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Innovators’ views on involving users and patients in surgical device development: a qualitative interview study
OBJECTIVES: Involving 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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8381300/ https://www.ncbi.nlm.nih.gov/pubmed/34417218 http://dx.doi.org/10.1136/bmjopen-2021-050801 |
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author | Woudstra, Kas Tummers, Marcia Rovers, Maroeska M Reuzel, Rob |
author_facet | Woudstra, Kas Tummers, Marcia Rovers, Maroeska M Reuzel, Rob |
author_sort | Woudstra, Kas |
collection | PubMed |
description | OBJECTIVES: Involving 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. DESIGN: A qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts. PARTICIPANTS: 15 interviews were conducted with 19 innovators of 14 surgical devices. SETTING: Innovation practices of surgical devices in the Netherlands and Belgium. RESULTS: End-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. CONCLUSION: Innovators 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. |
format | Online Article Text |
id | pubmed-8381300 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-83813002021-09-08 Innovators’ views on involving users and patients in surgical device development: a qualitative interview study Woudstra, Kas Tummers, Marcia Rovers, Maroeska M Reuzel, Rob BMJ Open Surgery OBJECTIVES: Involving 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. DESIGN: A qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts. PARTICIPANTS: 15 interviews were conducted with 19 innovators of 14 surgical devices. SETTING: Innovation practices of surgical devices in the Netherlands and Belgium. RESULTS: End-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. CONCLUSION: Innovators 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. BMJ Publishing Group 2021-08-20 /pmc/articles/PMC8381300/ /pubmed/34417218 http://dx.doi.org/10.1136/bmjopen-2021-050801 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Surgery Woudstra, Kas Tummers, Marcia Rovers, Maroeska M Reuzel, Rob Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title | Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title_full | Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title_fullStr | Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title_full_unstemmed | Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title_short | Innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
title_sort | innovators’ views on involving users and patients in surgical device development: a qualitative interview study |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8381300/ https://www.ncbi.nlm.nih.gov/pubmed/34417218 http://dx.doi.org/10.1136/bmjopen-2021-050801 |
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