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The History and Evolution of Biomaterials and Medical Devices

Allan S. Hoffman, Professor Hoffman studied at M.I.T., where he received B.S., M.S., and Sc.D. degrees in Chemical Engineering between 1953 and 1957. He taught on the faculty of the Chemical Engineering Department at M.I.T. for a total of ten years. For the past 47 years he has been Professor of Bioengineering and Chemical Engineering at the University of Washington in Seattle, Washington, USA. He is currently Emeritus Professor of Bioengineering at the University of Washington. He recently held a four-year appointment as WCU Distinguished Professor at the Kyungpook National University Medical School in Daegu, South Korea. He is currently an Honorary Professor at: Sichuan University, Chengdu, China; and Aarhus University, Aarhus, Denmark. Prof. Hoffman’s major research interests and activities have been in drug delivery, bioseparations and diagnostic assays, “smart” polymers, biomaterial surfaces and hydrogels. He has published over 400 peer-reviewed articles and is co-inventor on over 30 issued patents. He is co-Editor (along with BD Ratner, FJ Schoen and JE Lemons) of the “Textbook of Biomaterials Science”, Elsevier Publishers, now in its 3rd Edition. Prof. Hoffman was elected President of the US Society for Biomaterials in 1983. In 1990 he was honored by the Society for Biomaterials, Japan with the “Biomaterials Science Prize”, the first time it had ever been given to a foreigner. In 2000 he received the Founder’s Award of the Society for Biomaterials (USA). In 2003 he received the Chandra Sharma Award of the Society for Biomaterials and Artificial Organs of India. He was elected to the US National Academy of Engineering in 2005. In 2006 he was awarded the “International Award” from the Society of Polymer Science, Japan. In 2007 he received the Founder’s Award of the Controlled Release Society (USA). Special symposia have been organized to celebrate his 60th, 70th and 80th birthdays. Four other symposia have been organized by his former Asian students. These have been called “Hoffman Family Symposia” (HFS) and two have been held in Japan, one in Korea, one in Taiwan. A fifth, HFS5, is scheduled to be held in Shanghai, China this October, 2017.

The History and Evolution of Biomaterials and Medical Devices

Allan S. Hoffman

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 use 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 of “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 the early history of the key developments in the field of medical devices, and the pioneers who helped create them, how the field has evolved to the present…and how it may evolve into the future.