[00:00:00] Speaker A: Hi, everyone. This is Tom Salemi of Device Talks. Welcome back to the Device Talks weekly podcast. Yes, yes, yes. It's another great episode of the podcast coming your way. First, Chris Newmarker will be visiting with his armful of newsmakers. We couldn't keep count of how many there were. Pretty sure there were five. But they're all great stories in Medtech and I know you'll enjoy that conversation. After that, I will share the interview I did with Cecilia Soriano. She is president of Baxter, excuse me, Global president of, of Baxter's Infusion Therapy and Technologies business. And Cecilia will be at Device Talks Boston, where we'll talk about how Baxter came back from the damage, the terrible damage brought on by Hurricane Helene. So looking forward to hearing that story. And I think there's going to be a video that will sort of help start the conversation and tell the tale. So make sure you join us at Device Talks Boston and you can
[email protected] the registration numbers are off the charts. Very excited to have a full house there at the Boston Convention Exhibition Center. Make sure you join us and use the code DTWeekly25. It's code I created especially for you loyal podcast listeners, so you can save yourself 25%. So go to boston.devicedocs.com to register. Look forward to seeing you there after we hear from Cecilia. I am very pleased to bring a conversation that I had with Andrew Cleland. He's the CEO of, of the Fogarty Institute, which is obviously a great medtech innovator, incubator and entity out by Santa Clara, actually by the by where we do Device Talks West. I've known Andrew for, I guess, closing on 20 years. We met when he was the CEO of Artyon and he's one of my favorite medtech people. And you'll see why. He's just a great person to talk to. Great insights, great humility, and he's doing a lot of great work. And that's a lot of greats, but they are all great. He's doing a lot of fantastic work. How's that to help entrepreneurs get their medtech stories off the ground. So our spirits are aligned in that. And I was happy to talk with Andrew about his experiences at Artyon and 12, what has him concerned about Medtech. And he also offers some advice during our interview, which I will encourage you to just completely ignore because it goes against what I do for a living.
I will offer it to you anyway because Andrew's a great resource for startups. So this is, again, a fantastic episode. I'm really proud of all this, all the great thoughts that are coming your way and I know you'll enjoy this conversation. Before I let you go, though. Coming up next week on April 1st is our device Talks Tuesdays, sponsored by Millar. And the topic is mastering chronic disease management. The role of implantable pressure sensors in medtech. And sensor conversations are always great. Millar is always great. They're a regular contributor to Device Talks Tuesdays and I hope you'll join us there. Go to devicetalks.com, go to devicetalks.com to register. I gotta slow myself down. Go to devicetalks dot com to register. You can register and watch it live when you'll get your questions answered right away, or you can watch on demand when it's convenient for you. And you can still ask questions, but you'll have to wait a bit. But Millar will get back to you. So I hope you'll be part of Device Talks Tuesdays. This Tuesday, April 1st, the live presentation is at 4:00pm Eastern. All right, folks, without any further delay, let's get this podcast started.
All right, you ready for this?
[00:03:45] Speaker B: Ready.
[00:04:05] Speaker A: Chris Newmarker, how are you, sir?
[00:04:08] Speaker B: Good, good, Tom. Good to be here, man.
[00:04:11] Speaker A: Are you sure you couldn't even get that out? Holy moly.
[00:04:17] Speaker B: So you just managed to ask, ask that to me, like right when I was sipping a coffee. So it's like choking. Chris is gone. That's it.
[00:04:25] Speaker A: Answer the question. Newmarker, how are you?
[00:04:28] Speaker B: That's a wrap on choked on his cock.
[00:04:32] Speaker A: Death by podcast.
[00:04:33] Speaker B: Death by podcast.
[00:04:36] Speaker A: So I was watching. I just put those on LinkedIn. I was watching the TV show the Pit yesterday. Have you watched the Pit? No.
[00:04:43] Speaker B: That sounds exciting. Something called the Pit that says. What's that about?
[00:04:45] Speaker A: It's very good. It's an ER type show with Noah Wiley from formerly Every ar, but now he's the Anthony Edwards role. He's a senior guy. It's a very good show. But this is episode 13, I think, and I won't give away too many spoilers, but they were waiting for an onslaught of patients and one guy whipped out a ultrasound system from Butterfly Networks.
[00:05:09] Speaker B: Oh, my gosh.
[00:05:09] Speaker A: Portable ultrasound device. It works with a cell phone and they use it several times throughout the episode and saved any logic.
[00:05:16] Speaker B: And they showed the logo or they said what it was.
[00:05:18] Speaker A: They didn't say the logo.
They did say butterfly. I think that's a good question.
But yeah, yeah, it was. They called it the butterfly.
[00:05:28] Speaker B: Was it a product placement Does.
[00:05:30] Speaker A: I don't know. I don't know. Maybe the folks from Butterfly will listen and then we'll have them on the podcast.
[00:05:35] Speaker B: I'd be interested. I mean, I mean, which makes.
[00:05:38] Speaker A: If they didn't pay for it, good for them because they got. I mean, obviously no one's gonna run out. Like, I watched the Pit last night, so I just went on Amazon and ordered a $3,000 portable ultrasound. But. But it's.
[00:05:52] Speaker B: They're wheeling somebody to an er. Yeah. They're like, do you have a Butterfly Network ultrasound? I saw it on the Pit. Why don't you guys have it? Like, I know they should have it.
[00:06:02] Speaker A: On billboards now, but it was cool to see Medtech portrayed in a cool lightsaber role. So, yeah, finally we get our time.
[00:06:11] Speaker B: Yeah. And it's a lot better than like some like, legal drama where it's like the device, you know, like the COVID up was like, whoa, come on.
[00:06:22] Speaker A: We watched Monty Python's the Meaning of Life a couple of weeks ago.
[00:06:25] Speaker B: Oh, that's always good.
[00:06:26] Speaker A: The OR scene where I need the machine that goes ping.
And then there was another segment where the woman was wheeled in to deliver and she's like, just so you know, we have brought the most expensive piece of equipment to use on you. You should be very thrilled.
[00:06:42] Speaker B: You should be very thrilled.
[00:06:44] Speaker A: So Medtech was not necessarily portrayed well back then, but that was also the 80s before it became terribly cool as it is now.
[00:06:53] Speaker B: It's just such a joy writing about innovative med tech. But at the same time, I think if I was at a health provider, I would worry if they were like, you're going to be the first person we've use this on. Like, that would be a little like, oh, you know, could you grab a. Dude, check it out on a few other people first. I don't know. Like that sounds.
[00:07:13] Speaker A: Yeah. Well, what was interesting, I mean, this was the setting was that they were expecting so many patients that they weren't going to be able to run normal tests. So this was a perfect placement for Butterfly. So good for Butterfly. So I know we both have short days, so let's roll into the newsmakers.
[00:07:30] Speaker B: Christian Walker.
[00:07:31] Speaker A: What is number five on this vaunted award winning, Nobel prize winning nominee?
[00:07:36] Speaker C: Wow.
[00:07:37] Speaker B: Nobel Prize. Yes.
[00:07:38] Speaker A: Yeah, you should get one.
[00:07:40] Speaker B: Thank you, Pulitzers. I'm really working for world peace, man. I really am.
[00:07:44] Speaker A: We could use that.
[00:07:45] Speaker B: Yeah, seriously. Amen, man.
[00:07:48] Speaker A: We'll talk about that on signal later on.
[00:07:49] Speaker B: Yes.
[00:07:52] Speaker A: Go, go.
[00:07:54] Speaker B: We have Alcon. Yeah, let's just. Alcon agrees to They've agreed to acquire Lensar. And one of the really things that stuck out to me and to our read this got some good attention on mass device from the story from Sean Hooley was that Lensar has its ally robotic cataract system. So this was, I mean, it's just amazing what robotics is being used on these days around medtech. So I mean, it's just like, there we go. All right, we got an acquisition with a robotic angle in the eye care space. So very cool.
[00:08:36] Speaker A: And we'll have our device talk Surgical Robotics digital series the week of April 8th. And we'll have Lupin Dental. Dental or Lupine Robotics.
[00:08:45] Speaker B: Dental Robotics, yeah.
[00:08:47] Speaker A: So we're definitely using that week to explore some different applications for surgical robotics. Moving away from we'll have one larger or system, SS Innovations, which is the company based in India. Yeah, DaVinci like system that they're being really pushing toward or at least not pushing toward. They're able to perform cardiac surgery and did a lot of work. Surgery.
