Sudden Cardiac Arrest and the Avive Story, Lock the Quill Office Hours - EP 14

Three alumni stop by the lab to tell the story of how they took a class assignment at 2am, developed it into their senior capstone project, and ultimately founded a medical device company that, six years later, received Class III Premarket Approval from the FDA. Avive is the youngest team to receive such a PMA and their founders were selected for the 2024 Forbes 30 Under 30.
Their Automated External Defibrillator, the Avive Connect AED, is the first major innovation in the space for decades, and will, no doubt, save lives.
https://avive.life
IG: @avive_solutions
...but we start with Lock the Quill Office Hours.   

 

Podcast specific:
Podcast Instagram: @lockthequill
Comments or questions: lockthequill@mit.edu

The Lab at MIT:
Pappalardo Lab Instagram: @pappalardolab
Comments or questions: pappalardolab@mit.edu
Pappalardo Lab website

Transcript

Danny: Today, we're speaking with three former students and friends of the lab, Rory Beyer, Priscilla Agosto, and Moseley Andrews of Avive, maker of the Avive Connect automated external defibrillator. This concept was born of their senior product engineering capstone class in the fall of 2017. Their team received class three pre-market approval from the FDA last year and has been shipping products since. They are the youngest team to receive a class three PMA and were featured in Forbes 30 Under 30 for 2024. Be mindful of your company there. We'll be talking about the Avive innovation and journey right after our Lock the Quill office hours.

[music[

Oh, you know what? We actually have a caller.

Bill: Let's go to the board.

Danny: Welcome to lock the quill homework help. Who am I speaking with?

Wilhem Hector: My name is Wilhem Hector. I'm a junior in mechanical engineering.

Danny: Oh, Course 2.

Wilhem: Yes, I'm straight two actually. I'm taking my measurement and instrumentation class. I want to do something related to the wind energy industry. I recently built this, it is like a mini turbine. It's not really a turbine.

Danny: You have a propeller.

Wilhem: I have a propeller, actually, because I was recently corrected. This is not a turbine, it is a propeller.

Danny: It is a propeller.

Wilhem: Yes, it is not oriented the right way.

Danny: Why don't we start there. If you want to do something in wind energy why don't you get the propeller going in the right direction?

Wilhem: [laughs] The professor who actually told me that this was not a turbine is one of the most famous course 16 professor. He told me, the first line was like, "Stop calling this a turbine, it's a propeller." I would love to potentially redesign this so that it is an actual turbine.

Danny: What's your question?

Wilhem: First of all is advice on like how to potentially design a setup that can allow me to measure the thrust on this.

Danny: Bill, what are you feeling? You have a background in wind power.

Bill: Maybe hot air.

[laughter]

Danny: Look, you just took your little propeller thing. I call it a whirly gig.

Wilhem: Whirly what?

Danny: Whirly gigs.

Wilhem: Whirly gigs.

Danny: Yes.

Wilhem: I need to Google this.

Danny: No. Don't Google it. Electrical power is probably going to be a better measurement than measuring the thrust.

Wilhem: It might. It might.

Danny: I would punt on the thrust.

Wilhem: That's a very good point. I think.

Danny: Wait, wait, back up. That was what? I didn't hear that.

Wilhem: That was a very good point.

Danny: Oh, okay.

Wilhem: My instructor today told me that I should also measure power. She said that like the thrust thing might actually not work.

Danny: You got some soul searching to do, my friend.

Andy: Hector, how many blade designs do you plan to test?

Wilhem: This whole blade geometry thing, I've never done any of this. The course is already 30 hours a week.

Danny: Oh, my gosh, you're 3D printing them.

Wilhem: No, as in like, I need to write that thesis. I need to explain the theory behind the airfoil.

Danny: Oh my God. You're at MIT. You're bellyaching over that? You got to do a little write-up on propellers.

Wilhem: Propeller design, you mean turbine design?

Danny: Turbine design. Yes, that's right. Yes. Whirly gig design. It's actually whirly gig, is the technical term.

Wilhem: You need to spell that. I don't know how to spell this. Whirly.

Danny: Don't worry about it. Even if you get it close.

Wilhem: Whirly gig. All right.

Danny: Is that right, Andy?

Andy: It's good for an extra half point on the grade.

Wilhem: Yes. Yes.

Andy What is this? Whirly gig.

Wilhem: Thank you. Is this Andy talking?

Andy: Yes.

Wilhem: Nice to meet you, Andy.

Bill: Hector, this is Andy. Could you tell us about your interactions with Bill during 2.007?

Wilhem: Bill is like, he's a genius.

Bill: Go on, go on.

Wilhem: In short terms, he's like a cheat code.

Andy: I'm getting static in my earphones. Can you hear anything, Danny? I can't hear a thing.

Danny: I don't know about that.

Wilhem: He's amazing. I have a very good relationship with the Pappalardo people.

Danny: I think you have enough information to get started and we will talk to you later.

Wilhem: Oh, okay. All right. I'm out. Thank you. Bye-bye.

Danny: Hello, Chuck. You're on the air with Lock the Quill. How can we help you?

