In 1985, Dr Jay Stein and his good friend David Ellenbogen teamed up to co-found Hologic with 12 employees and the intention to develop a single product – an X-ray bone densitometer (US4811373). Now, after almost 40 years, having served as the company’s chief technology officer and chairman of the board, Stein has retired from his professional career. As he bids adieu to Hologic, he leaves behind a successful enterprise that has 6,400 employees and last year generated revenues of $5.6 billion. Importantly, the company has made an enormous contribution to improving women’s lives.
Having earned an undergraduate degree in physics at Brown University, Stein pursued his doctoral studies at MIT, graduating in 1968 with a thesis on the design and construction of an X-ray telescope. His first job was at American Science and Engineering (AS&E) where he was given the task of developing a system for inspecting baggage at airports. The system was required to counteract the frequent hijackings occurring at the time, especially between the United States and Cuba.
Stein was awarded his first patent (US3780291) for a system that employed a pencil beam of X-rays to scan an object. Seen at left is a figure from the patent that illustrates how the scanner operated “to produce an image of concealed objects, such as guns.” As an aside, 25 years later De Beers developed a similar scanner called Lodox that was designed to prevent theft of diamonds from its mines (US5404387). Stein has been a prolific inventor and, over the past 50 years, has been awarded more than 100 patents, most of them in the field of medical devices.
“I was always interested in the medical field on the side of doing some good,” said Stein. “Hologic started with an act of doing good … and it has continued on this path for so many years, doing good for employees and for many customers and patients around the world. And I truly hope that the act of doing good for people, which was the core foundation of the company, continues far into the future.”
Aside from the bone densitometer, Hologic was among the first companies to introduce full-field digital mammography, digital breast tomosynthesis, and in 2020, a molecular diagnostic test for COVID-19. Stein observed, “Innovation is the method by which the company arose from a small obscure medical manufacturer to a world-class organization that it is today, and it will be the mechanism by which the company expands from its status today to an international giant in the future.”
I completely agree that Jay Stein has done remarkable things, but I think it is important to fill in some of the missing history.
I worked with American Science and Engineering (AS&E) in the 1980’s (when it was under the leadership of Martin Annis) when they agreed to develop one of the first whole breast, full field digital mammography system (FFDM). I am not sure what role Jay had in its development, but it is my understanding that Paul Bjorkholm, PhD was the individual who invented a novel, and incredibly efficient, line scanning system for the breast that virtually eliminated scatter radiation with pre and post breast collimation (see Kopans “Breast Imaging” Lippincott 2007 Chapter 27 Digital Mammography Fig. 27-4), but also by aligning the photodiodes along a fluorescent screen that was tipped 90 degrees so that the x-ray photons entered the screen along its edge creating a long path for the photons to be detected with a short path for the generated light to reach the photodiodes greatly reducing the photon path preventing light spread in the detector. We had the prototype at the Massachusetts General Hospital (MGH), and, in 1985, produced the highest resolution digital mammogram that I believe has ever been created (9 lppm). Unfortunately, the system was way ahead of its time (the RAM for a single image was a box 3 ft on a side!) and AS&E couldn’t sustain the program.
In the late 1990’s my group had patented and developed Digital Breast Tomosynthesis (DBT) (the name that I gave to the approach). At the time we were helping GE develop their Full Field Digital Mammography System and we had obtained Defense Department funding to pay GE to build the first, clinically useful, DBT device. We offered GE a licensing agreement for DBT. While they were trying to decide, we demonstrated our device to Siemens and Hologic. Jay Stein believed that stereo mammography was the next advance, but I convinced him to come to the MGH where we showed him our DBT images of patient volunteers. Needless to say, he was impressed. Jay and Hologic put in a bid to license our patent. The MGH administration, which controlled my patent, decided to license it to GE with the agreement that they would develop a commercial system by 2005. For unexplained reasons, GE sat on the patent. They did provide us with a second prototype in 2002 that could have been commercialized but they did nothing with it.
I felt it was important to have companies competing to further advance the technology, so my group also worked with Siemens and Hologic to develop their DBT systems while keeping intellectual property separated. Although GE had a 3-year head start on the others, they chose to delay. Jay Stein at Hologic, I suspect to get around our patent, developed the name “3D Mammography”, and while GE did very little, Hologic was the first to get FDA approval for DBT in 2011.
Many thanks for contributing these historical insights about the origins of FFDM and DBT, Dan.
As you say, Jay Stein accomplished some remarkable things during his career, and yet it is necessary to fill in some of the missing history.