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MU Biodesign and Innovation Program: Medical design from need to market

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MU Biodesign and Innovation Program: Medical design from need to market

MU's 2008-2009 Biodesign and Innovation team includes, from left, Anthony Harris, Jon Thompson and Rebecca Rone. With business, medical and engineering degrees respectively, the three fellows spent a year collaborating to identify a medical/surgical need, developing a solution and marketing their product. Photo by L.G. Patterson

If you were to hear that Brad Snow, a University of Missouri doctoral candidate in mechanical engineering, won a student design competition with his “wall warper,” chances are you wouldn’t guess that the device was designed to alleviate a distal aorta blockage in the human abdomen. Snow’s warper took top honors in MU’s Biodesign and Innovation Program (MUBIP) student challenge last November.

Held during Global Entrepreneurship Week, an effort of the Kauffman Foundation to bring entrepreneurship awareness worldwide, the competition follows the same basic model as the two-year-old MUBIP fellowship program, at a miniaturized level. The program consists of a three-fellow team – a surgeon, an engineer and a business professional – who spend an entire year in a rigorous three-phase collaboration to identify a surgical need, develop a product solution and then devise a financial plan that will eventually allow them to take their invention to market.

“With our fellowships, we’re trying to teach people, early in their careers, how the entire medical design process works,” said Stephanie Carani, MUBIP’s coordinator.

Each of the team members brings his or her essential expertise to the table and at the end of the year all three have been baptized by fire in the complete process from concept to implementation. And even better, a solution to a surgical dilemma is potentially available to the medical community.

“The program is ultimately about improving patient care. It’s the patients who will benefit in the long run,” Carani said.

When the MU biodesign program was initiated, it was the second of its kind in the country, but with growing recognition in the value of the model, programs are proliferating. The MU fellowship program owes its early debut to Steven Eubanks, professor and former chairman of the Department of Surgery in the MU College of Medicine.

With 20 patents and several start-ups in his professional history, Eubanks knows firsthand how daunting the medical device innovation process can be.
“I made many mistakes and traveled down many blind allies,” Eubanks said of his entrepreneurial endeavors. “It was all trial and error, and then when I came to the University of Missouri, I saw there were some unique opportunities with engineering and business to address this.”

Engineering Dean Jim Thompson tapped Doug Smith, associate professor in mechanical and aerospace engineering, to coordinate the partnership from engineering. It is a good fit since one aspect of the work being done in Smith’s computational analysis and design laboratory is computational biomechanics. Projects include modeling patient specific lumbar discs and an evaluation of stresses caused by various hip replacement implants. Graduate student Snow’s work in the lab involves the examination of hernia mesh products.

Both Eubanks and Smith point out that there are upward of 100 faculty members involved in the program, which begins in the Department of Surgery with four months of clinical immersion. For approximately four months, fellows observe daily hospital operations and procedures from waiting rooms and clinics to the operating room. They also attend lectures given by faculty members from the Department of Surgery, always mindful of surgical procedures that might be improved through innovation.

Rebecca Rone, a 2006 graduate of MU’s bioengineering program who received her master’s degree from the University of California-San Diego, serves as the current engineering fellow. Rone said it took her three or four weeks to feel comfortable in the clinical situations, but that lectures, discussions and the team dynamic were extremely beneficial.
“You learn about the procedures in the discussion before the surgery, and things are clarified,” she said. “The operating room is where innovation begins. As an engineer, it’s something you just can’t find anywhere else.”

Already working with family members in the medical device field, the program is a perfect fit for Jon Thompson, the current medical fellow who received his undergraduate degree from Miami University, and attended medical school in Cincinnati. He has completed two years as a surgical resident and is on a two-year research sabbatical from doing his clinicals. His approach to the immersion portion of the program is predictably different from Rone’s.

“It took a while for me to leave the training mindset and look at things with fresh eyes. You can’t go directly to a solution without fully evaluating the problem,” said Thompson, adding, “It’s been an eye opener.”

The business fellow, Anthony Harris, earned his undergraduate degree from Florida A&M, and completed a five-year medical/business program at Indiana University. Admitting that he has always enjoyed tinkering with things, the young man had filed two patents before completing med school. “The clinical immersion was like home to me,” Harris said, having already spent a year in general surgery. “I was able to jump in with both feet.”

As the first phase of the MUBIP draws to a close, and the second begins, the fellows present their list of targeted problems and potential solutions to teams of experts in medicine, the medical device field and to those familiar with the market, all arranged by the faculty at MU.

