DESIGN AND DELIVERY OF MEDICAL DEVICES FOR HOME-USE: DRIVERS AND CHALLENGES
Author: Gupta, Suresh P
Supervisor: Clarkson, P. John
Institution: Department of Engineering, University of Cambridge
In recent years, there has been a significant increase in the number and types of medical devices used in the home environment by lay-users such as patients and their carers - a trend which is likely to continue in the future. Apart from a general hunch about the increasing use of medical devices in the community and a growing concern to some about the safety and effectiveness of their use by lay-users, very little knowledge exists in this area. This research attempts to investigate two fundamental questions: what factors are drivingthe move towards the increasing use of medical devices in the home environment, and more importantly, what the challenges are to product developers who want to design and deliver medical devices for the home-use marketplace. Before that, however, the research attempts to understand the current healthcare practice in relation to questions such as what types of medical devices are used in the home, where patients and their carers get their devices from, what support they receive and who the key stakeholders are. Because of the lack of a preconceived theoretical framework based upon which research hypotheses could be deduced, this research has been carried out by takingon an empirical, qualitative and theory-building approach. In particular, grounded theory methodology, which is specifically suitable for research in a novel and applied field where pre-existing theories are often hard to get hold of, was adopted for this research. In addition to describing the current healthcare system in relation to the objectives posed above, the research identifies fourteen major driving factors behind the increasing use of medical devices in the home environment and ranks them into high, medium and low categories according to their prominence. The research also recognizes a number of key issues and challenges to product developers in designing and delivering home-use medical devices. These issues are grouped into ten core issues which are then integrated into a model that conforms to the different stages of the product life cycle of a medical device. The core issues are related to business, technology, the design and development process, regulation, manufacture, point of provision, use, support, liability and disposal of home-use medical devices. Finally based on the understanding of the issues and challenges, a design tool is formulated. The tool is a diagram, based on the idea of Gough‘s design tool for packaging, that presents all the challenges and issues in a succinct form and allows product developers to assess whether they have considered the issues, and if so, to what extent. This tool also gives an opportunity to product developers to make comparison between their different products. Compiling and developing the results of this research into a form more suitable for professional use form, such as a quick-reference workbook, evaluating its usefulness and effectiveness to product developers through case studies methods, and disseminating it to a broader audience has been proposed as future work. It is believed that this research has shed light on the poorly understood area of home-use medical devices, making it easier to understand and easier to communicate about.