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Allan S. Hoffman, ScD
Department of Bioengineering
University of Washington
The original pioneers of medical implants and extracorporeal devices were the medical doctors who were dealing daily with patients suffering from many different medical problems. In the 1950s-1960s some of the more courageous and creative MDs began to fabricate and apply devices clinically that they had personally designed to alleviate various medical problems. In 1976 the Medical Device Regulation Act was passed by the US Congress giving the Food and Drug Administration (FDA) the responsibility to control the
clinical use of those devices. (It is important to note that the FDA does not approve specific biomaterials for clinical use. Approvals are only issued for clinical use of specific devices and systems). Subsequent to this Medical Device Regulation Act, the MDs had to find biologically-trained engineers to help them improve their designs using “FDA-friendly” materials and receive FDA approval for the clinical use of their devices. The devices included kidney dialysers, blood oxygenators, vascular grafts, bone and joint implants and the cements used to hold them in place, burn dressings, and so on. The engineers who were working with the MDs could be called the first “bioengineers”. As time progressed, these bioengineers had better training in molecular and cellular biology, and they began to include
drugs within their biomaterials systems. This early “spinoff field” is called Drug Delivery Systems, or DDS, and it has grown rapidly since the 1980s. More recently the introduction of cells within the biomaterial-drug DDS systems has led to the newest spinoff field, known as
“Tissue Engineering”. Today the Bioengineering field includes Biomaterials, Drug Delivery Systems and Tissue Engineering as “spin-off” technologies.
This field is truly an interdisciplinary engineering/medical profession whose graduates are in great demand around the world. This lecture will cover (a) the early history of the key developments in the field of medical devices, and the pioneers who helped create them, (b) how
the field has evolved to the present, and (c) how it may evolve into the future.