[00:09:12] Speaker B: So it's Friday. It's Friday. Sean's on vacation. I've been cranking out stories on mass Device. This morning I had SS Innovations news like they got regulatory approvals in Philippines and Ukraine and they also unveiled this cool, you know, bus thing with, with their surgical robotic system inside. That's like a mobile telesurgery unit to roll around India. That was pretty cool.
[00:09:37] Speaker A: I visited Moon Surgical's little van that they had at SRS last year. I got to use the device, use the Maestro. It was very cool.
[00:09:44] Speaker B: That's very cool.
[00:09:45] Speaker A: All right.
[00:09:45] Speaker C: Yeah, well, cool.
[00:09:46] Speaker A: Number five, Surgical Robotics. Go. All right. What's number four?
[00:09:49] Speaker B: Number four, we got, you know, this week we got, you know, U.S. senate confirmation of Dr. Martin Macri as the new commissioner of the FDA. So I mean, you know, Mac well known, he's, you know, well, well known TV personality, you know, especially, you know, you know, seen on, on Fox News. And you know, but he's, he's, you know, I liked it like this was from a senior editor, Danielle Kirsch. You know, the story about the Senate confirmation. But, you know, she was, you know, pointing out his history at a Johns Hopkins where, you know, he's a, you know, surgical, you know, oncologist and gastrointestinal laparoscopic surgeon. And you know, he, you know, he, he pioneered some procedures over there. So, you know, he's someone who's, you know, really interested in medtech innovation. So that'll be, I mean, even as, you know, fda, you know, grapples with everything going on around the government right now. You know, this will be interesting to see what, you know, Macri does with medtech innovation at fda.
[00:10:56] Speaker A: Yeah, no, I mean, we'll certainly see.
I'm one of these people who never know these stuff. TV person, well known TV personalities. Like, I hadn't really heard much about him before this, so I need to do a little research. But this news was sandwiched with some more, more news regarding the FDA.
[00:11:15] Speaker B: Yeah.
[00:11:16] Speaker A: And RFK Jr. The HHS secretary. What was, what was the news there?
[00:11:22] Speaker B: Yeah, I mean, he had a announcement on X that, you know, the, you know, the cuts, you know, layoffs. The federal government are coming to hhs, including the fda. So, you know, the, the plans he announced on X were layoffs of 10,000 full time employees, 3,500 FDA employees. So, you know, those will be coming down over there. And though, you know, HHS did say that, that the FDA inspectors and drug and medical device and food reviewers would not be affected by the cuts. But we'll. Yeah, we'll see what the effects of these are.
[00:12:07] Speaker A: Okay, so new leader at the FDA, but cuts planned at HHS, including FDA.
[00:12:14] Speaker C: Yeah.
[00:12:15] Speaker A: Scott Whitaker of AdvaMed is quoted in both stories, or at least his statements are included in both stories.
Giving an optimistic tone.
Thankee said, where are we about Dr. Macri? He said, as a renowned surgeon and health policy expert, Dr. Macary understands the importance of improving patient access to transformative medtech. So very general statements. I think he had one in your story about HHS as well. So Med's involved in making the case.
[00:12:51] Speaker B: Yep. In the HHS story, which came from managing editor Jim Hamran. You know, like Whitaker was, you know, saying that his understanding was that FDA experts whose entire mission is to improve and not stand in the way of patient access to innovative medtech will not be affected. So he was kind of.
[00:13:08] Speaker A: That was in an email, Jim apparently emailed with Scott Whitaker. So that was directly from Scott Whitaker.
So we'll see.
[00:13:14] Speaker C: Yeah.
[00:13:15] Speaker A: Buckle up, folks. All right, buckle up.
What's number three on the list?
[00:13:19] Speaker B: A lot going on in the news right now, Tom. A lot going on in the news. You know, number, you know, two on the list. We've got, you know, Abbott is number three.
[00:13:28] Speaker C: Oh, gosh.
[00:13:29] Speaker A: That was a combo, right? That was an FDA combo meal.
[00:13:33] Speaker B: Sure. Yeah, let's do an FDA combo meal. That sounds good. So sounds like fda. I don't know. That doesn't sound like something I won, actually.
[00:13:49] Speaker A: Good point.
[00:13:49] Speaker B: Right.
[00:13:50] Speaker A: Let's just throw the numbers away. What's next on the new market?
[00:13:53] Speaker B: Is this ham sandwich safe? Like.
[00:13:55] Speaker A: Like.
[00:13:55] Speaker B: Well, let me look at it really quick for you. Oh, God.
Wow.
Well, we got.
[00:14:09] Speaker A: Whatever the next number is.
[00:14:11] Speaker B: Whatever we got here. We got Abbott making an IVL play. They've received an FDA IDA for their IVL system. And so the studies are gonna be getting up on the way. I mean, they're enrolling up to 335 subjects at 47 US sites. So this will be helping them step up to compete more against Shockwave Medical, which is part of JJ and others. So that's very exciting. And there was other Abbott news this week as well, that they had a CE mark for their volt pulse field ablation system, so they're stepping up into that space as well.
[00:14:53] Speaker A: That's excellent. Yeah. We'll have an IVL intravascular lithotripsy panel at Device Talks, Minnesota. I'm expecting we'll have folks from Shockwave, folks from Fastwave, and folks from AVS there at least on a panel. And definitely I'll reach out to Abbott and see if they want to be part. But. And also, I think having some conversation about their new PFA system will be great. It's just interesting how all these big strategics are lining up around ivl, around pfa, around renal deriner innovation. So there's definitely some competition.
[00:15:34] Speaker B: Yeah. I mean, those are. You just listed pretty much the three really hot cardiology treatment techs right now.
[00:15:42] Speaker A: Yeah. I mean, that's Boston Tsai had a renal renovation with the acquisition of Sonavy, adding that, of course, to Medtronic and Recore. There wasn't a fourth. Right. Boston side was the third one.
[00:15:58] Speaker B: But three is a good number. Yep. So, like, a lot of. Just a lot of exciting stuff going on. I mean, and I just got to think innovation, like, really competition can just really fuel innovation. So, I mean, it's great to see this all going on. So.
[00:16:15] Speaker A: And I think you're right. That was number two, because I'm looking now at my browser here, and I had an extra.
[00:16:20] Speaker B: James, There you go. Yes.
[00:16:22] Speaker A: Story up there.
[00:16:23] Speaker B: Alcon's number five.
That's all right.
[00:16:29] Speaker A: Sorry, everybody. Let's do this over. Let's start over. All right.
[00:16:32] Speaker B: Say no. Yeah, let's not do that.
Alcon number five. Macri number three. RFK junior number.
Sorry. Alcon number five.
MacRI number four. RK junior number three. Abbott, number two. Number one. We've got.
[00:16:49] Speaker A: This is brought to you by Sesame street, where learning how to count down from five.
Sorry.
[00:16:59] Speaker B: Number One Elmo says Big Bird is sad now. J and J Metech launches. It's. They've launched. They launched their electrosurgical generator Dualto in the United States. I mean, and this is like the big innovation with. This is the saying, you know, JJ was saying this combines multiple energy modalities into just like one integrated platform that you can use across open, minimally invasive surgery.
And, you know, any even more interesting. I mean, the company plans to use this in the future with its, like, highly anticipated ATAVA surgical robot, which is like its play to compete against, you know, intuitive DaVinci systems. So this is really big news, and this came on top of news that we had last week about, you know, JJ announcing they're going to invest $55 billion in their U.S. operations. You know, and that's both pharma and medtech. So, you know, new facilities, new R and D. So, yeah, a lot of exciting stuff. A lot of exciting news for J And J.
[00:18:07] Speaker A: Absolutely. $55 billion. And I notice you had your pinky held up to your, your mouth when you said that, Dr. Evil.
[00:18:15] Speaker C: Billion dollars.
