Tuesday, December 2, 2014

Creating a roadmap to bring innovative medical technologies to market

Robert Hergenrother, Ph.D., isn’t a surgeon, but he has done some of his best work in the operating room. In his three decades in the medical device industry, Hergenrother has led engineering teams that have created 15 products, including new technologies for use in brain surgery, wound care and diagnosing disease. “When you have a surgeon come up to you and say, ‘If it wasn’t for your device, I couldn’t have helped that patient,’ that’s pretty powerful,” Hergenrother said.

As the director of the new Alliance for Innovative Medical Technologies (AIMTech), Hergenrother is focused on creating the next generation of life-changing medical devices in Birmingham. AIMTech is a partnership between UAB and Southern Research Institute, modeled after the two institutions’ successful Alabama Drug Discovery Alliance. It will identify promising projects already in development at both institutions and launch new projects that meet pressing clinical needs, Hergenrother explains. AIMTech will provide investment and support to bring these projects through clinical trials and FDA approval. Then the devices will be spun off in startup companies or licensed to major medical device makers.

Scouting for the Next Big Thing

Hergenrother, who also has a faculty appointment in the UAB Department of Biomedical Engineering, is now meeting with clinicians and researchers across campus. “In one day I can go from drug delivery to sports medicine to physical therapy to radiology,” he said. “I get to see a lot of different ideas and work with people who really are excited about moving these ideas forward.”

AIMTech director Robert Hergenrother (right) and David Brown (left)
test new rehabilitation technologies in Brown's lab. AIMTech's goal
is to develop promising projects into market-ready medical devices.
Some projects are already highly developed, Hergenrother says, including high-tech rehabilitation devices created in the lab of David Brown, Ph.D., in the UAB Department of Physical Therapy. Others are simply intriguing concepts. Hergenrother recently met with a surgeon who wants to develop a new tool for cartilage repair. “He had an idea and a drawing,” Hergenrother said. “We were able to come in and make a quick prototype and put it in his hands. He was fired up. It’s a great way to just start answering questions: ‘Is this working, yes or no?’”

Conversations with UAB clinicians will lead to opportunities to create entirely new types of devices. “We want to focus on what is causing people problems now,” Hergenrother said. One of his main jobs, he explains, is to connect clinicians with researchers who can develop solutions to meet their needs.

Hergenrother, who holds 18 patents of his own, understands the thrill of a new invention. But creating a successful medical device isn’t a matter of innovation alone, he points out. As part of the initial scouting phase of the program, “I’m asking investigators to work with me to conduct 20 interviews with the people who will be the ultimate end-users of their product,” he said. “They need to find out how people are doing the job now, what the current solutions are and what advantages their product has to offer.”

Competitive Advantages

Major medical device companies are always eager for new ideas, Hergenrother says. As the industry matures — it is projected to grow by nearly 21 percent by 2016 — those companies are focusing more on international expansion and production efficiencies, he adds. “They’re relying on smaller companies and universities to drive innovation.”

Top Targets

AIMTech will initially focus on developing projects in five key areas:
Rehabilitation Engineering
But companies aren’t as quick to make deals as they once were. In the past, “it was enough to have neat graphs and some bench data” to attract a licensing agreement with a device manufacturer, Hergenrother said. Today, the financial stakes are higher, and “companies want short- and long-term animal data, and even human data” before they are willing to invest in unproven technology.

In industry jargon, this is known as “de-risking” — building up the scientific and marketing data necessary to justify a major financial investment. AIMTech will be able to supply that proof by tapping into the combined capabilities of Southern Research and UAB.

UAB’s Institute for Innovation and Entrepreneurship (IIE) will vet the intellectual property position of every project that enters the AIMTech program. IIE and Southern Research will also evaluate potential market size, regulatory pathways and reimbursement strategies so that only the strongest, most market-ready technologies advance through AIMTech’s pipeline. Southern Research has extensive experience in assembling product-development systems and negotiating the regulatory requirements of clinical trials and FDA approvals, Hergenrother notes. “Someone has to do that work,” he said. “If we can take our projects further along than another university, ours will be more attractive to potential partners.”

AIMTech’s ultimate mission is to get life-changing products to market as quickly as possible, Hergenrother says. “We always want to keep in mind why we’re doing this. It’s not to get another patent, but to save lives. We have an opportunity to really make a difference here.”

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