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CEA Profile: Health Care Winner OrthoKinetic Technologies

By Katelyn Litalien | Archives
Jim Wichersham and Dr. Lisa Ferrara: Founders of OrthoKinetic Technologies.

Dr. Lisa Ferrara formed OrthoKinetic Technologies in 2005, with the purpose of guiding the orthopedic, neurosurgical, and cardiovascular medical device companies, along with dental companies, towards the development of safe medical implants through consulting services.

She and her husband, Jim Wichersham, took every means
necessary to get OrthoKinetic Testing Technologies off the ground, including the construction of a primitive cooling system during their first days of operation.

“We had to make do with a very attractive, low budget piece of equipment,” Ferrara said, explaining how they created a cooling system involving a bath tub, screens and fans to keep their equipment’s pump below 120 degrees during test runs and
calibration.

“We work a lot with companies to determine if their great widget or their mediocre tool is going to work,” Ferrara said.
“We can provide test data and the comparative analysis to really determine if it’s safe or not.”

In the first three years of operation, Ferrara focused on the consulting side of her business, outsourcing any implant testing necessary for her clients to gain FDA approval. But, in 2008 Ferrara, with the help of her husband, decided to open OrthoKinetic Testing Technologies, bringing testing facilities in-house to provide a full-service medical device testing enterprise.

“Questions would come up because I farmed [testing] out and I didn’t have the control over it. Now if I have a question, I just pop [devices] on the machine and answer it immediately,” Ferrara said.

This allows her company to provide a better service to her customers and aids in a better product analysis, she said.
With the addition of OrthoKinetic Testing Technologies and a new office space in Shallotte, Ferrara and her husband can offer a wider range of services. Currently, they specialize in regulatory tests followed by product reports, which can be submitted to the FDA for approval.

Ferrara also offers evaluations for already-approved implants and implants experiencing a redesign. The majority of testing they do revolves around orthopedics with emphasis on the spine.
OrthoKinetic Testing Technologies attributes their success to Ferrara’s 25 years of experience in medical design, development and testing. The company is often asked to test implants to avoid future liability damages.

“We help the companies work through potential future problems,” Ferrara said.

Ferrara plans to expand into new markets, steering the business towards the testing of smart technologies and smart biomaterials including micro-electro-mechanical systems. These implants will be able to detect failures and changes for themselves, resulting in a longer life span as people with these implants change and age.

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