Stakeholder 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.

We 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.

From 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.

This 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.

Multi-stakeholder engagement in the development and evaluation of medical devices is crucial for aligning devices with stakeholders’ views, needs, and values. Focus groups, interviews, and surveys are often used to involve stakeholders, but these methods have rarely been compared to analyse their relative merits. Therefore, we systematically compared these three methods in terms of themes, interaction, and feasibility.

The methods were compared in a case-study on surgery with a new endoscopic device for patients with intracerebral haemorrhage. We asked patients, relatives, healthcare professionals and decision-makers about their perspective on this device, and about their perceived quality of hospital care. We conducted the focus groups and interviews in one explorative and one interactive round. The comparison was made in terms of number and content of themes, who and how participants interact, and in terms of hours that needed to be worked by researchers to apply a method.

We enrolled 18 participants in the focus groups, 17 in the interviews and 43 in the survey. Focus groups generated 31 and 19 themes, and interviews 58 and 40 themes in the explorative and interactive round. Surveys generated 42 themes. Interviews produced various themes about the device that did not occur in the other methods. In the two rounds of the focus group, 13 and 42 percent of the interactions were directly between participants. In interview round one, 98 percent of the interactions were between the interviewer and participant, whereas 80 percent of the interactions in round two were discussions of other participants’ opinions. In focus groups participants were inclined to emphasise agreement, whereas the interviews generated more in-depth discussions. Interviews took three times as many hours as the focus groups and survey.

Methods for multi-stakeholder involvement in device development vary considerably. These methodological differences should be taken into account when selecting a method for engaging stakeholders in the early stages of the lifecycle of a medical device.