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Medical device design
& development

Empowering MedTech innovation to create breakthrough products
that improve health and save lives

Our Services

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Product Design & Development

Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.

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New Product Introduction

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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Quality Assurance and Regulatory Affairs

We help you navigate complex regulatory landscapes to achieve commercial success. Explore our integrated approach to quality and regulatory services.

Working with StarFish

We help MedTech innovators across North America overcome challenging technology obstacles to create breakthrough products that improve health and save lives.

See how we can help you
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Meet ELLA

Introducing ELLA, an AI-powered tool designed to transform how medical device companies navigate regulatory compliance.

Learn more about ELLA
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Latest Resources

See all Resources
Two men sit at a table discussing glucose monitors, with the text "How Glucose Monitors Really Work" overlaid on the image. One man gestures while speaking, and both have coffee mugs labeled with their names. The background features a whiteboard with blurred writing.

Bio Break: Understanding Continuous Glucose Monitors

Continuous glucose monitors (CGMs) are revolutionizing how people track blood sugar levels in real time. But how do they work, and where exactly do they measure glucose? Nick and Joris explore the science behind CGMs, explaining the difference between blood glucose monitoring and interstitial fluid measurement.

Common Mistakes for Medical Device Projects A businessman wearing a blue suit and an orange tie is pointing at a transparent virtual interface with hexagonal icons. The central hexagon displays the words "REGULATORY COMPLIANCE." Surrounding it are four smaller hexagons with white icons, including a scale inside a gear (symbolizing legal and ethical standards), a stack of binders (representing documentation), a checklist (indicating compliance requirements), and a person next to a legal symbol (denoting regulatory oversight). The background is blurred with a brick wall visible.

Common Mistakes for Medical Device Projects

Common mistakes in medical device projects can create roadblocks that, if left unchecked, can snowball into costly setbacks.

Two men sit at a table discussing the science behind freeze-drying. One of them holds a jar of freeze-dried coffee, illustrating the topic. The text overlay reads "The Science Behind Freeze Drying" in bold letters. A whiteboard with diagrams is visible in the background, reinforcing the technical discussion.

Bio Break: The Science of Freeze-Drying

Nick and Joris dive into the fascinating world of freeze-drying, exploring how this process extends shelf life and maintains the integrity of various products—including reagents used in in vitro diagnostics and even instant coffee!

Two men, Nick and Joris, are seated at a table, engaged in a discussion. Both are wearing checkered shirts and have coffee mugs with their names on them. The background features a whiteboard with faint blue writing. The text overlay reads "Imaging for Targeted Drug Delivery" in bold, purple and black letters. The setting resembles a laboratory or office environment.

Bio Break: Real-Time Imaging for Targeted Drug Delivery

In this episode of Bio Break, Nick and Joris discuss the fascinating world of real-time imaging for targeted drug delivery. When delivering drugs to precise locations in the body, how do we ensure they reach the right spot? The answer lies in medical imaging technologies such as MRI, CT, and ultrasound, which play a crucial role in guiding complex drug delivery devices.

packaging plant line and signal.

Clarifying ASTM D4169 Options – It’s all in the details

ASTM D4169 is a standard test method for performance testing of shipping containers and packaging systems. It evaluates the ability of shipping units to withstand the expected distribution environment. FDA recognizes it as a consensus standard as part of sterility testing that is commonly applied to all sorts of medical devices.

Biggest Medical Device Success Factors

What are the most important medical device success factors during development and manufacturing? StarFish employees from QA/RA, NPI, Optics, Computational Analysis, Project Management and Manufacturing answer that question with the factors they deem most important for their area of expertise.

Sectors We Serve

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Diagnostics

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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Drug Delivery

Our team creates innovative devices that combine your drug with optimal delivery methods for the most effective treatment.

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Therapy Devices

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 Published on: January 4, 2023
See case-study Details

Aurora DNA Sample Preparation Device

Published under: Case Study Published on: January 6, 2011
Fast, simple, specific biomolecule extraction
See case-study Details

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