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

TLDR

Medical device development must involve both healthcare professionals and end users—patients, people with disabilities, and caregivers—because users often reject devices that fail to meet their expectations, revealing a gap between manufacturers’ and users’ perceptions. The study proposes a generic theoretical framework to guide the involvement of diverse user types throughout the medical device development process. The framework outlines routes, methods, and stages for engaging users at each phase of the device lifecycle and illustrates its application with multiple development scenarios and device examples. The framework identifies two user involvement streams—end users and professional users—covering all development stages from concept to market, and is positioned as a step forward for manufacturers in planning user engagement decisions.

Abstract

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.