From Concept to Commercialization: Lessons from a Digital Health Session at UNH

On March 26, Simbex joined healthcare, engineering, and business leaders at the University of New Hampshire for a digital health session hosted by the Center for Digital Health Innovation and the UNH Entrepreneurship Center. The event brought together a diverse cross-section of the innovation ecosystem, with opening perspectives spanning the Entrepreneurship Center, UNH Innovators, Assistive Technology in New Hampshire, and Rehabilitation Science and Technology.

Hosted by Marguerite Corvini, Director of Simulation & Digital Health, the session moved beyond the idea of innovation as a singular breakthrough. Instead, it traced the full journey that digital health products undergo, from regulatory definition through development to commercialization, mirroring the sequence required for successful real-world adoption.

This progression was intentional. It underscored an often-overlooked truth: in digital health, success hinges less on what is built first and more on what is defined at the outset.

The session began with opening remarks from Marguerite, followed by a discussion led by Chad Killian. Attendees were invited to share current projects, including contributions from Trish Kelshaw, Navy Heng, and Sajay Arthanat, highlighting the breadth of work underway across the UNH community.

The program then shifted to available UNH resources, with perspectives from the Entrepreneurship Center, UNH Innovation, and the Assistive Technology program, along with an overview of the Rehabilitation Science and Technology course. Marguerite then introduced Simbex to continue the conversation.

Defining the Regulatory Strategy

The session opened with Amaris Ajamil, PhD, RAC, Director of Regulatory and Quality at Simbex, who provided immediate clarity on a question that many teams delay addressing.

Is this digital health product a medical device?

This determination, based on intended use and indications, defines classification, regulatory requirements, and the path to market. It’s not simply a procedural checkbox but a decision shaping all subsequent steps.

A recurring theme was the essential role of quality. Regulatory compliance is not just documentation. It is built on systematic quality processes.

Quality systems govern design, testing, validation, and ongoing monitoring across the full product lifecycle. Without that structure, teams are not building toward compliance. They are accumulating risk.

Framing regulatory strategy this way shifts compliance from an afterthought to a core component of product design.

Addressing Market Realities

With that foundation in place, Ilsa Webeck, VP of Commercialization at Simbex, shifted the discussion toward market viability.

Even when a product can be defined, built, and approved, success depends on adoption. The question is not only whether a product can exist, but whether it will be used within the realities of healthcare delivery and payment systems.

In digital health, the user is not a single individual. It is a network.

Ilsa introduced the 5Ps, patient, physician, provider organization, payer, and policy maker, to capture the complexity of digital health stakeholders. Each group shapes success, and their priorities often diverge: patients value outcomes, clinicians focus on workflow, organizations assess operations, payers consider cost, and policy makers define requirements.

When even one of these perspectives is overlooked, friction is introduced. This is where many digital health products fail. They are designed for a user, but not for the system they must operate within.

Ilsa grounded this in a set of critical questions: What problem is being solved, who experiences it, and why would they choose this solution over alternatives? These answers determine whether a product fits into real-world workflows and has a viable path to adoption.

Reimbursement is crucial: even a compliant product will falter if it lacks proper payment alignment, which depends on well-coordinated coding, coverage, and payment.

This introduces an additional design layer. Products must deliver not only clinical value, but economic value. Success in digital health requires alignment across both.

Connecting Strategy to Execution

Greg Lange, CEO of Simbex, closed the session by translating these constraints into development.

Once regulatory and commercialization considerations are defined, execution begins. But execution is not a linear path from idea to launch. It is an iterative process that moves through feasibility, prototyping, validation, and production.

Each phase reduces uncertainty, tests assumptions, and refines both the product and the strategy behind it. Strong products are not built all at once. They are shaped over time through structured learning.

By the time a product reaches the market, it is not just engineered. It aligns with regulatory requirements, is informed by user and system needs, and is positioned for adoption.

Sequence Drives Outcomes

What made this session particularly effective was not only the content but also the clear identification and sequencing of key takeaways at each stage, ensuring participants could directly apply the main lessons.

Starting with a regulatory definition clarified what was possible. Addressing commercialization defined what was viable. Concluding with development demonstrated how to execute within those constraints.

Too often, teams begin with development and defer everything else. This approach increases risk and limits the likelihood of success.

A more effective model is clear: define the product, understand the system, and then build it. These steps serve as the main takeaways for bringing a successful digital health product to market.

A More Integrated Way Forward

Digital health innovation is complex, but it is not unpredictable.

When regulatory strategy, market realities, and product development are aligned early and approached in the right sequence, the path forward becomes clearer. The central takeaway is that success depends on understanding and integrating all constraints from the outset, not just on building the product.

Acknowledgments

Thank you to the University of New Hampshire, the Center for Digital Health Innovation, the UNH Entrepreneurship Center, and the HSSC SIM Center for hosting a valuable session and bringing together the digital health community.

Interested in Partnering?

Simbex supports teams at every stage, from concept to commercialization. We work with technology transfer offices, translational science groups, startups, and multinational manufacturers. Our focus is on aligning regulatory strategies, assessing market viability, and guiding product development.