitative research, but also because they methodologically differ on various aspects from interviews and focus groups (13).…”

“…Interviews and focus groups are the most often-used methods in participatory research of medical devices (13). Surveys are chosen because they are also used in qualitative research, but also because they methodologically differ on various aspects from interviews and focus groups (13). Qualitative surveys offer open text boxes and therefore researchers cannot ask follow-up questions, and there is no direct interaction between researchers and participants.…”