De-Risk and Execute to Create Value

How to Derisk Your Idea

Good ideas are always exciting, but it’s important to keep development grounded in real-world needs and ensure your innovation translates into practical improvements. That’s why, before diving into development, it’s crucial to evaluate the risks associated with your idea.

Nitin highlights two main risks in the medtech space: clinical and technical. When working on a completely new therapy, you’re dealing with clinical risk—where there’s no precedent for how the therapy might work or be received. On the other hand, introducing new technology within an established therapy category brings technical risk. And sometimes both of those may coincide. “That's how the risk levels can exponentially go up,” Nitin explains.

Obviously, derisking your venture is essential, but trying to tackle everything at once can be overwhelming. He advises entrepreneurs to assess whether they’re taking on both risks simultaneously or if they can stage them to manage the challenge more effectively.  “If I have a choice, I prefer to take on just one of these risks at a time rather than both simultaneously,” Nitin advises.

That said, throughout his career, Nitin has often dealt with technical risks rather than clinical ones, as his work has focused on established therapy areas. These domains provide a wealth of clinical evidence, whether from studies, case reports, or patient and physician experiences, making it easier to define what’s needed to improve the space and create advanced devices. For example, reducing the size or profile of the device’s delivery system provides immediate benefits for both patients and physicians. If you can combine this with enhanced efficacy, you’re well on your way to developing a successful next-gen product.

Create Value for Everyone While Keeping Your Options Open

Nitin joined Supira in February 2020. Just one month later, the world entered a global lockdown. It was uncharted territory for every industry, especially in medtech, with no roadmap for navigating such challenges.

Fortunately, Nitin’s intuition served him right. He says, “You have to strike a balance between being confident and optimistic. You don't want to be overconfident or overly optimistic. But both qualities can be helpful when facing unexpected headwinds."

When starting or building a company, Nitin believes the ultimate goal is to create value that aligns with your objectives and resonates with your investors.

In his view, whether you’re founding a company or stepping in to lead it, two aspects of value creation should always be front and center. First, what are the biggest challenges, and are you addressing them step by step to de-risk the company?

Second, are you creating value not just for your end users—physicians and patients—but also for your investors? You might feel confident about addressing technical or clinical risk, but you won’t really know what investors are looking for until you engage with them.

To build investor confidence, it’s crucial to consistently demonstrate two key things: execution and the ability to derisk. Execution shows that your company delivers on its promises. When you hit milestones, whether they are clinical, technical, or commercial, it signals that you can turn plans into results. This builds credibility and trust, which are essential for attracting and retaining investor interest. Systematically reducing uncertainties increases the likelihood of success and positions your company as a safer and more compelling investment opportunity.

Such a focus on value creation carries over to Supira’s clinical roadmap. During the early stages, Nitin likes to have multiple options to consider instead of having a single clinical or regulatory option. External factors like market changes, therapy-specific challenges, or issues with competing products can create headwinds outside your control. It is always better to have more clinical experience and case information with the technology to understand its generalizability and readiness for a pivotal study. By doing this, you de-risk the acceptability of the data as viewed by the FDA. 

This approach has worked well for Supira. The team pursued clinical validation in South America while simultaneously working on FDA IDE approval in the U.S., which created an advantage in two areas. As Nitin explains, “One, it gives us confidence that the product is clinically working as expected. And two, it allows us to generate additional clinical evidence, which we can use for our subsequent regulatory filings.”

“Once you are a clinical-stage company, your currency is the clinical data,” Nitin says. That is to say, the more positive data you generate, the more value you create in the eyes of investors and other stakeholders. Having additional patient experiences to present at conferences or scientific meetings is a powerful way to show that you have clinically de-risked the concept and the company. It’s how you demonstrate progress and build credibility.