[00:18:18] Speaker A: No, you did not. You did not. No, that's. It's great to see JJ pouring more, more resources into, into their, their, their two life sciences businesses and, and otava. Yeah, we'll see where we're going. I look forward to hearing from Steve Bell. He'll be at Device Talks Boston, and he'll help me understand the importance of the dewalto energy system and where it puts OTAVA on the competitive landscape, because I need a whiteboard just to track all of the different applications that's going on with surgical robotics. There's just so much happening. So Steve will be there actually giving two presentations at Device Talks Boston. Yes. On April 30th, he'll give a presentation to the whole group, but he'll also have a presentation in our engineering theater on May 1, which will be a longer presentation. So if you need to understand everything that's going on, join us at Device Talks Boston. Steve Bell will be there, Joe Mullings will be there, and we'll have lots of great surgical robotics companies presenting as well. Maggie Nixon of Capstan will be interviewed by Joe Mullings. So. So it'll be a great couple of days.
[00:19:22] Speaker B: It's almost like you take the listings for those 57 companies that we had at our mass device Surgical Robotics Special Port down still available for download. But I mean, you could like, get a, get a whiteboard, just take that report and start, like, marking it up like this. Is doing here and here and here. And, you know, it's just, and, you know, we're still like, you know, like, covering like, new systems, like, since that report came up. It's like we'll have to include that next year. I mean, it's just the amount of different companies doing things, it's just that's another very exciting space. I mean, it's a great time to be covering medtech, Tom. I mean, there's just a lot of really cool stuff going on.
[00:19:56] Speaker A: All right, man. All right. Great job with the newsmakers and we'll talk to you again. Take care, Chris.
[00:20:02] Speaker B: Talk to you again. Take care, man. Bye.
[00:20:05] Speaker A: All right. Now I'd like to bring in an interview I did with Cecilia Soriano. Of course. She is global president of Infusion Therapies and Technologies at Baxter. She will be at Device Talks Boston. She and I will talk about how Baxter came back from the devastating damage brought on by Hurricane Helene. So we were initially going to have her speak at Device Talks west, but the hurricane hit a few weeks before. Obviously, they could not be part of Device Talks West. So we're very thrilled to have Cecilia Soriano at Device Talks Boston. I know it'll be a fantastic conversation. I spoke with Cecilia at The studios, the 160 studios at the Mullings Group, and I was joined by my good friend Holly Scott of the Mullings Group. So let's listen.
Hi, everyone. This is Tom Salami of Device Talks. I'm very happy to be here at 160 Studios. We're visiting with some of our keynote speakers for Device Talks Boston, which is happening on April 30 and May 1 at the Boston Convention Exhibition Center. Right now I have the opportunity to visit with my friend Holly Scott of the Mellings Group. And our guest today at this moment is Cecilia Soriano. She is the worldwide president of Infusion Therapies and Technology at Baxter. Cecilia, thank you for joining us today.
[00:21:17] Speaker D: Thank you for having me both.
[00:21:19] Speaker A: So, folks who pay attention to our websites, May noted that you were going to be a keynote speaker at Device Talks West. But last fall, of course, Hurricane Helene struck and it was all hands on deck at Baxter. And we are happy that things are moving forward there, and we're extremely happy that you're going to be sharing that story at Device Talks Boston. So, Cecilia, just give us a breakdown or a sense of what those times were like at Baxter when the storm first hit. And then, of course, we want to get into the recovery a bit. But what happened back In October.
[00:22:00] Speaker D: Yeah. So it seems like ages ago, but I'm going to take you back to late September.
So we were, as, you know, I was supposed to be elsewhere, but unfortunately, you know, as Baxter, we track all storms whenever we have a facility. We literally during hurricane season, track where storms are across the US and otherwise on a daily basis. So we were definitely tracking Hurricane Helene. And if you both recall, it was a storm that was coming up from, from Florida.
And we had, you know, as usual, implemented our hurricane preparedness plan. We have a very robust plan in place with of course, our employees being our number one priority. So we had already executed, you know, 24 hours prior to the projected timeframe in which the hurricane was going to hit our plant. We evacuated our employees. We also had, you know, kind of proactively moved product, finished goods to higher ground. We secured storage, you know, just getting ready for, for the storm.
For a little bit of context, however, our plant is located in western North Carolina. We call it our North Cove manufacturing plant. And it is the largest manufacturing IV solution plant in the US so we make over 1 million IV solutions per day in that plant. And I'm sure if either one of you have ever a procedure, have been in the hospital or maybe one of your loved ones, IV solutions are definitely critical to the healthcare system.
Anytime you're in either again, acute or outpatient procedure, you will very likely get fluids via an IV bag. So these are the types of products that we manufacture in North Carolina. So giving you a context of where it was, how we were preparing.
However, I don't think anybody could have predicted what actually happened happened.
We've actually been at this plant for over five decades.
[00:24:09] Speaker A: Wow.
[00:24:09] Speaker D: And we have never ever experienced a storm like this. It has even been characterized as 1000 year storm.
So as I mentioned, we were all prepared. We had a core route team on site that stays always as part of our hurricane preparedness. But unfortunately, the unprecedented truly rain flooding just provided and the storm surge honestly triggered a levy breach. So there's a levy protecting, you know, access to the site and ensuring that water doesn't to contain the water, blocking water from, from entering our plant, unfortunately, it was breached. What does that mean? First and foremost, we had tremendous water permeating our entire facility. Honestly, it damaged finished goods, inventory, raw materials. And then the second consequence was that the bridges that provide access to our site were also completely damaged.
[00:25:11] Speaker A: Wow.
[00:25:12] Speaker D: So we had no access to the site.
And if you can imagine kind of the bigger picture, you know, that's our manufacturing site, but the entire all the surrounding communities were flooded. There was no power, no cell phone, no Internet.
You know, across the entire area. I'm sure you've all heard of Asheville. We're just a few miles down the road from. From Asheville, North Carolina. All the roads were closed, homes destroyed, and unfortunately, you know, lives were lost.
So the storm truly wreaked havoc across the entire region. And it's hard to imagine now, you know, what we found, because I was at the site, you know, 48 hours after the fact of what we found when we got there, versus the tremendous, tremendous work that the Baxter team did. And the community, honestly, to get us where we are today is truly mine. Nothing short of a miracle.
[00:26:13] Speaker E: Well, being in Florida and a native Floridian, I'm no stranger to hurricanes, but that one surprised everyone. We're on yeast.
[00:26:21] Speaker D: Yeah.
[00:26:22] Speaker E: It came out of nowhere.
[00:26:23] Speaker D: And.
[00:26:23] Speaker E: And through even our area, we saw tornadoes that had never been seen in history. These are tornadoes that are classically in the Midwest, that some of the things that came through.
It was crazy. That facility, 2,500 people. Is that right?
[00:26:40] Speaker D: At that facility? Yeah, yeah. 2,500 people.
[00:26:42] Speaker E: What do you do with people that are now. So you've got this facility and obviously, the.
The ripple effects of products and the patients that need them. So there's that whole side of it. And then you've got these employees.
What do you tell them? Okay, standby. How does that work?
[00:27:02] Speaker D: Yeah, so we wanted, first and foremost, for them to be safe. Right. So, again, that's why we evacuated as soon as we saw the storm coming. And that's just part of our normal procedure. But after the storm, as you can imagine, we needed to account for every single one of those 2,500 employees, and we did.
But as I mentioned, you know, no cell phones, no Internet, roads closed. It was hard.
Many employees, honestly, because if you can imagine, Baxter Plan is the major employer in that area. Right. So we had family members and employees literally come down to the site, to the manufacturing site, you know, within hours in the days that followed. But we took the time. We accounted for every single employee. And if that meant. And we did this, going knocking door to door to each employee's homes, we did. And several of these employees, by the way, live up a mountain, which was extremely hard to get into.
So that was our number one priority. And I'm happy to report, of course, that within days, we had accounted for all 2500 rules.
Secondly, though, once our employees are accounted for and safe, it was also just assessing before we could Even assess the impact. You can't even imagine the amount of just cleaning up that needed to happen before we could even assess each one of our lines if they were working or not. And then our top priority, as you mentioned, this is a critical product for health care, right? For patients.
How do we ensure supply?
So the good news around that is, although obviously our plant was shut down, I mentioned before, we had put. We have a really large warehouse on site, which most of the product there was safe. And we had containers that were already loaded with finished goods that we could not ship that day. And they were put on higher ground. But we had no bridges. Remember, we have no access to the site. So we had all this product sitting there. We couldn't get it in and out. So if I can anchor back on the employees, right? So these are incredible statistics in my mind. But within two days, we had established an employee assistance center, basically. So just a couple miles down the road from where the plant was, in a much more accessible part of area, we set up, you know, access to generators, laundry, food, water.
