A conversation with:
Dr. Thomas Sorrentino

The Cutting-Edge of Surgical Innovation

Welcome to the latest episode of the med+Design podcast. This platform is dedicated to investigating the extraordinary journeys of many medical innovators worldwide. Today, we're excited to have Dr. Tom Sorrentino, a General Surgery Resident and Surgical Innovations Fellow at UCSF, join us. With a robust biomedical engineering foundation from Yale University and a zeal for surgical innovation, Tom has been pivotal in the development of advanced medical devices and technologies.

The Intersection of Clinical Practice and Research

Dr. Sorrentino is a driving force in combining clinical practice and research to enhance patient care. His work at UCSF's Surgical Innovations Program has significantly advanced surgical practices and brought him to the leading front of medical device innovation. His perspective offers a refreshing insight into the interplay of engineering principles in the field of medicine. Through his in-depth knowledge and hands-on experience in surgical innovation,

Making Strides in Surgical Innovation - The Kidney Pod Project

One of Tom's major projects is the Kidney Pod. The idea was born out of the Biodesign process, initiated by Keith Hansen, in efforts to maintain kidney organ transplant at a specified temperature. The aim was to mitigate the issue faced during the sew-in period of the kidney transplant, referred to as the 'last mile problem.' During this period, the organ warms up from the optimal four-degree Celsius, leading to potential organ damage. The Kidney Pod fights this problem by maintaining the temperature at four degrees Celsius, reducing the risk for the patients and potentially increasing the total number of successful transplants.

Addressing Physician Burnout

Dr. Tom Sorrentino acknowledges the rising prevalence of physician burnout and states it as a mostly systemic issue. This problem often springs from the pressure of an unpredictable and overwhelming schedule, leading to a loss of control over personal life. To mitigate burnout, Tom suggests setting a larger mission, fostering a sense of control over one's time, pursuing passion outside work, and ensuring quality time with loved ones.

Advancing Medical Innovation - Words of Wisdom

Breaking into the world of medical device development can seem daunting. But for those inspired by Tom’s journey, the key is to persevere, embrace the uncertainty, and relentlessly pursue opportunities that come along the way. You may encounter obstacles and detours, but remember, there is always a path forward.

Exploring Dr. Tom Sorrentino's journey has been insightful and inspiring. His innovative contributions to medical research and surgical practice are invaluable. As we sign off from this episode of the med+Design podcast, we encourage you to stay focused, remain creative in your work, and continue to advance the medical world with groundbreaking inventions. Stay tuned for more exciting conversations!

Episode Transcript

[00:00:00] Jared: Hello everyone and welcome to another episode of the med+Design podcast where we explore the unique journeys of medical innovators and today we're delighted to welcome our guest, Dr. Tom Sorrentino. Tom is a general surgery resident and surgical innovations fellow at UCSF, where he is actively involved in the development of cutting edge medical devices and technologies.

With a strong foundation in biomedical engineering from Yale university, and a passion for surgical innovation, Tom is at the forefront of bridging clinical practice and research to transform patient care. Tom's work at UCSF's Surgical Innovations Program has not only positioned him at the cutting edge of medical device innovation, but is also leading to significant advancements in surgical practices.

His unique journey offers a fresh perspective on the integration of engineering principles in the field of medicine. His deep knowledge and hands on experience in the realm of surgical innovation make him a remarkable guest for our podcast. We're eager to delve into his journey, his work in medical device development, and his vision for the future of surgical innovation.

So without further ado, let's dive into our conversation with Dr. Tom Sorrentino. Welcome.

[00:01:04] Tom: Thanks Jared and Ty. Really pleased to be here and especially thank you to Ty for inviting me to be on the podcast. We're happy to

[00:01:11] Jared: have you.

Just, getting started, can tell our listeners about your current role as a general surgery resident and surgical Innovations fellow at UCSF? Yeah, so

[00:01:21] Tom: I am in my fourth of seven years of general surgery training at UCSF.

So for people who aren't familiar, most academic general surgery programs are five clinical years. So five years when you're in the hospital, and then two years of what's called research or more now more commonly professional development time where we have two years. It's a gap in the middle and you can go off and do whatever you want.

Basic science research, global health, clinical research where you know, more and more commonly programs are starting to offer some version of medical device innovation, surgical innovation, medical device development. There's a whole bunch of different names for it. And so I am just on the tail end of my first of the two years of my professional development time within the Surgical Innovations Fellowship program at UCSF.

And so we're housed a joint between the bioengineering department at UCSF and then housed under pediatric surgery because UCSF and Stanford to have a joint pediatric device consortium that does some of our funding. And so our group is a legacy of someone named Mike Harrison, who's one of the sort of big innovators in pediatric surgery and fetal surgery.

And the whole like innovations group at Surgical Innovations Group at UCSF founded under that and continues now with two Surgical Innovations Fellows every year. Awesome.

[00:02:38] Jared: And looking into your background a little bit, it's really interesting how you've got your biomedical engineering background and your passion for medical device innovation, now with the surgical innovation as well.

And maybe can you tell us your most interesting or innovative project that you've worked on?

