Wi Medical Device Development - a TE Connectivity Company


XVIVO Inc. came to Wi seeking a development firm with the skills to conceive, prototype, and produce a system capable of perfusing lungs harvested for transplantation while also providing a work space for doctors to assess and prepare the lung for transplant. Wi sketched the preliminary incarnation of the system during the first meeting and rolled the device off our floor within 18 months.  The development process included integration of a perfusion set and ventilator, system hardware and software development, system enclosure design, fabrication management, assembly.  Wi Inc. also provided XVIVO Inc. with FDA submission support and PMA process support.  The XVIVO Inc. device was a featured device at TEDMED 2010 by Dr. Shaf Keshavjee.

XVIVO Features:

  • Concept to rolling prototype in 18 months
  • Management of strategic OUS (outside of US) for perfusion pumps and ventilators
  • System architecture and layout
  • Clinical research at University of Toronto
  • Regulatory research and support
  • Regulator submission documentation and support
  • System build in-house
  • System compliance testing