We even provide them access. We have, as Baxter, we have an employee disaster relief fund, honestly, literally, to provide, you know, again, personal property had been damaged. If they had any emergency expenses, whatever. Like, literally, Baxter took, you know, no, there was no cost that was too high in order for us to ensure that our. Our employees had what they need and their families. Right. Like many, many, many of our employees lost their entire homes. We had homes floating down the river, literally, then the bridges. So this was critical, right? We needed to get product out to customers within one week.
We installed a temporary bridge. So we literally built a bridge so that we could access to the plant and start transferring these containers, you know, truckloads. So for context, by the end, I think it was by the end of November, we had literally moved, transported about 1200 truckloads of product out to customers, even though our plant was completely shut down. So, again, those bridges were absolutely critical.
And then I will be showing you a video when we go to Boston, so you'll get a better picture of kind of the devastation at the plant. So this will become a little bit more clear. But the amount of mud and water that needed to be drained and just deep cleaning every single single inch of the plant.
I have to say, our plant now is absolutely impeccable. It is absolutely impeccable now. But as you can imagine, it took tremendous amount of effort.
I saw a statistic just last week that we've estimated about 2.5 million hours of work have gone into this whole recovery effort to, you know, to get back to, to where we were before. So within a month of the hurricane happening, we already had our, our number one manufacturing line up and running. That's the line that produces saline, which is the highest IV solutions product that we have. And I'm happy to report we were like what, four months, months post. All 10 of our manufacturing lines are back up and running. So tremendous, tremendous effort. And I have to say, like, as a Baxter employee, I could not be more proud of all the work, all the people cross functionally, you know, that made this happen.
[00:32:19] Speaker A: We're going to be able to unpack a lot of those steps at Device Talks Boston. But you gave us the recovery of the status of the recovery. You've got all 10 lines up. Are you. When would you expect to be producing what you're producing in September of 2024?
[00:32:36] Speaker D: Yeah, we're almost there. I would say by the end of this, this month. However, as you can imagine, it's going to take a while to build the supply chain, right, the inventory levels within the channel, et cetera, to truly get back to, you know, pre hurricane levels. But we are already, we're almost, almost there. Just weeks away from getting back to the, the same volume of manufacturing. We're playing catch up more than anything right now. So I truly appreciate, also I do want to call out our customers have been absolutely amazing. This, this, we put them in a very. Well, the hurricane has us in a very, very difficult position and with our. And ultimately obviously it's about the patients, right. So they've been extremely flexible, excellent partners. And one of the things that I think is critical in all this, the level of communication that we've had. We've tried to be as transparent as possible.
You know, many times we didn't know, we literally did not know how long it would take us to get back up and running. But the dialogue, the partnership has nothing amazing with our customers and the government. I have to say we could talk about that a little bit later as well, but we actually activated our global network. And so working with the FDA and HSS to have special import licenses to bring product was also critical for us to bridge the gap until our plant was fully up and running.
[00:34:09] Speaker A: Well, we'll certainly look back at your experience at Device Talks Boston, and I think we'll have an opportunity to look forward as well. Are there any lessons that you've incorporated from the recovery that are now part of your regular practice and you think makes you even stronger than you were five months ago?
[00:34:27] Speaker D: Yeah, we're always in learning mode. So even after Hurricane Maria and I don't even recall when that was a few years ago, right. Hurricane Maria coming out of that. We have satellite phones on every single site. We have generators. So every time we have an unfortunate weather event, we incorporated know our hurricane preparedness plan is extremely robust. But I would say from a lessons learned perspective, and this is something that's I believe very unique to Baxter. I mentioned that we activated, we actually activated nine of our manufacturing sites in Asia and in Europe. So we imported product and we were able to turn around, turn that around like extremely quickly. So having a very strong supply chain and manufacturing network is absolutely critical. So for us it's more, you know, that supply redundancy and by the way, the local teams in those individual countries working with the government on their local countries, you know, to make sure U.S. volume was, was prioritized. It was, you know, many, many people, many, many functions and, and countries that got involved. But the redundancy does not mean replacement. Right. One can never fully replace an entire site, you know, manufacturing site if something like this happens. But it is more than anything about the, the contingency plans that you have. So you build that resiliency within the supply network. So we're getting better and better at doing that. I think it's one of the unique strengths that we have as Baxter because of our footprint that we have globally.
I would say the second maybe lesson learned is just having really good end to end like a supply chain visibility, you know, as consumers, right. Like Amazon, like you know, at our fingertips, where is my package? And you know exactly where it is until it gets to your door. Unfortunately in healthcare doesn't quite work that way yet. So I think there's a little bit more opportunity.
You know, we know when we manufacture, when it leaves our site, but then sometimes we lose a little bit of sight track of exactly where it is in the process until it gets to that patient. And so I think that's an opportunity. Working with our distribution partners, with the hospitals that we serve, et cetera, a little bit more to do there.
And then I think just as I mentioned, the cross functional, cross collaboration and having those strong relationships, be it with a government, with associations with again some of our distributors is fundamental. So having a kind of a clear and coordinated engagement plan maybe I would call is something that was critical and something we will continue to reinforce. And we learned a lot from here, especially as I mentioned, since we activated our global network. Right. So it wasn't just the US that so? Yeah, I would think. I think those are our three main lessons learned, but as you can imagine, many, many more.
[00:37:37] Speaker A: Excellent. Well, we really appreciate your offering to come and share your story at Device Talks Boston. I know our attendees will find it's reassuring that you're back up and running and certainly will be up at that point at the end of April, early May. And I'm sure there's a lot of lessons that they'll take away from your really unfortunate experience. Thanks for joining us today and look forward to seeing you in Boston.
[00:38:01] Speaker D: Thank you.
[00:38:04] Speaker A: All right, well, I hope you'll join us at Device Talks Boston. And when you register, make sure you use the code DTWeekly25 to save 25%. Now let's get into our keynote conversation with Andrew Cleland, of course, the CEO of the Fogarty Institute. We'll talk about the award that the Fogarty Institute is helping to organize, and of course, we'll include a link to the release and to the forum where you can make your own nominations in the podcast. Show Notes.
Well, Andrew Cleland, welcome to the podcast.
[00:38:37] Speaker C: Pleasure to be here. Thank you very much.
[00:38:40] Speaker A: It's great to connect with you always. I still remember the early Artyon days. I don't know, meeting you. I think it was at a domain associate conference or something. That's when we first met and you were just my sort of my prototypical startup CEO. You had the sense of humor, you had the drive, you had the vision, and it's always good to reconnect. So thanks for coming around.
So what brought you into the medtech industry initially?
What was the lure?
[00:39:09] Speaker C: Yeah, I'd love to say it was planned.
The real story is I was doing a degree degree, biophysics degree in Melbourne and Australia and we did some work, had to do work experience as part of the degree program and all the smart kids went off to the local hospitals and the BioMed and ICU, CCU. And they ended up sending me to the TGA. So the Australian version of the FDA.
[00:39:36] Speaker A: Oh, really?
[00:39:37] Speaker C: Yeah. So I went off and did my, did my six months there, left, went back, got the degree and to my surprise, the TGA reached out and offered me a job.
So I thought, yeah, why the hell not?
Went back to there and became a reviewer, believe it or not.
Yeah. So that there for a while and then got recruited out of there to sort of the premier medical device company in Australia at the time, company called Telektronica.
And that gave me an opportunity. They were headquartered Australian company but headquartered in Denver and gave me the opportunity to move over here.
My whole career since that time has been med tech. And, you know, you ask why. I mean, I don't think there's a more rewarding field to work in than what we all do.
[00:40:31] Speaker A: Absolutely. So did you hesitate at all about moving to the States, or was this a plan or just something cool that you hadn't had anticipated doing but grabbed the moment when it was offered to you?
[00:40:42] Speaker C: Yeah, we do an internship here at Fogarty every year, and I tell the sort of origin story, and kids these days are so structured, so planned out. I told them that I spent weeks going through all the pros and cons of moving to the States, and then I tell them the truth. Truth, which was, you know, I'll lighten the words a little bit, given we're on a podcast, but it was like, you know, they offered me the opportunity and it took all of two seconds. Yeah, why the hell not?
What an opportunity. I was mid-20s, come and live in another country for what I thought was going to be, you know, a year or two.
Obviously, that was in 1993.