[00:02:53] Tom: Yeah, so probably the thing that I am most, most interested that even though it's not my full-time job that I probably spend a full-time job on because it's I really think is hopefully gonna change.

One aspect of the field is something called the Kidney Pod. And what this is was actually started by a resident a couple years ahead of me in the UCSF surgical residency program for his professional development time, he did the Stanford Biodesign Program, which some people may be familiar with.

And so his name is Keith Hansen. And he basically the Biodesign process developed a device to keep kidneys at a specific cold temperature about four degrees celsius while they're being sewn into organ transplant recipients. So the sort of big problem is that patients who get kidney transplants, they do a really good job of sort of temperature control the organ.

So in order to prevent cell death and necrosis, you want that organ to be not totally frozen, but right about four degree celsius. And so they get it down to four degree celsius really fast. When it gets taken out of the donor, usually they at a different hospital. And then there's all these sort of fancy devices.

The sort of most prominent one is this lifeboard kidney pump that can regulate the kidney right at four degrees celsius all the way through the transportation phase, which sometimes can take up to 24 hours. But what we effectively have is a last mile problem where all that great temperature management sort of gets thrown out the door at the recipient operation.

And so in the 30 to 60 minutes that it takes you to sew in the kidney, that kidney warms up from the four degree celsius where it's supposed to be all the way past room temperature within 10 to 15 minutes. And there's a lot of good clinical data to suggest that if you can eliminate this warming injury you can reduce what's called delayed graph function.

Which is when patients after their kidney transplant have to go back on dialysis for a certain period of time, sometimes it's only a day or two, but sometimes it's months and months. And so obviously, no patient with a kidney transplant would wanna have to go back on dialysis to certain defeats the purpose.

But the bigger picture is that we think there's about 3000 kidneys a year that get thrown out because they're what we call marginal. And which means that, the surgeon thinks that with that extra warming injury that they get when they sew them in the kidney's not really gonna fly.

And so they end up discarding them. And so we think that we can with this device, which will keep the kidney at four degrees celsius for the duration of the sew in we think that we can increase the number of transplants that get done. And then also enable robotic transplantation, which the sew in times or even longer just cuz it's a little bit technically more difficult, but it's the new hot thing.

And so we're hoping that this addresses a number of the sort of challenges that kidney transplant surgeons face as they're going to, sew in these kidneys. And should, ideally significantly improve the outcomes for these patients and enable more patients to have access to really what is a limited resource, which is organs.

It's an interesting thing in that this is not a new problem that people have recognized. But usability is a big thing. And so while I can't get into the specifics of the design, we've designed it in a way that is as surgeon friendly as possible.

So that, if you're a surgeon, you want to use this. Not that it's something that interrupts your workflow, but that, you can't wait to get your hands on it. As design and usability has been a big part of the the process here. Do you mind touching on

[00:06:20] Ty: Design and usability so that surgeons want to use it?

Cause that's just an interesting topic in its own right.

[00:06:25] Tom: Yeah. So I think for anyone, who's here or who knows surgeons that they tend to get, especially as you've moved through your career, pretty stuck in your ways you like, especially for operations that are the same.

So like a kidney transplant, ideally you wanna do it about the same way every single time. That's what breeds success, right? And so if a surgeon has a set way of doing something and you're gonna introduce something new into their workflow, it either has to, if it's gonna take a lot of extra effort, it better, significantly improve that patient's outcome.

Or it needs to be something that is gonna be so seamlessly integrated into the workload that they're almost not even going to notice it or it's gonna make their life easier. And so what we saw as we did this sort of, competitive analysis and understood the landscape of what had already been done in this space, we realized that a lot of the existing devices had usability issues where they'd have, different things that were connected to them or whatever the cooling agent was, had to be exchanged and they increased the amount of time it took the surgeons to sew in the kidney. We use really fine sutures to do this that are like barely thicker than a sort of human hair. If one of those gets caught, you basically have to start over.

So everything has to be very easy for the surgeon to use. And I think one of the things that has gotten people really interested in this device, when we show them the prototypes. Is that, it should add 15 seconds to their workflow and it actually helps them do the surgery a little bit easier through some of the features that are designed into the device.

And I think that, at least in our early discussions, has helped separate us a little bit from some of the prior projects that never really left an academic lab. But yeah, usability, you want a happy surgeon, give them a device that is simple to use and intuitive and has, packaging that's designed well and all the sort of design aspects that go into it, I think really can't be undersold how important that is.

Because it can be the death nail for what otherwise might be a great device. But if no one wants to use it, then you're never gonna go anywhere with it. Which that's such a big

[00:08:28] Ty: gate for I guess medical devices. That's, until you get to a commercialization stage is when it ultimately becomes the test.

But, there's previous steps and I guess that's something that as a vision for putting this device together where that's been a priority. In part probably because you are the user. And I guess from the founding standpoint as well. Yeah. I'm curious for the profile or the personality of the surgeon who would adopt this, you've got the diffusion of innovation is always a challenge, and if you've got some surgeons who are set in their ways more so than others who are perhaps new and willing to adopt new techniques.

