AdvaMed Webinar Recording - Transcript

WEBVTT
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Monty Sylvan (msylvan@advamed.org): Alright.
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Monty Sylvan (msylvan@advamed.org): Good afternoon. Everyone my name is Monty Sylvan, and I'm the Coordinator
for the membership department. Here at Admin. Today we have a beautiful
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Monty Sylvan (msylvan@advamed.org): webinar aligned with you in partnership with Sunrise Labs.
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Monty Sylvan (msylvan@advamed.org): Entitled Lessons CEO Forum Lessons from the front lines of Med Tech
Innovation.
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Monty Sylvan (msylvan@advamed.org): Today, I want you to be mindful of any questions that you may have. Please
direct them to the QA. Section on zoom and not the chat. Any questions that will be in chat that aren't about the
webinar. I'll just direct you to the QA. Section
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Monty Sylvan (msylvan@advamed.org): aside from that, we have a fantastic presentation aligned for you. Opening up
today. We have the president of Sunrise Labs. Brian Gilpin.
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Monty Sylvan (msylvan@advamed.org): Brian, I'll let you take it over from here.
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Bryan Gilpin: Okay, thank you very much. Monty. 1, st 1st off. Can can everyone hear me? Okay.
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Bryan Gilpin: my good. Okay. Good. So 1st off, it's a real pleasure to to be here with you today.
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Bryan Gilpin: I'm really excited about what we're going to talk about today.
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Bryan Gilpin: 1st off, I've been involved with advent for pretty much most of my career, and really exciting to do
something that helps out with Adventmed and the community there. And it's really excited to present to you 3
entrepreneurs that have just a tremendous amount of respect for for what they're doing and and who they are, and how
they're going about it.
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Bryan Gilpin: and some of the things that we'll cover. So you know, before we dive in and and have each of them give
introductions.
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Bryan Gilpin: Really want to focus this on the journeys that each of these Ceos have had, and they're all at different
stages and different types of products, and have faced some very big, unique challenges in their own own ways. So I
want them to talk about that, share their experiences there, share some of the lessons learned to all of you and what it
means to be be developing innovation at the scale that they're developing it, and the type of innovation that they're
developing.
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Bryan Gilpin: And then again hope for a constructive dialogue. We'll try to save about 10Â min at the end for some
questions for all of you from the audience.
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Bryan Gilpin: And again we'll make it from there an interactive dialogue.
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Bryan Gilpin: So with that, maybe I'll open it up to introductions. So for each of the panelists here, if you don't mind,
introduce both yourself
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Bryan Gilpin: and your company, or most recent company. In some cases serial entrepreneurs here, who are engaged in
different activities, and have been engaged in other activities. So maybe I ask that we focus on your most recent
company. But please tell us about the company, the technology, and then for the audience out there. Love to hear how
you got to where you are. What was that journey that brought you to being a CEO for an innovative Startup Technology
company.
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Bryan Gilpin: So, Jim, maybe I'll start with you.
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Jim McGlone: Thank you, Brian, appreciate it. And as you said, it's a journey, right? So the number of
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Jim McGlone: steps to get here. My most recent experience I was a President CEO of Vitera.
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Jim McGlone: or spin out of preclinical spin out of Children's Hospital.
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Jim McGlone: We're focused on the extreme preterm babies.
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Jim McGlone: and with that, trying to develop as the FDA would coin it as an artificial room technology
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Jim McGlone: which is cutting edge. And again, it's preclinical
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Jim McGlone: multiple discussions with the FDA.
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Jim McGlone: And very, very exciting, almost like we defined as a moonshot. So
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Jim McGlone: that's my latest experience, and I'm sure we'll talk about
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Jim McGlone: my other experiences going forward. Thank you.
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Bryan Gilpin: Okay, good. Thank you, Jim. So Mark, maybe we'll turn it over to you.
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Mark Pacyna: Thanks, Brian, for the invite to join this group, and
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Mark Pacyna: so let me 1st talk a little bit about reprieve cardiovascular. So I'm the CEO of reprieve, cardiovascular. It's
a clinical stage Med Tech company pursuing a treatment for acute, decompensated heart failure patients. So these are
these are patients
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Mark Pacyna: that show up in the hospital with volume overload. Typically have swelling in the limbs and have a hard
time breathing. It's actually the second most common admission for Medicare age patients in the hospital, in the Us.
And around the world. And so we are pursuing and just finished a large pilot study in the us, and just about to embark
upon our pivotal trial
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Mark Pacyna: so look forward to sharing more about that journey here in a second, and then personally. Before I
jumped on the the startup journey with reprieve. 3 and a half years ago I actually grew up at Medphronic. I spent 6, 16
years with the large organization.
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Mark Pacyna: a number of different roles in that time, primarily, in either the Corporate development group which was
doing mergers and acquisition and venture investing in startups or in in the businesses and sales and marketing roles.
The previous 6 years. Before I jumped into the Startup world. I was leading in the peripheral vascular organization for
the business. So I came from a big company, and now
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Mark Pacyna: I feel like, after almost 4 years in the startup. I can. I can at least represent what it what it takes to be a
entrepreneur on this side of the fence.
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Bryan Gilpin: Good. Thank you, Mark Jonathan. Maybe we'll turn it over to you next.
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Jonathan Gunn: Yeah. Great happy to be here.
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Jonathan Gunn: I'm the CEO of Brightseed. We're a preclinical technology company helping surgeons see what's
otherwise invisible in the body.
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Jonathan Gunn: We're specifically addressing the ability to see and assess critical structures and disease tissue in
surgery. And we're doing that with a technology called hyperspectral imaging that we kind of turn on its head and use
the technology in a sort of a unique way.
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Jonathan Gunn: And actually introduce that optics right into the jaws of
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Jonathan Gunn: surgical devices. So before a surgeon cuts or cauterizes, they know exactly what they're about to
interrogate as as they go.
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Jonathan Gunn: I started my career a little bit differently where I grew up actually in academia, researching
intraoperative imaging with fluorescence, and Mr. Took a diversion into intellectual property law, and was on my way
to becoming a patent litigator at a firm called Fish and Richardson, and actually began to fundraise for Brightseed
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Jonathan Gunn: during my second year in law school and ended up deferring my law job indefinitely, and became an
engineer out of school. So a slightly different
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Jonathan Gunn: path for me, and have been at the helm of Brycede for a number of years since.
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Bryan Gilpin: Okay, very good, Jonathan. Thank you.
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Bryan Gilpin: So thank you for the background. As you hear, we've got a diverse set of backgrounds from each of the
entrepreneurs. One thing I'll say is so through these paths, whether it be through a Medtronic or Jonathan through your
path, is medical and legal, and so forth, or Jim through a variety of different avenues. One thing, when you started the
CEO of the companies, I can imagine.