[00:41:23] Speaker A: So I got lost and found.
[00:41:28] Speaker C: I should say you did get found.
[00:41:30] Speaker A: Or you found us anyway, or we found you and you moved over to Baxter. So you got a bit of a big company of experience, was that?
[00:41:39] Speaker C: Yeah, Telektronics for a while, then to Baxter out here with a little group called Novacore.
So it was part of Edwards, basically, before Edwards spun out from Baxter. So that's where I first met both Tom Fogarty and Mike Masalam, who will become part of this story.
[00:41:58] Speaker A: That's a very good. Very good pair to meet. So when you. Now I'm doing the math in my head. When did you take over at Artyon? What year was that?
[00:42:07] Speaker C: That was around 2006. Yeah.
[00:42:09] Speaker A: All right. So that wasn't a long time after you're coming over from the States. So did you. Was that a plan?
[00:42:16] Speaker C: It was a couple years. 13 years.
[00:42:18] Speaker A: Yeah, I guess so.
[00:42:19] Speaker C: I came in 93. Yeah. So I spent. Spent four or so years with Telektronics, then another six. Would that have been another two years with Baxter? Two or three years, and then to a little startup, then to Adyen, where I got the first opportunity to be a CEO.
[00:42:40] Speaker A: Did you have designs on being a startup CEO at some point, or was that another piece of serendipity that fell into your.
[00:42:47] Speaker C: I think as a. I've always wanted to lead an organization, so, yeah, I think it was. I wouldn't say it was a well written out plan. But it was a process.
[00:42:58] Speaker A: And how did you come to lead? How did you come to know the Foundry group and talk a bit about your experience with that? I mean, it was really a remarkable collection of people putting together some really terrific projects.
[00:43:08] Speaker C: Yeah, still are. I mean, they're still going. Going really strongly.
So I met them. The little company that we sort of skipped over was going to be called Radiant Medical. So that was my first startup.
There were some board members. Hank Plain was a board member at Radiant. Hank was one of the co founders of the Foundry. So through him got introduced to Alan Will, got introduced to Hanson Gifford and the folks there, Mark Dehm, obviously. And when they were looking for a CEO for Adyen, which I think at the time was very much of a science experiment, they took the punt on the first timer who was not out of a traditional background. You know, my background is Red Glen, so they gave me a chance and I think the rest was very fortunate in that history does.
[00:44:06] Speaker A: Do you see Artians today in that. I mean, that early stage of technology becoming companies or is that idea becoming a company? Does that not happen any longer? Do companies.
[00:44:21] Speaker C: No, absolutely happens. I think the unique thing about the Foundry is they don't pick little problems to solve, they pick big problems. And I think if you're having a shot at any big problem, big problem is big market, big opportunity, I think you're going to find those things will get funded. It's definitely difficult. More difficult today.
[00:44:40] Speaker A: Yeah.
[00:44:41] Speaker C: But no, I, I still think good ideas are going to get funded and are getting funded, I should say.
[00:44:47] Speaker A: What were some of the lessons learned at Arty? And we can talk about the exit in a moment is to sell to Medtronic.
But what was it? How does one build what essentially is a science project into a company? What does that process look like? And what can folks take away from your experiences to make their own a little bit easier?
[00:45:07] Speaker C: Yeah, I think I give you two things. One, team first, team first, always that. I think building the right team at the right time and bringing on talent and ensuring that talent is directed. One of the things that if you talk to any Artyan teammate now, it's always one mission. We had one singular mission. Everyone within the company was focused on that.
And I think the other one is sort of beginning with the end in mind. We kept quiet, as you well know.
People don't believe that at this point with all of the hoopla around the potential exit, around the exit at the time, but for years we were, for years we were.
We just kept things to Ourselves and built an organization based off science. And so it was a science experiment, we knew that. So we had to make sure that we could develop the story. And so a ton of work going into building not only the sort of the clinical background and the clinical experience, but pre clinical.
We spend a lot of time on ip, we spend a lot of time just building out all elements of the organization, looking ahead. I think a lot of companies fall into the mistake of looking to the next milestone and not you need to have that dual focus, right? You need to head down and just get that next thing done. But you've also got to have a head up in recognizing what's over the horizon and what you need to ultimately accomplish.
[00:46:52] Speaker A: What do you miss when you don't keep your head up and look at the horizon?
[00:46:56] Speaker C: I think you can end up going down blind alleys sometimes and then not realizing that you, you needed to, you know, to be clinical evidence today is not only for, for physicians and for fda. There's obviously a large, you know, payer component to this.
And so I think a lot of. Yeah, if you don't think, you know, we call it end in mind at Fogarty. If you don't keep the end in mind, you're going to make decision decisions that are short term, look at long term are mistakes.
[00:47:30] Speaker A: And what do you see? What qualities do you look for in the people that you bring on board? You mentioned the importance of team.
What made someone a right fit for that company and is that person a right fit for any startup company or is there really kind of a specific genotype for a specific company?
[00:47:51] Speaker C: I think the latter, I think so. One of look for, I look for intelligence, right? You got to be smart to work in one of our companies. I need a lot more smart people around me because I bring the IQ down.
But it's number one is you got to be smart, but you also got to be committed to your teammates.
I think that that is one of the biggest things that both companies have the chance to lead. And now this third, third one is we've got a group who perceives themselves as family. So they're committed to each other, but you know, just get the stuff done.
All right, so there is a sort of action oriented orientation.
But yeah, look, I think that every single company is different, you know, depending on where you are in the, in the lifetime of that company.
And then the leadership too. Like, you know, certain leaders attract certain people and there, I tell you, there are probably a ton of really good folks that didn't end up working with us that we interviewed. Just because they, you know, and I'm sure they've gone on to successful careers. It's just they weren't the fit for the team.
[00:49:11] Speaker A: Interesting. And let's just close out the Artyon story with the sale. I mean, I think, if I remember the number correctly, it was 800 million up front. And a billion and dollars are important, but they're not important.
But it was big. It was a big acquisition and certainly woke a lot of people up. But then, of course, the technology ran into some roadblocks and some disappointing clinical trials. Specifically the clinical Trials announced at JPMorgan in 2014. I believe that's out of your hands. You sold the company, but it's still your baby. You raised it. You kind of sent it out into the world. What is that process like?
What is the emotional ride like for you watching that happen? And what has it been like watching the FDA approval come through finally? Last year?
[00:50:00] Speaker C: Yeah, so it's gut wrenching. Yeah, it was gut wrenching at the time.
You know, I believed then, I believe now that this works and works extremely well. It's a very important therapy that, you know, 70 years of animal experimentation, 50 plus years of surgical precedent, so, you know, it worked. It's a difficult clinical trial to run. And I give tremendous, you know, credit to Medtronic in the way in which they've gone about bringing this to market. You know, they never lost faith.
They believed in the fundamental, you know, the fundamental science, but also in the business potential here. I think I heard Jeff, Martha, on one of his recent earnings reports say this could be the biggest thing that they've done. And I totally agree, but, you know, you got to give the team there incredible props for continuing and fighting the fight. You know, I think as with most things, most people don't truly understand what's going on and they react, you know, to the highlights or the headlines, I should say, rather than to the fact.
We saw that and, you know, look, we went from being really quiet and stealthy to all of a sudden we're the bell of the ball. So, surprise, surprise, we became a target when. When things went awry.
[00:51:31] Speaker A: No, that's good.
[00:51:33] Speaker C: It's good to see you. Long way. And you are. Sorry, I want to. I wrote a little article up in the. In the newsletter that we sent out about the day that, you know, we. I probably shouldn't say this, but got a little heads up that this was coming.
Was sitting at a local bar with one of my Artyon mates and it came through while we were sitting there talking about this stuff, and it's just the two of us, and you got these two grown men sitting there crying together.
[00:52:01] Speaker A: Oh, my gosh.
[00:52:02] Speaker C: So it was. It was really emotional. It was wonderful to see that.
[00:52:07] Speaker A: I mean, clearly you have a fiduciary responsibility to your shareholder, at least the board of directors do, and they're going to sell things, but it kind of runs.
You start off with a mission to start a company to create a cure, and then you're required essentially to hand it off to someone else and to go through what it's gone through.
