Volume 17 Number 3 FALL 2000

SHORT TAKE

transforming ideas into products

Advice from inventor-surgeon Thomas Fogarty, MD, winner of this year's Lemelson-MIT prize for invention and innovation.

BY CHRISTIE RIGGINS

THE HOLDER OF 65 PATENTS FOR MEDICAL DEVICES -- AND COUNTING, Thomas Fogarty, MD, knows a thing or two about transforming ideas into products. He developed his first medical device, the industry-standard Fogarty® balloon catheter (see sidebar), some 30 years ago. Since then, he has continued to create surgical tools that make operations safer, more effective and, often, less expensive. His zeal for inventing won him this year's Lemelson-MIT prize for invention and innovation -- a prestigious award that comes with a $500,000 prize. Fogarty says the recognition is very meaningful to him and that he plans to use the prize to launch a public foundation to reward outstanding efforts to advance clinical medicine.

"He's a brilliant, caring man, and one of the most prolific medical device inventors ever," says Paul Yock, MD, Stanford professor of medicine and director of the Medical Device Network, a Stanford program to encourage patenting and early-stage development of medical devices.

Fogarty, a professor of surgery at Stanford, teaches residents and also maintains a part-time surgical practice -- activities that provide the inspiration for most of his inventions, he says. He also devotes much time to sketching, building and testing his ideas as well as founding companies to develop and commercialize the resulting products. In addition, he enjoys advising would-be inventors attempting to negotiate the maze of medical device inventing, he says. Here is what he tells them:

"If you have an idea for a better tool, first talk to your colleagues and gather hard numbers to validate that it will address a widespread problem -- such as the high rate of graft failures within 48 hours of surgery," says Fogarty. "Next, secure the origin of your intellectual property. Write down your idea, sign and date it, get a trusted friend to co-sign it. Then visit a patent attorney."

After confirming that your idea will, in fact, address a widespread problem, make a prototype and evaluate it, he says. "Find design engineers with clinical or operating room experience to construct a prototype and find clinicians who understand the ongoing process of development. Then set aside your ego, really listen to their feedback, and incorporate those ideas that will produce the best product," advises Fogarty, whose company, Fogarty Engineering, in Portola Valley, Calif., west of Stanford University, employs five engineers who help design and test new medical devices.

"Once you've modified your product to reflect your advisers' best suggestions and you've demonstrated its utility, safety and efficacy through bench testing, gather clinical data for the Food and Drug Administration. The FDA must approve all implantable medical devices, such as defibrillators, and most other devices as well," says Fogarty. "Gathering enough clinical data to satisfy the FDA can take years, even for devices that are inherently safe, so plan to have your patience tested."

"After getting your device approved by the Food and Drug Administration, approach the 'payors' -- large HMOs, the Health Care Financing Administration (HCFA) and other third-party payors. Securing reimbursement is the biggest challenge of all," says Fogarty. "I've found that the most effective approach is to help these organizations understand that paying for better technology is in the best interests of the patient. In addition, ask your congressional representatives to allocate more money on a long-term basis to HCFA, so that the agency will be more likely to invest in newer, better technologies."

"Once you know that the payors will reimburse hospitals and doctors using your device, you can license it to an established company or form your own. If you have a product that will create a new market by addressing a previously unaddressed problem, approach a small company about a licensing deal or start your own company," says Fogarty, who in 1994 created AneuRx Inc. (now Medtronic AneuRx) of Santa Rosa, Calif., to produce and market his latest product, a stent graft for treating aneurysms. "But if your device, such as a better scalpel, will not create a new market, seek a licensing deal with a big company, like Edwards Lifesciences (Irvine, Calif.), that produces and sells similar products within a defined and limited market," he advises.

Any final words of wisdom? "Don't get invested in 'owning' your idea," says Fogarty. "To make the best product possible, one that is attractive to doctors, patients and payors, welcome criticism and consider alternatives. A superior solution may come from an adviser or collaborator." SM

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