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Bryan Gilpin: Things may not have always gone, as you expected, or as you envisioned
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Bryan Gilpin: there might have been some things that came up that that weren't exactly as you expected.
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Bryan Gilpin: What would you say, looking back?
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Bryan Gilpin: In the development of the technology and development of the company were the one or 2 biggest
challenges that you had to face. And then can you talk a little bit about how you address them, or how you are
addressing them?
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Bryan Gilpin: And maybe I'll start Mark with you on that one.
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Mark Pacyna: Yeah, sure, Brian, thank you.
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Mark Pacyna: so you know, I think it depends on the stage of the organization that you join. Of what what you really are
going to tackle. So when when I joined Reprieve originally 3 and a half years ago.
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Mark Pacyna: you know, we were really wrestling with the fundamental science and physiology of acute heart failure.
And truly to understand that is so critical, to ultimately developing the right product, to address those needs. And so you
know whether that's animal studies, whether that's, you know, 1st in human experiences, really being mindful of the fact
that you don't know everything.
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Mark Pacyna: it's critical, because when you make assumptions that this is going to work, or that's going to cause XY,
and Z to happen, you always get surprised, at least in my experience in early development. So I think it's really
important that you know that organizations and companies plan for failure when they're really trying to still understand
that fundamental physiology that we're all trying to address.
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Mark Pacyna: and then and then once you get it right, or at least you think you get it right. I think then, it's really a
question of how can you create and and rapidly develop the minimum viable product to test that that out? And I think
that has been
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Mark Pacyna: both, the the biggest learning that we've had around how we go approach developing a new technology is
to to really be focused on that minimal viable because you're gonna find other things along the way. That is that are,
gonna you know, want to divert your attention to. And you, you really need to stay focused as
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Mark Pacyna: a small, you know, small startup company that has limited resources to address those critical things. So I
think, you know. Really, you know, coming back to understanding what you're trying to do in terms of meeting the
needs of those patients.
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Mark Pacyna: And then, you know, being laser focused on just trying to do enough to prove out what is going to work.
As as you move along the pathway, there's always time to add more later in the in the development of a program. And
it's really hard to know where that line is. Sometimes. So I think that's been the biggest, both opportunity and challenges
we've faced so far.
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Bryan Gilpin: Yeah, mark any advice on how to stay focused. That's 1 thing. I think we consistently see, when we work
with companies from sunrise, it's it's
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Bryan Gilpin: see sometimes easier said than actually done. And
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Bryan Gilpin: what? What are some advice that you could give.
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Mark Pacyna: Look. I think I think I don't have all the answers on this, Brian, because it's a constant challenge every
single week. And I think it's because of the nature of
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Mark Pacyna: you know, most of these organizations. When you're small and a startup you're focused on, you know the
possibilities you're focused on what we can do to address this big unmet need. And you're focused with a lot of
engineers, scientists, and clinicians who want to think about all of those things. And so I actually think it is the biggest
challenge that that most startup space is, how do you truly truly focus on
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Mark Pacyna: just those few things that are most important. And so, you know, I think our team asked. All the time is,
when do we need to do that? Not. Should we do that? Because when you ask, when you in effect, you know, have
prioritization as part of that discussion.
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Mark Pacyna: it's not. We should do this, and then everything gets put on a plate. So I think you know a simple question
like, When do you think is the right time to add, you know X or Y or Z from an innovation standpoint, a technology
standpoint, or even adding different clinical considerations. That, I think, is probably a more powerful question for us
and our teams than, it is to say, should we do it or not?
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Bryan Gilpin: Nice. I love. It sounds good, Jonathan. What about you at Bright Seat, would you see? Is some of the
biggest challenges you've had to face.
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Jonathan Gunn: Yeah, I mean, I guess I'll sort of go back to the beginning, because I think it's a little bit unique. But you
know the the
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Jonathan Gunn: fundamental foundation for bright seed sort of started through an academic exercise. Right? We were
following sort of the Biodesign path that had been sort of spelled out by, you know the folks at at Stanford, you know,
considering an unmet clinical need where there's not necessarily a technology solution, you know, in within view.
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Jonathan Gunn: And so I think that now there are a lot of innovators that are thinking about it with sort of that same sort
of Greenfield perspective. And there are a lot of advantages to that. Right? I mean, once you lock in on an unmet
clinical need, then you have the ability to pick the best technology, whether that's based on performance, feasibility,
cost, manufacturability.
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Jonathan Gunn: intellectual property, right and freedom to operate right? So there's a lot of advantages to sort of being
able to think about. You know the right technology for the problem. And importantly, you don't have to worry about
translation and and negotiating a licensing deal.
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Jonathan Gunn: But there's a key disadvantage. Right? There's there's no technology and there's no validation that the
technology you're gonna look at
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Jonathan Gunn: will be will work specifically for your problem that you have to solve.
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Jonathan Gunn: And so when we started brightseed, we were thinking about things like laser doppler, ultrasound right?
A wide range of different technologies, and we iterated on a number of different variations of technologies that could be
used to help surgeons identify critical structures.
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Jonathan Gunn: and once we locked in on hyperspectral imaging and diffuse imaging, you know. Then we had to go out
and convince people to invest in us right with the idea that we're going to be able to deliver on that technology. And we
had to build the team around it
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Jonathan Gunn: right? And so the challenge was, you know, you've got to go and raise money with a longer timeline
than maybe alternative. You know, teams and companies have, and higher cost
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Jonathan Gunn: and you still need to balance that you're gonna be able to execute and deliver a product within a
timeframe that made sense.
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Jonathan Gunn: So we sort of mitigated that in a few different ways. You know, we we've sort of managed a smaller
team right? We've never had more than 10 full time employees.
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Jonathan Gunn: We've targeted sort of a mix of non dilutive grant support. So these sbirs or small business innovation
research awards along with angel funding and eventually venture financing. So we've always had sort of a healthy mix
of about 50 50 grant support and investor dollars
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Jonathan Gunn: and we've now raised over 15 million for the company, but that has helped sort of offset, the the the cost
of developing a new technology.
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Jonathan Gunn: and then, importantly, thinking about sort of what product development partners exist that would be in
it for the long haul that could deliver product at scale, you know tens of thousands of units per year, but are also able
and interested in delivering small prototype batches to help our R. And D team.
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Jonathan Gunn: And so one of the 1st things that we did that was, I think, pretty key to to the company was we
partnered with a local product development firm that had experience in the minimally invasive surgical space
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Jonathan Gunn: and aligned our sort of you know, Phd level researchers with a lot of their you know, development
expertise. So that we had a healthy mix of early stage innovation with being able to deliver a technology that could be a
product and a scalable product as well.
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Bryan Gilpin: Good. Okay.
