The 2017 MDEA Lifetime Achievement Award winner shares a few of his best stories, including how he put Alfred Mann in the medical device business.
If you get to be 88 years old, you'll find you have a lot of good stories to tell. Robert E. Fischell, PhD, is certainly no exception to that rule.
|Robert E. Fischell, PhD, will receive the MDEA Lifetime Achievement Award during a special ceremony at MD&M East in New York City on June 13, 2017.|
Fischell, a prolific inventor and a pioneer of the medical technology industry, shared a few of his best stories with Qmed this week, including how he put Alfred Mann in the medical device business.
Fischell and Mann's journey together into the world of medical devices began more than three decades ago, but Fischell tells the story like it was just last week.
He was the chief engineer at the Johns Hopkins University Applied Physics Laboratory, where he designed spacecraft for the United States. Mann's company at that time, Spectrolab (now part of The Boeing Company), provided the solar cells and panels to power the spacecraft.
"So, I was lying on my couch in my living room, reading the journal called Spectrum of the IEEE, the Institute of Electrical and Electronics Engineers, and I saw an advertisement for the Mallory Battery Company [now known as Duracell International]," Fischell said. "And the advertisement was that their battery is so good, that it could last as long as two years in the heart pacemaker. And it showed an x-ray of a person with a pacemaker in their chest with five Mallory batteries, each an inch long, and half-inch in diameter."
Suffice is to say, Fischell was not all that impressed with the claim. "I looked at it and I said, 'you mean that only lasts two years?' And then, obviously, it has to be removed, so it takes surgery every two years in the person's life."
To Fischell, the solution was rather obvious. Why not use one rechargeable battery, make the entire device one-quarter of the size, and recharge it by magnetic induction through the skin, so that it will last for the rest of the patient's life.
The next morning, Fischell called Johns Hopkins Hospital and asked to speak with the person in charge of pacemakers, who at that time was Ken Lewis, MD. That's when Fischell learned that pacemakers, at that time, really only lasted 14 months, on average -- two years was rare.
"So I said, 'I tell you what. I will bring to you next week a working breadboard of a pacer one-quarter the size that will last the patient's lifetime'," Fischell said, then he chuckled as he recalled Lewis' reaction. "He says, 'the hell you say'."
It was a mighty ambitious promise, but fortunately for Fischell, he didn't have to fulfill it all on his own. He was chief of a group of 300 engineers and he recruited his three most talented engineers to join him on the project.
"I wrote on the blackboard, as I often did, the system block diagram of how something should work," Fischell said. "And I drew a diagram of a rechargeable heart pacemaker. And I said, 'I promised the doctor at Johns Hopkins that in one week we'll have this working in breadboard form'."
His trustee team of engineers did not let him down.
"Three days later, they brought it to me," Fischell said. And that, he added, is how Mann started his first medical device company. "He said, 'Bob, I'll work with you, and we'll start Pacesetter Systems Inc. to make the world's best pacemaker'."
That was in 1969, and the first rechargeable implantable pacemaker was just the first of many implantable medical devices that were invented by Fischell and his team at Johns Hopkins University's Applied Physics Laboratory, and manufactured by Pacemaker Systems.
"The company, known as Pacesetter Systems, had the goal of developing a smaller device with a rechargeable battery, which we did," Mann told Qmed's sister publication MD+DI in 2011. "Our second patient, who was implanted with the new pacemaker technology in 1973, is still alive today, and is using the same pacemaker after 37 years."
Siemens bought Pacesetter Systems Inc., but then sold the business to St. Jude Medical in 1994. The company also developed the implantable insulin pump, which was spun off into Medtronic MiniMed.
The Nature of Being an Inventor
Pacesetter Systems was the first of 15 private companies that Fischell began the formation of, and licensed medical device patents to. He said he currently has about 210 U.S. patents, and about 300 foreign patents.
"I have this odd thing in which, when I see a problem, my mind sees solutions," Fischell said. "There's no explaining that. I think that is the nature of being an inventor."
Granted, the man does have a doctorate in physics and engineering, which has certainly played a part in some of those solutions appearing, he acknowledged.
"And I feel really good, to get credit for things that sort of just appear," he said.
As is often the case in the medical technology business, Fischell has found the inventions he is most proud of, and that have had the most pronounced impact on tens of millions of lives across the world, are not necessarily the most difficult developments. Take his contribution to the coronary stent business, for example.
After attending a lecture with his son, Tim, an interventional cardiologist, some 25 years ago, he saw a problem with what was, to him, a rather simple solution.
"I heard this lecture about something called a stent. And they said they haven't worked out all the problems, they're still getting a 50% failure rate, but they think it's [got] a great future," Fischell said. "So we looked into it, and we found that the stents were so stiff that they couldn't go around any kind of bend in the coronary arteries, and coronary arteries have a lot of bends."
So Fischell went straight to work on inventing a way to make all heart stents flexible, so they could be more easily navigated through the arteries. With that seemingly simple adjustment, the failure rate of the technology dropped from 50% to 8%.
"It was just as simple as saying, 'oh, it's not good to have stents that are stiff, make them flexible'," he said. "So that is what we did, and it has worked out extremely well for me, and for the heart patients."
Not only did Fischell invent a way to make stents flexible, he also developed an improved delivery system for implanting the stents into the heart, which brought the failure rate of the technology down to just 3%. "So, we've come a long way in just 25 years," he said.
His honors are numerous and fitting of his many achievements. Last year, Fischell received the National Medal for Technology and Innovation from President Barack Obama for his contributions toward the betterment of mankind. But he is quick to recognize those who have played a starring role in his medtech career.
"I've been fortunate to surround myself with great people, like Al Mann, who like me are determined to make the world a better place," Fischell said.
Amanda Pedersen is Qmed's news editor. Contact her at [email protected].