Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Apr 12;24(1):462.
doi: 10.1186/s12913-024-10887-3.

Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey

Affiliations

Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey

Kas Woudstra et al. BMC Health Serv Res. .

Abstract

Background: Stakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders' views, needs, and values. Methods for these engagements have however not been compared to analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, interaction, and time-investment.

Methods: We compared focus groups, interviews, and an online survey in a case-study on minimally invasive endoscopy-guided surgery for patients with intracerebral haemorrhage. The focus groups and interviews featured two rounds, one explorative focussing on individual perspectives, and one interactive focussing on the exchange of perspectives between participants. The comparison between methods was made in terms of number and content of themes, how participants interact, and hours invested by all researchers.

Results: The focus groups generated 34 themes, the interviews 58, and the survey 42. Various improvements for the assessment of the surgical procedure were only discussed in the interviews. In focus groups, participants were inclined to emphasise agreement and support, whereas the interviews consisted of questions and answers. The total time investment for researchers of focus groups was 95 h, of interviews 315 h, and survey 81 h.

Conclusions: Within the context of medical device evaluation, interviews appeared to be the most appropriate method for understanding stakeholder views since they provide a scope and depth of information that is not generated by other methods. Focus groups were useful to rapidly bring views together. Surveys enabled a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.

Keywords: Comparison; Medical devices; Neurology; Qualitative methods; Stakeholder involvement; Surgery.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Number of themes constructed in three data collection methods
Fig. 2
Fig. 2
Percentage of themes addressed by multiple stakeholder groups in three data collection methods in round 1 (exploration) and round 2 (reaction)
Fig. 3
Fig. 3
Which participants interact with each other: presented as percentage of total number of interactions
Fig. 4
Fig. 4
Form of interaction as percentage of total number of interactions
Fig. 5
Fig. 5
Accumulative number of hours worked by researchers

Similar articles

References

    1. Royal College of Surgeons. Future Surg. 2022 [cited 2022 Jul 14]. https://futureofsurgery.rcseng.ac.uk/#start. Accessed 4 April 2024.
    1. Marcus HJ, Bennett A, Chari A, Day T, Hirst A, Hughes-Hallett A, et al. IDEAL-D framework for device innovation. Ann Surg. 2022;275(1):73–79. doi: 10.1097/SLA.0000000000004907. - DOI - PMC - PubMed
    1. Food and Drug Administration (FDA) Patient Engagement in the Design and Conduct of Medical Device Clinical Studies Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents.... Accessed 4 April 2024.
    1. The European Parliament and the Council of the European Union Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. http://data.europa.eu/eli/reg/2017/745/oj. Accessed 4 April 2024.
    1. Bitkina OV, Kim HK, Park J. Usability and user experience of medical devices: an overview of the current state, analysis methodologies, and future challenges. Int J Ind Ergon. 2020;76(November 2019):102932. doi: 10.1016/j.ergon.2020.102932. - DOI

LinkOut - more resources