Development of a Fuzzy Front End design framework to optimise commercial success of low risk medical device development
The aim of this research is to focus on developing an alternative approach to determine unmet user and clinical needs in low risk medical devices.
Ireland is one of the leading global hubs for the medical devices industry, generating €10.6 billion in exports and employing more than 25,000 people. Ireland is now the second largest exporter of medical products in Europe, behind Germany, and The National Research Prioritisation Report reinforced in 2014 the need to support Ireland’s position as a hub for medical device innovation, through integrating existing enterprise and research strengths to drive development of next generation devices.
Development and commercialisation of high risk medical devices is exceptionally difficult within university ecosystems compared to large multinationals where there are significant IP, regulatory and engineering supports. Class I and IIb devices have lower barriers to entry during development but such products must be very carefully differentiated relative to other products in order to succeed commercially.
The aim of this research is to develop an alternative approach which focuses on unmet user and clinical needs in low risk medical devices; with design innovation at the start of new product development, otherwise known as the Fuzzy Front End, to optimise the success of new medical innovations.