Class II Neuromuscular Wearable Stimulation Device
The client is an innovative Medical Device company that is developing a new wearable device to aid rehabilitation and fitness levels in demographics unable to exercise.
Gentian Health partnered with this client from the concept development phase, technology development, design validation, clinical trial batch, FDA submission and through to launch in manufacturing
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
- Detailed Analog electronic design
- overall schematic design and PCB layout
- Firmware development involving Bluetooth communications with connectivity to an app and client’s cloud-based dashboard
- Human factors design and Usability
- Detailed Industrial and mechanical design
- Wearable Neoprene garment design and commission in manufacturing
- Biocompatibility testing for both the wearable and electrodes
- Plastics design and tooling commissioning
- Design for Manufacture
- Preclinical prototype build and evaluation
- Technical File compilation and FDA submission
- Design Verification and Validation
- Manufacturing commissioning
- Complete supply chain solution development
- Injection Mould Tooling commission and Validation
- Launch in Manufacturing
Gentian Health provided a full turnkey solution from concept through to launch in manufacturing for a complex wearable device. This is a project where gentian used its Human factors design and industrial design skills to develop a comfortable aesthetically pleasing fabric based wearable device. The electronic design involved complex front end Analog electronic design coupled with Bluetooth communications back to the cloud. The end result was a fully designed wearable which incorporated all electronic, mechanical, wearable, firmware and packaging elements. In addition to the design solution a full turnkey supply chain and manufacturing solution was developed and implemented. Gentian Health provided the solution from Design concept development through to manufacturing solution for the full kit certified to both CE and FDA regulations.
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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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