Have you seen like profiles for adoption? It seems like usability helps to short circuit that reluctance for

[00:09:09] Tom: adoption, but yeah. Yeah. It does. I think some of the other conversations that we've realized that we've had showed us that, there are some surgeons who think that they can defy the laws of thermodynamics, in a sense where I don't really need this because all my kidney transplants take 15 minutes.

So I'm very fast and I don't need this. And the reality is that no one is perfect. And so maybe you approach that surgeon in a different way. The other thing is that most kidney transplants are done at academic centers where there's a surgeon and then someone like me who's a trainee, right?

And so I've done maybe 30 or so kidney transplants in my training so far, but I'm not nearly as facile at them as, a surgeon who's been doing for 10, 15, 20 years. And there's lots of pressure in the operating room to get these done fast. I've been on the receiving end of the, go.

Like everyone being very stressed and having a device like this actually lets you slow down and allows the surgeon to be able to teach. And so one of the benefits that you might sell to that surgeon who says, I am faster than God. Is that well, but you love teaching and this is gonna let spend the time to really teach your residents how to do these operations well without worrying about any side effects for the patient.

And so I think one of the things that we've learned that's a really good lesson for anyone who's starting to design to make a new device, is to really do those early user interviews. And understand a sort of variety of perspectives about why someone might want to use your device. I think that's something that a year ago before I started this, I didn't really appreciate.

And now having seen lots of, worked on this project and other ones and seen lots of other people talk about their projects, I think the ones that tend to be more successful, are the ones that really understand the landscape of all the stakeholders and their motivations. And if you can do that, then I think that, even though it's really early on, that you're understanding that, three years down the road that affects your marketing plan, right?

Three, four, or five, years down the road. And so you can use that both upfront for your designing the actual device and then down the road when you're trying to figure out how to convince people to use it. Yeah.

[00:11:17] Ty: A good friend, Dr. Arlen Meyers has four questions he asks, so who cares? So what, who pays how much? Yeah. And so what you've addressed is the who cares, and the so what and you've gotten into yet of who pays and how much, because that obviously, like who pays in the hospital system is always a completely different set of

[00:11:36] Tom: stakeholders. Yeah.

So I think he hits it right on the nose. One of the things that this device has benefited substantially from mentorship through UCSF, Stanford Biodesign, and then the team at Fogerty Innovation, which some people may be familiar with. This is a medical device incubator and accelerator that was founded by Tom Fogerty of Fogerty Embolectomy Catheter Fame, one of the most, well-known serial medical device developers and entrepreneurs. And we have a good fortune of going through their invention accelerator program. And one of the things that they harped on us is beginning with the end in mind. At the end, as you say, are that the device needs to be used and it needs to be paid for. And so the used part we talked about the paid for part is equally important and complicated and without getting into all the details, transplant reimbursement in particular is quite complicated in how all these devices get paid for. But I think a big thing that we've seen in, pitching this device to both, grants and, grant funding agencies and internal things at UCSF and Stanford and externally, is that we actually, figured out a an approximate cost for the device.

That's value-based that, we did some economic modeling and we engaged really early with reimbursement specialists to try to understand how this is paid for, so that when we went to people, that's always gonna be one of their questions, and we could say with, relative certainty, this is how it's gonna get paid for based on, predicates X, Y, and Z.

And we think based on, this model that we put together, that this is roughly what we could sell it for. This is our, cogs, so we're gonna have, X margin and you can't forget about those things early on. But again, a year and a half ago, that would've been so far from my mind as someone who's, squarely focused on the clinical part of the engineering.

But later on we can talk about how you raise money for these kinds of things, but you don't know that kind of stuff. People are gonna be much less willing to give you money.

[00:13:33] Jared: Yeah. I think actually that really tee'd us up for our next question that we had for you as well, which is what are those challenges around, bringing new medical devices to market.

There's regulatory hurdles, funding hurdles interdisciplinary collaborations, and just so many things along that process. Throughout your experience, what would you say are some of those hurdles that you've encountered so far?

[00:13:54] Tom: Yeah, I think. Again, being relatively new at this one part of it is just coming from an academic and engineering background.

Like a clinical surgery background and engineering background. Very little knowledge all the business side of things. And so I think one of the biggest lessons has been be open-minded. Understand that there's almost nothing that you know right now. And that you're gonna every day have to be learning, new things.

And stuff that I never thought I'd be doing as a surgical resident, like understanding how venture capital deals are structured and reading like entrepreneurship books and stuff like that. I never thought I was gonna be doing that kind of stuff. But I think that immersing yourself in the sort of business side is actually really important.

The other sort of hurdles that I've seen for both my own projects and then, other projects that have been spun out of academia. And these are mostly specific to devices, but not unique to it is finding good engineering partners. I have an engineering background, but I don't have like in an academic sense, I don't have a professional engineering background.

And there's a big difference between, a kid who did a bunch of design courses in college a decade ago, and someone who spent 30 years doing medical device R & D. And we have benefited not just in this project, but all of our projects at UCSF. Within the surgical innovation group have benefited enormously from the expertise of both staff engineers and advisors who have, some, like I said, up to 30 years of medical device R & D expertise, and can really walk you through the process of doing this, not only making prototypes, but can advise you about all the hurdles that you're gonna face along the way.

