Medical device design & development
Empowering MedTech innovation to create breakthrough products
that improve health and save lives
Our Services
Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.
Medical device design and development with a commercial launch focus. See how we support clinical trials and facilitate seamless tech transfers.
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.
Meet ELLA
Introducing ELLA, an AI-powered tool designed to transform how medical device companies navigate regulatory compliance.
Latest Resources
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.
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.
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.
Getting a PCB (Printed Circuit Board) for a medical device right the first time is almost impossible. Datasheets can be misleading, or assumptions and architectures change. As a result, modifications are almost inevitable. Sometimes the modification is as simple as swapping resistors or adding capacitors. Other times it involves tacking on new circuits you had no idea you needed.
This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.
Nick and Joris explore the fascinating world of repurposing existing medical device technologies for new market sectors. As engineers and innovators, we often focus on creating brand-new solutions, but what about leveraging tried-and-true technologies to expand into untapped markets? This strategy not only opens doors to new revenue streams but also maximizes the potential of existing innovations.
Sectors We Serve
From remote diagnostics to powerful imaging systems. We design and develop diagnostics for use inside or outside a traditional healthcare setting.
Our team creates innovative devices that combine your drug with optimal delivery methods for the most effective treatment.
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
Aurora DNA Sample Preparation Device
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