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

Technician operating a custom aluminum-framed drop test rig with a white platform and green background wall.

Medical device drop testing helps ensure that products and packaging survive real-world handling. We demonstrate in-house drop testing on an actual device and its packaging using a custom-built drop tester.

Balancing the needs of startup and enterprise medical device partners in CDMO projects.

Medical device startups/founders and enterprise partners have unique strengths and goals, which are often reflected in the way they work with CDMO (Contract Development and Manufacturing Organizations) partners.

Technician using digital calipers to validate component dimensions during medical device testing.

In the highly regulated world of medical device development, ensuring product safety, quality, and compliance is essential. One critical yet often overlooked aspect of this process is test method validation (TMV) in medical device development.

Engineer presenting a 3D CAD model during a design review meeting at StarFish Medical.

A structured, well-documented design review process is a critical component of successful product development, particularly in the medical device industry.

Project manager using digital tablet to update cloud-based Gantt chart for medical device development planning.

In medical device development, we deal with complex projects that span multiple disciplines, timelines, and regulatory gates. It’s a constant balance between moving fast enough to innovate, but slow enough to stay compliant.

Sterilizing medical devices using various FDA-approved methods - Image showing three medical-related items—a pulse oximeter, surgical scissors, and a catheter with a Luer lock—on a light background. A bold label at the top reads ‘How to sterilize?’ with an arrow pointing to the pulse oximeter, indicating a question about sterilization methods for these devices.

Ariana and Mark walk through FDA-approved options and explain how to select the right one for your product. From metals to plastics and electronics, not all devices can handle the same process.

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