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.
ObjectivesInvolving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic choices in research and development (R&D). Nonetheless, research into innovators’ views on end-user and patient involvement is rare. This study explores what end-users and patients are being involved by innovators during development, what methods for involvement are being used and what topics are being discussed with these end-users and patients.DesignA qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts.Participants15 interviews were conducted with 19 innovators of 14 surgical devices.SettingInnovation practices of surgical devices in the Netherlands and Belgium.ResultsEnd-users were engaged in R&D with formal methods and in unsystematic ways. These users all work in the clinical domain, for example, as surgeons or nurses. The innovators engaged users to analyse problems for which a device could be a solution, define functionalities, make design choices, analyse usability, ensure safety and improve aesthetics. Patients were rarely involved. Innovators stated that patients are not considered to be end-users, that physicians can represent patient interests and that involving patients is unethical as false expectations could be raised.ConclusionInnovators involve end-users with methods and unsystematic ways in the development of surgical devices. Despite governmental calls for patient involvement in the development of medical devices and surgical devices, innovators do not generally involve patients.
IntroductionStakeholder involvement in medical device development draws much attention. To make well-considered methodological choices while involving stakeholders, it is essential to know what approaches are available and what challenges they bring in practice. Therefore, the aim of this review was to study which participatory approaches are used in the early stages of the lifecycle of medical device development, and to describe the most important characteristics of these approaches.MethodsWe conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 – 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. We describe four characteristics of each approach: the stakeholders involved, data-collection methods, topics addressed, and the challenges associated with the approaches as perceived by the researchers.ResultsFrom the 14,838 papers from the initial search, 278 were included. All papers could be categorized into three levels of participation: collaboration, involvement, and consultation. The results show that patients and healthcare professionals are most frequently engaged in all approaches, besides stakeholders like citizens, relatives, and experts. The most often used data-collection methods are workshops in the collaboration approach, and interviews in the involvement and consultation approach. Topics addressed in all approaches are: the initial problem, requirements of devices, design choices, testing of devices, and procedural aspects of the involvement. Challenges in the approaches are related to sampling, analysis, social dynamics, feasibility, and closure.ConclusionsThis review shows that despite the abundance of methods mentioned in literature, there are three main approaches to involving stakeholders in device development: collaboration, involvement, and consultation. These mainly differ in the degree of power that is granted to stakeholders, but are comparable in terms of data-collection methods, stakeholders, topics, and challenges.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.