FDA grants emergency use authorization to Coventor
Before COVID-19, the idea of moving a device from concept through to FDA authorization and manufacturing within a month would have seemed unfathomable. But in the face of a global pandemic, we are challenged to use our skills and resources in new ways—iterating quickly and collaborating with a wide range of partners to bring the Coventor, an emergency resuscitator (ventilator alternative) to market in record time.
Since the onset of COVID-19, ventilators, which are used in clinical settings to help patients breathe, have been in short supply. Recently, a cross-functional BSC team has been working with the University of Minnesota Medical School and Earl E. Bakken Medical Devices Center and several other industry collaborators to bring the Coventor—a simple, cost-effective emergency resuscitator—to life.
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization jointly to Boston Scientific and the University of Minnesota to manufacture and distribute the Coventor as an emergency alternative to traditional ventilators, which are much more complex and costly to produce.
Randy Schiestl, vice president, Research and Development at Boston Scientific, describes the Coventor as “a one-armed robot that can pump an Ambu® bag—replacing the need for a person to stand beside a patient and provide manual resuscitation.” Designed to stabilize and compress a commercially available ambulatory ventilation bag, the compact Coventor mechanically drives air through a tube into an intubated patient’s lungs, typically supplemented with pressurized oxygen.
With input from other collaborators, the Boston Scientific team worked to bring the Coventor from a concept developed at the University through the entire product development process in less than a month.
“This was an opportunity to leverage our strengths—agile product development and an ability to quickly scale up manufacturing—to bring forward a truly meaningful innovation in a time of crisis,” said Brad Sorenson, senior vice president, Manufacturing and Supply Chain at Boston Scientific. “We are grateful to the university team and all of the collaborators involved, as well as to the FDA, for the collective effort required to make this happen.”
With FDA authorization, Boston Scientific is moving forward to manufacture an initial run of approximately 3,000 Coventors to be deployed by UnitedHealth Group, with plans to scale up production based on demand. In the coming weeks, the final Coventor design files will be made available through an open-source license agreement with the University of Minnesota, so that other manufacturers around the world can help address this critical need.