Physicians who use medical devices for diagnosis and therapeutic patient care in day-to-day practice often notice unmet patient care needs that could be filled with new devices or technology.
There are many steps between having an idea and creating a viable product. Some physicians have made the leap and have developed their own medical technology, rather than waiting for products to appear on the market. Often, doctors whose work is heavily procedural are the ones who develop devices, but primary care physicians have created their own devices as well.
The process is not easy, nor is it impossible. Important steps for physicians who are planning to develop medical devices include securing funding, making prototypes and templates, testing the technology, getting a patent, obtaining regulatory approval, and marketing the product.
Research demand and competition
While ideas are plentiful, a physician may not have a strong sense of the true size of the market or whether there similar products already available or in development.
Sam Slishman, MD, an emergency care physician in San Luis Obispo, Calif., developed the Slishman Traction Splint which he started working on in 1999 during his residency. He says getting started requires research to see whether your concept for a device is truly original and whether there is a need.
“You really have to soul search and Google search to know whether your idea merits a patent and whether you are willing to do what it takes,” he advises.
Michael Gorn, MD, a pediatrician in Austin, Texas, who developed the Quickloop Abcess Treatment Device agrees.
“First you have to do a patent search and research the market size for your invention,” he says.
New York City-based internist Jennifer Meller, MD, co-founded Navimize, a digital health company focused on reducing patient wait times. She surveyed patients to get feedback about the demand and value of her product.
“Lots of doctors have great ideas, but not every great idea is something that other people are willing to pay for,” she explains. And getting input from seasoned professionals played an important role right from the beginning.
Meller, who was working on an MBA when she decided to start her company, teamed up with a woman in her class at Wharton, Kavita Mangal, whose background is in technology. “We began by networking and talking to healthcare industry leaders,” she explains. While Meller’s product is specifically focused on patient wait times, an area in which there are not necessarily specialized experts, they spoke to hospital administrators and leaders who work on patient satisfaction.
Clear up conflicts of interest
Employed physicians often have specifications in their contracts that stipulate whether intellectual property belongs to the employer or to the physician.
Gorn advises physicians to carefully examine and discuss proprietary details with employers before starting a project. He explains that employer buy-in is a mixed bag, which can help defray costs, but can take away from a physician’s profit and control.
Gorn explains that he talked to his employer about collaboration, and when they agreed not to work together on his project, he was able to verify in writing that his invention belonged to him. Gorn explains that when working without the benefit of a partnership from a hospital system or a university, physicians need to secure funding for building prototypes, getting a patent, and going through the regulatory approval process, which can be costly and time-consuming, depending on the complexity of the device.
The cost of creating and testing medical technology can run between hundreds of thousands of dollars to millions of dollars, according to these innovators, and the cost of a patent runs in the tens of thousands of dollars, according to data provided by the U.S. Patient and Trademark Office.
Gorn went to medical technology conferences to understand the process when he was getting started, and this helped direct him to funding sources. “Startup accelerator programs are private entities, many associated with investment groups”, he explains.
Doctors can obtain funding from friends and family, angel investors, and grants. Grants can award money, and some are also designed to provide free services, such as financial guidance or marketing advice. Doctors can look for grants on university websites, state and federal government websites, and sometimes through non-profits or private companies.
Meller and Gorn both initially funded projects themselves, then raised more from friends and family. It takes a long time for a business venture to become profitable. “We are now working on raising a round of seed funding, which will allow us to hire a sales and marketing team, bring on some developers, as well as pay ourselves a salary,” says Meller.
Getting a patent
As physicians talk with investors, engineers and legal advisors, there is a concern that someone could steal an idea. Slishman advises doctors to apply for a provisional patent early in the process.
“For very little cost you can essentially purchase ‘patent pending’ status for a year. It's a great way to protect yourself as you talk with folks about ideas”, he says. Legal website Upcounsel.com notes this cost as around $1,500 without the assistance of an attorney.
Gorn warns that if a company or individual does steal an idea, the legal expenses of trying to sue the company that stole your idea can add up after you hire attorneys, take time away from your work, produce all of your supporting evidence, and pay for court fees.
Creating and testing the product
Creating the product is where the highest cost comes in. When doctors share the intellectual property and potential profits with a university or a big company, the high cost, while still an issue, may not be impediment to progress.
But, when a doctor attempts to fund manufacturing a product, budgetary constraints can delay development. “I probably spent $50,000 to $100,000 over a decade in prototyping, flights, trade shows, and websites,” Slishman says.
Now, he works with a company, Rescue Essentials, which creates and markets his product.
Meller started by constructing a plan, and then testing it. “We built an MVP—minimum viable product—which was a very basic, manual electronic blueprint of what we wanted to ultimately build. We’ve spent the last 18 months building the product, piloting, and are now gearing up for sales/ marketing”, she explains.
And after the value of the product is established to potential customers, the selling begins. Meller’s company just recently signed a contract with an EHR company to integrate software, and they are talking with hospitals about pilot programs.
Gorn explains that when a manufacturer buys a product, the physician inventor can negotiate payment terms, such as royalties, which, based on his information gleaned from technology conferences, can run between 2 percent and 15 percent of the product’s net profits.
Overall, creating medical technology is not an easy feat, and doctors who have done it put a great deal of work in the process.
According to Gorn, the time devoted to creating a new product is similar to the time a doctor spends at a full-time job. After that, physicians who have invented new products have the benefit of being able to use the product in their own clinical work, as well as having income generated from sales of the product.