Fogarty chief financial officer Gayle Kuokka has identified a common challenge among many of the entrepreneurs who came to Fogarty with an exciting idea aimed at resolving a medical problem: they are often unsure how to build the business case behind it.
“Initially they spend the majority of their energy thinking about the technical product before considering the business aspects,” Kuokka says. “One of my goals is to help them see that sometimes they need to slow down and consider the full business model before investing so much capital into product development. Foundational business elements can impact the design and even the viability of the idea, given that the ultimate goal isn’t building a product—it’s getting that product to patients. Regulatory, reimbursement, sales channels and potential acquirors all factor into building a successful company.”
With her business acumen, Kuokka plays an integral role in Fogarty’s unique approach to coaching medtech startups. “I like to act as a sounding board and ask a lot of questions, with the goal of getting them to understand the business holistically,” she said.
Addressing business fundamentals as a first step
A significant focus for Fogarty is helping startups navigate the complexities of fundraising and financial planning. “Many people think about entrepreneurship in the way it is portrayed in tech—where you have an idea and can quickly get to market. But medtech is far more difficult,” Kuokka said.
She has developed an analogy to help explain startup valuations by comparing them to real estate. As she puts it, seed-stage companies are like someone purchasing a plot of land with plans to build a house. The value of that land isn’t just about what it is today—it’s about its potential and what price the finished home could eventually command.
Valuation isn’t as simple as saying, “I’m a seed-stage company, so I’m worth $5 million.” Just like two plots of land in different neighborhoods can have vastly different prices, the same goes for startups. Their value depends on a range of factors, from market opportunity to team strength and execution potential.
Fundraising is arguably one of the highest interest areas for startups. However, while everyone wants to know where to go to attract capital, Kuokka points out that there’s no one-size-fits-all solution or predefined list of targets. Instead, companies must do the legwork, leveraging resources like LinkedIn and PitchBook and talking to fellow CEOs and industry peers to see where they’re finding funding.
Moreover, understanding how much to raise requires developing a comprehensive budget that explains where the money will be used. The budgeting process ultimately defines the company’s strategic plan.
Turning pitches into home runs
Another area where the Fogarty team excels is helping startups refine their pitches– focusing on storytelling beyond the technology and adding in the market, clinical, regulatory and other elements that tell the comprehensive business story.
“We hear pitches for so many exciting new products, but you have to think about how to actually get something to market, which is where we come in,” Kuokka said. “We help entrepreneurs focus in on what they want to achieve and the problem they’re trying to solve by starting with their value proposition and the passion they have around it and then helping build that narrative.”
She finds it particularly rewarding when a clear path forward emerges. “I love to see the transformation that occurs when an entrepreneur truly understands their business and can confidently respond to investor questions,” she said.
A virtual C-suite for startups
Kuokka acknowledges that Fogarty Innovation is hard to define. For example, the general impression of the organization as a nonprofit medtech incubator doesn’t accurately capture the breadth and depth of its approach. “We provide full-contact coaching. It’s not just about coming to see us once a quarter so we can tell you what we think. We’re involved throughout the process, advising on all aspects of the business.”
As part of that holistic perspective, Fogarty continually hones its offerings, developing innovative ways to provide value to startups. A member of the team since 2018, Kuokka believes one of the most significant improvements has been the accessibility of expertise across the organization. While each team has a designated lead coach, the entire team makes itself available so companies can tap into the specific expertise they need.
For example, recently when Kuokka was working with a company whose regulatory approach needed to be refined, she sought the experience of another Fogarty expert, who is now taking the lead on advising them in that regard.
“What makes Fogarty so unique is that we are here for the companies —not for ourselves in any way. We just want to train the next generation of entrepreneurs and help new technologies that benefit patients get out there,” she said.