And so I think that's a, if you're someone who works in academia has a good idea. Find someone who, you know, even if you have to convince them to work for cheaper, for free to start off with find someone who knows what they're talking about. Cause that can make a huge difference once you get to serious R & D work.

I think the other two things that I think are big ones that people forget about are regulatory, like your regulatory pathway. Because most people know the way that the features that you add to your device can really dictate what regulatory pathway you go down.

As an example, for our device, we were really hoping to fit it into a, 510 K pathway. Something with a, it's a class two device. Something that would just go into a standard 510 K pathway. Cause that's gonna shorten your time to market, time to approval, and subsequently the amount of funding that you need to raise to get there.

And when we were thinking about features that we wanted to add onto this, we made it so that it just had the minimum feature set to get to through an easier regulatory pathway. And obviously, if you're making some implantable device that just, it's a class three device, it's gonna need a pma.

There's nothing you can do about that. But a lot of people I think are making simpler things and if you have some leeway in design such that you fit into a different regulatory pathway. Always try to pick the simplest one. This is not something that I really appreciated until you see what these timelines look like.

And then I think funding is the other big one. So unlike I think a lot of basic science research, which I've done quite a bit of in the past and then other things like, doing clinical research where, honestly, you really don't need that much money to actually do it.

Developing medical devices is expensive, even initial prototyping. And most people don't wanna give you money. If you just have an idea in your head, unless you're really experienced, no one's gonna give you anything. And some universities might have a little bit of startup funds that you can get with relatively low bar, but even at, somewhere UCSF would, I think they support this quite a bit.

There's a pretty high bar to getting even, 50 to a hundred thousand dollars to do some prototyping work. And very competitive applications. I've sat now on the other side of the judging panel for our, what's called the Catalyst program at UCSF, which is designed exactly for that to help people get from like a proof of concept or like a prototype to a real, like proof of concept device.

And it's very competitive. And I think people need to, within their own institution and then externally really explore what small grants are available. Because the threshold for meaningful venture capital money is seemingly very high compared to especially compared to other industries.

As a example of a friend from college who works in the sort of crypto web3 space. Who raised a 6 million seed round off of a 10 slide deck without a single line of code written. Now he had some experience, right? Pretty good seller there, yeah. But again, the point is no team, no lines of code, like just him and an idea.

There are very few people in the medical device space who could pull that off, right? And certainly not someone like me. So looking around for those small grants the, phase one SBIR type things if you fall into a sort of relatively niche market, whether it's, for pediatrics, the, five pediatric device consortia around the US that are funded by the federal government, they all have competitions where you can, win up to a hundred thousand dollars.

Each institution has little things going on, so it's important to find those cause that's how you're gonna get that money to pay that first engineer and to develop that first device that then is gonna, allow you to attract real money to move. I wanted to circle

[00:18:56] Ty: back to something you said, which was like the critique of the 510 K pathway is that it almost incentivizes more incremental innovation within healthcare.

[00:19:07] Tom: Yeah. I think that's definitely right. I think that it's a hard balance that have to face. And I think for us, like for this kidney pod device, there's other things that we would want to explain further on. That'll just end up being like post-approval work that we're doing and we'll do tiered claims on top of the device.

But getting it to market quickly, I think is important in this particular instance. Okay, so you

[00:19:32] Ty: can describe it as like the 510 K is for your mvp, and then you can do the more elaborate stuff later. Yeah, you can

[00:19:38] Tom: do the more elaborate stuff once you have a little bit of traction.

But like I said, this is not an implantable device, so you know all these people that are making, some new cardiac valve or some hip replacement or whatever the things that actually need to be. That are class three that need to be a pma.

You can't get around that. But then again, you can also raise a lot more money for those because the amount of money that you can make on something like that is much more than on the device that I'm working on. Yeah. Yeah. One more question before we move on is I

[00:20:06] Ty: can't move past this cuz I'm a book nerd, but of the entrepreneurship or venture capital articles and books you've read, was there one that stood out to you as a particularly helpful one?

[00:20:16] Tom: Yeah. The one that I really liked was Build by Tony Fidel. Yes. That is such a great book. Yeah. So if you haven't read this or not familiar everyone thinks of Steve Jobs as like the iPhone guy and like yes, Steve Jobs fantastic, but Tony is really the one who made those things.

He ran those projects and was really the brains behind all of that and, I learned so much just from reading that book about how to think about, team building and how to think about how present the device, whatever you're building to the world, why it's important to really, even if you are the CEO of something to care about the little details and how much of a difference that makes.

And so many other lessons, but it's really a fantastic book. It's one of those things that I picked up and, finish in a couple days and have skimmed through again, from time to time as we're like prepping for something or I gotta go read, go back and read this section.

Great. Or go find the podcast

[00:21:15] Ty: you mentions in the footnote and go listen to that

[00:21:18] Tom: and, yeah. Really loved loved that book.

[00:21:20] Jared: Yeah. And I think, we did get a question about your program with UCSF, but I think before we get into that question, maybe can you just tell us more about UCSF's Surgical Innovations Fellowship?

Just in general, its goals and it's how it's impacted your career trajectory so far.

