ArticleBMJ open2021
Innovators' views on involving users and patients in surgical device development: a qualitative interview study.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 3 of them syntheses that pooled it.
What it found
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Who cites it
4 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.International journal of technology assessment in health care · 2025Pooled it
- User involvement in the design and development of medical devices in epilepsy: A systematic review.Epilepsia open · 2024Pooled it
- Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2023Pooled it
- Perceptions and Attitudes Regarding Medical Device Development in Canada Among Canadian Innovators: A Qualitative Study.PharmacoEconomics - open · 2023Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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