Skull Menders

Perhaps nothing more intimately represents your identity and sense of self than your face.
 
You look at it every morning, its expression lets others know how you feel, and it subtly changes as you age to reflect your life experiences.
 
Now imagine if a traumatic event like a car accident fundamentally changed its shape (like shooting victim Arizona congresswoman Gabrielle Giffords). That kind of trauma has both a physical and aesthetic affect on the victim, and it takes many delicate surgeries to restore a person’s looks and healthy brain functioning.
 
A growing Cleveland area startup OsteoSymbionics is working to improve that process, by developing a range of skull implants designed to help those recovering from skull trauma. These custom implants have two basic functions: protect the brain and restore a natural head shape.
 
“I don’t think there is more rewarding work,” says OsteoSymbionics founder Cynthia Brogan, an entrepreneur with a deep background leading tech and medical startups. “In our jobs, we all work to support a bigger cause, but to work on something so specific, that gives such immediate feedback, you feel very directly that you are making a contribution.”
 
Brogan’s professional history has long prepared her for today. A graduate of Case Western Reserve University, she has an MBA in marketing from the school’s Weatherhead School of Management. She started her career as a senior accountant, moving on to business development in a partnership with Case where she was Business Director for a development and commercialization center that incubated three medical tech companies.
 
Before starting OsteoSymbionics, Brogan ran her own interim management and consulting firm. Clients included ValveXchange, Inc., a producer of minimally invasive heart valves, and BF Goodrich.
 
Brogen says she “danced around” the entrepreneurship for years, often helping other companies grow. When this single mom’s child entered high school, she decided to start her own company.
 
Brogan, a former Director of Business Formations at what is now BioOhio, started this OsteoSymbionics in late 2006, after working to help turn around a similar, but struggling, business. That business eventually failed, but the idea lingered.
 
Brogan explains, “After the company went out of business, some of the people who worked there said, “It didn’t fail because of you, let’s give it a shot again.”
 
So she did.
 
More than five years later, the company has developed two products, including one that just launched, and has several more in the pipeline. Trauma victims, soldiers and cancer patients have benefited from these cutting-edge implants.
 
OsteoSymbionics’ first implant is the Clearshield ™ craniofacial implant. It’s sculpted to replace large portions of the skull that have been lost. A second implant, the ST Temporalis ™ is smaller and designed to fill in the temple area, which can look concave after a trauma. That concave look is known as “temple hollowing.”
 
These durable, permanent implants are designed to fit each patient’s skull, and to restore head shape. The precision implant is based on patient’s CT scans and is developed in close partnership with patients’ surgeons. The implants are made from a photoreactive plastic. They are designed both by computer and by hand, a rarity, Brogan says. 
 
“We are the only company in the U.S. and possibly in the world to (design) both ways,” she says. “It all starts with the CT scans that defines the shape of the face and the skull. All the design work can be done with a computer model. But one of the limitations of that is that you are still designing a 3D implant with a 2D model.”
 
That’s where the art of skull making comes in. In more complex cases, such as an asymmetric skull or severe skull defects where a patient doesn’t have an opposite side of the skull to mirror, the “old fashioned” sculpting model can work best.
 
There’s a simple reason OsteoSymbionics takes that extra, offline step, in sculpting skulls.
 
“I’m a perfectionist. I want the best,” Brogan says. “I want to feel we have done the best thing possible for that patient and for the surgeon.”
 
Their implants have been used by an impressive list of hospitals including Johns Hopkins in Baltimore, Cleveland Clinic, Vanderbilt University and Medical Center and Stanford Hospital & Clinics in California.
 
OsteoSymbionics implants are developed, designed and manufactured in-house. The company is located in Cleveland’s MAGNET (Manufacturing Advocacy & Growth Network) incubator, has nine employees and ‘a bevy’ of consultants Brogan says.
 
Her employees’ backgrounds are diverse, ranging from business to art to science and engineering.
 
“My employees use their right brains, left brains, and everything in the middle,” Brogan says.
 
It’s her top-notch, skilled employees and the personalized services they offer surgeons that set her company apart, Brogan says.
 
“We provide the best service in the market place in terms of quality and the way we interact with the surgeon. We are truly partners with the surgeon and we make communication easy. When they call, they can talk to a tech person, not a sales person. We have very direct communication and are partners in planning the surgery,” Brogan says.
 
The company’s aim is to make the surgeon’s job as easy as it can, she adds.
 
OsteoSymbionics is continuing to attract interest and grow, based on its track record. The company plans to release at least two new products in the next two years.
 
Source: OsteoSymbionics founder Cynthia Brogan