Case Study

Class II Endoscopic Surgical Device

connected health - medical device design

The Client

The client is an innovative Medical Device company that is developing a new product from concept through to full commercialisation. The client specialises in developing proprietary ground-breaking technology and devices that incorporate optical technology with complex electronic and mechanical systems to deliver a range of Class II endoscopic surgical devices.

Gentian Health partnered with its client from concept development phase, preclinical prototype development, design validation, clinical trial batch and on to launch in clean room manufacturing and sterilization.

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
Electronic design
Firmware development
Human factors and usability design
Detailed Industrial and mechanical design
Design for Manufacture
Preclinical prototype build and evaluation
Technical File compilation
Compliance and regulatory testing specification and coordination

Design Verification and Validation
Manufacturing commissioning
Labelling to medical device standard
Complete supply chain solution development and implementation
Injection mould tooling commission and validation
Sterilization validation batch builds
Clean room assembly and packaging
Clinical Trial batch build
Full turnkey manufacturing solution

The Result

This is a project where Gentian Health brought its skillset and established infrastructure to complement its clients innovative Engineering team which were focused on meeting an unmet clinical need. The combination of the teams enabled the client to bring its product from early concept stage through to launch in manufacturing and ready to scale. Medium scale manufacturing is now in place for this product and has been configured to adapt as the scale up requirements change.

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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