Who better than the user of a device to design a better mouse trap?
Dr. Jim Youssef and Dr. Douglas Orndorff, surgeons at Spine Colorado in Mercy Regional Medical Center, turn their hunches about spinal implants into patents.
Orndorff’s first patent, just released, is a plate that expands bones in the neck to accommodate the spinal cord. It doesn’t fuse bones, but preserves motion.
“The unique part of this system is that it allows for fusion if necessary,” Orndorff said. “I’ll be doing my first cases here in Durango next month.”
Youssef, who holds 13 patents, said spine surgeons may find themselves dissatisfied when an implant or procedure leaves something to be desired.
The idea for an improvement can strike at any time, he said.
“I find myself leaving cases with ideas on an improvement,” Youssef said. “Ideas come to me during and after surgery and even later sometimes.”
Insights strike Orndorff at any time.
“One of the most exciting moments for me is when I’m in the middle of an operation and I realize, ‘Hey, if we tweaked this or improved that, we could make this operation better,’” Orndorff said. “These moments can lead to collaboration and design with industry and engineers that result in products and procedures that advance spine surgery.”
The road to a patent isn’t always a superhighway.
A surgeon has to make sure, through a patent attorney, that no one else had the idea first in order to avoid an infringement lawsuit.
“I always perform a patent search prior to pursing an idea,” Youssef said. “This also provides clarity and opportunities to improve on an idea or seek a novel idea.”
Patents, which protect intellectual property, go back to the founding of the nation. The firm Fish & Richardson, established in Boston in 1878, and which advised the likes of Alexander Graham Bell, Thomas Edison and the Wright brothers, is going strong today.
After reviewing an application, the U.S. Patent Office can ask for more information, accept the application, accept part of it or reject it.
Once the coast is clear, inventors refine their idea and then pass it along to a designer and/or an engineer to come up with a model for testing.
A new implant – usually stainless steel, cobalt or titanium – is tested in animals before clinical trials begin with humans. Ultimately, the Food and Drug Administration must sign off on the invention.
The entire process can take years, but the payoff can be handsome – worldwide recognition and an end to financial worries through royalties.
The runaway winner in royalties is Los Angeles resident Dr. Gary Michelson, an orthopedic surgeon who invented the most widely used innovations in spinal surgery. He holds more than 250 patents on devices, instruments and methods and has 900 patents pending.
In 2005, Michelson sold ownership of many patents to Medtronic for more than $1 billion. The deal occurred two years after he defended himself against a patent lawsuit by Medtronic, which established a legal precedent covering who pays for pre-trial discovery of electronic evidence.
Michelson, whom Forbes lists as worth $1.4 billion, has donated $100 million for medical research and $10 million for solutions to pet overpopulation.
Spine surgery for decades had a bad reputation because it was incredibly invasive and the technology was inadequate to achieve even moderate success, Orndorff said. But in the last decade, technology and surgeon skills have turned minimally invasive surgery into better outcomes and a decrease in mortality and morbidity, Orndorff said.
The presence of Youssef and Orndorff in Durango gives residents of the Four Corners easy access to their creativity, Mercy spokesman David Bruzzese said. Spine patients elsewhere learn of the inventions to the degree that their surgeon stays abreast of developments in the field.
Mercy spine patients, Bruzzese said, “benefit from having access to highly skilled surgeons who are literally helping define the future of spine care.”
Healthgrades, a health-care rating company, for the second consecutive year, has awarded Mercy a Specialty Excellence Award for spine surgery, ranking it among the top 100 hospitals in the country, Bruzzese said.
The award goes to hospitals where patients have fewer complications and are more likely to survive their hospital stay.
daler@durangoherald.com
