Details of Grant 

EPSRC Reference:	GR/R05888/01
Title:	Design Process Integration - Defining Good Design Practice For Medical Devices and Equipment
Principal Investigator:	Clarkson, Professor J
Other Investigators:
Researcher Co-Investigators:
Project Partners:	Akos Ltd Assoc of British HealthTech Industries Assoc of Clinical Research for Bespak Industries plc Cambridge Consultants Ltd Smith & Nephew
Department:	Engineering
Organisation:	University of Cambridge
Scheme:	LINK
Starts:	01 July 2001	Ends:	30 September 2001	Value (£):	201,487
EPSRC Research Topic Classifications:	Design Processes
EPSRC Industrial Sector Classifications:	Healthcare
Related Grants:
Panel History:
Summary on Grant Application Form
Regulations alone do not ensure that medical devices and equipment are fit for their intended purpose. There is a need for good design practice to encourage device developers to take a more concurrent, integrated and cost effective approach to design, production and validation. The purpose of the proposed research is to define and disseminate such good practice, with a focus on the role of clinical and usability trials in the device development process. Supplementing the regulatory demands with such guidelines for good design practice which will promote effective, efficient, and ultimately more profitable development.The proposed research builds on previous work regarding Requirements Capture, Design for Validation and Design for Verification. The new work will focus on Design for Effective Use, initially with reference to single-use wound dressings, drug delivery devices and electromechanical equipment, before exploring the applicability of GDP to the wider medical device and equipment market. In particular the scalability of GDP from large to medium sized organisations to SME's will be explored through a number of SME based case studies, which will also test the transferability of GDP to a broader range of products.
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Organisation Website:	http://www.cam.ac.uk