Good Design Process for Home-use Medical Devices

Research Theme: Healthcare Design

Many medical devices, whether or not originally designed for home use, are increasingly crossing the boundary from clinical settings into the home environment. Patients discharged with infusion pumps, diabetics using blood glucose meters and women using pregnancy test kits, are a few examples. This research attempts to understand the driving factors behind the move and aims to investigate the challenges to product developers in designing and developing devices for home use.

Motivation

Home-use medical devices fall within an area where medical devices overlap consumer products. Very little research seems to have been carried out in this area. It is envisaged that this research would shed more light on this little explored territory.

Objectives

  • Understanding the 'big picture' of the system in which medical devices forhome use are designed, developed, regulated, sold, purchased, prescribed, used,and disposed
  • Understanding the driving factors behind the increasing use of medical devicesin the home environment
  • Understanding the challenges to product developers in designing and developingmedical devices for home use
  • Developing a 'deliverable' for product developers in order for them to designand develop medical devices for home use more effectively and efficiently

Method

A mixed-method approach was taken to address the research questions. This included the study of published documents, observations, open and semi-structured interviews with stakeholders and a postal questionnaire survey. Qualitative data were transcribed and analysed using a QDA software named Nvivo. Some of the findings from the analysis were then formulated into a questionnaire and a survey was conducted to 'generalise' them.

Findings

  • The 'big picture' understanding of the system has been developed.
  • 14 major driving factors behind the move towards the increasing use of medical devices in the home environment have been found. Also, 8 different categories of medical devices used in the home environment have been identified.
  • A range of challenges to product developers in developing these devices has been discovered.

Details

This project was carried out in 4 stages:

  1. Literature Survey: An extensive literature survey was carried out to establish the pre-existing knowledge in this area.
  2. Exploratory Study: An exploratory study was done to understand the 'big picture' – who, what, when, where and how – of the system. This included study of healthcare and device industry related documents, open interviews with healthcare professionals, pharmacists, device trainer and EBME staff; email contacts with regulators, visits to places, etc.
  3. Descriptive Study: Building on the knowledge acquired from the exploratory study, 19 industrial designers, 7 manufacturers and 8 patients were interviewed. The interviews were based around the ‘total product life cycle’ of a home-use medical device. They were then transcribed and analysed using Nvivo. Some of the findings from the analysis, mainly the driving factors, were then formulated into a questionnaire which was sent out to 106 medical device manufacturers and suppliers, 70 industrial designers and 126 community pharmacists. The response rate was over 51% (59, 38 and 59 respectively). The responses were analysed using Excel.
  4. Prescriptive Study: It is hoped that this part of the research will produce a booklet for the product developers in order to assist them in designing and developing medical devices for home use more effectively and efficiently.

Acknowledgements

Support provided by:

Financial support for this project was provided in parts by the Cambridge Overseas Trusts and the EPSRC.

Selected Publications

  • GUPTA, S.P. (2005) 'Understanding the big picture of currentpractice regarding the use of medical devices by non-professional users inhome environments: an exploratory study', Cambridge University EngineeringDepartment, Technical Report CUED/C-EDC/TR135
  • Gandhi, A. (2005) 'Market Analysis: The Home-Healthcare Marketplace', MXBusiness Strategies for Medical Technology Executives, USA, Issue Jan/Feb 05.
  • Weick-Brady, M. (2003) 'Medical Devices: Going Home', UPDATE, FDLI, USA,Issue 5.