CelluTome Epidermal Harvesting
FOR MOMELAN technologies
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Services
Electronics
Systems Analysis
Systems Architecture
Design Verification
CPLD Coding
Manufacturing Clinical Trial Units
IMPACT
Conducted successful clinical trial
Company acquired by KCI
Accelerating Time to Clinical Trial
Sunrise Labs was asked to design an electronics system architecture for a device that harvests patient skin to treat aesthetic and medical disorders. The design minimized scarring at the donor site. The client was able to go from a concept to a proof-of-concept to a finished product in 6 months with a controlled build of 15 units at Sunrise for use in a clinical study.
Custom Engineering Solutions
Sunrise performed systems analysis, electronics, electro-mechanical and electro-thermal design, implementation and verification. Multiple custom solutions were implemented, including the use of ni-chrome heating wire by the harvester, an high infra-red transmissible lens, a PID controller with redundant sensors and override switches, and a vacuum-heart interlock to ensure correct harvester placement.
The product was designed for 60601-1 compliance, with CPLD coding using IEC 62304 design process. A Field-Programmable Gate Array (FPGA) was chosen to limit the amount of software development needed.
Clinical study units were verified and delivered to the clinical sites on schedule. The company was acquired by KCI in 2013.
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