[00:21:36] Tom: Yeah, so the Surgical Innovations Fellowship is a two year program that is open actually to any surgical trainee in the us. Often it's ended up being just based on interest levels.

It's been one fellow from UCSF and one fellow from outside of UCSF. For example, in my year, it's myself. And then a resident, Columbia named Taja Sate who's amazing. And so he's been here now for a year and he, staying this year to do the second year of the fellowship.

And the way it's generally structured is that there's a bunch of like long-term ongoing projects at UCSF. And so the way that it's primarily structured is that most of the fellows have what we refer to as an anchor project. So one of these sort of long-term projects that's going on that has funding.

And the fellows will spend about half their time working on that. For myself I work in Shiva Roy's lab at UCSF. He's the sort of engineering lead for the Surgical Innovations program. He's a bioengineer with a background in like mems work and he has this long-term project called The Kidney Project, which the goal is to build a totally contained implantable bio artificial kidney.

And so I work on one part of that, which is building and designing a kidney cell bioreactor. So that sort of leverages my background in basic science and engineering or putting everything together, depending on the day, I'm doing some CAD work, this morning I was building devices and putting cells in them.

So it varies a little bit day to day, but, everyone has an anchor project that's mine. And then there are a bunch of other new projects that we work on developing. This year our sort of overarching theme this year, next year, our sort of overarching theme were operating rooms sustainability.

And that can mean a number of different things. One is just like waste reduction, and another is like surgeons sustainability in the sense that lots of surgeons get musculoskeletal injuries. So thinking about surgical ergonomics. So we have a couple of projects that are ongoing in that space that Tajas and I have sort of started from scratch. And really our primary focus at this point is developing a project around supply chain optimization within the operating rooms at UCSF to reduce waste and cost. And so the two of us have been working closely with a lot of the both perioperative staff and all the start processing and supply chain people to try to figure out how to optimize some of those processes because unlike things like, companies like Amazon and, all your logistics companies or really any big company that has large inventories, hospitals tend to not do a very good job of keeping track of what they have, unfortunately.

And so we're working on a couple of projects to try to make a dent in that. Yeah, talk about a competing

[00:24:15] Ty: value between I guess sustainability and then sterilization, because

[00:24:20] Tom: those are two almost competing topics to try to optimize for. Yeah, no, for sure. It's a thorny thing and what most people might not realize is that healthcare accounts are about a third of the carbon emissions in the US.

And the operating room is the biggest, if you break it out into like segments. The operating room is the biggest part of that. Actually, between the very high use of disposables and then some of the anesthetic gases, which they're slowly phasing out. But some of the off-gassing from the anesthetic gases is

one OR cases can be equivalent of a large plane flying like across the country, which sounds ridiculous, but that's how potent, some of these OR gases are. They've now the particular one that caused all this problem, they've stopped using at UCSF, but there's still lots of places around the country to do it.

Getting back to the rest components of the Surgical Innovations Fellowship there's lots of other programming around that you can get involved in. UCSF has a Life Sciences for Entrepreneurship class that's run out of our innovation group. That where they bring in basically like big name people to give lectures on all different parts of how you develop life science technology.

[00:25:29] Tom: Examples would be like be Fern Norville, who's one of the big medical device and pharma, biopharma, IP lawyers founded that sort of space in the Bay area. They had Steve Blank who founded the launchpad. A bunch of, big name people across all the different aspects of medical technology development who come and, give lectures. It's a couple hours a week. Very interactive. So that has been great. We have the Catalyst program at UCSF, which as I said is our own like sort of mini accelerator where there's funding and both funding and advice attached to teams that have successful applications.

And so I worked on the back end with them a little bit now, but actually got started in that as an intern while I was a third year resident. They have an internship program that I applied to, and I actually worked on this kidney pod project intentionally through that, and that's how I originally spun up through there.

And then as I said, we have this uses of Stanford Pediatric Device Consortium. Which funds a bunch of different pediatric medical devices every year. And we host a weekly innovators forum, which is how Ty and I originally got to know each other. Where we bring in medical device innovators or, design people, everyone from all the different sort of spokes that form the wheel of medical device innovation and have them give presentations on what they're working on.

The audience is a sort of variety of people with engineering, business, regulatory, clinical backgrounds, and you can get feedback. Get pointed in the right direction for your needs within the UCSF ecosystem. And that's every, week, it's really a valuable resource for both understanding what's going on in the UCSF and Stanford and outside

med device development world and hearing all these really smart people give feedback about other people's projects and I learned something new every single week just from hearing people who are much smarter and more experienced than me talk about how they might direct a project that's come to us.

Those are just some of the sort of opportunities that are available through there.

[00:27:32] Ty: That was such a fun experience to get to come, be invited to be part of that. Yeah,

[00:27:36] Tom: and

[00:27:37] Ty: I didn't realize you were part of the Catalyst program. If you don't mind the pop question then target product

[00:27:41] Tom: profiles.


[00:27:45] Ty: Do you mind describing that real quick? Cause it just is a mechanism for early stage for med device development.

