Package Design of Medical Devices, 1990 Polymers, Laminations & Coatings Conference Proceedings
The design phase is the single most important phase in the life cycle of a device: the inherent safety, effectiveness and reliability of a device is established during this time, without a good design, device performance cannot be improved no matter how carefully a device is manufactured or how perfectly a GMP program is devised". Frank E. Young, MD, PHD, commissioner of Food and Drugs. Speech: "FDA’s Concept of Medical Device Quality", Health Industry Mfg. Assoc., Washington, DC. Nov. 17, 1987.
From the earliest sterile packages to the present, good design has been the key. Some new considerations, such as human factors and predicting failure points are proving useful in improving and refining the design process.
Package Design of Medical Devices, 1990 Polymers, Laminations & Coatings Conference Proceedings
