From concept to proof-of-concept to finished product in 6 months for a device which harvests patient skin for treatment of aesthetic and medical disorders.
Sunrise Labs Solution
- Systems analysis, conceptual designs, proof of concept, architecture
- Electronics, Electro-mechanical, and Electro-thermal design, implementation and verification
- Controlled build of 15 units at Sunrise to support clinical studies
- Designed for 6061-1 compliance, CPLD coding using IEC 62304 design process
- Simple operation with play/pause buttons and timer
- Designed for 60601-1 compliance, CPLD coding using IEC 62304 design process
- Use of ni-chrome wire heater for slim profile
- Combined vacuum and low-wire-count electrical cable between tabletop control box and harvester
- Accurate PID control; control safety with redundant sensors and override switches, vacuum-heater interlock to insure correct harvester placement
- LED illumination of harvester site for monitoring
- Simple operation with play/pause buttons and count down timer
Clinical study units were delivered to clinical sites on schedule. The device incorporated accurate control of skin temperature and applied vacuum to generate microblisters while protecting patient from heating elements in a slim package. The technology was acquired by KCI in 2013.