Console Instrument For Powering And Controlling A Single Use Endoscopic Device
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.
The Client had a requirement to develop a console which would be used in conjunction with its single use endoscopic device. The Console is the medical instrument transported on a cart which the disposable surgical instrument plugs into during the surgical procedure.
Gentian Health supported its client across 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
- Complete Supply Chain solution
- Injection Mold Tooling commission and Validation
- Clinical Trial batch build
- Full Turnkey Manufacturing solution
- CE and FDA testing and approval
The result of the project was the development of a high-end Medical Device instrument which comfortably fits in with other equipment in an operating theatre environment.
The combination of the Gentian Health team and the client’s team enabled the client to develop a number of concepts, evaluate each one and then proceed to a final selected design for CE and FDA approval as well as launch in manufacturing with Gentian Health.
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 and Final assembly and test facility to complete the supply of the system to the customer.
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