I don't know if I have a question there, but I've never really kind of realized the sort of dichotomy of, or the diversion of interest where you want to develop this cure, but you also are forced to hand it over. Is that a conflict that entrepreneurs go through if they're lucky enough to be offered to have their technology acquired? I mean, to turn a success into a problem. But passion is so much about this, and mission is so much about this. It's tough to hand it over to someone.
[00:52:54] Speaker C: Look, it's always incredibly tough. But it's also, when you live in our world, which is the venture world, there is a responsibility to get a return for your investors.
The other way of thinking about this, because people have always asked past, you know, what would have happened if, if you guys just continued it yourselves.
And look, I. If we ran into the same issues that.
That the Medtronic did in the clinical trial, we would not have survived.
[00:53:21] Speaker A: Yeah, right.
[00:53:22] Speaker C: They. They survived and they were able to continue through now, would we or would we not have hit the same problems? Who knows?
[00:53:28] Speaker A: Yeah.
[00:53:29] Speaker C: So I, Look, I. I feel very thankful for that opportunity. Obviously, it is coming. It will be out there. It is out there. I should say, give it a couple of years. It is going to be huge. It's going to help a lot of people. So I can look at my kids and say, look, I did something really good here.
This is why dad's away from home.
But the other element, I can also look at my employees and say, well, we changed their lives financially, and that's a wonderful thing, too.
Or maybe it's also helped some investors.
[00:54:07] Speaker A: Along the way, maybe a little bit.
No, that's great. And it's one of the stories I sort of, when people ask me favorite medtech stories, I think Harding is the one I always come up with. But you were involved in another success. 12 account out of the foundry. One that I didn't follow as Closely. But what was. You kind of hopped right back into it. If I looked at the timeline and LinkedIn right. It was probably a few months after Arty and that you took on another role. Was there a temptation to hold back or did you just have the fever to do it again?
[00:54:45] Speaker C: There was a lot going on at that time. So I did. I was working for Medtronic post post acquisition for a little bit, then had some family health issues, so then left there. And Hanson, remember I was actually away on vacation and Hanson rings me up and brought up the idea of 12.
I wasn't quite ready, but it didn't take too long and too much convincing to jump back in again. It was a.
A moonshot, to pardon the pun. But no one at the time had done a mitral valve play and I just thought it was a challenge.
And it always helps working with the foundry.
[00:55:29] Speaker A: Absolutely.
[00:55:30] Speaker C: Start off with a good idea.
[00:55:32] Speaker A: So could you run the same playbook you ran with Arty and keep things quiet, keep things close to your chest and keep it as a science project nowadays? Or is it. I mean there weren't as many. There were press releases by this time. Back then when I first started covering, we didn't have press releases of venture investments, but.
Or is it required now that startups get out in front and stay out in front and keep in front of people?
[00:55:55] Speaker C: That's a dilemma we face, right? Look, I'm still anti publicity for the sake of publicity stake. Right. If you have a good idea and you believe, believe it's going to get funded, you don't need to be telling the world.
I've seen it so often that these little companies go and do one of these shark tanks for $10,000 prize potentially without realizing that there are folks out there in the audience that are remarkably good, strong entrepreneur engineers who are looking at what they're doing and saying, huh, that's interesting. Interesting. It's like, why give away information?
I think that when you're in the venture, you know, in the venture world like we are, you really have two sets of customers. One are your potential clinical, clinical sites, then to your commercial sites. But when, once you're commercial, you're public, but when you're in that early stage, it is the clinical sites that are going to partner with you and it's the potential acquirers there are, you know, the, the fact that the rest of the world knows who you are to me is more of an ego trip than a business necessity. So I do think, and we do counsel companies to really consider when they Go public.
Everyone has to have a website, but, you know, keep a website without too much information.
[00:57:21] Speaker A: Creator, podcast and events. I'm going to cut this completely out of the podcast.
Don't listen to him, folks. He doesn't know what he's talking about. He's only had successful exits of two major meds. Listen to the guy with the podcast. He knows everything.
[00:57:37] Speaker C: Tom, that's the. That is such an important thing, right, that it's balancing. How do you.
It's just beginning with the end in mind. Right. You have to understand why you're doing the podcast, why are you doing this publicity, why are you doing this thing. And if it is not meaningfully impacting your way forward, you shouldn't do it now. I'm sorry.
[00:58:00] Speaker A: No, that's.
[00:58:01] Speaker C: Yeah. When you get to the point, that's. And you want to talk about companies that are changing practice, and that's later.
[00:58:10] Speaker A: That's great advice. And I think that is. And it. And it makes sense. I mean, people come to me with stories and I kind of wonder, like, why would you. Like, why would you want to tell me this at all?
But moving on. So what transpired after 12 that led you to lead the Fogarty Institute?
Well, actually, before I get into that, I'd love to just sort of. This is kind of a typical question, but how has entrepreneurism chained in MedTech from 2006 to today? Not when you joined Fogarty, because I'm assuming you joined Fogarty because you wanted. You obviously love entrepreneurs and you love medtech and you wanted to further that along. Did you see joining Fogarty as sort of an opportunity to fix something, to strengthen something? Does entrepreneurship in medtech need to be fixed or it always needs to be strengthened? But what is the state of medtech entrepreneurism?
[00:59:03] Speaker C: Yeah, I think it's strong, but I think you just hit the nail on that. I mean, our whole mission here is to strengthen the early, early stage medtech ecosystem. So the ecosystem, I think, might be a little out of whack, but it always continues to. To change, Evolve. Right. That's like any ecosystem is going to evolve. Is it harder to get funding today? Yeah, but that just means you'd be. You need to be better at your job. And I'm probably going to end up with a lot of people in here throwing things at me.
But look, you've got to find a way.
My favorite saying at the moment is a quote that's attributed to Hannibal, which is Hannibal of Carthage, I'll either find a way or make one.
That to me, is the essence of startup. Whether you're an entrepreneur in 2000, 90, 92,020, 12, 25, you know, you have to understand the environment as it is, not as you want it to be, and simply find a way or make one. And so yeah, you know, we'll get back into the question of why Fogarty, you know, why here?
So I don't. Yeah, look, I think it always needs to be strengthened. The, the purpose here is to say, look over my career, I've made tons of mistakes. Don't make the same ones. You know, learn from the positive experiences, learn from the negative experiences. And I have a remarkable team of people here who believe the same thing. Help the next gen, you know, get through.
[01:00:39] Speaker A: What is more difficult today? I mean, I'll be honest, I've been talking to entrepreneurs for a long time and I've never heard anyone ever say plenty of money out there, no problem raising money at all. It's always a difficult time to raise, raise money.
[01:00:49] Speaker C: Correct.
[01:00:50] Speaker A: Is it? But what makes today and I, if I were to look at the roster of MedTech VCs, it's certainly a lot shorter than it was 20 years ago. I'm sure that contributes to it. But specifically, what are some of the challenges today that entrepreneurs face? That maybe you or someone that you were in the foundry. So that's a bit unique. You had that kind of network. But someone, another entrepreneur not in the foundry at that time, what did they have that entrepreneur today, 20 years later may not.
[01:01:17] Speaker C: Yeah, look, I think there is one fundamental difference. I think the amount of capital that is out there is the same, if not more these days. So there is, but where it is in the, in the, in the system is different.
[01:01:30] Speaker A: Yeah.
[01:01:31] Speaker C: And the biggest change that we've seen is the rise of the payers. Right. That reimbursement is, is the, is, is the issue of the day. Right. And the, the sort of opaqueness of that. What the, what, what's. What it's causing investors to look at is when are they going to exit?
They used to exit on clinical data, potentially on approval or on early commercialization.
I think what you're seeing is that the strategics are waiting longer these days. And so now you're in. Most companies are exiting on commercialization and commercialization is directly impacted by whether or not you get reimbursement. And so if you are something like an arty and something like a 12, something new, there is no clear path to reimbursement.
It becomes an issue in raising money. So it's not not that the capital is not there. It doesn't make financial sense for some of these investors.
And I think the guys up at Stanford did a wonderful review or paper that showed that the average time to getting reimbursement is about 5.4 years post approval.
If you think about any little startup, that is when they're burning the most capital.
And so that's a very costly experience. And so that's where you get a lot of investors looking at that, at that timeline. And so you just end up with a, you end up with a little bit of a mismatch in the timelines. So that's the big issue these days.
[01:03:15] Speaker A: So let's now focus about Fogarty Innovation. What led you to talk a bit, introduce people to Fody innovation which I'm guessing folks, most folks know about it, but tell us a bit about what you do and why did you decide to take a leadership role there?
