"We worked with Sunrise Labs over the course of a year to design an electronic (with software), class II medical device.

Bottom line, they delivered on commitments. I was very impressed with the Sunrise team's technical skills, level of design experience, their unwavering commitment to respond to our needs, and the project leader's wisdom and leadership skills.

Together, we produced a product that sailed through FDA review and delivered 100% functionality in clinical studies."

Mike Barsness,
Senior Director of Engineering,
Transport Pharmaceuticals, Inc.


CLIA Waived Desktop blood analyzer

Objective

Create the electronics and software to control the microfluidic disposable cassette and analyze optical sensor data to perform complex laboratory-quality assays in minutes with untrained operators. Architecture, electronics, and software completed in six months to meet business objectives.

Sunrise Labs Services CLIA Waived Class II medical device

  • Managed all electronics and software development of the CLIA Waived Class II medical device


  • Created an architecture that could serve as a valuable research tool as well as a product for clinical use


  • Provided the Industrial Design team with quick turn-around of high-fidelity implementations of all-important usability tested user interface


  • Worked with Claros to Develop effective control and analysis algorithms with efficient implementation


  • Supported product through internal and contract manufacturing as well as FDA and CE-Mark processes


Results

  • Met Claros business and technical objectives


  • Developed a unique user-friendly Point of Care and blood analyzer


  • Created a flexible development platform enabling future menu expansion for a family of diagnostic products


  • CE Mark expected in 2010.  FDA clearance and CLIA waiver expected in 2011

(return to Diagnostic Portfolio)

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