Chuck: All right. I'm trying to put together my thesis committee for my PhD. I'm debating between a professor who can help me get my PhD done at a reasonable time versus a professor who can give me the most thorough feedback on my thesis project. Unfortunately, those two sometimes does not align. If ideally will find a professor that aligns for both. Any tip on how to balance between the two?

Danny: Do you have a vision for what you want to do post thesis defense?

Chuck: Ah, yes. I would like to work in industry part time.

Danny: Okay. You just answered your own question.

Andy: All right. You just need to get the PhD fast.

Chuck: It's one vote for speed. Anybody else want to chime in?

Danny: That's Andy's advice and I'm concurring.

Andy: Should I wake up, Bill?

Chuck: Yes, I want to hear.

Bill: Being familiar with Chuck, I think whichever path you take, you're going to be successful for sure.

Danny: Wow, that was really nice, Bill.

Chuck: Academia is nice, but there's like something missing for academia that I wish to get. I think industry is a good place to get it.

Danny: Yes. You're talking about money.

Andy: Yes, money.

Danny: The other thing, Chuck, don't think of this as an either/or. If someone is keen to graduate you, that doesn't mean that they're not going to give you sound advice.

Chuck: That's true, too. I don't know why I think that there are two things I can't get at once, because I could get it at once.

Danny: Scott always says it's not the destination, it's the journey.

Chuck: Oh, I'm having a good time here.

Danny: All right. Do you have two particular individuals in mind?

Chuck: I do.

Danny: Do you have any more clarity or thought on who you may reach out to join your committee?

Chuck: Yes. I think I'm going to send an email this week.

Danny: Did we play a part of that?

Chuck: You did.

Danny: Holy cow. Wait. 

Andy: Now we own that.

Chuck: I'm going to take action. I'm going to do it now or else I'm going to keep questioning myself and I'm going to lose the motivation to take action, so I'm going to do it.

Danny: Okay. Before you do anything that's attributable to anything that we said here, I think you should think long and hard. You know what, Chuck? Do what you think feels right. That's it. You're going to do an awesome work. You do awesome work.

Chuck: All right. Thank you, guys. I'm glad I joined the call.

Danny: All right, Chuck. Thanks for calling and good luck with your committee. Please call back and let us know how it goes. Yes, of course.

Chuck: I'll talk to you guys later.

Andy: Bye.

Bill: Bye, Chuck.

Chuck: Bye.

Bill: How'd you like to go through life like Chuck? She's just so smooth and happy all the time and helpful and engaging and curious and pretty fantastic. Definitely pretty fantastic.

[music]

Danny: Why are you guys here today?

[laughter]

Rory: Aside from just wanting to come say hi, we are here because we are deploying the first 100 of what is going to be over 300 AEDs to every building, every dorm, every fraternity and sorority, many mobile instances as well all across MIT's campus. We are swapping out the current devices that are currently here. We are adding over 150 devices, I think, to the fleet that exists in the campus, and there's going to be one in every single building on campus. If you're on campus and see a defibrillator, that is the device.

Danny: That is your device.

Rory: Yes.

Danny: That is awesome.

Rory: We've shipped many devices to many great people, but this one, it comes full circle and is just so exciting and amazing, and we are very proud of this one.

Danny: You should be. We're excited for you. Before we talk about Avive's story, can you just tell us about Avive, your mission, and your products?

Rory: The whole focus, the whole mission, the whole premise of Avive is improving survival rates from cardiac arrest. That's where we focus. That's where we build products for, and that's what we do. Today, there's about 400,000 cardiac arrests every year in the United States. There's about a 10% survival rate. Of those 400,000, 360,000 of them will pass away, unfortunately, today. Every minute that you are in a cardiac arrest and you don't get treatment from a defibrillator, which is a life-saving shock to restart the heart into a normal rhythm, your chance of survival goes down 7% to 10%.

If you wait 10 minutes, 12 minutes for an ambulance to show up, your chance of survival is exceedingly low. The name of the game here is when there is a cardiac arrest, which can happen anywhere, anytime, to any person, how do you get that life-saving therapy, an AED, to that person as quickly as you can so they have the best chance of survival? We make a whole ecosystem of software products and hardware products, the centerpiece of which is the Avive Connect AED. It's an internet-connected device that is super miniaturized compared to what you would see today.

It can be anywhere and can get places quicker. It has a whole arsenal of software products that help us maintain these devices, help them network how we get these devices brought to those patients who are having a cardiac arrest and how we transfer the incident data after the device is used to a hospital or to the ambulance who might be responding to that patient. Everything that we do is centered around responding to and improving the survival rates of cardiac arrests.

Danny: You alluded to connectivity or the internet, and I think about the AEDs that we see currently that are not connected.

Rory: One of the biggest value adds that we have is the internet connectivity. The device has Wi-Fi, it has cellular, it has location capabilities, it has Bluetooth, it has all the things. We use that for three big areas. One of those is the automation of maintenance. Today, typically to maintain these devices, make sure they're good to go and ready to use, somebody has to go physically inspect each device that you might own. On MIT's campus, that ends up being a huge project. If you're a gym chain that has multiple locations, trying to maintain these things becomes very cumbersome.