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Bryan Gilpin: Jonathan, yeah, you hit on a lot of themes there. Everything, from the unique technology to the how to
fund it and and managing the costs. And we'll definitely want to dive some more into your approach to product
development. You've got some unique challenges there. So, Jim, maybe we go over to you. What do you see as your
biggest challenges and maybe ask that you address it in terms of itera
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Bryan Gilpin: so big, big big program coming out of the of Chop, the Children's Hospital of Philadelphia. But also, if
there's other examples from your past that you'd like to share, appreciate that as well.
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Jim McGlone: Yeah, no, Brian, thanks again. I mean, this is an exciting area to talk about. And from my experience,
having started with Siemens years ago, and
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Jim McGlone: dealing with a large company, a large structure, and then getting into smaller startups.
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Jim McGlone: in the oncology urology space with Galeo, which eventually merged with a division of Amersham and
then sold General Electric.
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Jim McGlone: You get to see the be. You know what a large company can do and what a small company can do.
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Jim McGlone: And it really comes down to resources and people right? So
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Jim McGlone: you don't want to take in a small environment. You don't want to take large company processes and
procedures, and over overlay that on top of a small startup.
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Jim McGlone: So you have to look at what's practical.
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Jim McGlone: I think Mark and Jonathan did an excellent job of summarizing
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Jim McGlone: some of the challenges that were in front of them.
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Jim McGlone: as you know, when you go from a preclinical to clinical, and then go from there and starting with some
of the evaluation. But it all starts with the unmet clinical need.
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Jim McGlone: So what is it? And in our case on the Vitera side. It's very, very apparent.
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Jim McGlone: It's the extreme preterm baby.
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Jim McGlone: And in that environment
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Jim McGlone: it's a very unique.
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Jim McGlone: When you look at medical devices, and you're in the mainstream of surgical devices, adult
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Jim McGlone: reimbursements, etc.
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Jim McGlone: You're dealing with mainstream technology. You get into pediatrics and you get into even what we'll call
fetal.
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Jim McGlone: You're getting to a smaller addressable market, right? So
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Jim McGlone: one has to understand that as a backdrop.
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Jim McGlone: however, as I mentioned earlier, this is a moonshot.
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Jim McGlone: This is something that is going to revolutionize, how
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Jim McGlone: infants and preterm babies are treated.
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Jim McGlone: The implications aren't just for the immediate technology, but the
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Jim McGlone: cascade that could come from it.
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Jim McGlone: So we take a step back and we say, What's the unmet clinical need? It's extreme preterm, babies.
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Jim McGlone: But you look beyond that, and there's a market beyond that.
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Jim McGlone: as Mark alluded to earlier, you have to look at what you need to do, what what is needed today.
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Jim McGlone: What do you need to do? What do you want to do? What do you have to do?
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Jim McGlone: And the wanna do's are on the shelf.
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Jim McGlone: The need to do have to do are right in front of you, and you've got to do them. You have to address them.
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Jim McGlone: And in our situation
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Jim McGlone: we're not talking about one product.
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Jim McGlone: We're talking about several products within one.
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Jim McGlone: That's a symphony of technology.
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Jim McGlone: So the complexity is off the scale.
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Jim McGlone: And so you have to be able to manage that
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Jim McGlone: on a day-to-day basis.
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Jim McGlone: and to Mark's comment earlier.
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Jim McGlone: you know, expect to fail. You don't know what you don't know. You know those type of things you
discover as you go forward
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Jim McGlone: on the vitera side, multiply that by, you know it's it's
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Jim McGlone: every different phase. And then, as you look at the physiology of the problem. What is the physiology of
the problem?
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Jim McGlone: You're talking about fetal physiology.
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Jim McGlone: You're not talking about neonatal.
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Jim McGlone: You're not talking about adults.
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Jim McGlone: You're talking about a new field that's now being explored.
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Jim McGlone: And so all this is a discovery process.
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Jim McGlone: And as you discover more information, you have to have a team that's able to digest that information, a
fairly quick process.
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Jim McGlone: understand it.
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Jim McGlone: not react to it, but respond to it in a manner that anticipates the next effect.
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Jim McGlone: and to do that across a whole breadth of different products. It's extremely, extremely challenging.
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Jim McGlone: So if you look at, you know a solution for one product and say, Well.
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Jim McGlone: this widget isn't seeing through a certain thickness of tissue. Okay, we have to make certain adjustments.
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Jim McGlone: But in our situation.
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Jim McGlone: if we had a a part of our component that wasn't
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Jim McGlone: acting properly.
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Jim McGlone: That then affects the downstream of another component which then trickles into the software, which is
the hub of everything. So again, there's this domino effect.
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Jim McGlone: and everybody sees it in their own product lines.
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Jim McGlone: So it's very important to focus on what you have to do.
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Jim McGlone: Engineers. We all love to create, and we all love to build beyond.
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Jim McGlone: One of the things I learned from Siemens
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Jim McGlone: is that you can easily over engineer things if you have too much money or too much time.
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Jim McGlone: And so that's the the challenge that all startups have is, do you want to run hungry?
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Jim McGlone: But you don't want to run
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Jim McGlone: money so, and the markets drive that. So
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Jim McGlone: the challenges that we have Vitara are, you know, it's again extremely promising technology. It's
preclinical. As I mentioned before.
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Jim McGlone: But there's a hierarchy of decision making needs to be made in our company or by Terra and any other
company.
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Jim McGlone: What's the priority? The priorities focus on the unmet clinical need.
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Jim McGlone: And that is it. You know the rest of the stuff you can talk to investors about. You can talk about the
roadmap. You can talk about the other available markets.
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Jim McGlone: but you have to execute on the near term, because if, without executing on near term those, there is no
long term.
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Jim McGlone: So yeah, that's that's
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Jim McGlone: anyway my feedback on your question.
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Bryan Gilpin: Yeah, that's great, Jim. Thank you. And just maybe on on that point, I
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Bryan Gilpin: as an engineer, I I would love at some point in my career to not have to worry about time or money.
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Bryan Gilpin: That would be the dream job, right.
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Bryan Gilpin: of course, wouldn't get anything done. But still it would be
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Bryan Gilpin: pretty pretty wonderful environment. But the the actual constraints that you face, of course, doing these
kind of programs. Especially the complexity that you faced up. Itera in particular, was just extreme
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Bryan Gilpin: So maybe it would be helpful, I think, to expand a little bit from each of you on your approach to product
development.
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Bryan Gilpin: And you know, Jonathan, maybe I'll start with you if you started to get a little bit into that, and I'd love if
you could expand a little further about. So how would you describe the approach that you've taken? What's your strategy
there? How are you going about it different, maybe, even if if it's gone well, what you might be doing differently
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Bryan Gilpin: and so forth.
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Bryan Gilpin: Can you expand upon that.
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Jonathan Gunn: Absolutely. I, you know. I think that
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Jonathan Gunn: When we started bright seed, we really thought about sort of what are the crown jewels that we're
creating what creates the value, where it's what's the intellectual property that we can that we can, you know.