[01:03:32] Speaker C: Yeah, so I think a couple of things. So post, post 12 I did go and work for Medtronic for a little while and transition there.
Didn't take too long. You know, I love the company, smart company, capable people. But I'm a startup person from, you know, just by design, I think sat back and thought what would be next.
Had experience with Tom. Tom had been an investor in the three companies, three startups that I'd been involved in.
Had a look at, had a look at this place in the beginning, I think, you know, got asked to have a look and said no in the, in the beginning and then went and had a chat to a few of my very close sort of friends and thought wow, you know, this has a beautiful structure here, you know, a beautiful skeleton. We really could impact the industry. So not, not an opportunity to, to go and sort of enrich ourselves, but an opportunity to give back.
You know, I've been very fortunate as you've pointed out, an opportunity to be able to give back to the, to the community.
Our mission here is pretty straightforward. It is to strengthen the early stage medtech ecosystem. We do it in three ways. We help incubate companies, so teach innovators, we educate the ecosystem. So again, not just innovators, but a couple of our folks have just got back from Singapore where we're helping the Singapore government educate and develop their own ecosystem.
And we spend a lot of time with FDA in helping them understand what our world's like. So we incubate, we educate and then we try to find like minded souls out there and an ally with them to spread the message.
[01:05:33] Speaker A: So looking Back to the problems or the challenge facing medtechs today. The 5.3 or 4 years from approval to commercialization to getting paid, that seems like a problem that needs a fix. And you're in that business of fixing things. Is Fogarty. I mean I guess I look at companies, entities like Fogarty Innovation. I see you helping to start many more companies but I wonder if you're just sending these startups into a process where they're going to be having to clear that five year gap and not everyone's going to, obviously not everyone's going to make it, but it's a long gap for anyone to make. How are you helping to address this systemic problem, including the payers? What's the solution there?
[01:06:19] Speaker C: So, and I think that's a fair assessment that we're hoping, hopefully preparing folks in a better way so that they can, you know, they can negotiate that process better. But the fundamental thing is to change that process. Right.
And I think that that's through from our perspective that's working with, you know, the, the organizations like mdma, it's supporting the biodesign program with Josh and the work that, that they're doing on policy.
It is increasing awareness that this is an issue that we all face and how important and how critical the issue is.
So I think there it's, you know, I mentioned that we work with the FDA quite closely.
We're hoping to do the same thing with cms. Now CMS is obviously only one of the targets. It's a third party payers out there that I think have probably greater impact.
But you know, then, and they're not policy adjustable like CMS is.
I think a lot of it's just going to be awareness and highlighting that.
Don't take this industry for granted. You know we currently, you know, I think in a very important industry globally, you know, in the United, United States. But you know, let's not take this for granted. There are some other countries out there that are developing their own industries.
[01:07:49] Speaker A: Do you feel medtech is largely taken for granted even not only in this country, but just overall? I mean everyone hears about pharma and they hear about biotech and they hear about apps and Facebook and social media and no one ever says, ooh, Medtech. Wow, that's very cool. Tell me more.
[01:08:06] Speaker C: Only when they need it.
[01:08:07] Speaker A: Exactly.
[01:08:08] Speaker C: Only when they need it. And I think that, sorry, you saw me smile when you're saying that because that is probably the biggest chip on the shoulder that I carry is exactly that. Right. And that's, you know, The. I don't know if that was an extremely good lead in to the Thomas J. Fogerty Innovation Prize, but that's the thing that quite frankly pisses me off that there are folks like Tom, like John Simpson, like Mike Masala, go down the list. There's a ton of folks who have changed our society.
Right. They have changed our society and they're not mentioned in the same breadth as some of these other folks. Right. And that's. And that. Yeah, it just pisses me off.
[01:08:54] Speaker A: No, you're right. I think if, like I've said, if some, if aliens came down and said, you can keep pacemakers or you can keep face book, what do you think people are going to choose?
[01:09:02] Speaker C: Like totally right.
[01:09:05] Speaker A: Going with pacemakers.
[01:09:07] Speaker C: Well, Unfortunately, I'm not 100% sure.
[01:09:11] Speaker A: That's a good point.
[01:09:14] Speaker C: I would.
[01:09:15] Speaker A: That is a good point. Yeah.
[01:09:17] Speaker C: It's amazing to me. And so that is the point of this prize, which is not only to recognize a remarkable interaction individual, it is to promote an industry.
It is to promote something that I think is just essential to our society that is overlooked.
[01:09:39] Speaker A: Let's talk about the prize. So it's a hundred thousand dollar cash prize.
What is the.
Who would be considered a recipient of the prize?
What is the process?
[01:09:51] Speaker C: Yeah, well, I think got to go back and just talk a little bit about Tom first.
[01:09:56] Speaker A: Right, absolutely.
[01:09:57] Speaker C: Dr. Fogarty.
[01:09:58] Speaker A: Yes.
[01:09:59] Speaker C: Right. Because I'm not sure everyone. What they all should. Should be taught in school. Know who this guy is, right, That I call him. I use three words to describe him. Icon, sorry, innovator, icon and iconoclast. Right. Because he absolutely upsets the status quo. Quo, yeah. He's a unique person.
He's grown up and he's a natural at building and fixing things. I think he has, and I've seen it, he has a remarkable ability to look at the way things work and come up with a better way. And that became one of his sayings, that there must be a better way. I mean, I don't know how many kids of 15 would come up, up. And he had a friend who had a little scooter, one of these Cushman scooters. I'm not sure if you heard this story. He's grown up in Cincinnati, Ohio, and they'd hit this same hill every time they're going home. And this thing only had two gears, high and low, and it would just clunk down into low gear and Tom would fall off the back.
And I don't know about you. At 15, I. First thing would have Been would have been like a left hook to the driver. Second. The second would have been to hang on tighter. Right. No, he went off and in a little machine shop that he used to clean and work and he invented the centrifugal clutch.
Right. F15.
And then went on as the, the legend is right. You know, he went on. He was working as a scrub tech at the Cincinnati Good Sam of Cincinnati. Cincinnati.
One of his responsibilities was to autoclave or sterilize surgical tools. Sort of looked at them and started to put them in a. On it like a kit of how. On a tray. As to how he thought they would be used again, I would have just chucked them all on. Here he is thinking about it. That brought him to the attention of one of the surgeons who wanted to know who was doing this, because it was, it was really well thought through. This guy, a guy called Jack Cranley, took him under his wing and, you know, the rest is history. Cranley was the one who was doing the embolectomy work with remarkably high morbidity mortality and looked at Tom and said, you got to solve this.
[01:12:17] Speaker A: Wow.
[01:12:18] Speaker C: So as a med student. He was a med student. He came up with the embolectomy catheter.
[01:12:23] Speaker B: Right.
[01:12:23] Speaker C: And that thing sold tens, if not hundreds, Hundreds of millions. Probably hundreds of millions by now are still used today. And this was invented 70 years ago.
[01:12:32] Speaker A: Amazing.
[01:12:33] Speaker C: It's just truly remarkable. All right. He went on, he's started 50 plus companies. He's started a venture firm or two actually.
And at the end of the day, he created this place to give back. So Fogarty Innovation.
I just think he's had a remarkable impact. The other thing, have a look at. And we've got to do this one day. Look at the leaders that he's generated through the industry. Right. Guys like Alan will.
Now Alan has got a whole slew of CEOs that are underneath him.
And so, you know, we're a third or fourth generation of the, of the Tom Fogarty effect.
So, you know, we were sitting around and there was a conversation actually with Mike Masalam, who we all know was the previous CEO of Edwards. But those two go back a long way.
And Mike wanted to come up with a way of honoring Tom.
And so he. So it's actually the Linda and Mike Masalam foundation, where the generous foundation, additional donors to this award.
And the, the award is, you know, we tried to get it. So it's, it's. It reflects Tom. Right. So, you know, I've, I think it's what we're trying to do is this so annual Thomas J. Fogerty Innovation Prize. That's an annual award that's going to be given to a person or persons who have demonstrated extraordinary insight. Insight, creativity, perseverance and courage. It takes all of those things, I think, to come up with a, with an impactful technology. And then the real kicker here is it's got to be a medical technology or therapy that has proven to improve the lives of many. So it's got to have a demonstrated, meaningful clinical impact.
