Observations on medical device design, Part II: Good practice
Alexander, K.; Clarkson, J.; Bishop, D.
Medical Device Technology 10(8): 24-28
1999
ISSN/ISBN: 1048-6690 PMID: 10724775 Document Number: 511827
Current guidance on design is inadequate. This second article in a two-part series presents a framework for good design practice that attempts to improve designers' awareness of manufacturing and validation issues. Seven design tactics, derived from observations of current industry practice and design literature, seek to encourage good practice and achieve safer, more profitable devices.