From Problem to Product

The TMC Biodesign program, a one-year innovation fellowship, is reimagining the process for developing new medical devices and digital health solutions

From Problem to Product

6 Minute Read

The history of innovation is populated by precise moments in time. Archimedes abruptly leaping out of his bathtub; Newton lounging beneath a tree when he received a beneficial bump on the head from a wayward apple; Sir Paul McCartney waking up one morning with the tune to “Yesterday” perfectly crystallized in his mind. But what if innovating isn’t simply an innate ability waiting for the right catalyst? What if “eureka” moments can be gently elicited through the right combination of mentorship, resources and a well- defined curriculum?

That mindset underscores the recent launch of the Texas Medical Center’s innovation fellowship, TMC Biodesign. A one-year program, TMC Biodesign brings together teams of highly accomplished individuals from diverse backgrounds—including engineering, medicine, business, computer science, design and research—to create novel digital health solutions and new devices for health care’s greatest unmet needs.

“I think the fundamental premise of the biodesign model is that being a successful and active inventor and entrepreneur is a teachable skill,” said Robert C. Robbins, M.D., president and chief executive officer of the Texas Medical Center. “Most people think that Edison or Einstein were just born that way. A lot of people have an inquisitive mind or want to tinker and think about how to do something differently, but there are tangible lessons to be learned.”

With the first class slated to begin this September, TMC Biodesign aims to provide fellows with the expertise and experience necessary to cultivate those skills. As part of the Texas Medical Center Innovation Institute, the fellows will be in a privileged position to draw from the combined resources of the medical center community.

“Our first priority is to enable our fellows to have very unique experiences that are only possible if you are part of a program like this,” said Farzad Soleimani, M.D., assistant professor of emergency medicine at Baylor College of Medicine and co-associate director of TMC Biodesign. “If you go to, for example, a research institution, you’re confined to the resources of that institution. Because of the design of this program, we can establish a curriculum that cherry picks the most remarkable experiences from the collective pool of our member institutions.”

TMC Biodesign aims to nourish the evolving spirit of entrepreneurship stemming from the Texas Medical Center Innovation Institute—which currently includes TMCx, TMCx+ and JLABS @TMC. The biodesign methodology, a process for streamlining discovery and commercialization, will help support the steadily growing community of innovators in Houston. Identify. Invent. Implement. Those are the three established pillars of the biodesign curriculum, developed by Paul G. Yock, M.D., at Stanford University—and the model that TMC Biodesign will follow. First, fellows will go through an immersive clinical shadowing experience, closely monitoring both patients and health care professionals in a specified clinical setting.

“Biodesign fellows are trying to solve real-world problems—they can’t just read about them,” said Robbins. “They have to be out on the front lines every day talking to people. Many of the successes that came out of Stanford’s biodesign program were not necessarily physicians. They were technicians, word clerks, nurses and pharmacists.”

“When these fellows go out into the clinical areas and really listen, that’s the foundation for everything else,” added William F. McKeon, executive vice president and chief operating officer of the Texas Medical Center. “They’re not hammers looking for nails. That’s the exciting thing about this program— they go in as sponges to listen, learn, observe, and then identify those opportunities where they can advance care.”

Based on their initial observations, the fellows identify a broad range of unmet needs—anything from problematic processes to cumbersome technology—and begin a process of “needs screening,” exploring both current treatment options and analyzing possible target markets.

“After that comes the ‘invent’ stage, where they really dive into concept generation and selection,” explained Jessica Traver, business associate at TMCx, where she is helping to develop TMC Biodesign. “That’s where the fellows work to ideate and brainstorm potential solutions with help from their advisors and mentors. It’s also where they prototype as much as possible to find the ideal solution. We encourage fellows to iterate, iterate, iterate—that way they can ‘fail fast’ to find out what works best.”

The final months of the program (“implementation”) are dedicated to overcoming hurdles entrepreneurs are all too familiar with: development strategy and market integration.

“Once you’ve built out your product, you have to figure out how to integrate it into the complex web of hospital systems,” said TMCx Business Analyst Sandeep Burugupalli, another asset in the launch and execution of TMC Biodesign. “For example, you have to think about reimbursement—how will you sustain and scale your solution? It’s one thing to create it, but it’s another thing to integrate it into the existing fabric of health care.”

The TMC Biodesign program is predicated on a simple assertion: with the right mixture of mentorship and resources bolstered by a solid curriculum, it’s possible to pave a path that leads directly from identifying a problem to developing a solution. The missing ingredient? Bright, fearless individuals who relish the thought of extending themselves beyond their discipline.

“The key to a successful biodesign experience is the willingness to invent, create and be open to new ideas,” said Eric S. Richardson, Ph.D., professor of bioengineering at Rice University, where he is developing a master’s of engineering program with a focus on the biodesign model. “Fellows have to be comfortable with an unstructured design setting. There are certain people who thrive on ambiguity.”

Two teams of four individuals each will populate the inaugural class of the fellowship.

“We want fellows who not only enjoy thinking outside of their specialty, but also thrive on multidisciplinary interaction,” said Robbins. “You put these talented people who are at the top of their discipline together, and it’s like putting the team together that led to the first person on the moon. It wasn’t just the astronauts, it was the rocket scientists, the engineers and the administrators. There are a multitude of people who have to come together for these big moonshot projects.”

According to Robbins, while nurturing budding startups is an important component of TMC Biodesign, it isn’t the sole driving force behind the program.

“I think it’s important to remember that this is an education program,” he said. “The goal is not necessarily to create startup companies. It’s a nice byproduct, and it’ll clearly be a secondary objective, but I think our main focus will be ensuring that the fellows receive an incredible education about how to design new devices, diagnostics and digital platforms to improve human health.”

The benefits of that education become tangible through the successes of individuals like Lily Truong, chief executive officer of Clear Ear—a consumer health company that developed a product line for better ear wax management and one of the 22 inaugural TMCx startups. Conceived as a class project at the Stanford Biodesign Program, Clear Ear was born when Truong discovered that the number one cause of treatable impaired hearing worldwide is earwax buildup. That discovery—and Truong’s relationship with her co-founder, Vandana Jain, M.D.—would not have been possible without the structure and support of her biodesign experience. “Biodesign changed my life,” said Truong. “I’ve always had a passion for health care innovation. That’s where I want to make an impact. Before biodesign, I didn’t have a full idea of how to accomplish that. Now I know how to find an unmet clinical need, invent a solution that meets that need, and then ultimately implement a strategy and bring it to market so it can improve the health of those around the world.”

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