By Bob Marshall, Chief Editor, Med Device Online
In a previous article on the Coulter Foundation, I wrote about the motivation for the translational research partnership program, the process of selecting 16 universities, and I interviewed the Coulter program director at Case Western Reserve University. In short, Coulter assists universities in developing and commercializing medical technologies by forming working partnerships and promoting translational research. Case was among 10 universities in the program’s first phase. Today, I focus on phase two, and the six schools that were selected for participation in 2011. We will go inside the Coulter Foundation for perspective, explore how the second phase benefited from the experiences of the first phase, and visit with program leaders from one of the phase two schools, the University of Pittsburgh.
An Inside Scoop — Or Two — Of Coulter
I spoke with Elias Caro, VP of technology development with the Coulter Foundation. Caro came to the foundation in 2006, from Beckman Coulter, just after the phase one universities had been selected. He shared with me some background and observations of the phase one programs.
The program’s first year at the phase one schools was basically a loss, in Caro’s opinion. There was disagreement about how structured the process should be. Some felt that systems hinder creativity, while Caro and others wanted to have systems in place to provide focus and to streamline the innovation process. In the end, the systems-based approach championed by Caro won out, and a high-level process map, including follow-on training, was created for the Coulter oversight committees. The phase two universities have greatly benefited from the process formed and tested during phase one.
Another of Caro’s observations related to existing technology transfer offices at the schools. “Many of the offices of technology transfer were focused solely on intellectual property (IP). They did not have the necessary connections to industry, and therefore had historically struggled to get technology commercialized,” he explained. Caro also commented on the importance of biomedical engineers, whom he said are “uniquely positioned to be the translators of innovation. They have one foot in life sciences and the other in engineering.” Caro believes that biomedical engineers help to interpret theoretical ideas originating from doctors and scientists, and then translate them into successful commercial products that can improve the quality of life for patients around the world.
What Is A Killer Experiment?
Albert Einstein is credited with saying, “No amount of experimentation can ever prove me right, but a single experiment can prove me wrong.” That is the thinking behind a killer experiment. In a 2014 Coulter College presentation, Stephen Snowdy — a client manager for the Coulter Foundation at that time — provided the following definition: the killer experiment is meant to “kill” a project before significant resources are put into developing and perfecting the technology. The idea is to leave as little doubt as is practical that the technology is going to work, once refined, and is going to be better than what is already available to treat a condition. A killer experiment has very tight controls so interpretation of the data is definitive.
Snowdy explains that there are several key inputs to designing a killer experiment and establishing tight controls. He recommends getting input from regulatory professionals to ensure there is a clear pathway for the commercialization of the product. Secondly, he recommends talking with potential investors. What will they want to see in an experiment to justify them putting their capital at risk? The third group to reach out to is medical professionals. What would it take for them to use the product? One does not design a killer experiment in a vacuum.
Lessons Learned From Phase One
Caro provided three specific lessons learned as part of the agreements with Coulter’s phase two universities. First, translational research programs would be implemented in a very programmatic way, based on the tools developed during phase one, and including well-designed killer experiments. Second, the Coulter grant would be provided not only to the biomedical engineering department and the school of medicine, but the office of technology transfer would be an equal partner. Finally, phase two universities had to put up one-third matching funds to receive the grant, to ensure that they had some “skin in the game.”
How well have these lessons served the phase two institutions? The ultimate measure of success for Coulter Schools is follow-on professional funding; the target is for 33 percent of the Coulter-funded projects to receive follow-on professional funding. Recent results from Coulter show that 33 percent of phase one projects have received follow-on professional funding, with 22 percent of those being in the commercial market. For phase two, 40 percent of projects have received follow-on professional funding, with 27 percent of those being in the commercial market. This is a nice little increase showing that continuous improvement and organizational learning do make differences.
I reached out to Dr. Harvey Borovetz, former chair in the Department of Bioengineering at the University of Pittsburgh, to gain his perspective. Borovetz was instrumental in Pitt’s application process for Coulter phase one (which was unsuccessful), and in its successful application for phase two. He provided a great statement on transformation that has occurred at Pitt because of the Coulter Program: “The actual funding from the Coulter foundation, while generous and helpful, pales in comparison to the amount received from the National Institute of Health (NIH) and other sources. The real value of the Coulter translational research partnership was the shift in mindset.”
When I asked Max Fedor, Coulter Program Director at the University of Pittsburgh, what he has learned from the Coulter Program at Pitt, he simply replied, “The Coulter process works.” He added that technology transfer has seen positive growth since Coulter arrived on campus. “Prior to the Coulter Program, the Office of Technology Transfer didn’t always have a clear picture of how new ideas get to market,” Fedor explained. “The staff did not receive a lot of mentoring along these lines.” Interesting that Fedor and Caro both observed this challenge and, at least at Pitt, the Coulter process has spurred improvement.
Bringing us back to the primary function of the university, Lindsay Rodzwicz Burns, Coulter Program Manager at the University of Pittsburgh concluded, “Over 100 students have participated and grown tremendously in the first four years of our Coulter Program. In addition, there have been positives for the faculty, the university, and the region.” Who says you can’t have it all?