With us, you have a device that checks in at least daily, and it shows you the location and the status of your product. You can get notified if there's anything that needs your attention, so low battery or a pad that's expired, or a self-test that failed, whatever it might be. It tells you real time instead of having to wait until the next person goes around to inspect the device.

A second aspect is how we get these devices to a patient. We have a program and a functionality we call the nearby emergency function, where if you call 911 in participating communities, the 911 dispatcher can now press a button that makes any of our AEDs that are nearby that cardiac arrest literally light up and show you a map of here's where you are. There's a patient across the street from you at your neighbor, for example, that's having a cardiac arrest, can you bring this device to go help save their life. That's how we get the device there, as opposed to you waiting for the ambulance, because typically you're not going to know where the nearest AED is. The person who does know doesn't know you have a cardiac arrest, it's happening one block away from them.

The third is the incident data. As soon as the device is used, and even during its use, we transfer information about the cardiac arrests and about the usage of the device. You have the device itself, which is very portable. You have the ability to maintain it in a better way. You have the ability to get it to that patient faster. You have the ability to transfer incident data. That's where the internet connectivity really comes into play.

Danny: You can use this device as a standalone device, not necessarily network to anything. Is that true?

Rory: You can, yes. To use the product in an emergency to actually treat somebody in cardiac arrest, you don't need any of that connectivity. To use the device when somebody is having an actual cardiac arrest, you really just take it, you turn it on, you place two electrode pads that go on the patient's chest and on their side. The device analyzes the heart rhythm of the patient and will only deliver a shock to patients who have a shockable rhythm, who are in a cardiac arrest. If I put it on you right now, you are alive and well, it will say shock not advised and it literally won't shock you, right?

Danny: Maybe it should.

[laughs]

Rory: Yes, it'll analyze that heart rhythm, deliver that shock, and then instruct you in two minutes of CPR, at which point it will analyze again, shock again if needed, and it will continue that cycle for as long as it's connected to a patient. None of that's dependent on internet.

Danny: This idea too of dispatch service, hitting a button and then notifying the others. Is this a program that people opt into? How do you build up that connectivity?

Rory: Yes, it is. We have this program that we call the Four Minute City Program. The most classic way that this happens is that a city or community or a nonprofit in a community or a hospital system in a community will purchase a large number of these devices and strategically deploy them around the city. They might say this city needs 500 devices to be able to get any device to any patient within four minutes. That's where the four minute city premise comes from.

You deploy them to people's homes, you put them in buildings, you put them in restaurants, you put them on sports fields, you put them in police vehicles, in delivery vehicles, really to get this density. Such that whenever there's a cardiac arrest anywhere in that community, you're able to get a device there quickly. It's actually the first instance ever where 911 is alerting a device. Not even just for defibrillators, just ever. It's a completely novel and new program, which we're very excited about and we believe is going to be a very important step in trying to improve survival rates on a mass scale. We're very excited. We're very bullish on the Four Minute City Program.

Danny: If you were to ask me where the nearest AED is, I would have no idea.

Moseley: I think there's one down the hall, but I'm not sure. Probably right up the stairs by the infinite. We just put it in today.

Rory: You put it in.

[laughs]

Priscilla: Pretty soon you'll have one right in the lab, right over there in that wall.

Danny: Once we have one in the lab, if our lab thing starts flashing, I could say, hey, someone in the student center needs help. That's a big idea. That's awesome.

Rory: It is, right?

Danny: We first met Rory Moseley and Priscilla as second year mechanical engineering students in 2.007, the robot competition, later for the Pappalardo Apprenticeship, undergraduate thesis work, and the class that led to Avive, 2.009. I've talked about 2009 in previous episodes, and I encourage you to listen to a conversation with Rebecca Thorndike-Breeze, where we talk quite a lot about the course. It is the senior capstone class, the brainchild of Professor Wallace. Student teams seek out multiple product opportunities and vet their concepts for the first half of the semester. Through prototyping, research, and user studies, each team winnows their concepts to a single idea that they work on for the remainder of the semester. Occasionally, a student team will continue the project beyond the class, believing in its market potential. This is what happened in the fall of 2016.

Okay, so let's back up in time and talk about the origins. What originally motivated this concept?

Moseley: Oh, maybe we go back to, I think, Rory's fraternity bedroom late one night. Were in 009 in the first semester. I think we were already like six weeks into the course. We were brainstorming. We were riffing on like this emergency response theme at the time in pink team. Anyway, late, I think it was 2:00 AM or something in Rory's room, I was like, "Oh, I have this cool one. It's like a cell phone powered AED." Rory's like, "Ah, that's the stupidest thing I've ever heard of."

[laughter]

I was just like, "I'm tired. I'm going to go to bed." I put it in the pile and presented it and then we ended up choosing it in the pink team as one of the things to try doing.

Rory: I think specifically it was like, we had to come to our 2.009 session, that week with 20 new ideas, each person, right?

Moseley: Yes, I remember.

Rory: We're on idea 18 and we're trying to get number 19 and 20. That's what we're riffing on at this point at 2:00 AM. Yes. That's what came out of Moseley's mouth and that's what he put in.

Moseley: I think I have a little picture of the cell phone, the cord going to like a person with a shock symbol.

