When mechanical engineer and biomedical professor Hani Haider was recruited from London to teach at the University of Nebraska Medical Center in 2000, he worked from a small laboratory in the basement of a hospital.
Now, Haider is the director of the Biomedical Engineering Research and Advanced Surgical Technologies Lab in 6,000 square feet at the Scott Technology Center in Aksarben Village.
He and a team of surgeons and researchers have been working on a way to simplify joint replacement surgery for more than 10 years. And now the university's commercialization branch, UNeMed, is aiming to get Haider's research out of the lab and into the hands of surgeons.
Invest Nebraska, a state-funded venture capital organization; a CEO from Silicon Valley; UNeMed; and Haider's team have formed Trak Surgical Inc. That company could change the business of joint replacement surgery by making it easier and cheaper to perform.
The conventional method of performing successful hip and joint replacements relies on mechanical instruments to align the correct placement of the new joint or implant, which is much easier said than done. Incorrect placement can result in more surgery down the road.
To place the implant precisely, X-ray or other imaging technology is used to plan the procedure. A series of “fixtures and jigs” are used as a guide to prepare the bone for surgery.
The problem? The fixtures and jigs are expensive and require sterilization after each use. They're also difficult and cumbersome to use, increasing the amount of time the patient is under anesthesia and the risk for complications, and requiring intensive training and experience.
Haider's research, which he calls “navigated freehand bone cutting,” involves simplifying total knee and hip replacement surgeries by “adding smartness” to the tools used to perform them. Rather than relying on mechanical instruments to guide the saw, drill or other tools used to prepare the joint, Haider's team has developed software and technology that can map the position and orientation of the tools, guiding the surgeon's hand to cut and drill in the correct places.
If the surgeon is cutting bone in the wrong place, the on-tool tracking system has the ability to force the saw to turn off. “Drivers don't have to be geographical experts to know where to go,” Haider said. “We have GPS for that.”
Haider compared the system's possible effect on joint replacement surgery to the effect Lasik eye surgery had on optical surgery — the technology “hides the science,” he said, enabling more surgeons to fix the problem with better results, driving costs down.
Haider's technology would allow more surgeons to perform the surgery and reduce the time it takes to prepare the joint for the implant.
It also has promise to reduce the need for revision surgery and recovery time, Haider said.
Although the system has been tested only on bone models and cadavers by surgeons — including Drs. Kevin Garvin, Beau Konigsberg and Curtis Hartman — it was published in peer-reviewed medical journals and won the HAP Paul Award by the International Society for Technology in Arthroplasty in 2005.
The technology has been tested in the lab only on knee joints so far, but it's expected to work with total hip replacement surgeries as well.
While the system has promise to change total joint replacement surgery for the better, it's useless unless it can have tangible benefits for real patients. But getting research from the lab and into the marketplace is no easy feat in the biomedical industry.
In addition to several years of research, it requires millions of dollars, approval by the U.S. Food and Drug Administration, manufactured prototypes and successful marketing to hospitals or implant manufacturers.
Federal funding often covers the research and development phase — Haider's team received more than $1 million in federal funding from the Naval Research Center in 2010 — but just getting the technology approved by the FDA requires regulatory experts, lawyers and a business plan.
“There's a huge gulf between the prototype and the actual product,” said Michael Dixon, president and CEO of UNeMed. “The government doesn't fund that.”
That's why UNeMed recruited Bruce Lichorowic, a serial entrepreneur from Silicon Valley with the business experience that researchers usually lack.
Lichorowic already has secured about $500,000 of investment so far from angel investors, some of whom happen to be surgeons, from California, Texas and Arizona.
Invest Nebraska, which helps administer the Business Innovation Act passed by the Nebraska Legislature in 2011, also contributed $500,000 to match the angels' contributions.
Invest Nebraska has contributed to four companies the maximum match of $500,000, chief operating office Dan Hoffman said. One is another biomedical company, ScanMed, which manufactures, repairs and refurbishes coils for magnetic resonance imaging machines.
Hoffman said the return of investing in high-growth companies like ScanMed and Trak Surgical Inc. are high-paying jobs.
“If you want to keep young people in the state, you need those kinds of jobs,” he said.
Trak Surgical hopes to submit a prototype for approval by the FDA in about a year. The next step on the to-do list: hiring regulatory experts, programmers and software engineers in Omaha.
Haider said he is pleased that UNMC, UNeMed and the state have come together in the patenting and commercialization effort, recognizing that there is potential for researchers to put Nebraska on the biomedical industry map.
“The state is waking up to the fact that technology doesn't have any boundaries,” Haider said. “If they can do it in China, we can do it in Nebraska.”
Contact the writer: 402-444-1414, firstname.lastname@example.org