Issues and challenges of involving users in medical device development
Open accessAbstract
Background User engagement has become a central tenet of health‐care policy. This paper reports on a case study in progress that highlights user engagement in the research process in relation to medical device development. Objectives To work with a specific group of medical device users to uncover unmet needs, translating these into design concepts, novel technologies and products. To validate a knowledge transfer model that may be replicated for a range of medical device applications and user groups. Methods In depth qualitative case study to elicit and analyse user needs. The focus is on identifying design concepts for medical device applications from unmet needs, and validating these in an iterative feedback loop to the users. Results The case study has highlighted three interrelated challenges: ensuring unmet needs drive new design concepts and technology development; managing user expectations and managing the research process. Conclusion Despite the challenges, active participation of users is crucial to developing usable and clinically effective devices.
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Previous studies revealed that barriers and challenges can occur during UCD processes that can influence collaboration between multidisciplinary stakeholders, including communication between team members from different backgrounds, management of expectations, and availability of resources for user involvement.
“Previous studies revealed that various barriers and challenges can occur during UCD processes that can influence the collaboration between multidisciplinary stakeholders. Examples of such barriers are communication between team members from different backgrounds, management of expectations, and availability of recourse for the involvement of users [14,24,25].”
From Experiences of Multidisciplinary Development Team Members During User-Centered Design of Telecare Products and Services: A Qualitative Study (2014) · cites this paper as [24]
Most barriers identified in this study were in line with previous research.
“Most barriers that were identified were in line with previous research [14,24,25].”
From Experiences of Multidisciplinary Development Team Members During User-Centered Design of Telecare Products and Services: A Qualitative Study (2014) · cites this paper as [24]
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- Authors
- Bridgelal Ram, M., Grocott, P. R., & Weir, H. C. M.
- Affiliations
- King's College London (GB)
- ORCID
- Grocott, Patricia R.
- Venue
- Health Expectations
- Publisher
- Wiley
- Published
- 2008-02-11
- Volume
- 11
- Issue
- 1
- Pages
- 63-71
- ISSN
- 1369-6513 (ISSN-L)
- 1369-7625
- PMC
- PMC5060429
- OpenAlex
- W2064275072
- Cited by
- 83
- References
- 26
- Citations by year
- 2025: 2 · 2024: 6 · 2023: 5 · 2022: 7 · 2021: 3 · 2020: 4 · 2019: 4 · 2018: 6 · 2017: 4 · 2016: 7 · 2015: 5 · 2014: 6 · 2013: 5 · 2012: 5
- FWCI
- 5.25
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Health Expectations (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- Funders
- Engineering and Physical Sciences Research Council (GR/S29874/01)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Physical Sciences › Computer Science › Human-Computer Interaction › Usability and User Interface Design
- Physical Sciences › Computer Science › Human-Computer Interaction › Innovative Human-Technology Interaction
- Keywords
- user engagement, medical device development, user involvement in research, unmet needs, knowledge transfer model, design concept, iterative feedback, user expectations, usability, clinical effectiveness
- MeSH terms
- Diffusion of Innovation, Epidermolysis Bullosa, Equipment and Supplies, Equipment Design, United Kingdom, Humans, Models, Theoretical, Nurse-Patient Relations, Patient Participation, Technology Assessment, Biomedical, Wound Healing, Wounds and Injuries, Problem-Based Learning, Organizational Case Studies, Needs Assessment
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