Danny: You ran with a cell phone thing for a while. The whole semester.

Moseley: Yes.

Rory: We did.

Danny: The whole semester.

Rory: Yes. The whole semester in 2.009 was based on the cell phone. The device didn't even have a battery inside of it. The premise was that you were going to draw this power from a phone and use the phone for the interface and things of that nature. That is not what we do today. we've moved on from it post 2.009.

Danny: Yes, let's make that clear.

Rory: To be clear. Today you do not need a cell phone, right? It has its own battery and it works autonomously, but yes, that was the original idea.

Moseley: It helped to like just challenge the assumptions around what the product should be like generally anyways.

Rory: It also inspired a different-- Typically many existing defibrillators, their batteries are the size of, or even bigger in some cases than our entire device. The idea of having a, I'll call it a cell phone-esque battery, right? Something much smaller, much different than this huge one and how that's architected, came from the cell phone idea. It helped us miniaturize the product in the end, even though we now have a battery inside of it.

Danny: The three of you were on the team at the time.

Rory: We all were. Yes.

Danny: All right. Priscilla, were you on part of this task force? Were you on Qband or Stretchcatch?

Priscilla: Oh my God. I think I was part of Qband at some point. obviously that idea did not-- it wasn't mine [crosstalk]

Andy: Oh, you're throwing someone else under the bus.

[laughter]

Rory: I don't think I think that was stone and John Matthews, not to call them out.

Priscilla: Yes, I think it was. Hey, I worked hard on that one. I thought it was a good idea at the time.

Danny: Your heart was in it.

Priscilla: Yes. Always in it. Regardless of what I was doing, I think.

Danny: Stretchcatch was some sort of active suspension system for stretchers and wheelchairs and Qband was a wrist worn notification device when a piece of gym equipment became available. No more waiting for squats. Luckily for us, these concepts hit the cutting room floor and the team pressed on with Moseley's cell phone powered AED. All right, I'm going to-- let's just play something here.

Priscilla: Oh, God, our presentation?

Danny: Crowd goes wild.

Narrator: Every year, roughly 300,000 people die from sudden cardiac arrest. The only immediate treatment is the use of CPR coupled with an automated external defibrillator or AED, which delivers a high voltage shock to try and return the heart rhythm to normal. With every passing minute waiting for an AED, the victim's chances of survival drops by 10%. Our product can provide immediate support, Revive, a portable cell phone powered AED. Revive is unique because it takes the battery computation and speaker and use the phone for that instead of the physical device.

Danny: Okay, I'm going to pause and just let her listen. Just know that the three of you are smiling and giggling.

Priscilla: I feel like this sounds like our pitch today.

Danny: This is vintage 009. This is the Avive origin story.

Rory: It is. Revive can go places that other AEDs can't, like in the glove box of your car, on a family hike, or on the sports field.

Moseley: I think Rory still uses that line.

Narrator: We'll now demonstrate Revive in an emergency situation. A softball player has currently gone into sudden cardiac arrest.

Coach: Anne, Anne, are you Okay?

Moseley: That's Rory.

Coach: She's not responding.

Anne: What should I do, coach?

Coach: There's an AED in my backpack. Please get it.

Danny: This is character acting at its finest.

Steph: Revive is on. Stay calm and follow instructions. Tell a friend to call 911.

Coach: Erica, can you please call 911?

Erica: Okay.

Steph: Pull loop on dark gray cap. Remove pad.

Danny: You still have voice instructions in the current device?

Rory: We do.

Steph: Expose patient's face.

Danny: Different narrator?

Priscilla: Yes.

Rory: Yes, this was Steph. She was in our group. We now have a--

Danny: No kidding.

Rory: Yes.

Steph: -peel lining from pad.

Rory: Her voice has not stayed, unfortunately. 

Narrator: AEDs will deliver a shock if, and only if, they detect an irregular heartbeat. While Revive was charging, it had already determined that Anne had ventricular tachycardia. One of the many treatable--

Danny: Okay, so it goes on from there, but it's striking to me, other than the major architectural change that you made. Yes. You were right on.

Priscilla: The pitch sounds very similar. Obviously, there's a lot of differences with, the actual product and using the cell phone, but--

Rory: Yes, it is spot on.

Priscilla: Yes.

Danny: Let's listen to how this ends.

Rory: We owe a huge thank you to our instructors, mentors, and the rest of the 2.009 staff, who has worked tirelessly to support us throughout the entire time.

Danny: It's awesome.

Rory: We are Pink Team, and this is Revive.

Danny: Yes.

[applause]

Danny: Listen, the crowd is going wild.

Priscilla: We closed the night.

Danny: You had a very successful 2.009 experience.

Rory: Yes.

Danny: I remember kicking you out of the lab late at night. I was like, you guys, enough, go home. The last week.

Rory: Yes, we were in retrospect, a bit shocked that you guys let us work on such a high voltage thing. I think some folks were not as happy as others, but what an amazing opportunity.

Priscilla: I'm pretty sure you extended your hours to allow us to work longer. We really appreciate that.

Danny: I don't think we left. We are operating at 15,000 volts and bloodshot eyes. It's time to go home. Okay, so how about after 2.009, I'm interested in hearing how you actually launched the company. At what point did you say as a group, I think we're on to something here?

