When Herb Schwartz left his research and development management job at DePuy Orthopaedics Inc. seven years ago, he also left behind all the data and ideas he’d helped generate at the global orthopedic device maker.
It was, he admitted, a big risk to chase the innovative freedom he so desperately wanted by starting from scratch and forming his own company.
“I thought, ‘OK, this is great,’ he said. “‘I’ve got the freedom to do what I want. Now I’ve got to perform. I can’t blame anybody but myself if this doesn’t work.’”
Zip forward to 2011, and BioPoly LLC, a subsidiary of Schwartz Biomedical LLC, is on the verge of self-sufficiency with plans to sell and distribute in Europe the company’s first permanent implant.
The implant — the BioPoly RS Partial Resurfacing Knee System — is deceptively simple looking for a product that took five years and millions of dollars to develop. Indeed, BioPolystaffers liken the various shapes of the implant to cuff links.
But Schwartz said the implant, which is made with a patented biocompatible combination of an orthopedic polymer and a lubricating molecule, is cutting-edge science that can be used to replace damaged articular cartilage on the ends (condyles) of the femur (thigh bone). BioPoly has received approval to market the implant in Europe, hopes to get approval in the U.S. within the next four years and plans to retain all the rights to the product — including manufacturing and instrumentation — so it can apply the technology to other areas of the body. It’s a different route for Schwartz’ enterprise. The assets of another Schwartz subsidiary, BioDuct LLC, were sold to Stryker Corp. in 2009 along with a site-specific technology that involves absorbable tubes that facilitate healing by temporarily restoring blood supplies to damaged meniscus cartilage in the knee. As part of the sale agreement, Schwartz retained certain rights to use the technology.
Schwartz’ research and development attracted $1.35 million from private investors for the BioDuct product and $8.1 million for the BioPoly implant from private investors and Indiana’s 21st Century Research and Technology Fund.
Although a portion of the $8.1-million remains to assist with clinical trials, manufacturing, marketing and distribution of the BioPoly implant, Schwartz said the aim is to begin making BioPoly LLC self-sustaining through the sale of its products to end users. The applications for the BioPoly technology are many, Schwartz said, and may include using the durable material for total joint implants.
“There’s all sorts of applications for this material because it’s so ultra-biocompatible — it interfaces so well with orthopedic tissues,” he said. “It gives us a true competitive advantage, not just a marketing sleight of hand. And it really helps patients.”
The soft-spoken Schwartz, a 47-year-old Berne native with a doctorate in biomechanical engineering from the University of Cincinnati, said this juncture of success was what he had envisioned all along, although there were certainly hurdles for his startup, not the least of which were naysayers.
“The big thing for startup companies is, you know, it’s a roller coaster ride. I don’t think anyone really knows what it’s like until you get into it. There’s so many times when you need to say, ‘Let’s just do it. Let’s just go down this path, even though some people may say, ‘No, you can’t do it.’
“It’s just perseverance. You just keep checking off everything you need to check off.” Schwartz said there were a number of things he did correctly in building his enterprise, including surrounding himself with the right team members who, among other things, bring structure to his fertile, innovative bent.
“The thing I struggle with most is staying focused,” Schwartz said. “We’ve been working on this particular (BioPoly knee) implant since 2006. So I’m ready to go onto the next thing with BioPoly.”
“Herb is definitely the idea guy,” said Frank Proch, director of engineering and quality and one of five Schwartz staffers. “I’m the guy that says, ‘Here’s the plan. Let’s get it done.’” Another thing Schwartz did was align his enterprise with the Northeast Indiana Innovation Center. The home to the startup helped Schwartz with a business plan and lined him up with key business contacts.
Finally, Schwartz took a risk that many dare not take — even when their employment circumstances don’t fit their strengths.“To be innovative, you have to take a risk,” he said. “And (with a big company), you’re not really in an environment to take risks and be innovative. And that’s what I do best. I innovate. I try to come up with solutions to problems that exist.” He also cares about one more thing: improving the lives of people.
“You know, at the end of the day, we raised this money and we try to make investors happy. But really, the end goal is to improve people’s quality of life.”