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Jonathan Gunn: And for us, that was really around sort of integrated optics and hardware on the one side. And then the
algorithms, the deep learning, the sort of the special sauce that allows us to
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Jonathan Gunn: detect critical structures or disease tissue right? And so from that perspective, we wanted to own that
those areas internally. And so we've always had team leads internal to the company that that own
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Jonathan Gunn: sort of the the hardware, the optics, and the and the software.
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Jonathan Gunn: We did begin interestingly by bringing in a translational researcher, a Phd. That was that had spent time
defining clinical opportunities and working with clinical partners to understand how we should prioritize for thinking
about what what Mark and Jim was were emphasizing Early on right. So what's the what's you know?
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Jonathan Gunn: The initial market segment we should approach? What's that initial
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Jonathan Gunn: patient or or surgeon
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Jonathan Gunn: and really understanding sort of you know what what that initial product or technology would need to
be, and then how we could test it right?
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Jonathan Gunn: And then we brought in optical hardware lead, electrical engineering signal processing leads.
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Jonathan Gunn: and then and then began to add team members around data collection and processing.
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Jonathan Gunn: So that was really sort of the core team internally. And then we began to look for external partners that
could help us to deliver on
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Jonathan Gunn: on the product and the implement implementation of the technology.
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Jonathan Gunn: And you know, in that case, we're really looking for partners that could scale
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Jonathan Gunn: and that had sort of lived, the product development of the product categories that we were interested in.
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Jonathan Gunn: So we wanted to make sure that we were finding partners on the instrumentation and the software side
that had domain expertise.
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Jonathan Gunn: That understood the operating room
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Jonathan Gunn: and that had in- in house support for early stage products that would be able to sort of deliver on sort of
iterative development. So
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Jonathan Gunn: you know, understanding that projects weren't gonna be a million dollars, they were gonna be tens to
$100,000 projects right?
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Jonathan Gunn: But that they would also understand what manufacturing and quality trends exist. So things like cyber
security right being able to be mindful of of what we were building and how it would align with product in the future.
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Jonathan Gunn: So that's how we began to think about sort of how we would sort of divvy, divvy up the work internally
and externally. And then we've always had sort of an In house project manager to help work with those external partners
to make sure that you know we were getting the right questions answered, and we were providing directionality instead
of sort of open questions to our external partners to make sure they were efficient relationships.
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Bryan Gilpin: Right? So thank you. That's I'm gonna come back to you. And some more details of the questions and and
how how you thought about those partners, because I think what you described in terms of partners sounds a little bit
like the Holy Grail. It's the the partners that can have the depth
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Bryan Gilpin: of the technology space that you're in hyperspectral spaces. It's not a simple technology, right? Especially
the way that you're you're putting it to use. It's pretty unique.
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Bryan Gilpin: But also be able to develop out all the other components around the product.
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Bryan Gilpin: As well as think about how to scale so it's a pretty unique combination. So let's get back to that in a
moment, Mark. Maybe we can go over to you. I'd love to hear some more from your side about how what your approach
was to developing your technology.
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Mark Pacyna: Yeah, Brian, it's building on what Jonathan and Jim have have said. I think there's a couple really unique
pieces that I just want to touch on is is that
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Mark Pacyna: you know when, when you're relatively early on, you want to be fast, you want to be nimble, and you,
you know you, you have to react to all of the nuances that you're seeing, whether it's in your development program or
your clinical program. And and you want a team that can support that nimbleness, whether it's, you know, all inside or
or a combination of partners.
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Mark Pacyna: What I think we're going through right now, though, is this transition, you know, both because the
technology has matured, but also the regulatory kind of process that we're going through, you know, getting ready to
start a pivotal trial, you know it becomes much more rigorous in terms of how quickly you can make some of those
changes, because you have to follow the processes and the testing, etc, to then pass through regulatory hurdles, not just
your internal hurdles. And so I think
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Mark Pacyna: that's a really big change that our team is going through right now of, you know, being as nimble as
possible, but also be mindful of how often and when and how we combine innovation to go back through those
regulatory processes. So I think that's just a a mindset as you go. And as the programs advance something that we're
very mindful of, you know, taking those innovations and taking those things off the shelf that Jim mentioned that now
we want to work on it.
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Mark Pacyna: But now we really need to have a product roadmap. When do we want to introduce these things? How are
we going to introduce those things? What other innovations are going to be paired with those things, and it's not as
simple as it as it once was 4 years ago for us.
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Mark Pacyna: and I think then the last thing I'll I'll mention, I think, is actually
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Mark Pacyna: really interesting because of the 3 companies that we represent is that I think most innovation is getting
smarter. And by smarter, I mean, it's it's it's involving software.
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Mark Pacyna: And it's involving algorithm. It's involving, you know, deep learning. And when you think about what
we're all doing. You know, hardware is so critical to ensure that we have the capabilities to then leverage the software to
continue to improve and enhance upon the therapies and technologies we're developing.
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Mark Pacyna: And I think you know, as I think about what's probably the biggest challenge we've faced is is software is
harder than everybody always thinks it is. So I am full admission, a computer science undergrad. And so
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Mark Pacyna: we've always talked about how software is hard. And it always takes longer than you think. And there's
all, all of the the requirements to really do this, especially with medical grade software, where you have to be
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Mark Pacyna: 100% sure that this is going to work 100% of the time. And so when we think about how critical that
component is is to, you know, build the hardware that enables us to leverage and update software, you know, and and
build programs and products that are going to be able to scale in the future with that. I think that's that's something that I
think a lot of companies are wrestling with right now, and I think probably
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Mark Pacyna: you know, if I was able to go back and just say, you know, you could probably never underestimate how
much time and attention the software side of of these businesses and these technologies plays a huge role in driving
timelines.
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Bryan Gilpin: Yeah, okay, Mark, thank you for that. And this
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Bryan Gilpin: this is an admin forum. But I will say that from a sunrise standpoint you're singing our music. So I
appreciate that. And same with you, Jonathan, on that note. Maybe I'll turn that over to you and did you tell us more
about vitera and the approach to the technology development.
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Jim McGlone: Thanks. Again. Brian and
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Jim McGlone: again. Jonathan, Mark are hitting some really good points when you talk about product development.
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Jim McGlone: But I think we take a step back and keep it in context, right? So to keep it in context, we are in a
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Jim McGlone: regulated industry.
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Jim McGlone: So as we look at any product development process. You have to keep that in mind from the word go.
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Jim McGlone: So you can't be developing things and not be cognizant of the fact that at the end of the day
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Jim McGlone: this is going to have an impact on person. At the end of the day you have to get through the FDA.
