🔒FHC’s Keri Seitz keeps focus on brain surgery

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Keri Seitz, promoted to CEO of FHC Inc. in June after serving two years as its president and COO, heads a 42-year-old company with an international reputation for making highly sophisticated devices used to monitor cellular activity in the brain. Its revenues in the current fiscal year are more than $10 million — a 16% increase over last year. It employs 70 people in Maine and almost 100 worldwide. Last year, it returned 25% of post-tax earnings to its employees in a profit-sharing program, marking seven consecutive quarters FHC has been able to do so.

So it's understandable that Seitz's ready answer to "Why are you located in Bowdoin?" is "Why not?"

"Some might look at us and say, 'Your access to 'this' is limited … your access to 'that' is limited," she says. "Those sound like excuses to me."

That can-do attitude is one of Seitz's traits that caught the attention of company founder and FHC Chairman Frederick Haer, who hired her more than seven years ago to work in the company's regulatory and quality department. FHC started making microelectrodes for neuroscience research but expanded into clinical products that facilitate the precision "micro-targeting" required by neurosurgeons as they diagnose and treat brain disorders, including severe forms of epilepsy and Parkinson's disease.

"We're small but we're nimble," Seitz says, describing how FHC's continuing close collaboration with neuroscience researchers has enabled it to quickly devise highly sophisticated instruments tailor-made to their research needs. More often than not, those innovations end up having clinical neurosurgery applications as well.

Attending to quality-control issues and keeping up with regulations proved to be a good fit for Seitz. A Presque Isle native and UMaine graduate with a background in science, she quickly showed an aptitude for wading through the dense legalese of regulations and rules from the Food and Drug Administration and other regulatory bodies overseeing FHC's products.

"There are few positions in the company that touch all the other departments like that one does," she says. "I felt like I was part of some fairly important business decisions early on; the role I played was fairly significant."

By 2009, she was promoted to manager of quality control and regulations. A year later she was named COO and president.

"Certainly it was presented to me as a stepping stone," Seitz says of her two-year tenure in the latter position. "It was a really great opportunity for me to learn about the inner workings of our product development and customer fulfillment [activities]."

One initiative she oversaw during that period focused on the manufacturing process for the most expensive piece of equipment FHC sells. By following good manufacturing practice guidelines — essentially making sure the components and their assembly met the highest quality standards at designated checkpoints instead of waiting until the device was completed — the company cut the production time in half. It also more than doubled the number of devices that could be made.

"It improved our efficiency and allowed us to identify potential issues early in the process," she says. "That wasn't a huge hurdle for us ... We're all on the same bus. We have a very clear understanding of what it takes to achieve high-quality production here."

Seitz says the improvements facilitated FHC's expansion of its clinical neurosurgery products, which have to be cleared by the FDA before they can be marketed and sold to surgeons operating on the human brain. "We can't have those products without having those [manufacturing] policies in place," she says, noting that FHC can now market itself accordingly as a company that knows how the FDA's permitting system works and can bring a new idea or product to fruition quickly.

Although sales of medical devices represent roughly 80% of FHC's yearly revenues, Seitz shares Haer's view that the company's future is tied to maintaining a strong focus on serving the needs of neuroscience researchers. Maintaining those connections, she says, ensures that FHC will always be at the forefront of brain research. As more becomes understood about how the brain works, inevitably that will lead to improved neurosurgery techniques and FHC will be in a prime position to assist in making a whole array of devices that make them feasible.

At the same time, she says, the company recognizes it is better suited to create products that assist neurosurgeons during the brain surgery — such as its "micro-targeting" systems — rather than make the devices that can be implanted in the brain to stimulate or block neurons as a medical treatment.

"The regulatory hurdles are huge for a company of our size," she says, regarding why it's not feasible for FHC to make brain implant devices used in treatments for Parkinson's disease, epilepsy and even clinical depression. Instead, it maintains what Seitz describes as a "very good partnership" with Medtronic, a large medical device company whose neural implant products benefit from FHC's narrower clinical focus on helping surgeons place those devices precisely.

But that doesn't mean the company intends to rest on its laurels, according to Seitz. This spring, the U.S. Small Business Administration awarded FHC the Roland Tibbetts Award, recognizing the company as one of 18 national small businesses creating new jobs through innovative strategies tied to research and development. As CEO, Seitz's goals include seeing that FHC's revenues grow 10% to 15% annually and making sure her sales and technical support teams are focusing on the many challenges involved in becoming a company whose products are sold worldwide. She recently traveled to Japan and Portugal, and the company has established offices in Bucharest, Romania and Medellin, Colombia.

"I wouldn't have accepted the CEO position if I didn't believe the sky is the limit in terms of our growth potential," she says. "As a company we are committed to staying in Maine. We are really committed to our community as well, which is why our child-care and fitness centers are open to the public. We do numerous community services events to benefit local projects. We get so much back from those partnerships. That's something we as a company will continue to do."

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Keri Seitz's business is brain surgery

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