Are you an innovative inventor and interested in patenting and marketing your surgical device? Here is some advice from a well-recognized physician inventor.
Dr. Thomas J. Fogarty is an internationally recognized cardiovascular surgeon, inventor, entrepreneur, and vintner. He has founded or co-founded over 30 companies in the medical device or services field and is president of Fogarty Engineering, the laboratory from which many of his start-up products and companies originate. Fogarty Engineering, in Portola Valley, Calif., west of Stanford University, employs five engineers who help design and test new medical devices.
In the past 40 years Dr. Fogarty has been named on over 100 surgical instrumentation patents, including the Fogarty balloon embolectomy catheter and the widely used Aneurx Stent Graft that replaces open abdominal aortic aneurism surgery. He has acquired over 63 surgical instrumentation patents over the past 40 years including an entire line of vascular clips and clamps.
The following exerpts are from advice that Dr. Fogarty provided for surgical device inventors in an online article in Stanford Medicine, published by Stanford University Medical Center. The full article is available at the Stanford Medicine website.
“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.
“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.”
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