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Jim McGlone: So you have to be cognizant of that. Every step of the way I've been associated with the companies
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Jim McGlone: not not have driven them, but knew of them
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Jim McGlone: that this whole concept of catch up on the documentation later.
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Jim McGlone: You know, that is a that's a dead end, because, you know, you can innovate and do certain things. But if
you're not keeping track of it.
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Jim McGlone: you're gonna wind up in in trouble in trying to file.
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Jim McGlone: So when it comes to the proper documentation, Qms systems, etc.
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Jim McGlone: I think in your development process, you need to be very sensitive to the quality aspect of it, right?
Because you're in a regular regulated industry.
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Jim McGlone: At the end of the day it goes into effects. The patient.
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Jim McGlone: So you have to early on. Think about that. There are a lot of companies out there that don't think about
that. They don't think about the parts. They don't think about
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Jim McGlone: traceability. They don't think about certain things
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Jim McGlone: that if you have to catch up to that at the 11th hour.
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Jim McGlone: you're gonna spend a heck of a lot of more money, and you're gonna delay your submission.
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Jim McGlone: but that also relates to you. Know what Jonathan said before. What do you? What do you develop in
house? What is your expertise?
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Jim McGlone: We talked about the clinical need. All right. We talked about that earlier. What's the clinical need? Then
you have to define what your resources are and what you can afford to do in-house. And what you want to decide to
keep in-house
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Jim McGlone: if it mark his comments about software, software is very important. Is that your expertise, or is it on the
hardware side?
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Jim McGlone: And then it's really finding the right partners, because the right partners will help you in that process.
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Jim McGlone: We've been very, very impressed with sunrise and the work you folks have done with us.
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Jim McGlone: And I will not share that with others in the sense of
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Jim McGlone: the other companies we've dealt with
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Jim McGlone: in our situation
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Jim McGlone: this program. Originally, as we were spending it out, was
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Jim McGlone: outsourced.
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Jim McGlone: And as you develop this technology and you look at it. And you say, Well, it's not one product. It's
several within one.
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Jim McGlone: and the breadth of the challenges.
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Jim McGlone: Candidly, I would say, even Medtronic would have a challenge with, because they're so diverse
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Jim McGlone: and so find those expertise. As Jonathan said. Do you go outside, or do you go inside? One of the 1st
things you have to decide
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Jim McGlone: what's your core competency.
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Jim McGlone: And in this area, as with the 3 companies, have talked about, it's developing product.
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Jim McGlone: It's not scaling manufacturing. It's not, you know, the manufacturing aspect. It's the innovation piece.
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Jim McGlone: and that core competency, then, can be divided down into software hardware whatever.
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Jim McGlone: And so that you have to decide on where you're going to invest
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Jim McGlone: and spend time on. So
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Jim McGlone: there isn't the fine process and product development, if, indeed, you're going to do stage gate. That's 1
way to do it. If you're going to do scrum on the software side, that's another way to do it or waterfall, whatever
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Jim McGlone: you have to decide which one works for your your group, and how you want to go forward as you
develop some of these things out.
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Jim McGlone: And that's a decision early on that you have to think about, based on availability of resources and people
and expertise.
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Jim McGlone: So
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Jim McGlone: those are things in essence comes down to basic questions again. Resources. Which ones can you,
Garner? Are you going to keep it inside? Are you going to keep it outside with it?
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Jim McGlone: Development process?
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Jim McGlone: You're in a regulated industry
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Jim McGlone: and keep it in context, there are milestones that you need to hit with the FDA,
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Jim McGlone: and they totally expect that so
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Jim McGlone: internally again, if it's going to be stage gate or scrum, or whatever word you want to put to it.
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Jim McGlone: that's going to be specific to the situation.
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Jim McGlone: So
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Jim McGlone: then it's a question of
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Jim McGlone: resources. And can you
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Jim McGlone: leverage those resources internally or externally? So.
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Bryan Gilpin: Thank you, gentlemen. Maybe hitting on one of your themes on the in source versus outsource when you
chose your partners for outsourcing that can be fairly tricky right? And and with a complex product like a vitera, and
also with the others as well. Obviously there's a lot of different partners that you need in order to get this thing done.
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Bryan Gilpin: Can you tell me how how you went about choosing the right partners? What did you consider what were
the trade offs? And maybe, if you have a lesson learned or 2 from that process.
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Jim McGlone: Yeah, no, we we went out to multiple companies in the process. And we we did find, I have to say the
word process 30 years ago. I hated the word. Now
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Jim McGlone: I live, I live by by, you know, because you have to walk through that process. It's a discipline, you know.
Replace the word process with the discipline you go through a discipline steps
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Jim McGlone: to be able to vet
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Jim McGlone: what you think is best for the company and and your your interests.
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Jim McGlone: And as we looked at
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Jim McGlone: symphony of technologies and broke it down into components, and we said, Okay.
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Jim McGlone: in this section.
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Jim McGlone: where do we want to go. How do we discover who are the experts in this space?
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Jim McGlone: Well, 1st you want to figure out, do we want to keep that in house and develop the expertise? Or do we
want to go outside?
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Jim McGlone: So that's the 1st question. So then you say, Okay, we're going outside.
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Jim McGlone: Then you have to then do your own homework, and you rely on the experience of some of the folks that
you work with, and you also do your own homework and say, Okay, now in our company. And my, I've learned this
from the Siemens days, it's people product and process.
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Jim McGlone: There are basically 3 things. And so
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Jim McGlone: in that process I always had a rule.
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Jim McGlone: We have to have 3. You always have to have 3.
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Jim McGlone: Do not get yourself suckered into well, they look good. They they sound good. We're gonna run with
them.
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Jim McGlone: No.
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Jim McGlone: I've always been trained. You gotta have 3. So we'd go out into that area, be it. Whatever widget we
wanted to focus on and say, Okay.
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Jim McGlone: what are the capabilities of them? And we look at their financials? You have to understand or
understandable, because if you go to a large Cmo.
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Jim McGlone: they're very financially stable. But are they going to be able to react to your request?
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Jim McGlone: So you look at the financials. You look at the number of people you look at project management, you
look at the technologies that are similar to yours. In our case, we have disposables. There's also capital equipment, so we
certainly don't want to go to a company that specializes in disposables to have them help us with capital equipment. So
you have to go into those spaces that make sense and that have expertise in
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Jim McGlone: so you go through your checklist of things and you compare A, B and C,
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Jim McGlone: and then you decide
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Jim McGlone: which one is the one that makes sense for you. So there, there's a discipline you have to go through while
you're also.
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Jim McGlone: you know, flying the airplane. Right? So it's a question of you gotta go out and do these things while
you're moving the organization forward.
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Jim McGlone: But that discipline is very important.
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Jim McGlone: and you know the well known well heeled. You know, Cmos, out there may not be the best choice for
you, because, although they can scale and do scale.
