I first heard of AAMI in 1965 when I was working for medical device company in the Greater Boston Area. The sales manager for our company had distributed a brochure for this new association whose goal was to develop a unified organization that would bring together physicians, manufacturers and designers of medical devices. The association hoped to create a better understanding between these groups, accelerate device innovation, and improve device quality and safety. An organization like AAMI would benefit manufacturers by providing them with a means of introducing new products to the medical community while physicians would be provided with an audience of designers and engineers who would be attuned to their needs. A number of leading physicians, like Michael Debakey, Adrian Kantrowitz and others lent their names to the effort.
The mid 1960s was an exciting period for the development of medical devices. Advances in the ability to visualize coronary artery blood flow coupled with the development of arterial bypass pumping and oxygenation plus improvements in cardiac and blood pressure monitoring had led many hospitals to begin cardiac surgery programs. President Kennedy had challenged the nation to go to the moon and NASA scientists and engineers were at the forefront of the development of new methods to monitor and assess human physiological activity. This resulted in the development of many new devices while simultaneously creating a marketplace for them.
Unfortunately, the FDA was not yet involved in device regulation and these newer devices and manufacturers were coming into the marketplace without regulation. While some of the old line manufacturers had achieved solid reputations for quality and reliability; without regulation, physicians, hospitals, and others had no assurance that the products they purchased were safe and would live up to manufacturer’s claims. The presence of this proposed new association would help assure physicians, nurses and other caregivers that the devices they purchased would at least perform according to a minimum standard.
It was an exciting time to be working in this emerging field and many of us looked forward to this meeting. It was held on the campus of the Massachusetts Institute of Technology (MIT). We especially looked forward to meet with and hear Isaac Asimov who had been announced as the keynote speaker. In addition to his prolific writings, Asimov was then a professor of Biochemistry at Boston University, located just across the Charles River from MIT. At the time, Asimov had been writing a novel based on the screenplay for a science fiction film called Fantastic Voyage. Because of his involvement with the film, we were given the opportunity to view it prior to its theatrical release.
The film involved a team of physicians who were placed in a submarine, shrunk down to microscopic size, and injected into the blood stream of a patient who needed surgery on a brain clot. Although the film does not measure up to the computerized graphics and special effects of today’s Hollywood productions, we were treated to Hollywood’s version of what it might be like to navigate the body’s circulatory system as we passed through the heart and lungs and into the brain. Although the film was science fiction, it and Asimov’s keynote address gave us a sense of what might lie ahead. Only a few years later, Christian Barnard performed the world’s first heart transplant. Since that time, we have seen a number of new and extraordinary devices like artificial hearts CT-scanners, magnetic resonance imagers, and surgical robots. These devices and others have transformed healthcare. Many of these products might have seemed like science fiction in 1965, but thanks to the vision of AAMI’s founders and others who understood the importance of bringing together physicians, manufacturers and designers of medical devices we are able to enjoy a future that few people in 1965 could have envisioned.
* Note: According to their website, AAMI was founded in 1967, but to the best of my recollection, this meeting was held in 1965.
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