Fogarty Innovation has multiple incubation programs designed to “meet innovators where they are” in terms of the development stage of their technology and company. The company-in-residence (CIR) program is the most comprehensive of these, providing a multi-year home for early-stage medtech companies, most of which are led by first-time CEOs. It is also the longest-standing incubation program, having been established when Dr. Tom Fogarty founded the organization in 2007.
“Dr. Fogarty used to say that ‘the only way problems get solved is by people focusing on solving problems,’” explained Mike Regan, Fogarty chief innovation officer. “He felt that as the journey to bringing new solutions into the patient care pathway got more complex, innovation teams needed more cross-functional help. And so, his idea was to bring them in and support them with coaching, practical education, and integration into a community of innovators.”
Designed for companies that have some seed or grant funding and a working prototype, the overall intent of the CIR program is to give teams the wherewithal to continue to make progress. “Their goal is to set a destination, then assess their business, build evidence and develop the arc of their story in a way that continuously attracts the needed resources and funding,” said Regan. “We help them determine what that progression of evidence looks like and achieve those goals.”
The Fogarty Advantage
There are a number of unique factors about Fogarty Innovation that give CIR’s a substantial leg-up in reaching their goals. It starts with access to Fogarty’s senior leadership, a team of seasoned medtech executives with extensive domain and functional expertise. These individuals have an average of 32 years in the industry and have collectively returned more than $8B to investors through acquisition or IPO.
Another major benefit for young companies is partnership between Fogarty and El Camino Health. “The ability to work with clinical researchers and integrate into real-world hospital workflow is incredibly valuable,” said Regan.
The most meaningful advantage, however, may be the Fogarty community itself. “Probably the most important element to our success is having a supportive, active and collaborative community,” said Regan. “Developing a new medical device is a lonely endeavor. Teams are small – typically just two-to-three people, and sometimes they don’t know all the things they need to know. Community and camaraderie are critical.”
Getting In
With limited capacity, only a handful of companies are accepted to Fogarty incubation programs each year. “What enhances someone’s chances the most is being really thoughtful about what their plan is and being proactive in talking to us and conveying what will change or be improved as a result of bringing this idea into the world,” said Regan.
In general, companies accepted into the program must be addressing a large unmet clinical need, have a team that will benefit from being part of the Fogarty community and will also contribute to that community, and have a fundable technology or idea. In addition, companies must not be in the same space and competitive with another company or entrepreneur currently in residence.
“It’s really important to us to make sure that our CEO community is a resource and a safe place for company leaders to be able to work through their challenges,” said Regan. “A CEO must project positivity but that can be tough. We want our CEO community to be comfortable place where they can vent, commiserate and problem solve.”
Full Contact Coaching
Once a company is accepted into the program, the first step is a Fogarty physical, a presentation across all aspects of the business that helps the Fogarty team identify key items to focus on initially. “Based on that physical, we create a development plan for each company where we lay out key goals and the methods and timing for accomplishing those items,” said Regan.
The team is then assigned a primary and secondary coach, who serve as “air traffic controllers” for the team throughout their stay. “We assign two coaches because people think differently and there are multiple pathways to get to a solution,” said Regan. “Then, depending on what stage the company is at, the coaches ask other staff members to contribute within their areas of expertise, from clinical trials to market access strategy.” This is supplemented even further with Fogarty’s “bench strength,” a network of ~300 people that Fogarty can call on to provide deeper or more esoteric proficiency.
The coaches stay deeply involved throughout the CIR’s stay, making sure the team has the resources and support they need as they advance their technology and business.
Contributing to the Ecosystem
Even as the companies work towards their goals, they also have a responsibility to give back by playing an active role in Fogarty’s broader mission to foster a healthy medtech innovation ecosystem.
As one example, Fogarty regularly hosts groups of FDA Fellows for a week of immersive exposure to the innovation ecosystem. “Our companies-in-residence are responsible for helping the Fellows see what it’s like to be a small start-up company,” said Regan. “They facilitate discussions and help the Fellows explore areas of interest.” The resulting dialog benefits both sides.
CIRs are also expected to participate as hosts in Fogarty’s Lefteroff summer internship program. “The expectation is that our companies will take interns because this is generational – we want to perpetuate a healthy ecosystem and continue to replenish the talent pool,” said Regan. This too comes full circle – the interns, who are matched to companies based on their interests, almost always end up making valuable contributions during their stay, and some have even returned to work for Fogarty or its companies-in-development full time.
Graduation
Not surprisingly, the endpoint of the CIR program looks different for each company. “For some companies it could be a relatively short-lived program because they need to establish only one evidence point to attract interest, for instance clinical proof that shows an idea in a new space will work,” said Regan. “Other companies are in for a longer stay that will involve proving a revenue model, a business model, and so on.”
The good news is that once a company is accepted into a Fogarty incubation program, it becomes part of the Fogarty Family. “We’ve got companies that graduated from our programs years ago that continue to cycle back with us and let us know what’s going on and ask for opinions and help,” said Regan. “And of course we say yes – it’s what a family does.”