[00:27:52] Tom: Yeah, so basically just to explain, each project that gets accepted into the Catalyst program gets between 15 and a hundred thousand dollars worth of funding, but then you get assigned a team of advisors and interns who are usually graduate students or residents like me.

And you put together what's called a target product profile. If you almost think of it as a combination of the lean business canvas and all the components of what the actual device are. And so I don't have it in front of me, so I can't remember all the segments, but it's like device description, the instructions for use, you put together a competitive analysis.

Like a sort of mini version of a business plan, but you know what the regulatory pathway is, what your IP strategy is gonna be. So all the major, it basically forces you to think about all the major components of your device that an investor will want to hear about. And you get this team of people that help you with it, but people have put together, the equivalent of this many times over and people are learning as you go.

And at the end of the day, you come away with this document that's almost like a very fleshed out executive summary. And it both helps to have all of your thoughts in one place and then direct what you're gonna do in the future. And so for our team, for the kidney pod team that sort of went through this that I interned on and, now work at it was a really valuable experience to help us put down in writing what we already knew and understand, what the gaps were and where we needed to go.

Yeah. Yeah. I

[00:29:16] Ty: mean, from other industries it sounds like a product requirements document, but much more specialized to the, surgical

[00:29:22] Tom: innovation space. Very cool. Yeah. And they have different ones, catalyst not only funds, medical devices, but they fund digital health products. They fund more like pharma and basic science kind of things. And they have their target product profile. The sort of format is different depending on what the sort of category the technology is, so it's very specialized to, whether you're developing a diagnostic or therapeutic device, digital health product.

[00:29:48] Jared: We did get a really good question from Franklin and the audience and sticking on the idea of the resources that you have available to you. Does the UCSF program have an ensemble of consultants and advisors to assist, their innovation fellows in the business, regulatory components of like bench to commercialization.

[00:30:06] Tom: Yeah, so we do which is really helpful. And some of them, I don't know how the financial structure works. I think some of them are volunteer and some of them are on some kind of a retainer. But there's a whole sort of roster of people who have connections to both the UCSF, Stanford Pediatric Device Consortium and the greater sort of innovations ecosystem at UCSF.

And it's very easy to, once you get plugged in, to get put in touch with the right people just to sit down and have a call to work through some of the questions that you have. We very frequently do that for different devices that come through our surgical innovations forum.

And then even through, for the Kidney Pod project, just gotten some funding through UCSF. We've been introduced to like our lead advisor actually through the Catalyst program. And a number of other really, like amazing resources. And that's something that's been cultivated over time by the leadership of these programs.

So this isn't something that, just happened overnight. These programs have existed for well over a decade. And so it's slowly cultivated this group of really fantastic, business people, engineers, serial entrepreneurs, executives, you name it. There's probably someone who can give you some decent advice about it.

So that's I think one of the sort of superpowers of this like Bay Area and MedTech ecosystem.

[00:31:25] Jared: We've been talking about some serious stuff for a while and I did wanna lighten the mood with more of a fun question about Yeah. Of your favorite inventors and innovators, since you're falling in some great footsteps and so what are some of them that have inspired you, to where you are today?

[00:31:39] Tom: Yeah. It's fun to think about that kind of stuff. Who are the people you're like, man, I wanna be like them when I grow up. I think at UCSF and particularly in our group that person that really stands out to all of us is Mike Harrison.

So Dr. Harrison is a pediatric surgeon now emeritus faculty at UCSF and basically invented an entirely new field of surgery and a lot of devices that go along with that. Prior to him when kids had various prenatally diagnosed issues there was really nothing you could do about it.

And he basically invented the field of fetal surgery where you actually go in and do operations on unborn babies and fix the problems that they have. And there are a number of medical devices that are named after him as a result of some of these inventions that he made.

There aren't very many people in the world that do these kinds of operations. But he's trained most of them. And the legacy of sort of pediatric device development really just comes through him. And so every year there's a Harrison Symposium that's held the UCSF that hosts our pediatric device consortium and is just a big meeting of all of the people that have worked under him over the last, five decades.

He's still there every year, on meetings. I don't know Ty if he was at our surgical Innovations Forum meeting, but he, he's still in our meetings every week, even though he's retired and. And still working on some medical devices. But he's a fantastic resource and always so excited about everything that the Surgical Innovation Fellows and the people in the Pediatric Device consortium work on.

That's so cool to have your hero as

[00:33:13] Ty: a mentor.

[00:33:14] Tom: Yeah. Yeah. He's so cool and such an interesting and visionary person. And then outside of medicine one of the people that when I was young, I was really into aviation.

My grandfather was a flight mechanic in the Korean War, and I used to build lots of model airplanes with him. And I could probably have told you about, every plane in the civilian and military fleets when I was like 10. But there's there's a guy named Burt Rutan, who people may remember back when Virgin Atlantic was first getting started.

They sponsored this thing called the Ansari xprize, which was basically the attempt, it was a 10 million prize for the first private group to send someone into orbit. Up to that time it had only been, governments like, NASA and the Russian Space Agency were the only people that ever sent people into space and for less than 25 million.

This guy, Burt Rutan developed this thing called the Spaceship One, which was built out of all these sort of fancy composite materials that had never been used in aerospace before. And I think it was the early two thousands, they sent the first people into space from a private company.

