My friend David Ewing’s experience was much the same as others who’ve suffered sudden major trauma. “I didn’t understand what happened. One moment everything was fine,” he said. “I was driving to meet a friend for lunch, and then I was waking up in an ambulance on the way to a hospital.” The collision that knocked him unconscious had shattered his pelvis. The treatment he would receive in the next few days would determine if he walked normally again, and how much pain he would have in the coming weeks and for the rest of his life.
The medical devices David needed were invented in Dallas not long before his accident, but the devices nearly did not reach the commercial market so they could get to the bedside, or in this case, to the operating table.
Let’s go back to the beginning. Traditional pelvic fracture repair involves a large abdominal incision to access the broken bones in order to rejoin them. The surgical wound takes a long time to heal, is painful and has a substantial risk of infection. Recovery is measured in months.
There was a newer technique being developed using slender steel pins inserted through small skin punctures without the large incision, but the technique was difficult. “Percutaneous pelvic fracture reduction,” required multiple surgeons moving the pins by hand under difficult circumstances to realign the bones and fix them in place. Properly done, it produced a better outcome, but was a very difficult physical struggle.
So there was the clear unmet medical need: a better way to perform percutaneous pelvic fracture reduction with better control, reduced risks and better outcomes for the patients.
Two orthopedic surgeons at UT Southwestern, Drs. Adam Starr and Charles Reinert, invented devices that made it far simpler to use the percutaneous technique, by eliminating the need to hold the pins by hand. Dr. Starr devised a framework over the operating table to clamp the pins in place once positioned, and Dr. Reinert invented threated instruments for positioning the pins that clamped to the frame and made it possible to move the bone fragments with minute control.
Although it sounds like assembling a ship in a bottle, the devices break down the procedure into a series of steps. This allows for a far more controlled and less stressful procedure, while reducing the postsurgical scarring, pain, and risk of infection. The doctors even produced a textbook to teach the procedure—a true medical breakthrough.
That’s well and good for the patients of these surgeons, but how could the rest of the world benefit? That requires commercialization. The harsh truth is that, unless a company licenses the technology and converts it into a product, medical breakthroughs do not get to the people who need them.
Here’s the problem. Many attempts were made to license the technology, but to no avail. There was good reason. The U.S. market for these devices would principally be the Level 1 trauma centers, with fewer than 300 in the country, perhaps 800 worldwide. For a large company, that is not attractive for a totally new product without market validation.
What do you do with an invention that is a great leap forward in medical care, but cannot be licensed to existing companies because they don’t see how it fits their business needs? Also, in order to justify creating a new company, there usually needs to be a huge potential market for the products. What could be done?
The solution to the frame and instruments commercialization was the formation of a small new company with a carefully disciplined business plan. Fortunately, two experienced North Texas medical device entrepreneurs, Bob Sudol and Frank Gerome, took the risks and formed Starr Frame LLC, to manufacture and market the devices while avoiding the need for traditional venture capital.
The devices have been sold to multiple Level 1 trauma centers in this country and internationally. It’s not only good for patients; it’s good for business. When regional medical centers obtain the system, they put out press releases touting their state-of-the art minimally invasive technologies. Of course, patients with fractured pelvises don’t shop among hospitals, but the publicity helps attract patients who need new knees and hip joints, helping build those practices.
The Starr Frame and Reinert Reduction Instruments have now gained nationally prominent medical validation—and market validation when once the devices couldn’t attract a licensee. Moreover, because Level 1 trauma centers across the nation are where new trauma surgeons are trained, the Starr Frame brand is gaining value by its presence in those key locations. Most important, of course, is the fact that in many cities, critically injured patients like David are now far better off.
After his other injuries had stabilized, it was time to put David’s pelvis back together. Using the frame and reduction instruments, David’s fracture was repaired percutaneously by Dr. Starr. Two days later he was sitting. In a couple weeks he was doing pool rehabilitation, then finally walking normally again, pain-free much faster than he would have been with the traditional procedure.
The technologies that couldn’t at first be licensed became Starr Frame LLC, the successful little company that could.
— Lawrence E. “Joe” Allred is assistant vice president for venture development at the University of Texas Southwestern Medical Center in the Office for Technology Development.