We're targeting individuals or up to, you know, a team of three.
So this is not for a company, it's for a person or, you know, if you've got a, a couple of co founders, it's for them as well.
It's not a lifetime achievement award. It reflects a specific, singular, clinical, clinically important technology or therapy. And that was from Tom himself. Right. He's just, he's just turned 9. 91. We had this conversation with him when he was just around the time he was turning 90. And he was explicit, you know, that this has to be for an individual and then for, for something that's actually got out there and is providing true impact to patients.
[01:15:20] Speaker A: So how will, how will the person or people responsible for technology be identified? We're talking about like original, original patent holders or engineers or process.
[01:15:30] Speaker C: So we're going to be opening nominations today, so anyone can be nominated. So a couple, couple of things I want to go through just to lay it out for you. I think, first of all, we want this.
Our vision here is to make this the preeminent award in the medtech ecosystem. We wanted to make it somewhere along the lines of the Laska or the, you know, the MacArthur Awards. So incredibly high profile.
It's the award itself. And you said it. The, the real important thing for me is the medallion that we're going, that we're going to provide. Right. That's actually, that acknowledgment to me is an important one. And it's going to be modeled up off the award that Tom got, the Presidential National Medal of Technology and Innovation.
But it does come along with $100,000 cash prize.
The nominations, as I said, are open, so they're open to anybody who meets those criteria that we discussed. We are going to be expecting at least three letters of recommendation that come along with that.
And we have. This is not a Fogarty Innovation Award. This is a, an independent to us. We are going to, we'll manage it, but we have an independent selection committee that you Would have seen. Yeah. And so those folks will get together in July. We'll keep it open till around the July time frame. They'll get together and they'll pick the winner for the year. It'll be announced. Announced in October. And we're gonna have a. You're gonna have to come. We're gonna have a big black tie dinner, which doesn't go over too well with me because I don't. I can pretty well tell you I don't have a black tie get up, but I'll be able to get one for the night.
But we want to make it.
[01:17:28] Speaker A: I'll get one.
[01:17:29] Speaker C: What we're trying. Thomas, we. I really personally am committed to this, that this needs to be seen for what it is. Recognizing a singularly remarkable person and representing an ecosystem or an industry that I think doesn't get the Jews. It should.
[01:17:53] Speaker A: And I see nominations will be open. They'll close on July 31st. Winners will be announced in August.
[01:17:59] Speaker C: There you go.
[01:18:00] Speaker A: And then you mentioned the dinner in the dinner in October.
So we don't have. I don't know how much time you have. But again, talking about Medtech's profile, I think it kind of for me came into play recently with the cuts at the fda, the cuts of reviewers, the pushback and the clearance clearly came from the industry and reversed something. Permanently or not? I'm not sure yet. But how are you feeling about things going forward? Not to make this a political conversation, but are you more concerned than you were before, given some of the turmoil at the fda? Is this just yet another speed bump that we'll have to clear and hopefully no one falls off the scooter when they do.
[01:18:51] Speaker C: Well done.
[01:18:53] Speaker A: What's your state of mind right now with things on a regulatory front and I guess industry wide?
[01:19:00] Speaker C: Yeah, I was thinking it's a. I'm trying not to be political. I'll just show you my personal view.
You heard the focus early on, right at the beginning of the conversation on team and people and respect. And you have a group of people that has, that wants to work together, believes in themselves, believes in their work and in their mission. You will get remarkable outcomes.
Fast forward to where we are today. I'm really concerned. I'm extremely concerned. I think that with an FDA perspective, we read a good point.
They haven't lowered their bar, but they became more engaged and more understanding of the process and of the impact that they have. And I thought we're, as a, as an industry, we're at a really good point.
I think what has happened has jeopardized that significantly that you are talking to folks there who I, you know, look, I. We get to interact. To interact with a lot of the FDA folks here.
You know, and just the thing we haven't pointed out throughout this is we're a nonprofit.
[01:20:20] Speaker A: Right.
[01:20:20] Speaker C: We're a charitable organization that's aimed at supporting the. The ecosystem, patients, their families, physicians, providers, payers, regulators, all the way through.
[01:20:33] Speaker A: Right.
[01:20:33] Speaker C: We. We want to focus on the whole ecosystem, but we've had the opportunity to interact with these folks, and I can tell you they had a strong sense of mission, of why they're doing what they're doing at fda.
And I think to be treated the way they were treated sucks.
[01:20:53] Speaker A: It's just.
[01:20:53] Speaker C: It's. There is no.
I just simply dumbfounded the disrespect that was shown to a group that does something that's incredibly important and. Yeah. Right. So we solved the problem. They got realized that and asked some folks back. But that doesn't under. Doesn't undo the insult that was provided. So I'm hoping that the FDA folks who are living through this see it for what it was, a political stunt and rise above it and continue to work the mission that they work.
I would totally understand if they didn't. Right. If they start to look for jobs elsewhere, I would totally understand that. But I really hope that they understand how much the rest of us appreciate what they do.
So, again, that wasn't truly political, but it goes back to. Right. This is. It goes back to fundamental respect and understanding.
[01:22:04] Speaker A: Absolutely. So final question. I mean, just put on your CEO hat now.
Is this, I think, an honest and sobering assessment of where we are at the moment? What are you telling entrepreneurs who are coming in? What are you telling the new members of your team at Fogarty to focus on and to ensure success and to help build MedTech's brand and help us tell our story.
[01:22:32] Speaker C: While we spoke about the end in mind before, I think that the number one thing is understanding that you're solving a problem for a patient or their family.
And so focus on that. Focus on why you're doing this. Right. That hopefully it's to solve a meaningful clinical problem.
If you do that and you're aware of everything else, you'll win.
It's not worth doing something that, at the end of the day, isn't going to help someone.
And I know that sounds pretty bloody obvious, but I think coming back to. To what value you provide primarily to the patient, is the key here.
[01:23:16] Speaker A: Yep.
[01:23:17] Speaker B: Yep.
[01:23:18] Speaker C: So always bring it Back to the fundamentals.
[01:23:21] Speaker A: Great way to end it. Andrew, always a pleasure talking to you and we'll definitely include the links to the, the award on the, on the website, on the, on the podcast website. And thanks for, for doing what you do with for medtech. Appreciate it.
[01:23:37] Speaker C: My pleasure. No, thank you. I do have an ask of you though.
[01:23:41] Speaker A: Sure.
[01:23:41] Speaker C: You get to. You're interviewing a lot of these folks who that we think would fit this. You should nominate a couple people.
[01:23:47] Speaker A: I will, I will, I will think about it.
[01:23:49] Speaker C: I mean think about it.
[01:23:51] Speaker A: I certainly will. I've. I do have an opportunity to talk to a lot of people who have made a big difference and, and I think who would really be honored to, to win this. So I will, I will make sure. I know that's a promise. Cool.
[01:24:05] Speaker C: And then last thing, I just want to thank you for what you do for this industry and this ecosystem. No, I really appreciate it. I've watched you for a long time now.
We went back a long way and to watch what you've built and the impact you're having. Thank you. Really appreciate it.
[01:24:23] Speaker A: Thank you. It is my pleasure every day to be part of this industry and to help it when I can. But thank you for the kind words.
[01:24:30] Speaker C: Thanks.
[01:24:33] Speaker A: All right, well, that is a wrap. Thanks so much for joining us on this episode of the Device Talks weekly podcast. I sincerely hope you'll join us at Device Talks Boston on April 30th and May 1st and also join us at Device Talks Minnesota on June 11th. Two great shows coming up to you in just a short amount of time. Even shorter amount of time. We have our Device Talks Tuesdays coming up. It's sponsored by Millar and the title is Mastering Chronic Disease the Role of Implantable Pressure Sensors in Medtech. Always enjoy a good sensor conversation. You can go to devicetalks.com to register for that. Please do subscribe to the Device Talks podcast network so you don't miss a future episode of this or other many great podcasts. Also connect with Device talks on LinkedIn. Follow us there. Connect with me on LinkedIn Tom Salemi, editorial director. Connect with Chris Newmarker, Editorial leader at Mass Device. And of course, connect with the fabulous Kayleen Brown, our managing editor here at Device Talks. Be great to be part of your future MedTech conversations. All right, folks, well, that's a wrap. We'll talk to you next week and we'll bring you another great episode of the Device Talks weekly podcast.
