Dermatology inventions solve problems, change patients’ lives

Successful dermatologic treatment innovations, such as the use of lasers to remove port wine stains, don’t come out of vapor. They come out of a deep understanding of patient problems and needs.

Shaan Patel, MD, MBA

“Clinicians are the best innovators because you are the only person who understands the depths of the problems in dermatology,” said Richard Rox Anderson, MD, professor of medicine and the director of the Wellman Center for Photomedicine at Harvard Medical School.

“I’m an inventor because I’m a problem-solver. Every clinician is a problem-solver with a front row seat to the endless problems and afflictions Mother Nature throws at people. Every medical invention is the result of striving to solve one of those problems, but the goal is always the same, to help people.”

Dr. Anderson discussed the process of taking an idea through development and into medical use during Sunday’s “Invention and Entrepreneurialism in Dermatology: Stories of Success and Reality Check” (F092). He was an early proponent of fractional photolysis and successfully developed devices to treat port wine stains, unwanted tattoos, and vascular malformations, and to offer hair removal, photodynamic therapy, and cryolipolysis.

Is there a need?

The key to creating a successful invention is finding a need, Dr. Anderson said. Academics may be experts in discovering new biologic pathways, new molecules, new technologies, but they do not always have a solid understanding of clinical problems that need solutions.

The most common reason startup companies fail is lack of need, he said. Academic inventors may create an outstanding product, but it may not fill an important unmet medical need. Clinician inventors may fail for lack of funding or other reasons, but rarely for lack of medical need.

Taking an innovative product from idea to medical practice is a complex process, he said. It begins with treating a patent and continues with developing and refining prototypes, obtaining necessary regulatory approvals, and marketing.

Patent protection

Clinicians in institutional settings likely have an established technology transfer framework. At Harvard, for example, the university oversees the process from patent to development partnerships. Simply obtaining patent protection can cost around $200,000 and often more, which the university covers.

In return, Dr. Anderson said, Harvard retains about 75% of any royalty income that derives from the patent.

Dermatologists in private practice must oversee and pay for patent protection and product development costs.

Be your own start-up

“I am a huge fan of bootstrapping, investing your own funds,” said entrepreneur Shaan Patel, MD, MBA, dermatology resident at Temple University Hospital. “You get 100% of the equity and 100% of the financial reward. But it is almost impossible to self-fund a capital-intensive product such as a new therapeutic agent or medical device. You need investors.”

Dr. Patel appeared on the popular TV show Shark Tank and was awarded $250,000 in funding for one of his own inventions. Mark Cuban, the funder, is an angel investor, a high net worth individual who invests in startup businesses in return for some share of equity. Angel investors can be helpful for apps, software, and other inventions that do not need large amounts of capital.

The next step up the funding ladder is venture capital. Venture capital typically funds risky or cutting-edge capital intensive startups, such as biotech or laser products, but require inventors to give up significant equity.

Private equity can also provide major capital injections, but usually favor more traditional projects such as practice expansion.

“Dermatologists make great entrepreneurs because the same skill sets apply,” Dr. Patel said. “Self-control is the best predictor of success in life and business, and it takes an incredible amount of control to become a dermatologist. Most important of all, you have the specialized knowledge to fill an unmet need in dermatology and start a business around your innovation.”

Inevitable regulatory hurdles

Many clinician-inventors see the Food and Drug Administration (FDA) as the ultimate regulatory hurdle. In many cases, the FDA is only the beginning. State regulatory bodies and attorneys general can also step in.

“State regulators are being much more aggressive in the medical arena,” cautioned attorney Craig Drill, MBA. “If they see anything that could be considered unsafe, state consumer protection acts come into play. And if they see overpromising of results like a perfect tan in a bottle, the Unfair or Deceptive Trade Practice Act can suddenly appear.”

Even something as simple as expanding an office practice can run afoul of local regulators. Drill reported a current case in which a state is charging a radiology practice for unsafe practices because the physician supervising injection of imaging contrast agents is not physically in the same room as the technician administering the injections.

“You need to be aware as an inventor and as practitioners,” he said. “In areas that are not regulated by the FDA, the states are becoming very aggressive.”