DESIGN OF MEDICAL DEVICES: A LIFE CYCLE APPROACH

LIFE CYCLE DESIGN (LCD) CAN BE DEFINED AS THE INCORPORATION OF VARIOUS VALUES SUCH AS MANUFACTURABILITY, RELIABILITY, SERVICEABILITY, RECYCLABILITY, DISPOSABILITY, AND FUNCTIONALITY OF A PRODUCT IN THE EARLY STAGES OF DESIGN. WHEN APPLIED, CURRENT ADVANCEMENTS IN THE AREA OF LCD HAVE SIGNIFICANTLY ENHANCED THE DESIGN, DEVELOPMENT, AND QUALITY OF PRODUCTS. THE MEDICAL DEVICE INDUSTRY HAS NOT FULLY UTILIZED THESE TECHNIQUES. THE APPROVAL AND USE OF MEDICAL DEVICES ARE REGULATED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION. RECENT LEGISLATION, SUCH AS THE SAFE MEDICAL DEVICE ACT OF 1990 AND ITS 1992 AMENDMENTS, HAVE HAD AN IMPACT ON HOW SUCH DEVICES ARE DESIGNED AND MANUFACTURED. A SIGNIFICANT PERCENTAGE OF A COMPANY'S RESOURCES AND EFFORTS IS COMMITTED TO COMPLYING WITH A MULTITUDE OF REGULATIONS DURING THE DESIGN OF A MEDICAL DEVICE. THIS IS A TREMENDOUS BURDEN ON SMALL BUSINESSES. RESEARCHERS HAVE IDENTIFIED A NEED FOR A MEDICAL DEVICE DESIGN GUIDE THAT INCORPORATES COMPLIANCE WITH FEDERAL REGULATIONS WHILE UTILIZING STATE-OF-THE-ART LCD TECHNOLOGY. A FEASIBILITY STUDY IS BEING PERFORMED TO ASSESS THE POSSIBILITY OF SUCH A GUIDE. THE POTENTIAL BENEFITS AND COMMERCIAL REWARDS FOR SUCH A DESIGN TOOL ARE VAST.