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Developing an artificial heart

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The commercialization of the total artificial heart by Syncardia is seen as a prime example of the successful combined application of modern day mechanical, electrical, and systems engineering to medicine. Straddling between engineering challenges, regulatory issues and ethical concerns, Syncardia managed to develop and deliver a product that to date has been credited with extending countless human lives.

In my presentation I will give my personal perspective on this journey, having served at Syncardia wearing multiple hats to include Chief Medical Officer, Board member and co-author of medical trials which advanced the device. I will show – in pictures and “war stories” – how we gradually refined the device from an artificial heart that required support equipment the size of a filing cabinet, into a mobile unit that allows for normal activities of daily living for many months and sometimes years – a journey that started with Dr. Kolff in 1952 and saw the application of then-state-of-the-art engineering solutions, modernized over time.

35 years on (my first contact with the artificial heart was in 1987), I am saddened to say that medical device technology is now years behind the state-of-the-art in industrial engineering, and the gap is widening every year. This gap is caused by many things, including complex regulation, legal aspects, and ethical concerns, but also an increasing distance between the engineering departments and medical schools.

The speaker

Dr Mark Goldberg received his medical degree from Medical College of Georgia and trained in internal medicine and cardiology at the University of Arizona.

In 2001 Mark joined Syncardia, maker of the first total artificial heart for use in humans, where he served on the board of directors and as Chief Medical Officer. During his time at Syncardia, Mark was an integral part in the design and execution of clinical trials which obtained FDA approval of the total artificial heart (TAH) as a bridge to transplant, miniaturization of the driver system and production of a mechanical valve for use in the TAH . He was also part of the design process for the ongoing study of use of the TAH for destination therapy.

In addition to Syncardia, Mark also served as Chief Medical Officer for Micro Med Cardiovascular (manufacturer of a left ventricular assist device), and Saguro Clinical Research. Mark has been the principal investigator on 53 clinical research studies. In addition to his corporate and research engagements Mark has also practiced cardiology/interventional cardiology in Tucson for the past 30 years.

Mark is sponsor to technology innovation and serves on the board of multiple early and mid-stage companies which have included Global Solar Energy and ei3. He continues to contribute his skills and experiences to help narrow the gap between engineering and medicine, and help bring life-saving technology to medical use quickly and efficiently.

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This talk is part of the Wednesday Seminars - Department of Computer Science and Technology series.

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