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.

Latest Resources

Team reviewing market data and planning a MedTech commercialization strategy around a table.

Every MedTech startup begins with a hypothesis, an idea that could transform patient outcomes, simplify delivery of care, or improve how clinicians diagnose and treat patients.

Close up of a dishwasher spray bar opened to reveal hidden internal gears, highlighted with a red arrow and the text “Hidden Tech.”

When Ariana Wilson and Mark Drlik take apart a common appliance, they uncover engineering principles that connect directly to medtech.

Nick showing a biofilm conference book while Nigel listens, with overlay text reading FDA Asked For It and a red arrow pointing to the book.

When reviewing evidence for a medical device, a single citation can shape an entire submission. In this Bio Break episode, Nick shares a biofilm referencing lesson that has stayed with him since the early 2000s.

Diagram showing medical device at the center connected to clinicians, patients, and regulatory bodies with text 'Who are we designing for?' highlighting stakeholder mapping in MedTech design.

Every phase of a device’s life cycle involves different people with distinct needs—from clinicians and patients to service technicians and regulatory bodies.

A fluorescent protein assay sample glows under UV light as part of medical device cleaning validation testing.

Nick Allan and Nigel Syrotuck explain how a fluorescent protein assay helps engineers measure contamination and cleaning performance in medical devices.

Engineer assembling electronic components during medical device design transfer process.

Your team is ready for design validation. The prototype performs well, test plans are in motion, and everything points to a smooth handoff to manufacturing. Then your partner calls with bad news: they can’t build the device as designed.

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