After years of research and development, the Center of Innovation for Biomaterials in Orthopaedic Research at Wichita State University is seeking manufacturers to produce the composite material medical devices it has developed.
CIBOR was started in 2009 as a partnership between Via Christi Health and WSU with the goal to develop and commercialize bioscience and medical products. It employs biologists and engineers to lend aviation expertise to medical product development.
Were somewhat unique because most device manufacturers dont have aerospace engineers, said Paul Wooley, a WSU professor of biology and orthopedic surgery and chief scientific officer for CIBOR.
The program has faced significant setbacks since its inception. Those included a lack of funding that it thought it had secured from the Kansas Bioscience Authority and leadership changes.
In 2012, the program was moved to the National Institute for Aviation Research at WSU to save about $1 million a year in administrative and office costs.
The good news, however, is that direct funding at the state level through a grant to WSU has continued in a somewhat smaller manner, but that has really allowed us to continue the major products, Wooley said.
Last year, the state of Kansas funded medical device research with $1 million through WSU. Other funding included Via Christi Foundation for $200,000 and the Knight Foundation for $170,000, according to Tom Aldag, director of research and development at CIBOR.
We expect the same level of funding from the state next year and are planning on additional funding from the industry, Aldag said.
Despite previous issues, the projects have gone well scientifically, Wooley said. Now the center is looking for partners to produce what it has developed.
The centers flagship project is a carbon foam bone scaffold that mimics the spongy tissue inside bones and promotes bone growth. Inventors with the center, including Wooley, have applied for a patent on the product, but that patent will become the property of CIBOR.
Its one of the first (composites) we discovered, Wooley said. Its used in (airplane) wing corings, so you can think of it as very high-tech balsa wood.
The material could potentially be used in spinal fusion replacing damaged discs or to fill large holes in bone from gunfire or cancer.
Currently, the center has sheep in Utah that are being used for large animal testing, Wooley said. Scientists create a defect along the long bones of the leg in sheep, then implant the material in the bone.
We put the material in and bone grows all the way through it and heals it completely, Wooley said. Thats a huge advance over current scaffolds that are available.
Oftentimes, people have bone tissue removed from their hips to fill holes in other bones, Wooley said. This material would make that unnecessary.
Nobody really wants to wake up with that hole, he said. Its painful and its another procedure with some risk attached to it.
It would be much better if the surgeon can go to the closet and get a material that performs quite closely to (real) bone.
They hope the material could be used in patients within the next few years, Wooley said.
With a successful sheep project and issuance of the patent, this really allows us to seek a major partner for clinical (trials in humans), Wooley said.
Another project CIBOR has developed focuses on surgical instruments made from composite materials, which have already been tested by some surgeons in Wichita, Wooley said.
Most surgical instruments are made out of stainless steel. They look like 18th-century farm implements, Wooley said. And theres nothing really wrong with them, but if youre dealing with fluoroscopy, which is real-time X-ray basically anything thats metal within that field obstructs the surgeons view.
The center has done extensive testing on the safety of the instruments and how much cleaning they can withstand, he said.
Theyre strong and light and we can engineer them so surgeons like the feel of them, Wooley said. You can no more break this than you can an aircraft wing.
At this point, CIBOR is looking for companies that are ready to invest in the products and begin manufacturing. Wooley estimates it would be a $200,000 to $800,000 investment to begin manufacturing of the instruments.
Ive always thought it would be really great if we could find someone locally to actually go out and make this, Wooley said. This type of production is well within the capabilities of companies in the aerospace industry.
The devices are considered a Class One device by the Food and Drug Administration, which is the same level of regulation as a tongue depressor, Wooley said.
Bottom line is if you can do FAA (Federal Aviation Administration) you can do FDA, he said. Its really not more cumbersome.
CIBOR is also starting to launch a project using composites to create operating room tables that can hold up to 1,000 pounds.
Aerospace design and cantilevering means it probably wont look too much like a table but more like an aircraft wing, which gives a lot more room for people to move around, Wooley said.
CIBOR has a Department of Defense sponsored program to create a rapid battlefield fixation device, which is basically a light-weight piece of material that hardens when molded around an injured limb and acts as a splint.
Broken ends of sharp bone cut vessels and nerves during transportation, Wooley said.
Just getting shot is your first problem. The next thing is just getting mobilized to prevent sharp ends of the bone from moving during whats usually a pretty rough transportation.
The device could also be used by campers or paramedics, Wooley said.
The goal is for CIBOR to become a self-sustaining program, Aldag said. To get there, the program will need companies to invest in its products and the research and design of other products.
The bottom line is we have to get (these products) into patients, Wooley said. If we can do that locally, that would be great.
The recession, along with the health care industrys uncertainty about changes in the law, affected the program initially, officials said.
We were a little unlucky, if you will, coming into that environment, Wooley said. But as we emerge, which we inevitably will since medicine is always going forward and people always want the best thing, we can bring partners alongside and come up with successful devices.
If weve got a locally made product out there in the orthopedic world, that will aid us in attracting the orthopedic industry to take a look at what weve got in Wichita.