Medical device specificities: opportunities for a dedicated product development methodology

Abstract

The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression ‘medical device’, and before entering the market, manufacturers must demonstrate their product’s safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, medical device specificities are identified, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.

Keywords::

• Europe
• Global Harmonization Task Force
• medical device characteristics
• product regulatory approval
• regulations
• standards
• USA

Financial and competing interests disclosure

This work was supported by the PhD grant SFRH/BD/42967/2008 from Fundação para a Ciência e Tecnologia (FCT), Portugal, and was partially supported by the project SenseCardioHealth: new technological solutions for smart cardiovascular medical devices – MIT-Pt/EDAM-EMD/0007/2008, sponsored by FEDER through COMPETE and national funds through FCT. The authors wish to thank A Torres (www.tdetangerina.com) for the illustrations. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.