The involvement of several different types of organizations and/or institutions is necessary in order to move this invention forward from the laboratory bench to the bedside of critically-ill patients.
Addressing this situation has been in a state of dynamic development over the last several years. Moreover, it is not unusual for a start-up company to find itself in this circumstance.
In general, there are two categories of participation that need to be involved.
First, there are the those institutions that can assist in addressing the basic science components of illumination, diffusion, and circulation.
Second, there are organizations that are able to support the clinical implementation of the invention. This includes research centers that are capable of conducting the animal studies which are needed to satisfy the FDA regulatory requirements. This is to then be followed by the medical facilities where the invention is introduced into actual medical practice whereby its clinical effectiveness is established and validated.
Needless to say, this represents a complex environment that is challenging for early-stage medical device companies to navigate.
Updates to this page will occur as various progress is made.