And it was really like him and a handful of other engineers who did this. And it was to me, really an inspiration for how you can use like repurpose technologies that are used for other things, for these composite materials that no one had used for aerospace before. Were used to build these super fast, super light airplanes that could take people into space and survive the whole sort of journey for 25 million is effectively nothing.

It's like a rounding error when it comes to the NASA budget or something, or SpaceX and things like that. And be able to send someone the space with that is kind of fantastic. And that technology was then used for some of the Richard Branson Virgin Atlantic private space stuff.

And so growing up he was one of my like real heroes. I love that.

[00:35:05] Jared: And then I guess just like looking towards, your own career, you are in your program currently, but at the same time, I'm just looking towards the future. What kind of innovation really gets you going? What do you wanna work in?

Now that the reins are gonna be turned over to you as you're the next generation,

[00:35:18] Tom: yeah. So I think the two things that are really important to me are so one I'm so just despite the fact that I work on all these sort of kidney and transplant related things, I'm actually gonna be specializing in colorectal surgery which is a field that sort of innovation has been dominated really by two things.

The intuitive, da Vinci surgical robot, and then like precision medicine, like cancer stuff, colorectal surgeons do all the colorectal cancer. There's hasn't honestly been that much device or other sort of like medical technology innovation in colorectal surgery.

So I think it's a field that is ripe for some technological disruption. And while patients generally do pretty good. There's still a bunch of big unsolved problems in the field, and so I'm really looking forward to like digging into that. And then the other thing that I see, which was a big part of the impetus for me transitioning out of all the basic science that I had done in undergrad in medical school, was that I saw so many really brilliant people around me have these, what seemed like great ideas that never went anywhere. And I'm talking some about surgeons, some is about basic science researchers. But it seems like there is really a gap in teaching people like me how to develop medical devices out of academic programs. And so my sort of career goal is for medical technology innovation, surgical innovation, to be on par with basic science, research with clinical outcomes research with global health research in academic institutions. And if you look back 15, 20 years ago doing clinical research outcomes, research you weren't really a serious academic surgeon, unless you would ran a lab. And now that's can't be further from the truth. In fact, less and less surgeons are running labs now. And more and more people are doing, clinical research and outcomes research. And so my hope is to have a career that is both focused on building devices and then expanding the academic footprint of medical technology innovation so that it's something that you're learning about in medical school, you're learning about in residency, that people are specializing in this technology development within their field and other fields and are able to spin that out into things that actually are able to help patients.

Sort of the way I think about it is that, at the end of the day, every single thing that we use in the operating room to do our jobs had to be formed out of a company had to be manufactured. The idea that, we shouldn't interact and work closely with industry, I think is not right.

So I hope that over the course of my career we can find a way to really normalize that and make it so that people with great ideas can learn how to turn it from not just a great idea, but actually get it all the way to the finish line. In a more structured way than the happenstance that I think happens a lot now.

[00:38:06] Jared: It's fascinating and I think also you talking about, bright ideas and good ideas, talking about the future of technologies right now. We are living in an age where new things are coming out all the time. I know Ty and I love messing around with Chat GPT and so for you, what also is interesting you as far as like on the emerging technology side. Yeah.

[00:38:26] Tom: I, you're talking about ai, I think that it's already disrupted so much, but even within, academia, if you go look at every publishing house now, you basically either have to attest to a statement that you didn't use Chat GPT

or they explicitly say you are not allowed to like use large language models to write your papers. And I think the reality is that, do you remember a time when you didn't use, when spellcheck wasn't a thing? Oh yeah, I don't. So I think the reality, whether people want to accept it or not, is that these technologies are going to continue to evolve and are permanent.

They're not going away, maybe they'll be regulate, Sam Altman was just in front of Congress talking about, regulation for ai. And I think there'll probably be some degree of regulation, but these technologies are not going away. And nature science, cell, like all these big publications have basically come out like against it.

And my perspective is, I think that it's a little ignorant. I think the reality is that these are going to be adopted, they're going to be used, and I think they're going to be used to make things better and faster and more efficient. And, we need to embrace them because it's gonna allow, technology to evolve for the betterment of patient care, hopefully faster.

So that's one of the things that I really think is gonna change a lot in the next and at different applications of it that I probably have no conception of how you can, use this technology but how it can really help advance medicine. There's a number

[00:39:54] Ty: of issues with that in terms of the traceability.

So being able to have the large language model be able to replicate its results, but that then degrades its performance. Even just in the case of submitting, say a journal article, I mean providing proper attribution to how much did it contribute. Did you just sign your name to something that came out of Chat GPT or did you like Yeah.

Was it the bad first draft and then you had a lot of heavy editing. So yeah, I think the nature of which it gets included as a co-author starts to get interesting. So are you assigning personhood to the large language model at that point? There's all kinds of interesting issues

[00:40:31] Tom: from that.

Yeah. Yeah, very interesting ethical issues and like you say, the authorship thing, it's a very powerful tool. I took the as just as an example one of the last papers that I had accepted, I took the introduction of it and basically asked it to write the introduction from scratch just by giving like a one line overview about what the article was about.

