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Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP). Methods: The authors propose a theoretical framework suggesting different routes, methods and stag... Full description

Journal Title: International Journal of Technology Assessment in Health Care 2009, Vol.25(4), pp.514-521
Main Author: Shah, Syed Ghulam Sarwar
Other Authors: Robinson, Ian , Alshawi, Sarmad
Format: Electronic Article Electronic Article
Language:
Subjects:
ID: ISSN: 0266-4623 ; E-ISSN: 1471-6348 ; DOI: 10.1017/S0266462309990328
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recordid: cambridgeS0266462309990328
title: Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process
format: Article
creator:
  • Shah, Syed Ghulam Sarwar
  • Robinson, Ian
  • Alshawi, Sarmad
subjects:
  • User Involvement
  • Device Development Process
  • Medical Device Technology Assessment
  • User Perspective
  • Conceptual Framework
ispartof: International Journal of Technology Assessment in Health Care, 2009, Vol.25(4), pp.514-521
description: Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP). Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP. Results: The suggested framework comprises two streams of users’ involvement in MDT development, that is, what might be called the end users’ stream and the professional users’ stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users’ involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented. Conclusions: Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users’ involvement at different stages of the MDTDP.
language:
source:
identifier: ISSN: 0266-4623 ; E-ISSN: 1471-6348 ; DOI: 10.1017/S0266462309990328
fulltext: fulltext
issn:
  • 02664623
  • 0266-4623
  • 14716348
  • 1471-6348
url: Link


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titleDeveloping medical device technologies from users' perspectives: A theoretical framework for involving users in the development process
creatorShah, Syed Ghulam Sarwar ; Robinson, Ian ; Alshawi, Sarmad
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subjectUser Involvement; Device Development Process; Medical Device Technology Assessment; User Perspective; Conceptual Framework
descriptionObjectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP). Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP. Results: The suggested framework comprises two streams of users’ involvement in MDT development, that is, what might be called the end users’ stream and the professional users’ stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users’ involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented. Conclusions: Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users’ involvement at different stages of the MDTDP.
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descriptionObjectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP). Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP. Results: The suggested framework comprises two streams of users’ involvement in MDT development, that is, what might be called the end users’ stream and the professional users’ stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users’ involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented. Conclusions: Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users’ involvement at different stages of the MDTDP.
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abstractObjectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP). Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP. Results: The suggested framework comprises two streams of users’ involvement in MDT development, that is, what might be called the end users’ stream and the professional users’ stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users’ involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented. Conclusions: Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users’ involvement at different stages of the MDTDP.
pubCambridge University Press
doi10.1017/S0266462309990328
pages514-521
date2009-10