Clinician checking X-rays on a display

Medical device design
& development

Empowering MedTech innovation to create breakthrough products
that improve health and save lives

At StarFish Medical, we blend deep technical expertise, regulatory insight, and user-centered design to bring MedTech innovation to life. From startups to global enterprises, we turn visionary ideas into breakthrough products that improve health and save lives.

25+

Years

200+

Professionals

1000+

Programs

Our Services

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Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.

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Medical device design and development with a commercial launch focus. See how we support clinical trials and facilitate seamless tech transfers.

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We help you navigate complex regulatory landscapes to achieve commercial success. Explore our integrated approach to quality and regulatory services.

Scaling & Selling in MedTech’s Shifting Landscape

Real conversations. Strategic Insights.
A curated room of industry changemakers.

Latest Resources

A laboratory or engineering workstation featuring a high-precision stereo microscope mounted on an articulated arm, positioned beside two computer monitors displaying 3D CAD models or imaging of a complex mechanical or biomedical device. The workspace also includes a keyboard, mouse, and a metallic container, all situated on a clean white desk in a dimly lit, modern lab environment.

In a sophisticated world of ever increasing complexity, we need our tools to evolve alongside us and assist in complex decision making, allowing us to understand the consequences of choices ahead. Computational Modelling and Simulation (CM&S) is emerging as an essential tool in building evidence for medical device development.

Three engineers are assembling or troubleshooting a large industrial or medical device prototype in a workshop. One person is seated in a wheelchair, another is standing behind the structure, and a third is kneeling on top of the machine for internal access. The workspace includes tools, laptops, electronic parts, and a large diagram of the device on the wall.

I routinely engage in the development of prototype medical devices. These prototypes typically incorporate at least one printed circuit board (PCB) installed within a plastic or metal enclosure, featuring numerous connections to external components through various connectors.

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.

Sectors We Serve

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From remote diagnostics to powerful imaging systems. We design and develop diagnostics for use inside or outside a traditional healthcare setting.

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Our team creates innovative devices that combine your drug with optimal delivery methods for the most effective treatment.

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From emergency ventilators to enabling home-based therapies, we have supported hundreds of therapy devices that treat patients inside or outside the clinic.

Axolotl BrainPrint Microsphere Generator

Published under: Case Study

Aurora DNA Sample Preparation Device

Published under: Case Study
Aurora DNA Sample Preparation Device uses SCODA™ electrophoretic DNA concentration technology. StarFish Medical Case Study.
Aurora DNA Sample Preparation Device Description - image of Aurora device