Bio Break: Finding the Path to MedTech Innovation with the Pathfinder Program

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Bio Break: Finding the Path to MedTech Innovation with the Pathfinder Program

Authors: Nick Allan
Topic: Bio Break

In this episode of Bio Break, Nick and Joris explore one of the most dynamic early-phase services at StarFish Medical: the Pathfinder Program. If you’re a medtech innovator with a promising concept or prototype, Pathfinder helps you identify the right path forward—before you invest millions in development.

Nick explains that Pathfinder projects focus on structured, interdisciplinary exploration to de-risk early innovation decisions. Whether it’s a new diagnostic platform or a novel therapeutic device, these short, intensive engagements are designed to define your target product profile, investigate regulatory and IP strategy, and uncover unmet user needs—all before a single part is manufactured.

The episode discusses how the Pathfinder team collaborates across human factors, industrial design, systems engineering, and sometimes even early prototyping to assess feasibility and market alignment. The outcome? A comprehensive Pathfinder Report. This document helps clients understand competitive positioning, reimbursement potential, freedom to operate, and how to prioritize the product’s unique value in the clinical space.

Joris and Nick also reflect on how Pathfinder enables clients to avoid costly pivots later in the process. By bringing in industrial designers and regulatory experts early, teams can explore device form factor, usability constraints, and even conduct basic visualizations or 3D-printed proofs-of-concept.

Whether you’re preparing for a funding round, seeking to understand your market fit, or building a go-to-market strategy, the Pathfinder Program can give your team clarity and confidence. Tune in to see how this process sets the foundation for successful medical device commercialization—and why it’s one of the most rewarding project types at StarFish.

A laptop on a wooden desk displays a digital document icon on its screen. Beside it, bold text reads "Design History Files Explained," highlighting the topic of regulatory documentation in medical device development.

Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle.

Two colorful paper boats—one red and one yellow—float on a blue background with illustrated white waves beneath them. Bold text reads "From Idea to Impact," symbolizing innovation and progress in medical device development.

Nick Allan and Joris van der Heijden revisit one of StarFish Medical’s most successful Pathfinder journeys, showcasing how a bold research concept evolved into a fully realized clinical diagnostic device.

A visual project roadmap titled "Finding the Path to MedTech Innovation" shows five development phases: Phase Zero (Pathfinder Product Definition), Phase One (Engineering Detailed Design), Phase Two (Transfer), and Phase Three (Manufacturing). Each phase includes activities such as contextual research, usability engineering, IP generation, design input development, regulatory strategy, prototyping, verification, manufacturing process development, and volume manufacturing. Arrows represent workflows across multiple functions like product development, quality, and regulatory support, with milestone gates marked by stars.

Nick and Joris explore one of the most dynamic early-phase services at StarFish Medical: the Pathfinder Program. If you’re a medtech innovator with a promising concept or prototype, Pathfinder helps you identify the right path forward—before you invest millions in development.

A stylized dart hits the center of a yellow target next to bold text reading "Future of Ablation Technology" on a white background.

Nick and Joris explore the wide world of ablation technologies—unpacking how each approach works and what it’s best suited for.