Engineering for Humanity, Fun and Profit
Editor’s Note – On September 10, the biomedical engineering department celebrated its 40th University at Duke’s Pratt School of Engineering. Distinguished speakers from around the country gathered to commemorate the occasion with a day-long series of presentations and discussions at the Washington Duke Inn. This is the first of a seven-part series of articles highlighting that day’s events.
Duke alumnus Robert E. Fischell, Sc.D., opened the day’s session by telling an audience of students, visiting alumni, faculty and others, “The difference between impossible and possible is perseverance and a desire to overcome obstacles. I have often been told ‘It can’t be done.’”
Fischell, the chairman of Fischell Biomedical LLC, has more than 200 American and foreign patents, most of which are for medical devices. He owns patents on approximately 70 percent of the stents sold in the world today. Fischell started out his career as a physicist at Johns Hopkins, working on satellites. In the late 1960s, he began inventing medical devices.
In his keynote address, which he called “Engineering for Humanity, Fun and Profit,” he described four of his more recent inventions and gave advice to engineers and entrepreneurs.
Here’s Fischell’s formula for predicting the success of a biomedical invention: “It must be good for the patient. It’s applicable to a large and growing population. The implantation technique must be well known to the physician. It will make more income for the prescribing physician. It increases income for the hospital. It saves health care costs.”
Later, in response to a question from the audience about diseases in small populations, he clarified that profit does not always have to be part of the equation. “If it’s good for humanity, anyone who’s a decent biomedical engineer should work on it,” he said.
Fischell’s most recent improvement to stent technology is what he calls “stent-on-a-wire” or the “Svelte.” The new stent is superflexible and doesn’t require a separate guide wire or pre-dilation of the artery, so insertion is easier, faster, and significantly less expensive than insertion procedures for conventional stents. It also contains a compound, originally discovered in the soils on Easter Island, to reduce the formation of scar tissue that can cause re-narrowing of the artery. The stent has recently been approved for use in the European Union.
Another of Fischell’s inventions is an implantable biomedical device to treat epilepsy. The device senses the beginnings of a seizure and, in response, produces electrical stimulation to short-circuit the seizure. The device is essentially a small programmable computer that replaces a section of cranial bone; the device itself is structurally strong enough to protect the brain. In early testing, most patients experienced fewer seizures and the seizures they did experience were less severe than before. Seven percent of the patients were completely free of seizures.
Fischell is also working on a hand-held device to treat migraine headaches. The device emits a brief magnetic pulse as strong as that produced by an MRI machine to decrease migraine activity. At the first indication of a migraine, the user holds the device against his or her head and presses a button. Fischell said the challenge with this device was reducing its weight. The first prototype was 80 pounds; the most recent version is 3.3 pounds. The device is approved for use in Brazil. In trials for the FDA, the device performed statistically better than triptan drugs (the current treatment) for reduction of pain, and phonophobia. However, it was not approved by the FDA because although the trials showed that the treatment of nausea associated with the migraine headache was improved with the magnetic pulse, the improvement was not statistically significant.
The last biomedical device Fischell discussed was an implantable device that monitors heart function and alerts the wearer to an impending heart attack even before the patient feels symptoms. The typical heart attack patient has symptoms for an average of three hours before arriving at a hospital.
“Four hundred thousand [heart attack] patients each year will be dead before they get to the hospital,” he said. “We can save those people.”
In clinical tests, subjects who had the implantable alarm got to the hospital in an average of 19 minutes, and no one in the trial died of a heart attack or experienced damage to the heart muscle. “We have already saved several patients’ lives,” Fischell said. The device is approved in Europe. The FDA is requiring a test in the U.S. in which all participants receive the device, but the device will remain turned off in half the patients. Of that idea, Fischell said, “We’re not happy and neither are the patients.”
Summing up his approach to all of his inventions, he said, “The most important source of innovation is recognition of a problem. Look for the problem. Invent a solution.”
He added one final piece of advice: “The harder I work, the luckier I get.”