Helping innovators and startup companies turn promising ideas into solutions that improve patient care has always been a core focus of Fogarty Innovation. To do this, FI offers a range of incubation and acceleration programs designed to match the development stage of the company and the goals of the innovator. Launched in the fall of 2019, the Invention Accelerator Program (IAP) is FI’s earliest-stage program.
The IAP helps physicians, academic faculty, and other first-time innovators translate their research projects and clinical insights into medical innovations. “These are often physicians who have seen an important problem in patient care and have a solid idea of how to address it, but don’t really know how to move forward in all the ways that are required to take an innovation from an idea to medical device,” said John Morriss, IAP program director. The IAP provides that guidance by helping the innovator (aka principal entrepreneur) determine the technical and business advances required to successfully translate their ideas into commercially viable and fundable medical innovations. It also uncovers any fatal flaws that could prevent these ideas from successful translation.
How it Works
Once a project is accepted into the IAP, the first step is the creation of a customized development plan to advance all aspects of the concept. “This varies by project, but can involve better defining the need, advancing the prototype, assessing the regulatory pathway, evaluating the intellectual property landscape and reimbursement strategies, and exploring business models and funding strategies,” explained John.
Over the next six months, the principal entrepreneur works closely with John, FI’s senior staff, key project advisors from the originating institution, and subject matter experts like regulatory and reimbursement consultants on activities that measurably advance and de-risk their concepts and strategy. At the same time, the principal entrepreneur gets an intensive, hands-on introduction to the many facets of the medtech development pathway.
“I knew that translation was a complex process,” said principal entrepreneur Helen Bronte-Stewart, MD MSE, the John E. Cahill Family Professor in the department of Neurology and Neurological Sciences at Stanford University, who is working on a remote diagnostic for Parkinson’s disease. Dr. Bronte-Stewart came to the IAP after receiving two Neuroscience: Translate grants from the Wu Tsai Neurosciences Institute at Stanford University and being mentored by Stanford Biodesign. “I realized very quickly how much I didn’t know. What made it so challenging – and so stimulating – was learning about so many new things– user needs, risk analysis, how to give a business or investor pitch instead of an academic talk. It was a huge learning curve and but also a really interesting six months.”
A Track Record of Success
Most of the time, the advances made in the IAP leave the projects well-positioned to achieve other significant milestones. Dr. Bronte-Stewart was one of two IAP participants to receive a $1 million grant from Stanford Medicine Catalyst to support further project development after completing the program. Another project leader was awarded a $750k NSF Convergence Accelerator Grant, and another successfully formed a company after graduating and closed an initial financing round. Others have launched successful preclinical and clinical studies, made significant product advances, or were accepted into additional incubation programs, including Fogarty’s own Company Accelerator Program.
Occasionally, the outcome is disappointing as the IAP process leads to the identification of problems that convince the principal entrepreneur not to pursue the project further. However, these can still be considered positive outcomes as they helped inventors appreciate the need for a different approach.
“The success of the program and rising number of applications confirm that there is a big need for early-stage medical device development guidance,” said John. “Medtech innovation is not a simple series of sequential steps. It’s hard to know who to ask, what to ask, and what confirmation you need to know you are on the right path. And conversely, how do you know when you’ve hit a dead end? There are lots of avenues that need to be explored.”
Understanding Bigger Picture Risk
The need for this guidance is particularly important for university-originated projects. “Translational projects that originate at an academic institution are typically grant funded,” said John. “To maintain this funding, the project leaders focus on hitting the goals they have outlined. However, when a project enters the IAP, we are looking further down the road and analyzing bigger-picture risk to determine whether the concept will succeed as a company or not.”
This perspective gives project leaders the opportunity to realize what their biggest challenges to commercialization will be and address them proactively. “By applying our years of experience mentoring companies through the later stages of development, we can help early-stage groups identify the greatest threats to their ideas and focus on those from the outset,” John said.
Over the past three and a half years, John feels the program has just gotten better. “With each project that comes through, we keep improving the process,” he said. “Given the progress that so many of the projects are making, I think we are going to see some of these turn into real products that make a difference in patient care in the near future.” To date, 13 projects have come through the IAP, including two that are currently in the program. The projects have come from Stanford University, Stanford Biodesign, Stanford Healthcare, and El Camino Health, and have involved technologies across clinical areas from interventional cardiology to sleep apnea.
“I feel like my whole idea of devices and the world of translation has expanded dramatically because I have a better understanding of what takes to bring something to market as opposed to just having a good idea and doing the science correctly,” said Dr. Bronte-Stewart. “I think this is training that every academic should have because it seems unfortunate to have a great idea and then hand it off to someone else. The ability to stay connected to the outcome of your work because you are passionate about the patients and the science is good for the project. And it is very exciting for me.”