“We’ve learned to take advantage of the huge resource base here on campus, enlisting professionals from the faculty, Jim Gann’s group [MU’s Center for Innovation and Entrepreneurship], friends and investors,” said Eubanks. “We base it so that they are members of a board panel providing feedback to the fellows as if they were employees.”
Professional feedback on the merits and/or disadvantages of each product helps the team narrow its focus. Though the fellows have chosen one technology to fulfill the program’s primary goal – a laparoscopic suction instrument to be used during surgery – the team has submitted three additional provisional patent applications. Innovations include a microtechnology fetal monitor, cosmetic dermal filler and a hydraulic tool with a “wrist” to give surgeons more freedom of movement when performing laparoscopic operations.
Besides refining their ideas during the engineering phase, the fellows attend lectures by engineering faculty researchers on a variety of topics, including development methods, intellectual property and patent law.

“We have an eager, aggressive College of Engineering that can help develop products to go to market,” said Eubanks. “In real life we have about 30 surgery/engineering project collaborations that may develop into medical apparatuses that will mature into marketable products.”
This year’s team contracted with Snow for his computer-aided design (CAD) modeling expertise to aid them in the development of their concepts. Prior to doing graduate work at Mizzou Engineering in Smith’s design laboratory, Snow worked for Lucent Technologies doing fabrication and modeling for clients in various industries.
“The medical device customers’ projects were always the most interesting. It’s fun to build something, but it’s much cooler to save someone,” said Snow, a perspective that is echoed by the current fellows.

“I liked starting from scratch, to look at things from a designer’s point of view, not a surgeon’s. In this program, I am refining my creative skills and I get to learn new things,” said Thompson.

“It’s completely creative,” adds Rone. “And I can help people.”

In the marketing phase, the fellows get down to business, conducting market analysis, developing strategies and working on a business plan, as well as taking a close look at potential avenues of funding such as venture capital and angel investors. Lectures in this phase are on topics of licensing, company development and legal issues. Experts at MU and others from Missouri and elsewhere lend their expertise.

Harris’ marketing background was put to use during the third phase of MUBIP, looking at markets and devising feasibility plans for their ideas. As the program winds to its end in June, all three are looking ahead to their futures. Thompson will head back to his family’s medical device company and the completion of his surgical residency, Harris has plans for a start-up with a local resident, and Rone may continue to work on the dermal filler.

“The groups are very different,” said Carani about the dynamics of the fellows. “Last year’s fellows have applied for a provisional patent for a hernia mesh, and all have gone on to jobs. It’s a long process and they’re completing what they started.”
Eubanks feels that the program model can be beneficial to the entire University culture, and successful patents and licensing of new technologies creates a much needed royalty stream that can both help the program and allow it to grow.

To raise the visibility of MUBIP, Canari came up with the idea for the biodesign competition. After a successful first year, the whirlwind competition was repeated last fall.
In the entrepreneurial model, participants are presented with a challenge on a Monday and must come up with a medical device solution and funding by Friday. Following outlined guidelines, contestants devise an idea for an apparatus or instrument that will solve an outlined surgical complication, and then flesh it out in a presentation.
Competitors have a maximum of five minutes to make their cases to the engineering and surgery faculty and staff who serve as “venture capitalists,” each with $1M in virtual money to fund those whose ideas or presentations they deem feasible and worthwhile.

Additionally, each day a different guest speaker presents a professional seminar featuring topics relating to entrepreneurship.

By noon on Friday, contestants must submit their ideas to Carani. Then a panel of judges and the acting venture capitalists send her their recommendations. A winner is announced that afternoon.

In last November’s competition, Rone won for the most venture capital raised, Snow placed first overall, and Matt Cozad, a doctoral candidate in biological engineering at MU, placed second.

Snow modestly insists he won, not because he had the best idea, but because of his modeling background. “I made a video model of a working device to show venture capitalists how it would work – a computational biomechanical simulation,” he said.
Cozad took a different route.

“It was my first semester as a graduate student, so why not get in the swing of things,” said Cozad who noted the competition falls in line with his intended career path.
In an internship earlier in the year with an orthopedic device firm, the graduate student had come across some balloon devices that he believed he could incorporate into a working solution, and he headed to the hardware store for items that would mimic a catheter. His illustrations and the apparatus he built obviously impressed the judges.

“We got to network with some really fascinating people  investors and entrepreneurs. It was an opportunity to step out and see a different side of myself,” said Cozad, adding that he will definitely compete again next year.

Snow intends to apply to be an MUBIP fellow once he finishes his doctorate. “The appeal is how much they can teach you in a one-year program. Even if I was in the medical device field now, I would be in a limited area – this program offers a lot more than any one company does,” he said. “I can pick and choose where I end up based on exposure to many different options.”

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