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Jim McGlone: If you're a small group and you're only doing 10 of these a year.
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Jim McGlone: And you sit around. Okay, this fiscal year. I need
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Jim McGlone: 10 of these things because I'm still in the development phase.
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Jim McGlone: Well, you know, a large Cmo may sit there and say, Yeah, we're not even gonna bother with that. I mean,
we, you're below our radar screen. So you need to find one company that can
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Jim McGlone: do that scaling for you or take it to a certain level.
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Jim McGlone: and they're out there. There are a lot of smaller, smaller houses that
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Jim McGlone: we'll do. Smaller batches.
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Jim McGlone: There are, and will help you scale to a certain point.
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Jim McGlone: and a lot of companies out there will say, No, you're below a certain threshold.
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Jim McGlone: We're we're not interested because they have overhead. They have monies, and they have allocation and
resources that they want to deploy.
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Jim McGlone: And if you know, you're only gonna do 10 of these a year.
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Jim McGlone: They're not interested. So you have to. You have to vet through that. And it's an extensive experience. I
mean, this is not something that you take lightly, because you're gonna be with this partner for a long period of time.
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Jim McGlone: and you want them to be able to do some scaling for you.
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Jim McGlone: Not necessarily make thousands and thousands of these, because at some point you may move to a larger
Cmo to be able to do that where the expertise is there. So I'm babbling a little bit, but there's lots to consider, but it has
to be a disciplined process. You put in place. The minimum needs to be 3. You put on the table, and you compare and
contrast
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Jim McGlone: all the strengths and weaknesses, and then you go and you make a decision. You don't look back.
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Bryan Gilpin: Yeah.
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Bryan Gilpin: and and any lessons learned Jim from that did it? Always work times, maybe where.
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Jim McGlone: No go back.
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Bryan Gilpin: Can do a little differently, or.
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Jim McGlone: Yeah, there is. I mean, there, there are times that you you think you've done everything right. And then
you you know.
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Jim McGlone: we we call it the honeymoon phase. Right? So you're you're doing this matchmaking, and you're in a
honeymoon phase, and everything is honky, dory.
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Jim McGlone: And then you realize, well, wait a minute. We've got this problem.
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Jim McGlone: How do you resolve it?
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Jim McGlone: And
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Jim McGlone: you know that problem solving scenario
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Jim McGlone: involves the 2 entities.
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Jim McGlone: And I've been in experience where you know that other entities sat there and said, well.
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Jim McGlone: I don't know. They go. Well, wait a minute. We thought you had that expertise.
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Jim McGlone: and so it kind of
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Jim McGlone: it kind of falters.
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Jim McGlone: if you know, I would say the process we went through. We're pretty good at it, you know. Is it? 8, 8 out
of 10. We got right? 8 to 9 out. Yeah. Great. But you you get a goose egg every now and then.
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Jim McGlone: or the level of expectation isn't met.
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Jim McGlone: or the response time isn't there? Right? So you sit there and you say, Okay, we need to pivot. We need to
make a modification to this widget.
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Jim McGlone: I need it done.
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Jim McGlone: and 30 days and they'll come back. Well, how about 90?
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Jim McGlone: No, no, no, it doesn't work.
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Jim McGlone: and so only come and get into the problem solving phase. And that's where the rubble meets the word.
That's where it really becomes. As I mentioned before, honeymoon phase. Everybody's hunky dory matchmake, that's
great, and then you get into the point of well.
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Jim McGlone: the spec is off, or we didn't see this, or we got delayed in this. How can you help us get back on timeline
and costs?
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Jim McGlone: And again, there are some Cmos out there that's that's
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Jim McGlone: not their problem, you know. They it's a cost plus scenario. How do you? How do you want to get into
Cmo situations?
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Jim McGlone: You know. How do you avoid cost overruns? That's by proper planning. That's by spending the time
upfront to do that.
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Jim McGlone: But there's always unforeseen. And then it's the problem solving that both entities get to the table and
say, okay, we didn't see that this component within the the product would fail.
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Jim McGlone: We've got to go get more of it. We've got to modify it. Okay, get it. Understand the problem. It's
resolvable
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Jim McGlone: now, much time, the money, all right.
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Jim McGlone: And that's the proactiveness of a Cmo that sits there and says, Hey, heads up. We thought we could do x
and timeframe, but now it's y plus z.
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Jim McGlone: What what can we do to help you get back? And that's you don't know that until you actually in
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Jim McGlone: in the weeds.
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Bryan Gilpin: Yeah, yeah, we see that over and over again, that that ability to work together, that relationship, that
partnership, the ability to partner is so important. What about from from your side? Yeah. How? How did you go about
selecting your partners
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Bryan Gilpin: and and any lessons learned.
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Jonathan Gunn: Yeah, I mean, I'll you know, I don't need to repeat with Jim just said, because I agree with a lot of that. I
think that, you know.
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Jonathan Gunn: when we 1st are making the decision of whether we're
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Jonathan Gunn: we're gonna own it internally versus looking at at outsourcing. I think the key decision point for us is.
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Jonathan Gunn: we take a consideration of what our unfair advantage for our product will be in the marketplace. And if
it's that key feature in our case. It's the optical information about tissue, right? It's not the.
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Jonathan Gunn: It's not the jaw tool per se, but it's that that optical sensing. Then we own it internally.
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Jonathan Gunn: Otherwise we'll we'll, you know, work with with partners on delivering the you know the
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Jonathan Gunn: the remainder of that of that product, and then, obviously for scaling, and so on. We we work with
partners.
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Jonathan Gunn: So I think that's the 1st question that we ask but then one of the things that we've learned along the way
is that you know
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Jonathan Gunn: you're gonna go through that process that Jim talked about. You're gonna assemble a
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Jonathan Gunn: quest for proposal. You're, gonna
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Jonathan Gunn: you know, define the knowns and the unknowns, and you're going to be as explicit as possible. But it's
really important that you've got clarity on what you need to deliver. You know as best as you can, so that you're
providing a path forward for your partner versus you know, creating a an opportunity. That's a broad investigation
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Jonathan Gunn: of a of a development right? Because the more you lock it down and spell out what the requirements
are, the easier it is to work with that partner. And there's gonna be less unknowns to define. There's gonna be less risk
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Jonathan Gunn: to take out of the project. And so, from our perspective, taking the time to, you know, really assemble a
very clear
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Jonathan Gunn: definition of what needs to get done. Can take a while, because you've got to wrangle with a lot of
questions about what your product is and what the requirements are, and you're gonna have to go back and
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Jonathan Gunn: talk to your stakeholders and engage with your your end users. But the the more you can lock that down
the easier the path is. When you're working with that partner going forward.
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Bryan Gilpin: Makes a lot of sense. Mark. What about for for you? Any things lessons learned on partner selection, or
any guidance on how you went about it.
