The prevalence and use of medical devices in the home environment continues to grow in the United Kingdom (UK) and Worldwide. It is recognised that such devices offer significant benefits to both patients and the National Health Service in the UK. The design of home use medical devices however represents a considerable challenge to designers and manufacturers alike. Developing devices that are usable and understandable by inexperienced, lay or dexterity impaired users requires an understanding across a breadth of disciplines. Previous research in this field has explored these challenges in attempt to offer support for developers of home use medical devices. There have been very few studies however that have explored whether the design community actually need, want or use such guidance, before considering whether this literature is adopted correctly. Through case studies, an online survey and in depth interviews this thesis suggests that industry practitioners are sceptical of the value of design guidance towards user involvement in home use medical device design. Consequently the practitioners in this research make little or no use of the formal design methods and supportive guidance documents available to them. More typically, practitioners in the home use medical device field use their own personal experiences and knowledge from working in the industry to adapt their own approaches to design. This thesis reports that the greatest challenge to involving users in the design of home use medical devices are the internal corporate and traditionally hierarchical barriers between stakeholders within the design process. In contrast to previous research offering support for designers and developers of home use medical devices this thesis calls for a wider change in design practice to facilitate the application of usability principles. As a conclusion to this thesis, recommendations for further research to address these changes in practice are proposed to industry professionals in the medical device industry. This thesis is submitted as part of the requirement for the Degree of Doctor of Philosophy at Loughborough University.

An emerging trend of the healthcare industry is the huge increase in the number of medical devices being used by lay people at home. Home use medical devices range from simple inhalers to very complicated devices such as defibrillators. This research aimed to assist designers in developing home use medical devices by providing information and suggestions regarding lay users and how to address their needs and expectations. For this purpose a qualitative and inductive approach was adopted and several studies were carried out, including: (1) a comprehensive literature review to understand the background of the phenomena; (2) observational studies with 40 lay users (i.e. 10 younger lay users, 10 older lay users, 10 users with mobility and sensory disabilities, and 10 users with cognitive disabilities) in order to identify their characteristics when interacting with products; (3) an online questionnaire survey with 53 designers to understand designers‟ requirements when designing home use medical devices, as well as their expectations for a proposed design support tool; (4) the development of the design support tool; and (5) an evaluation study with 12 professional designers in order to assess the effectiveness of the tool (in a format of a design guidance). This research adopted an inclusive approach which investigated both lay users‟ characteristics and designers‟ perspectives. It has, for the first time, outlined lay user characteristics based on empirical studies with different groups of people. It is also one of few studies focussing on designing home use medical devices; the requirements of professional designers have provided an in-depth insight into the challenges of designing medical devices for use in the home environment. The design guidance, as commended by the designers in the evaluation, was the first comprehensive information source in the UK for the emerging home use medical device field where little support is currently available.

Title from first page of PDF document. Includes bibliographical references (p. 20-21).

Det finns många människor med nedsatt funktion som hindrar deras mobilitet i vardagen. Sister Kenny Research Center är ett forskningscenter inom rehabilitering i Minneapolis, USA, där man utvecklar produkter och tjänster tillsammans med kliniker och patienter för att förbättra rehabiliteringen. Ett pågående projekt på centret är ett utvecklingsarbete av en uppfinning kallad Gravity Bed vilken tränar balans för människor med gang‐ och balanssvårigheter. Hur Gravity Bed bör vara konstruerad för att passa i en hemmiljö är den fråga detta examensarbete har i uppgift att undersöka. Metoden består i att med hjälp av en produktutvecklingsprocess ta fram ett koncept och en fungerande funktionsprototyp. I arbetet användes en manual kallad Innvotaion Handbook, framtagen av Sister Kenny Research Center. Att utvärdera Innvotaion Handbook är även det en del av examensarbetet. Examensarbetet utfördes på plats vid Sister Kenny Research Center i ett så kallat Clinical Innovation Team , bestående av centrets forskningledare, två kliniker, en patient, tre MBA‐studenter från Carlson School of Management samt författarna själva. Gruppen genomgick arbetsmetoden beskriven i Innovation Handbook, vilket resulterade i ett värdefullt beslutunderlag för produktutvecklingen. Resultatet av projektet är ett konceptförslag som redovisas dels i en vision, illustrerad i bilder, dels i en fungerande funktionsprototyp. Erfarenheterna av Innovation Handbook och Clinical Innovation Teams redovisas i en utvärdering. / There are many people with disabilities that affect their mobility in every day life. At Sister Kenny Research Center, which is a research center within the area of rehabilitation in Minneapolis USA, products and services are being developed together with clinicians and patients with the goal of improving health care. One project is the development of an invention called Gravity Bed, a device that trains balance for people with gait and balance issues. How the Gravity Bed should be designed in order to suit a home environment is the question that this master thesis has as an assignment to investigate. The method of doing this by is the help of undergoing a product development process to develop a concept and a fully functional prototype. The thesis was carried with the help of a manual called Innovation Handbook. Evaluating the manual is also a part of this thesis. The thesis was carries out at Sister Kenny Research Center in a so‐called Clinical Innovation Teams consisting of the research director, two clinicians, one former patient, three MBA students from Carlsson School of Management and the authors themselves. The result of the project is the concept that is presented both as a vision illustrated in imagery and a fully functional prototype. The experiences from working according to the Innovation Handbook and a Clinical Innovation Team are presented in an evaluation.

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