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

Indirect ELISA explained with antibody model showing enzyme linked immunoassay detection

Nick and Nigel walk through how indirect ELISA works, why it uses two antibodies instead of one, and when this approach makes the most sense in real diagnostic workflows.

Smartwatch displaying heart rate and ECG-style waveform, illustrating the difference between wellness devices and medical devices in digital health regulation

Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.

Nick from StarFish Medical demonstrating antigen detection using a toy antibody model to explain how monoclonal antibodies bind antigens in ELISA diagnostics

Nick and Nigel break down the ELISA assay explained in simple, practical terms using everyday models.

Magnifying glass revealing cracks with the text “This gets missed,” illustrating hidden risks in medical device validation and real-world use.

Ariana Wilson sits down with Mark Drlik to unpack why reprocessing is often one of the hardest challenges engineers face during development.

Thumbnail showing the text “ETO or Radiation?” with a cloud icon representing ethylene oxide sterilization and a radiating burst icon representing radiation sterilization for medical devices.

Nick and Nigel walk through how teams decide between ethylene oxide, E-beam, and gamma radiation sterilization.

Medical device pilot manufacturing workspace showing engineers supporting NPI and scalable production

In MedTech, success rarely comes from invention alone. Plenty of promising technologies make it through verification and early clinical work, only to stall when the team tries to turn them into something buildable.

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