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Mark Pacyna: Yeah, I I think. Look, I'm not gonna repeat with Jonathan Jim, you know already, City, because those
guys hit it on the head. So it's tough to go 3rd here on this one, Brian. But I I think there's a couple of things that that I
would want to emphasize. One is that
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Mark Pacyna: you know, we ask ourselves, what do we have to be better than anybody in the world at? And those are
the things that we automatically try to do ourselves and build the internal capabilities to do that just like Jonathan
mentioned.
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Mark Pacyna: But everything else should be on the table to potentially outsource, and I think outsource is actually the
wrong way. It is the way we're talking about partnership.
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Mark Pacyna: But one of the things that that we've learned along the the way is that you really have to have enough skill
sets inside so that you can manage the partnerships. You have to have credibility in in that building that program, and
the skill sets enough to know, to ask the right questions, to understand
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Mark Pacyna: where, where is the program at and not completely abdicate responsibility for that outsourcing partner it
right. It is ultimately our program and our responsibility to get this done on the timelines.
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Mark Pacyna: The schedule that that we state as as the owners of the program. And so I think that's really important to
have the skill set to build the team that way and augment with these with these partnerships, and I'm sure Jonathan and
Jim would agree. I think the other thing that I you know, when you, when you are trying to be capital efficient.
Sometimes partners are more expensive.
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Mark Pacyna: But you you really have to balance, you know. I always think every day that I'm delayed is $25,000 that I
just like burned and set on fire. So when when we really talk about burn rates, and we really talk about how important it
is to stay on these schedules and timelines, imparting that on my team, and then having my team impart that on our
partners is critically important, having having people that
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Mark Pacyna: understand the goals and what we're trying to do overall as a company. And I would say, the last thing
that that is really important is.
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Mark Pacyna: you know, I want to build a team that's going to be there for the long haul and so we do need certain skill
sets etc, you know, at different times in the program. And so we ask ourselves, when we're done with this, whatever
effort it is.
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Mark Pacyna: Are we gonna actually need that team to stick around, because the the hardest thing for startups is to do is
ramping up and down and up and down, and it's hard on the team. It's hard on, you know, to manage. It's hard to always
attract the right level of talent for some of those things, especially when they know it may be transient. And so, you
know, keeping in mind all of those different factors is just something that I would add in additional with Jonathan, and
Jim already said.
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Bryan Gilpin: Yeah, nicely said, well done.
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Bryan Gilpin: So as I think we're we're close to time. I do want to throw out there and that maybe I'll open up to the 3 of
you.
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Bryan Gilpin: Do. Do any of you have any last based on your experience so far and not necessarily related to technology
development. It can be anything for all the the innovators and entrepreneurs that are out in the audience. Any one piece
of guidance or advice that you'd throw out there, having gone through what you've all that you've gone through.
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Bryan Gilpin: and again I'll throw it out to the 3 of you. If any of you have an answer.
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Jonathan Gunn: I can hop in briefly. I you know, I'd say.
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Jonathan Gunn: especially in technology development, you need to get responses to
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Jonathan Gunn: your technology and your your Mvp. Right? So you wanna iterate and prototype and and and get that
into stakeholders hands, especially when it's a surgeon. They're very visual people.
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Jonathan Gunn: But I would say, you know your feedback. You have to take sort of with a grain of salt. And so I would
say, what's exciting about Brightseed has been that we created a core value proposition
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Jonathan Gunn: for our end user. And it was both a clinical value proposition to the patient and the and the surgeon, but
also an economic value proposition for the hospital. And that's really turned into our north star
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Jonathan Gunn: of critical structure detection. And so I think it's important for any entrepreneur to sort of, you know,
really think about what their north star is and how they're how they're gonna deliver a value that has
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Jonathan Gunn: a tangible benefit to the patient, but also an economic value to the hospital system, especially in this
current environment, where profitability is is so key to the success of any medical device, and so, being able to define
that with clarity is very helpful. You know, as you go to to get feedback and define that Mvp.
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Bryan Gilpin: Love it.
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Bryan Gilpin: Mark or Jim.
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Bryan Gilpin: you don't have to. So.
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Mark Pacyna: To go next, I think. Look, I get that question on occasion.
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Mark Pacyna: And I I would say the the simple answer is, pick a big enough problem.
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Mark Pacyna: And the the reason the reason I say that is that, like you can kind of probably hear it in most of our voices
is that developing any technology, doing anything you know through this long regulatory path, etc, there are always
challenges, even in the most straightforward things, that you would think this is going to be the easiest thing for us to
execute this part of the program. It's always harder than you think.
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Mark Pacyna: And so when when you think about pick a big enough problem to solve it. It makes it easier one. You can
get you yourself and your teams
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Mark Pacyna: passion about what you're trying to do and solving that is critical. Because then the other folks that that
you know want to be either investors
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Mark Pacyna: or ultimately, as Jonathan mentioned the stakeholders to say, this is a big enough problem that I value that
to solve it as well as to fund that problem to get solved in the 1st place. And so, as we all need to have the stakeholders
and the patient in the mind.
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Mark Pacyna: the stakeholders of who's gonna buy the technology, but also who's gonna fund our organizations. It has
to be a big enough problem to solve. And I think that's probably the the single biggest issue that I see with some
entrepreneurs is they're not trying to solve a big enough problem. They may have the kernel of it. So keep asking.
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Mark Pacyna: what does? What's the problem behind that problem to see if it's an even bigger challenge to solve. And
so that would be my final advice, because it is a journey in this space. I mean all of us. There's been no overnight
success stories that I've ever known in in Med Tech. And so it does take, you know, the better part of a decade for most
organizations to get from. You know, the genesis of the idea to something on the market. And so pick a big enough
problem.
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Bryan Gilpin: Love it very nice.
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Jim McGlone: Yeah. So to follow up on that comment. What's the saying? Go big or go home.
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Jim McGlone: So you know, yeah, Mark makes a good point there. So
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Jim McGlone: there are, you know, one of the challenges we talked about before was the market. That, you know fetal
market is very small.
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Jim McGlone: literally very small, so
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Jim McGlone: it has its complexities. But that's the point. You know, you've got to have an economic solution along
with the clinical solution. As Jonathan alluded to, and you gotta be a big enough market.
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Jim McGlone: All those are things that you know you. You have to have in your formula, going forward as you think
about
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Jim McGlone: what effort you're going to then undertake.
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Jim McGlone: You know, being a CEO, I think, is Elon Musk said. You know it's like chewing glass and looking into
the abyss. You don't know. You've got all the problems in front of you. You've got to deal with all this stuff. Oh, by the
way, you need to make a product that's clinically relevant, economically feasible. And it addresses a bigger market. So
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Jim McGlone: those are things that you keep in front of you. But from a day to day perspective.
