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Q&A with Amy Kavalewitz and Danny Blacker of Rice University

by Sean Ruck, Contributing Editor | June 19, 2020
From the May 2020 issue of HealthCare Business News magazine


HCB News: It sounds like YouTube algorithms put the project in front of people who really needed to see it?
AK: Yes, or Google. I think it really sparked when we got some inquiries from the Navy and Department of Defense. They ran across the project and reached out. There was some mechanism to possibly get funding to continue working on the project. We were initially being requested to turn over the plans for the original project, but we realized it was in a state where we didn’t feel comfortable with it being out there. That was, in part, because with the DoD and Navy, they wanted it to be out there as a DIY project, so we wanted to get it redesigned to do it safely.

HCB News: How many students were involved in the first iteration of it and how many people are involved today to bring it up to medical grade?
AK: Initially there were six students. They were seniors studying in bioengineering and mechanical engineering. When we decided to redesign it, there were limitations about who could be on campus, so we initially were going to do it staff and faculty, but were given permission to have a whiz-kid computational engineering student to come and help us with the coding. So in total, we have six to seven people on the team.

Members of the Rice University team developing the ApolloBVM bag valve mask automation device, from left: Rice staffer Fernando Cruz, project director Amy Kavalewitz, project engineer Danny Blacker, associate teaching professor Matthew Wettergreen, and senior Thomas Herring.
(Credit: Jeff Fitlow/Rice University)
HCB News: Are the initial six students aware of what their senior project has become?
AK: They are aware. I think they know their project has changed quite a bit, with the current design having little in common with the original. But we definitely got the inspiration from the students and wanted to give them credit for their work that helped us to move forward.

HCB News: By offering the plans for free online, does that help avoid having to get FDA approval?
AK: That’s a tricky question and we’re trying to navigate it now. It seems like the FDA has come out with an overarching guideline or policy that says things can be made under the emergency usage authorizations. But we’ve been unable to move quickly to get this tested on patients because of the concerns, because no one has really navigated this before.

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