Rory: The real origin behind that was that in January over IAP, we got invited by a group that we had done a user study with, not even a user study, just a user interview kind off--

Moseley: Pick their brain.

Rory: Pick their brain about what a defibrillator should be. It was a group that saw our final presentation.

Danny: Oh, wonderful.

Rory: It was like, wow, they really came up with something here. They invited us to speak at this conference. It's a cardiac arrest focused conference. I showed up and obviously knew nobody there. I brought the prototype out there. I had the first day of the conference go by. Then during my presentation, it was very well attended. When I did a demo, this conference room of 500 plus people just stands up in crowds. They mob the stage to just get a better look at this device. I was just sort of blown away by that. I was like, it's just a prototype.

Danny: I did this in the lab, guys.

Rory: Just the level of enthusiasm that stemmed from that. I was everybody's best friend after that. I had a lot of people coming up and wanting to learn more. Are you guys continuing with this project? It really just opened our eyes to, I think we've got something here. If we've got legislators, medical professionals, parents who have lost children to cardiac arrest, the full gamut who are really excited about something new, that really showed us that there is something worth pursuing here.

Moseley: That's when we realized like, "Oh, this is the first innovation these people have seen-

Rory: In quite some time.

Moseley: -in years."

Rory: We took that momentum and enthusiasm. We continued working on the project in the spring semester as sort of an independent study in electrical engineering, in mechanical engineering.

Priscilla: Was it just made up?

Moseley: I think we made one up. I don't know.

Priscilla: I think we made one up.

Danny: You made up a class?

Priscilla: Sort of.

Rory: It was like an independent study thing.

Priscilla: It was official.

Rory: We got credit for it.

Danny: That was the units beyond the GIRs.

Moseley: Exactly.

Danny: Good for you.

Rory: Frankly, that's how we convinced some folks to continue working on it in the spring.

Danny: That's spring semester.

Rory: That's spring semester. At the conference, we met an individual who ended up being our third co-founder, actually, who's not from MIT. Similar age to us, graduating in 2017. He had one of the largest non-profits in the country for placing AEDs in locations that can't afford them, and doing heart screenings for youth to test for warning signs of cardiac arrest, things of that nature. We kept talking about it as a group. Some folks from the original 2.009 group were, "Hey, wish you the best, but no interest. I got a job next year. I have my life going."

Danny: Too bad for them.

Rory: Most of them were in that camp, I would say. Some were, hey, this is interesting, maybe considered it, but a little bit too risky, a little too unknown. It ended up being myself, Moseley, and this other individual, Samir.

Moseley: Priscilla was down.

Priscilla: I was down in the future. I was like, when you need a mechanical engineer, just hit me up. I will come back.

Rory: Yes, we decided, to incorporate the company. After graduation, we took a little time off in the summer, and then we got started. We raised a little money to start some angel fundraising rounds. We actually had a lot of success from folks who were in this industry, folks who had lost a child or knew somebody who had had a cardiac arrest emergency medicine folks, or cardiologists. Folks who really saw cardiac arrest and knew the problems with it today and the pretty poor survival rates that exist today and were motivated to make a difference in that. That was where a lot of our initial angel funding came from.

Danny: Were any of those people linked to that first conference?

Rory: They were, yes. There were a few folks from that initial conference. There were other folks that those people introduced us to, and sort of the web grows organically from that. I think the first check in the company was somebody at that conference.

Danny: This is 2018 or 17 at this point?

Rory: It's like fall of 2017 is when we really, we got our first office and going into that office.

Danny: Okay, so paint the picture. how many employees? What's your biggest challenge? Are you still dealing with cell phones and PVC tubes? What's this thing look like?

Rory: Yes, pretty much. Three of us, Samir, Moseley, and myself in a room that is smaller than your office here.

Danny: Which is a big office, though.

Moseley: With a view.

Priscilla: All relative.

Rory: Yes, so really crammed in there. I think our elbows are touching when we're sitting on the lab space. there's one desk that's a electronics bench. We may have borrowed some oscilloscopes and probes and such from the lab here that we may still have borrowed.

Danny: It's on loan.

Rory: Yes, it's on loan. We had a 3D printer that was a pretty cheap one.

Moseley: Hey, durable little guy.

Priscilla: They're still there.

Moseley: It's still going.

Rory: It's still going. It was like $250.

Priscilla: It was great.

Rory: It was off Amazon and it was--

Danny: Top shelf.

Moseley: We got like five more of them. You can just pump them out. It's great.

Priscilla: I run them all the time. All day, every day.

Danny: For prototyping.

Priscilla: For prototyping, yes.

Rory: Really small space. Really, at that time, we were still going with the cell phone idea. Early on, we got an advisor in the company who was the former branch chief at the FDA overseeing the division that we submit to, that oversees defibrillators and pacing and cardiac EP devices.

Danny: How did you make that connection?

Rory: It's really funny because it just comes from those organic-- the web, right? From some of those initial folks we met at that first conference, we're introduced to some high profile cardiologists and electrophysiologists.