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Jim McGlone: Now, this is gonna get very personal for people
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Jim McGlone: I've learned through my experience. It's not as bad as you think it is, and it's not as good as you think it is.
You've got to be consistent.
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Jim McGlone: You have to deliver consistency for your personnel, your investors, every player that you deal with. You
have to be consistent in your how you present yourself.
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Jim McGlone: and you have to take care of yourself. You have to be balanced.
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Jim McGlone: and that we all forget about. So
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Jim McGlone: lots of things to do on the on the business side. But at the end of the day.
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Jim McGlone: if you're not here tomorrow.
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Jim McGlone: What's it worth.
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Bryan Gilpin: Well said, well done.
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Bryan Gilpin: Okay. So maybe with that maybe I'll ask Monty from admin. So
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Bryan Gilpin: do we open for questions.
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Monty Sylvan (msylvan@advamed.org): Absolutely so, as of now. We only have one question in the queue. But if
anyone else would have a question right now for everyone. Please feel free to ask it right now. But this was a very
thorough presentation, and I think you guys also like answered a lot of questions that were popping up in people's heads
as they were coming.
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Monty Sylvan (msylvan@advamed.org): But the one that I do have is what would you do differently if you had to do it
again. And this is
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Monty Sylvan (msylvan@advamed.org): around 1216. During the time you 1st were talking about the your startups.
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Bryan Gilpin: Someone wanted to throw an answer on that one.
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Bryan Gilpin: Would you do differently if you had to do it again?
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Jim McGlone: Well, that's interesting, because they asked the same question, the CEO of Nvidia
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Jim McGlone: and
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Jim McGlone: His response is, would you do it again if you could. And the answer was, No.
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Jim McGlone: why.
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Jim McGlone: now there's a guy sits on millions of dollars right? So he's sitting there. Why would you do that right, and
his comment was, it was a thousand times harder than he thought it would be.
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Jim McGlone: And I think what we all do is that we project
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Jim McGlone: this thing is gonna be in a certain timeframe. And we're gonna get these things done.
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Jim McGlone: And that projection.
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Jim McGlone: that antic, that visualization that we all have
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Jim McGlone: that basically motivates us
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Jim McGlone: is optimistic, and it's great to be an optimist. I
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Jim McGlone: welcome that.
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Jim McGlone: So the level of expectations.
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Jim McGlone: you know. So, having come back again and say to myself.
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Jim McGlone: You know, what have I learned through the process and would have done it again? Oh, sure, the answer
is, yeah. Left. A big company went to smaller companies, much more dynamic, much more exciting.
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Jim McGlone: But it's also
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Jim McGlone: you need to
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Jim McGlone: level your expectations.
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Jim McGlone: So anyway.
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Bryan Gilpin: Okay? I think we answered that question kind of throughout the presentation as well, things we do
differently. There's another question. Guys on cost of goods. So how do you balance product cogs and launched
timeline?
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Bryan Gilpin: So maybe, Mark, we'll start with you. Since you're kind of at a the stage where you're. You're thinking
very hard about that. I think.
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Mark Pacyna: We are.
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Mark Pacyna: I think. Look, I think I think there's 2 really, fundamentally different things. One is.
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Mark Pacyna: you know, what's the right product. And can you ultimately get to a cost of goods that's gonna make, you
know, make it very viable. And and that's not just like I think I have a plan, or whatever you have to have a plan to be
able to get there in in relatively short order. By the way, because, you know, when you think about
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Mark Pacyna: you know a technology adoption. And when you go from making a thousand to 10,000 a year, you really
need to understand how those things are going to scale. And so you know that that to us is is, you know, right out of the
gate, you know there there will be challenges. You want to make sure you have a great quality product. You know, that
meets the needs of the customers, because
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Mark Pacyna: if you don't do that, then it doesn't matter what your cost of goods sold are. The second thing, though, is,
as you, you know, developing. And and frankly, Brian, we're doing it right now, as you mentioned, is developing a plan
that that you can implement over the course of a couple of years to really get down to a cost of goods sold that is going
to be viable longer term. Whether that's you know, our organization is a standalone or somebody else that that may, or
on the organization in the future, so that you have credible plays to get there.
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Mark Pacyna: It's a great question.
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Jonathan Gunn: You're on mute, Brian.
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Monty Sylvan (msylvan@advamed.org): One more question is entered during the initial product configuration process,
trying to achieve product market fit, who is at the table to help find the right product permutation for the for your
business goals.
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Monty Sylvan (msylvan@advamed.org): Excuse me. Permutation.
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Bryan Gilpin: Who wants to go on that one? Jonathan, maybe that's for you. So who who's as you're developing the
product? Who who do you have at the table trying to figure out what the what the market need is, and and how to make
sure the product fits that need.
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Jonathan Gunn: Yeah, I mean, unfortunately, the market has changed since. I think we started Brightseed. So you know,
we've obviously we began Brightseed working with surgeon partners at Northwestern medicine here in Chicago, and
we've continued to work with surgeons around the United States to understand
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Jonathan Gunn: workflow and and what products are impactful in the operating room at the at the right time. But today
so much more of the decisions are not even made by senior members of the hospitals themselves, but by larger groups
and and the heads of supply chain. Right? So we're starting to have to think about how
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Jonathan Gunn: consolidation affects purchasing and what you know, or directors need in order to maintain profit in
their ors. And so we've sort of
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Jonathan Gunn: created a a broader group of straight stakeholders. Thinking about what we're delivering in it in this 1st
implementation, and what the platform can deliver in time.
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Jonathan Gunn: You know.
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Jonathan Gunn: it's a it's a much bigger tent now.
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Jonathan Gunn: considering the requirements for the product than we had when we started the company. And I think
that's a shift that we're seeing.
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Bryan Gilpin: Makes sense.
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Bryan Gilpin: Okay?
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Bryan Gilpin: Because I think we're right at the hour.
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Bryan Gilpin: so with that, we just want to thank Jim, you, Jonathan Mark
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Bryan Gilpin: really appreciate the discussion here, and and Monty to you to advimed for supporting this and allowing
us to hold this forum. I really appreciate the discussion. I think it was fantastic, and
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Bryan Gilpin: thank you very much.
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Monty Sylvan (msylvan@advamed.org): Absolutely.
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Jim McGlone: Thank you all.
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Jim McGlone: Thank you all.
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Monty Sylvan (msylvan@advamed.org): For attending, and also thank you all for speaking and providing all this
beautiful insight. I want to let everyone know that with everyone that remains that all the recording and information will
be available. Shortly we will send it out to all registrants.
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Monty Sylvan (msylvan@advamed.org): But for now everyone take care and have a beautiful day. Thank you.
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Jim McGlone: Thank you. Money.
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Jonathan Gunn: Right now.
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Bryan Gilpin: Hi! Everyone.
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Jim McGlone: Thank you all. Bye, bye.