The Need
Our customer, a leading medical device design house wanted to develop a Hysteroscope device that comes under the Type II Medical device category. They were expecting full ownership and support for the entire life cycle of the product from requirement, design, development, field trials, industrial and regulatory certifications & approvals, and production management for mass production.
Impacts Delivered
- The devices has successfully undergone required compliance and certifications and received the required FDA approval
- Specified video streaming Latency of maximum of 150 milliseconds achieved.
- Full engineering ownership of the product life cycle for a Class-II type medical devices from requirement spec to mass production.
Our Solution
- We received the product concept from the customer
- Gadgeon took the ownership of the Product life Cycle phases:
- Requirement specification phase
- System design
- Prototyping and verification
- Pilot production
- Mass production
- After market support
- Requirement gathering from the concept at the system and product level.
- The Hysteroscope device development consists of Hardware, Firmware, and Mobile apps required for video streaming.
- The Hardware consists of a compact PCB with a low-end low-power Microprocessor interfacing with a camera module and a Wi-Fi module.
- The Embedded Linux BSP is customized for the custom hardware, camera drivers are developed, and other peripheral drivers are integrated.
- The device then streams the image to the Mobile apps over the Wi-Fi interface
- Proto units are produced for field trials.
- Multiple product design challenges were resolved like:
- Ensuring the video streaming Latency to a maximum of 150 milliseconds and 30 FPS,
- Only one device is connected at a time to ensure maximum security.
- FDA Certification completed and the units are being moved for mass production.
- After Sales and Life cycle support with new feature enhancements as well as on field issue resolution.
- End-user training and support for mobile and cloud applications.
Tools & Technologies
- Gstreamer open-source framework
- Paho MQTT Library, Retrofit Library, Room DB
- AES 128 Encryption
- Microprocessor based PCB which communicates with a disposable camera module .
- A tablet app to stream the video over Wi-Fi-Direct (WPA2).
Product Life cycle Phases