And then Chat GPT is not very good about picking out academic references yet. So I just fed it the references and it wrote a almost verbatim, like 800 word introduction compared to what I actually wrote. So with a little bit of guidance it's frighteningly powerful. And so I see why people want to have some reins on it but I think pulling the blinders over and saying oh, we're just not gonna accept that this is a reality is not the right approach.

I think it needs to be, safely embraced. It's the probably the right way to think about it.

[00:41:19] Jared: Absolutely. I know we've got maybe a couple more questions left in this whole thing. Yeah. Something I think we also are very interested in, that's been coming up a lot and Ty's been speaking about this on TikTok is physician burnout and like you in particular, like you were taking on so much more than even other surgical fellows because you're on the innovation side as well and so how do you manage your life? Obviously you said you have a wife as well, you obviously have a life outside of medicine, outside of your career and are you noticing that's becoming a problem? Or do you think that physician burnout happens as a systemic issue, as a personal issue, someone can't manage their own life? Just what's your take on it in general?

[00:41:56] Tom: Yeah, I th I certainly think that there are massive systemic, components to this. And at least I can't speak for everyone, but for trainees, a lot of I think the burnout comes from a lack of control over your life. And I will say that even though right now, because I have this day job, with surgical innovations and then this company that I work for on the side, which is all of my free time before and after work, unless I'm riding my bike or hanging out with my wife I actually feel less burned out now or I actually think, I would say my life is great right now because I have control over my time and I'm working on exactly what I want to do.

And I love being a surgeon. I have no plans to leave training at all. But that lack of control over your life, I think is what leads to a lot of burnout. If you go into a week, knowing that you're gonna work a hundred hours that week, and that you're gonna be doing all these, big surgeries like great I'm totally happy if you want me to be operating a hundred hours a week.

I think it's the the expectation versus the reality is what really can get to some people. And especially for as medicine becomes more like administratively heavy, like the things that drive you crazy are when you are doing these things that don't really feel like they're moving patient care forward, that you're just doing it because someone else told you had to check some box or that there was some protocol that someone with no interaction with the actual like clinical medical system came up with.

Those are the kinds of things that kind of drive you towards burnout. And then, I will say not having enough time for your personal life can affect things. I think everyone is different. For me, the thing that really makes a big difference is being able to exercise enough and spend, quality time with my wife and my family.

And I think if you do that in a very intentional way in training it can really mitigate the amount of quote unquote burnout that you experience. But again, a lot of that is dictated by, how predictable or unpredictable your schedule is, and surgical training can be very unpredictable.

I would say that having control over your life probably makes the biggest difference. And even if you're working a lot like I am now, like I'm working on all things that I'm really passionate about and so it doesn't seem like that much work. It seems like you're happy to be doing it.

You're very creative

[00:44:06] Ty: in your work and you're advancing the field and you're plugged into the mission of making medicine better. Like even though you might have current day-to-day frustrations, it's tied into that

[00:44:16] Tom: larger mission. Yeah. I think that having a big picture mission really helps.

And honestly it helps make the, minutia even better when you're frustrated about something, you're like yeah you know what, it's fine because it's for something that really matters. Whereas, sometimes clinical medicine, you feel like you're just banging your head against a wall.

That's why, every surgeon their happy place should be in the operating room because there, you're there and fixing a problem. And that's what makes all of us happy. It makes, when I do some moonlighting when I'm on research and every time I'm in the operating room in the middle of night, I'm reminded about why I love

this job because there's a person who's a problem in front of you that you can fix. And that's the, ultimately the most satisfying part of the whole job.

[00:44:58] Jared: And just closing things up here, what advice or, recommendations would you give to clinicians and physicians that are interested in pursuing, the route that you're on right now?

[00:45:06] Tom: Yeah. I think that to me it was very intimidating and I almost didn't know where to start. And I would say almost just keep swimming. You'll find one thing that looks like a small opportunity, like the Catalyst internship program, and then you'll get introduced to some, people through one person or people through another person.

And you'll bother someone that you really wanna work with over and over again. And a bunch of people say no, but someone's gonna say yes and that's gonna open the doors for you. I think it's very hard for people who come from a traditional like academic medical background where they're just used to, these are the hoops in front of you, jump through the hoops.

Doing this is very different than that. And so it can be very uncomfortable. It was very uncomfortable for me, and I know it's very uncomfortable for a lot of people to go through this very nebulous, different process of developing medical devices. And giving yourself some space to just say, it's okay.

A lot of things are gonna go wrong here. I don't really know what the path forward is, but I'm just gonna plow through the door. And I think that has really opened up this whole world for me that I didn't know existed 18 months ago. And it's it's been a philosophy that I think, benefits, anyone who wants to do any kind of medical device development, med tech development, entrepreneurship, kinda work.


[00:46:13] Jared: And on that note, Dr. Tom Sorrentino, thank you for your time. We really appreciate your insights. Look for us on TikTok, Spotify, YouTube and yeah, just thank you so much for your time. We really appreciate it.

[00:46:24] Tom: Yeah, Jared, Ty, thanks so much for having me.

Awesome. It was great talking to you today, Tom.