Pipelines for translating research into the biomedical market are just one way the world is preparing for the future of medicine. Will ground-breaking research inspired by nature survive the feeding-frenzy of investments and regulations?
“Breakthrough discoveries cannot change the world if they do not leave the lab,” reads a headline on the website for Harvard University’s Wyss Institute for Biologically Inspired Engineering.
In the highly competitive biotech world, it’s not enough to be innovative. Research relevant to improving medical devices, therapeutic systems, or bioengineering often ends at publication of a paper or the filing of a patent. The ability to translate this research into a reality requires a strong understanding of business, communication, and, of course, the public policies for regulation. This translation from an early-stage concept into a practical reality is a journey. A key objective of today’s scientists is to avoid getting stuck in the complex environment of biomedical commercialization.
Clearing the technical, economic, and political hurdles of innovation requires a variety of perspectives that come from an effective team dynamic. The art of biomedicine extends far beyond the lab to many different areas of expertise. There is a skill set needed for tedious grant-writing and effective business proposals. Risk evaluations and manufacturing plans must also be considered and understood. And there is an art to gaining significant support for preclinical studies. Partnerships are critical in biomedicine in order to optimize the pathway toward the future of health.
In addition to a collaborative group of researchers and physicians, partnerships between an institution and its researchers can facilitate directed innovation. Dr. Jules Scheltes learned early on in his career that building a bridge between engineers and physicians is at the core of successful translation. During his PhD research in biomedical engineering at TU Delft in the Netherlands, Dr. Scheltes began working with Dr. Paul Breedveld on bioinspired steerable medical devices.
Bringing a concept to commercial readiness almost always involves failure – something Dr. Scheltes experienced first hand in his work on an octopus-inspired design for minimally invasive surgical tools. While working on designs for existing groups in the industry, Dr. Scheltes’ projects often hit roadblocks due to the nature of business and susceptibility to the will of a board.
After encountering frustration and failure multiple times, Dr. Scheltes and Dr. Breedveld decided to switch gears completely in 2005. Together they co-founded DEAM and took over full control of the product and business development. When Dr. Breedveld left the company to maintain his scientific independence in 2011, Dr. Scheltes teamed up with Wimold Peter. In 2017, they finally got the necessary funding for their first design: a next-generation surgical tool called LaproFlex, which allows surgeons to navigate delicate areas of the body with minimally invasive precision. LaproFlex is a highly maneuverable tool that moves with ease thanks to a strategy inspired by octopus tentacles.
Just as innovation is a journey of curiosity and discovery, biotech commercialization presents a new layer of complexity to business and marketing development. A key aspect of entrepreneurship in this industry is the ability to communicate a solution to potential investors, as well as the end user themselves. Recognizing a target audience can help a company better adopt an approach to more relevant language.
When dealing with surgery, any procedure presents risks for the patient. Surgeons want to operate safely and make no mistakes, so logically they might be hesitant to switch to a novel technology. For Dr. Scheltes, the added value for surgeons in LaproFlex is that “you can maintain a better posture at the operating table for a more relaxed flow of working.” A more relaxed flow of working and a better posture equate to better stamina and comfort for the surgeons themselves during long procedures. The evolution of a more convincing story for the DEAM team comes after observing over 50 procedures and noting the needs of surgeons directly. This was not a technical development, but an application in marketing and story development.
Translating bioinspiration into commercial biotech requires diligence and vigilance. Dr. Scheltes approaches each aspect of this process with creativity and demonstrates a capacity for learning through different lenses. Today, DEAM successfully operates by applying the same approach it was founded with: all production, assembly, sales, and patent writing is done in-house by and for itself. And with the same kind of hands-on approach, Dr. Scheltes believes that even within regulatory affairs he’s able to write the quality manual, because “there is a logic beneath it, and if you understand that logic you can become creative in writing procedures for your company in a way that you still fill requirements.” While he never expected to start his own company, Dr. Scheltes has been able to build a career with adaptive creativity to significantly impact the state of medicine across the globe.
The need to better prepare engineers and clinicians for success in entrepreneurial innovation has shifted the role of higher education. “Ideally our goal is to help mitigate these risks so that people can be attracted to their project,” explains Dr. Katie Reuther, professor of biomedical engineering at Columbia University. Dr. Reuther is the director of BioMedX, the University’s own engineering technology accelerator, which provides funding and educational resources to researchers in the hopes of directing life-saving science toward positively impacting all of society.
For Dr. Reuther, BioMedX represents a thriving community at the intersection of engineering, medicine, and business. She emphasizes that “understanding and identifying an unmet clinical need, developing the technology and solution to address that need” are crucial steps in the process for visualizing how a technology could be commercialized.
To paraphrase a classic trope, if you give researchers a grant, you fund their work temporarily; but if you teach researchers how to write a grant or business proposal, you fund their work not only for a lifetime, but potentially for millions more. By providing a platform to learn practical skills, like developing a business model and pitching to potential investors, BioMedX goes beyond funding promising innovation for teams of clinicians and scientists.
Columbia’s Boot Camp for lab-to-market knowledge teaches how to package and pitch ideas, as well as how to describe business risks. Additional resources for direct mentorship from experienced industry professionals enables developing technologies to overcome the tough challenges en route to commercialization. Biotech startup Xylyx Bio is revolutionizing a pathway for future drug discovery through this accelerator platform. Looking to the body itself for inspiration, Xylyx technology mimics the way organs develop in humans with something known as the extracellular matrix, the scaffold of cellular growth, to grow organ-specific tissues in a more native environment.
Pipelines in academia have emerged in recent years for generating, accelerating, and translating the critical research needed for the next generation of biomedicine and medical devices. Columbia’s BioMedX program is part of a bigger consortium with 16 other universities to share best practices for administering effective and strategic educational programs from the undergraduate to the professional level.
Dr. Scheltes’ made sure to focus on absorbing information on what to do from colleagues, mentors, and experts at the start of his own journey. Continuously working with the Dutch university TU Delft has allowed him to connect directly with students working on their own designs. While these students inspire creative activity at DEAM, his journey of determination and resilience inspires a mindset shift for future engineers. Now more than ever before, students are at a point from which they can start their own company with a lower level of risk.
At every stage of the process, it’s evident that an environment of support and empowerment is critical. The fear of working across sectors and disciplines should not be a roadblock to potentially saving millions of lives. Cultivating a team of clinicians, biologists, bioengineers in addition to patent experts, business savvy professionals, and creative communicators is highly beneficial. A diverse community brainstorming together can radically bring solutions to the challenges of patient care to the next-level. As research institutions reflect this dynamic, the medicine of the future can start today.
This is Part 2 of a 3-Part article series about nature-inspired medical innovation. Read Sticking with the Status Quo? How Inspiration from Nature Can Transform the World of Biomedicine (Part I), and stay tuned for Part 3 of this series on bioinspiration in biomedicine.
Isabelle Seckler is a second-year student at Columbia University in New York City. She intends to study sustainable development along with a pre-medical track with the hopes of advancing community prosperity at the intersection of our built and natural environments.
Twitter: @IzzySeckler | Instagram: @isabelle.seckler