Danny: As you're telling the story, that almost seems to me like a moment of, we've got an experienced adult in the room.

Rory: Yes.

Danny: Is that a fair assessment?

Rory: Yes. I think one thing that I would credit ourselves for is that from an early stage, we knew that we were getting into a highly regulated space. We know nothing about medical devices. We know something about engineering. We got several folks involved in the company from the business side, from financing side, from regulatory, from clinical areas that were in those positions, that had been veterans, had started many companies before or had been regulatory professionals for a very long time. We really sought out those advisors. We really were proactive in trying to get them because we thought that was going to really take us to the next level of being able to make good strategic decisions early on that hopefully would benefit us. I think it has. Yes, that is very much an adult in the room moment.

[music]

The cell phone powered idea, at least as a first product, was going to be exceedingly difficult to convince the FDA is a good idea. You're dealing with any number of phones from different manufacturers, different software versions, how you're going to validate that it works because that's the only power source you're going to be able to use. That's a very tough hurdle. I would say within the first six months to a year.

Moseley: It was like January we decided, "Okay, we're going to switch gears here."

Rory: Yes. Fairly early on. decided we've got to retain a lot of the advantages that we came up with this innovative idea, but we've got to find a way to do it not depending on a cell phone. That's what set us on that track of the product direction we're on today.

Danny: When you say do it, at that point, you didn't have the vision of the connectivity. It was do it, I need something that's portable and consumers can use? What was the definition?

Moseley: It was the same time there was the shift from-- Like we wanted to pull all the benefits from when the phone is connected. We had realized there's a lot of benefits to the connectivity early on, but the downside was it's only when the phone's there and connected to the unit. We in one transition, took all the connectivity, the battery, the stuff we liked about the phone, and pulled it into the product. I think we also realized more in those first few months, the whole maintenance side of things, which wasn't really as much of a focus during 009 or MIT days. We realized, gosh, this is a terrible system and pain point that I have in place now. That was another thing, "Oh, great, we can use the connectivity for this and address a lot of those issues." Then the new product was born.

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Danny: Rory, Moseley, and Samir got their regulatory and quality system ducks in a row, made the fundamental architectural change to the product that set their course for the next five years, and started building out their engineering team. Priscilla, you were not involved in the original group.

Priscilla: No. Not at the beginning of developing Avive.

Danny: Tell us how you reconnected with this team.

Priscilla: I just got this random call from this man that I used to know called Moseley one day. I was like, "Why is Moseley calling me?"

Moseley: I guess we haven't really kept in touch since, have we?

Priscilla: No, I don't think at all. Overall I'm not the best at keeping in touch.

Moseley: I did just call you, didn't I? I forgot about that.

Priscilla: You just called me out of nowhere, and I was like, oh my God, is it time?

Danny: Is it time?

Priscilla: Then Moseley was like, "It's time." I was like, okay, well, this is it. I'm moving across country.

Danny: Really?

Priscilla: Yes.

Moseley: Quit her job.

Priscilla: Quit my job.

Moseley: We later found out she also left her boyfriend at the time.

Priscilla: I quit everything. Move across country.

Danny: At this point, were you still three people in a crowded room with a borrowed oscilloscope?

Moseley: I think we were maybe at five, six.

Rory: I think I came after another funding round, and we were trying to build out the engineering team more, and we said, we know just the person.

Moseley: I am curious, though, this first time I've asked, what were your first impressions?

Priscilla: When you called me?

Moseley: When you started? Day one in the Avive office.

Priscilla: Oh, when I started. It was crazy. Dude, there were some days where we were working until 5:00 AM. We had the usability study-

Moseley: We had the usability study, that was rough.

Priscilla: -the first month that I started.

Moseley: First week, couple all-nighters.

Priscilla: All right, this might be too long of a story. I moved and I had three days to get my whole apartment set up. I moved right next to a Target. I got all my furniture in like three days, set it all up. It was raining the whole time. Never rains in California.

Danny: Must have felt at home.

Priscilla: I started working, and then I was just in the office from morning until like-- I don't even know. When did we leave? 10:00 PM. or something?

Moseley: One time I had traffic going home in the morning.

Priscilla: Oh, yes, that sounds about right. It was a crazy first month and it reminded me of MIT, the end of 2.009, sort of. Where we were trying to get everything together for the final presentation. It was like reliving that. Same people, same hours. It was great. I loved it.

Danny: How long did you operate as this eight person skunkworks burning the midnight oil? Has that changed?

Priscilla: Changed a lot. I think it took about a year to start--. It was a very slow adding one person here, one person there.

Moseley: At that time we were still hiring once we felt the burn and the need for it, rather than looking ahead and saying, we should start hiring this person now.

Rory: Because we know there's going to be a problem in three months.

Moseley: We've gotten better about that.

Priscilla: I think we were in that office for a year, right? In the Van Ness office. It was what? 15 people at the end of that, and then we moved to Potrero. We were there for another two years, At the end of that, we had what? 35 or something people. Then now, we have, 80.

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Danny: You also survived the whole pandemic.

Rory: We did.

Danny: How did that affect your operations?

