Case Study

Laboratory Instrument

The Client

The Client is a UK based medical device company developing a new sensor-based breath analysis system. It develops proprietary ground-breaking sensor technology which can analyse and help to diagnose conditions in the kidney and liver.

The client had already developed a proprietary sensor and required an instrument to interface with the single use sensor. The instrument is for use in both a clinical and home use environment and the requirement was that the device be developed to a level suitable for clinical trial deployment.

Gentian supported its client in the full product development lifecycle in the following areas:

Product requirements specifications
Detailed design specification
Overall system mechanical and electronic architecture
Fluidic pathway specification and design
Mechanical design
Electronic design
Demonstrator level outer housing development
Preclinical prototype build and evaluation

Technical File compilation
Compliance and regulatory testing specification and coordination
Design Verification and Validation
Complete Supply Chain solution
Small scale batch manufacturing
Clinical Trial batch build
CE safety testing and approval

The Result

The results of the project included the development of a complex microfluidic based electronic controlled Medical diagnostic instrument to be used for clinical trial deployment.

Gentian Health utilised its internal design team to bring the product through the design process and then the manufacturing team utilised its internal SMT production line, final assembly and test facility to complete the supply of the system to the customer.

Let our experts guide your project to success

With a diverse client portfolio from early stage start-ups to larger organisations, Gentian Health provide a full production service from clinical trial batch builds to finished, packaged products of the highest quality.

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