Class II Sensor Based Wearable Vital Signs Monitor
The Client
The client is an innovative Medical Device company developing a new wearable device to monitor and analyse respiratory rate in hospital based patients. The device consists of a reusable electronic wearable device coupled with a single use disposable custom designed sensor. This wearable device, developed by Gentian Health, communicated back to the customers cloud based dashboard and app.
Gentian Health partnered with this client from the concept development phase and through to technology development, design validation, clinical trial batch, FDA/ CE submission and launch in manufacturing.
Gentian Health supported this 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
- Custom disposable sensor selection and design
- 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
- Biocompatibility analysis
- Plastics design and tooling commissioning
- Design for Manufacture
- Labelling to medical device standard
- Preclinical prototype build and evaluation
- Technical File compilation to feed into the customer’s overall technical file
- Design Verification and Validation
- Manufacturing commissioning
- Complete Supply Chain solution development
- Injection Mould Tooling commission and Validation
- Launch in Manufacturing
The Results
Gentian Health provided a full turnkey solution from concept through to launch in manufacturing for this complex, wearable medical device. This is a project where the team at Gentian Health used their Electronic and Firmware design capabilities coupled with Human factors design and industrial design skills to develop a comfortable, aesthetically pleasing wearable device.
The electronic design involved a 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 a manufacturing solution for this client.
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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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