Rory: It was definitely an adjustment. We liked to joke at the time, it's hard enough to, start a class three medical device company out of college, and now we have a pandemic to deal with. I remember we had animal studies that we had to conduct remotely, because we couldn't be in person at the end of the study.

Moseley: The usability study.

Rory: And a usability study.

Moseley: There'd be like 75-person, in-person, random users coming in the heart of Santa Clara, worst flare-up, it was--

Priscilla: After every single user--

Moseley: We had to convince DoorDash delivery drivers, like, "Hey, you want to make $100? Come on in and do the study." Because we couldn't find people.

Danny: You had the delivery guys doing in your usability study?

Priscilla: Yes, I think we got a couple of them.

Rory: Because you're looking for people who have never heard of a defibrillator, and who have never used an AED, obviously, and in most cases, are also not aware of CPR, and don't even know what a cardiac arrest is. It's a screening question we ask, is do you know what a cardiac arrest is? Do you know what an AED is? Do what CPR is? The answer has to be no to those questions. You would get these-- it's a hard screening, in the sense that you have to have the demographic variety, the age variety, the lack of knowledge of the problem. We would have people cancel, because it was the height of COVID in Santa Clara, which was a particularly locked down area. There was some creative tactics, like asking the DoorDash delivery driver.

Moseley: It worked out, we got creative.

Rory: I think that it was definitely an adjustment, and running a lot of those studies, especially as we were gearing up towards our FDA submission, was just that much harder to do. It was definitely challenging.

Priscilla: I had to move, a bunch of the mechanical engineering equipment to my 400 square foot apartment. It was so cramped. It was just like--

Moseley: You had like a heat sealer in there?

Priscilla: I had a heat sealer, I had some 3D printers in there. It was just 400 square feet, and then 150 of those were machines.

Moseley: Yes, we would review the molded parts out on your little porch.

Priscilla: Yes. I remember that.

Danny: It's scrappy.

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Can you take me through the whole, I don't want to say the whole PMA thing, because we don't want to go through all of that. I think it's unusual that a team, so, I would say inexperienced, but certainly capable, went through that. That is not an easy process.

Rory: It is not. I think, frankly, if we had known what goes into a PMA when we started, I think we would have thought twice harder about starting at all, because it is an animal. I think an animal that we have come to love, there's a lot that goes into it. Our submission was 12,000 pages of documentation.

Moseley: I think you're short. I think it was 30,000 pages.

Rory: Something in the--

Priscilla: Tens of thousands.

Moseley: Tens of thousands.

Rory: We had several pre-submissions with the FDA before we even submitted to align on how we were going to do things.

Danny: How were they to work with?

Rory: The FDA's actually been very good to work with, from our experience. There's a funny story where, when we were in 2.009, we sent an email to the main clinical point of contact at the FDA for the defibrillation unit. It was basically this email of, "Hey, we got this new device we're thinking about building, do you have any recommendations for what we should be doing? Do we have to test it in a certain way?" Et cetera.

He wrote back a very nice response, and had some links in there and things of that nature. I remember we walked into our first pre-submission meeting. We flew out to DC. It was sort of like a, hey, here we are, we exist, this is what we're doing, this is our general plan. He was there, and he remembered. He came straight up and he says, "Hey, I remember you guys sent me an email when you were students at MIT, and you basically asked me, how do I build a defibrillator?" I like to think that we've had a very good relationship, and it's built up from that. They've been very helpful in the pre-submission process in helping guide us, and they're there to be helpful, which is great.

We have not had the experience of, you're sitting across a table and there's folded arms. There are some horror stories out there that people have, but that hasn't been ours, which is lucky.

Danny: The importance of the relationship, I think, can't be under-emphasized. There are people on the other side of the table who are trying to make this thing happen.

Rory: I think that's the thing that so many people maybe overlook or don't appreciate enough. Is that, the people that you're working with in a regulatory body, they're having to make a decision about, is this device safe enough to be used in the public? It's a huge decision to have, all this risk that's in these devices, and it has to go to the public, and it's going to be used everywhere. They have to be sure, and they should be sure. I think just empathizing with their position is an important thing that many don't choose to do.

Danny: From the time you had that first meeting with, your email buddy to actually getting the approval, what duration was that?

Rory: From the initial meeting, it's a little tough because we had a few pre-submissions, but our submission was basically 500-and-something days. 550-ish days from the day we submitted to the day we got our formal approval, which sounds very long.

Danny: I was going to say, that's a year and a half. That's not long at all.

Rory: Exactly, right? It sounds long, a year and a half, you're sitting there waiting, but for a class 3 PMA, it's actually quite fast. For a defibrillator in specific, it's very fast. We were actually very pleased and it was very exciting how quickly we got through that process. I think in part because we really set out to work with the FDA on it, as opposed to just doing it independently.

Moseley: I think the other part of it ties into when you're going through the submission review process also, there's times where there's misunderstanding or miscommunication going either way. If you weren't smart and conscientious in a human relations standpoint, it could have gone on for years in the submission process. I think being able to better understand each other, talk it out, communicate, like Rory was saying, is what really helped us understand each other and then move on.

Priscilla: We responded quickly to everything if they had any feedback. It was immediately like, okay, we need to respond to them now.

Moseley: We locked Rory in a room for two weeks. He wasn't allowed to leave.

