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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.

Latest Resources

Transparent medical device prototype surrounded by computational simulation mesh representing modeling and simulation during medical device development.

Many teams still underuse CM&S, often bringing it late in device validation, when key decisions have already been made. That approach leaves much of the value of CM&S untapped.

Biomedical engineer reviewing a thermal simulation of human head tissue on a monitor, color-mapped from warm to cool gradients

This article traces the Pennes bioheat equation from its 1948 origins to modern multiscale approaches, explaining how engineers select the right level of modelling complexity across device categories.

perfect. provide me with seo friendly alt text fort his image10:56 AMClaude responded: Technical team reviewing project estimation breakdown on whiteboard during engineering planning session (101 characters ✓)Technical team reviewing project estimation breakdown on whiteboard during engineering planning session

Five methods for building accurate project estimates, from gut feel to bottom-up, plus three add-ons that sharpen any estimate.

StarFish Medical engineer reviewing FEA simulation and CAD model for medical device development

Designers and engineers today have no shortage of tools to improve designs, accelerate timelines, and meet cost targets. The challenge is knowing what to use and when.

Nick and Nigel discussing the hidden costs of sterile medical device production including shipping in a Bio Break episode, with text overlay reading 30% Hidden Costs

Nick and Nigel breaks down what actually goes into the cost of getting a sterilized device into a user’s hands, and why up to 30% of costs can sit in places most teams don’t plan for.

Gloved hands handling a pharmaceutical vial through a shielded enclosure, illustrating the manual theranostics delivery workflow discussed in a Bio Break episode

Theranostics combines diagnosis and therapy into a single targeting system, using one ligand to attach to two different radioactive payloads, one for imaging and one for treatment. It represents a significant shift in how cancer is being identified and treated. But the theranostics delivery workflow tells a different story.

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