Innovation Alone Doesn’t Guarantee Market Success – An Interview with UC Berkeley’s Darren Cooke

Launching a medical device, diagnostic tool, or therapeutic is no walk in the park—especially when you need to win over the right stakeholders. As Darren Cooke, Executive Director of the Life Sciences Entrepreneurship Center and Interim Chief Innovation and Entrepreneurship Officer at UC Berkeley, points out, getting a breakthrough product to market isn’t just about innovation. It’s about aligning financial motivations, navigating complex regulatory landscapes, and understanding the true needs of everyone involved in the healthcare ecosystem.

The 5 P’s of Market Adoption: Aligning Financial Motivations for Success

“It’s not enough to just build something great,” Cooke says. “You have to understand the ecosystem around it. If you want your innovation to be adopted, there are five key stakeholders who need to be fully on board—and they need to be an enthusiastic yes.”

So, who are these stakeholders?

1. Patients – These are the end users who will ultimately benefit from the innovation.
2. Providers – Physicians, hospitals, and healthcare systems that will use or recommend the technology.
3. Payers – Insurance companies and reimbursement entities that decide who will pay for the innovation.
4. Partners – Companies or organizations that help with the commercialization of the product.
5. Permitters – Regulatory authorities like the FDA, who must approve the product for use.

Cooke emphasizes that understanding the motivations of each of these groups is critical. “You need to understand who these people are, what they do today, and what will motivate them to do something different tomorrow,” he explains.

To successfully navigate the complex life sciences ecosystem, Cooke advises innovators to develop a comprehensive framework—what he calls the Life Sciences Venture Canvas. “Startups need to map out these five stakeholders—patients, providers, payers, partners, and permitters—and determine what drives each group. Investors often want to know if startups understand the motivations of these parties,” he says.

This isn’t just an academic exercise—it’s about practical strategy. “Without understanding these stakeholders, your product could be amazing, but it won’t go anywhere,” Cooke warns. “The product can be great, but if you haven’t figured out how to engage each stakeholder, it’s very likely that it is not going to be adopted.”

For entrepreneurs trying to close the gap between a great idea and market success, Cooke’s advice is straightforward: “Map it out, understand the stakeholders, and ensure each of them is aligned with your vision.” It’s the foundation that can make the difference between innovation fizzling out and achieving widespread adoption.

Is Improving Patient Outcomes Enough for Market Adoption?

For many startups, it’s not just about innovation and then regulatory, but also about meeting the financial expectations of stakeholders, particularly in the US market. Cooke points out that understanding the motivations of all the players involved is equally important. “This is where a lot of innovators trip up,” he says. “A lot of people know that payers (like insurance companies) need a return before they’ll pay, but what they don’t realize is that providers (healthcare systems and physicians) also need to see a financial return before they adopt a new device, diagnostic, or therapeutic.”

Cooke adds, “It’s easy to think that if something improves patient outcomes, it will automatically be adopted, but providers also need to see financial viability. Especially in the U.S., where healthcare systems are largely profit-driven, financial motivation is key.”

But the real controversy comes when you consider the providers’ motivations. While everyone hopes that healthcare professionals are motivated purely by patient outcomes, Cooke argues that the financial incentives can sometimes outweigh this ideal. “What we’re seeing is that a provider’s financial return is often a crucial motivator.”

This doesn’t mean that patient care is irrelevant; rather, financial sustainability has to align with better patient outcomes for any innovation to succeed. The controversial part, according to Cooke, is that even in healthcare, where moral motives are assumed to drive action, money still talks. This dynamic plays out across various industries, even outside healthcare. “It’s like in the clean tech space,” Cooke reflects. “You might think that people will choose a product because it’s greener or more environmentally friendly, but in the end, it still has to be financially viable.”

Cooke stresses that innovators must bridge the gap by understanding how all parties benefit financially from a new product. “In the end, it’s about aligning the financial motivations of patients, providers, payers, partners, and permitters,” he concludes. If you can do that, you’ll have a much clearer path to market adoption.

Overcoming Regulatory Hurdles Is Easier Than It Seems

Regulatory hurdles are one of the biggest challenges for startups breaking into healthcare, but Cooke emphasizes that preparation is key. “What investors really want to see is that entrepreneurs understand what they’re up against,” he says. “They need to prove they know what it takes to get through the process.”

But it’s not just about technical expertise. “You can hire consultants and meet with the FDA, but if you walk into an investor meeting saying you hope you can get through regulatory approval, that’s not going to work,” Cooke warns.

The good news? Navigating these obstacles might be easier than it seems. “Regulatory bodies like the FDA are more accessible than people think,” he explains. “You can set up informal meetings to understand exactly what’s needed for your product.” Many startups don’t realize how simple it is to reach out. “You’d be amazed how many don’t even ask the FDA what they need to show,” he adds. “Just send an email, book an appointment, and have a conversation.” For many founders, realizing they can engage directly with regulators is a game-changer.

Putting Patients First: It’s About Ensuring Access to Meaningful Care

In healthcare innovation, patients should always come first. As Cooke puts it, “While money is a factor, it’s secondary to patient needs.” Financial considerations matter, but they shouldn’t overshadow the goal of improving care. “Patients aren’t looking to overspend,” he explains. “They just want affordable and effective treatments that truly address their concerns.”

Cooke encourages startup founders to talk to patients early on. “They’re the easiest to reach and the most open,” he says. This direct feedback helps innovators cut through complexity and understand real needs before dealing with regulatory hurdles. “Patients provide the most straightforward feedback,” he adds, making their insights invaluable for shaping better solutions.

The goal isn’t just about a patient’s ability to pay—it’s about ensuring access to meaningful care. “Patients rarely pay much out of pocket, but they still need affordable treatments,” Cooke notes. Sometimes, though, the status quo is enough. “If patients are content with existing treatments, is there really a need for innovation?” he asks. While rare, this scenario suggests the system—whether through payers or providers—may not require immediate change.

True progress in healthcare comes from addressing patient pain points. “Finding the pain of the patient is what drives healthcare evolution,” Cooke explains. If patients don’t see a need for change, there’s little motivation for innovation. That’s why collaboration between patients, payers, and providers is essential. “Doing the homework with patients is key,” Cooke insists. “It’s about truly understanding their needs and motivations.”

Scaling innovations globally requires the same approach—identifying key players and their motivations. “The process applies everywhere, even if the details vary,” Cooke says. In the end, while financial incentives play a role, the core of healthcare innovation is simple. “We want these innovations to enhance health and improve lives,” he concludes. At its heart, every breakthrough should serve one purpose: putting the patient first.

In an exclusive interview with GeneOnline, Darren Cooke, UC Berkeley’s Interim Chief Innovation and Entrepreneurship Officer, discussed the challenges of translating breakthrough innovations into real-world applications, stating, “The hardest part? Turning innovation into adoption.” As the mastermind behind the Berkeley Bio Showcase, held alongside the JPM Healthcare Conference in San Francisco for the past two years, he covered topics such as regulatory hurdles, industry-academic collaborations, and strategies for scaling biotech innovations. Image: GeneOnline.

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Bernice Lottering