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

Artificial intelligence ECG waveform with neural network overlay illustrating AI arrhythmia detection model

Electrocardiography (ECG) remains the gold standard for non-invasive cardiac assessment, providing a vital window into the heart’s electrical health. By recording electrical impulses through surface electrodes, clinicians can identify life-critical conditions such as arrhythmias, myocardial infarctions, and conduction abnormalities.

Fingertip pulse oximeter measuring SpO2 and heart rate using optical detection in a wearable medical device.

Wearable medical and wellness devices are increasingly commonplace in the healthcare field. For example, devices such as smartwatches incorporate sensors to provide continuous health tracking data to their users.

Medical device bioburden thumbnail showing gloved hand holding a device with arrow pointing to a petri dish illustrating bacteria before sterilization validation

Nick and Nigel explore how much bacteria can exist on devices and why it matters. They explain that bacteria are everywhere.

Sterile assurance level concept showing gloved hands opening a sterile medical device pouch with “Truly sterile?” text overlay

Nick and Nigel walk through how sterile disposables are processed and verified before they reach the field.

FDA agentic AI reviewer concept with robotic hand reviewing medical device submission documents

The FDA agentic AI is making headlines after the agency announced its own internal AI review tool. In this episode of MedDevice by Design, Ariana and Mark discuss what this could mean for medical device submissions and regulatory efficiency.

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