Priscilla: This is all you can work on now.

Rory: We would get some questions back and it was truly a drop everything, nothing else matters. Anything that we need to do to respond to this is what we are doing as an entire organization. It doesn't matter who you are.

Priscilla: Yes, they have a clock that freezes as soon as they respond to us. We were like, we need to get that timer to restart.

Rory: There's this metric where they have a certain number of review days that their goal would be to review within. As soon as they ask a question, that clock freezes because now they're waiting for us. The longer we take, it's not--

Priscilla: Moving the clock.

Rory: It's not moving the clock down. You've got to respond really quickly.

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Danny: Okay, I'm just pulling up an older email. Yes, here we go. November 4th, 2022. Hi, Professor Wallace, Rob, Danny, Georgia. You may or may not remember me, but my name is Rory Beyer and I was in the 2016-2017 edition of 2.009. We kept going with the project following the course, founded a company, and have been working at it since we graduated in summer of 2017. Well, earlier this week, we received our full FDA approval. The device has changed a bit from what we had in 2009 as can be expected, but it's still an AED and we believe more than ever that it's going to change the industry.

The approval makes us the first new company in this market since 2003 and makes our founding team the youngest to ever receive a PMA from the FDA. It's pretty crazy to think back to 2009 and now be in a position just months away from saving our first lives with this product. I hope that the semester is going well and I hope this news brightens your days just a little. All the best, Rory Beyer.

Rory, we never forgot you and the team and this news most certainly brightened our day. Reflecting on where you are now and how you started, 

I'm just wondering, are there any points in time that you view as, Oh, this was particularly challenging?

Rory: In the initial days, it was the decision to change from the cell phone powered device to the device we have now. That process was a very challenging one, I think. The preparation of the final submission, this little blemish, is that going to get us tripped up or is that not a big deal? At the end of the submission process, just wrapping up the last questions and making sure that we're responding to them quickly, I think was a challenging time.

Shipping our first device, it better be ironclad because we are not putting a device into the world that could have any possibility of an issue. We just can't do that. We even had this mantra of testing for literal months of just making sure that every single edge case that we could try to identify, we did. That the product was going to work the way we want it to work in the world.

Priscilla: Ramping up production?

Rory: Ramping up production. Even today, we are trying to catch up on a significant backlog. You could say it's a good problem to have and it is in the sense that it's better than not having any devices to sell, of course.

Danny: You still got to deliver though.

Rory: Yes, but you still got to deliver. The number one reason we lose a deal today is because we can't ship it tomorrow. We do have a backlog that we're trying to catch up on. Ramping manufacturing has tons of its own challenges.

Danny: This is the next phase for--

Rory: It's a huge phase for us. That is today's big push, is getting the manufacturing scaled and dialed and growing it and improving the processes and making efficiency improvements.

Danny: I am so happy for you guys. As we wrap up, I'd like to play for our listeners the audio to your product release video. It's such an effective and succinct portrayal of the Avive value proposition. I recommend listeners visit the Avive website, avive.life, to see the video and learn more about your company. Here, let's listen.

911 Operator: 911, what is your emergency?

Man: It's my wife. I've been shaking her, but she's not moving. I don't think she's breathing.

911 Operator: Okay. Is she awake?

Man: She's not responding. What do I do?

911 Operator: Okay. My partner is dispatching an ambulance to you and I'm going to work on getting an AED to your location. I'm going to give you some instructions for CPR, okay?

Man: Okay.

Automated voice: Cardiac arrest nearby. Take this AED. Cardiac arrest nearby. Take this AED. Cardiac arrest nearby. Take this AED.

911 Operator: Okay. I've located an AED. I have one nearby. It's on its way to you.

Man: Please hurry.

911 Operator: Okay. Looks like the AED is getting close. Can you go to your front door and meet them?

Man: Okay.

Automated voice: Powered on. Stand back. Delivering shock in three, two, one.

Danny: Incredible.

Rory: Yes.

Danny: Incredible.

Rory: It remains one of the most gratifying things about working on this. Is that you are working with a situation that is often the worst situation that a bystander, certainly the person having the cardiac arrest, is going to have in their life. You hear about somebody who has had a save, or where their kid had a cardiac arrest, or their wife, or their spouse, or their father, or their mother. There's nothing more meaningful to work on than that.

Danny: Thanks, guys, for coming out. Congratulations on everything you've accomplished. It really is exceptional. everyone here wishes you continued success. I've got to say that it's an extraordinary privilege to be able to say that you were our students.

Rory: Thank you.

Moseley: Thank you.

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Danny: I want to thank Rory, Priscilla and Moseley of Avive. Congratulations and good luck. Your work will save countless lives. To all our followers, thank you for listening. If you'd like to participate in our office hours, watch our Instagram for occasional Zoom details. Just join the meeting to speak with our expert team for P-SET research or fabrication help, or life advice. Next time, we're connecting with a former MIT colleague who is now at the University of Georgia in Athens. Laura McKee recently published a collection of poetry and well, MIT mechanical engineering and poetry. You've got to love it. Have a happy and healthy 2024 everybody.

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[00:48:32] [END OF AUDIO]