Bryant Grigsby 0:05
All right, welcome to ROI or RP. So my name is Bryant Grigsby. I am the CEO of PDV MedTech. So we used to be called Phoenix deventure. So if you've been in the Medtech industry for 2025, years. You've heard of us as PTV Medtech. We sold to into mem this spring, and did a branding change as well. For those of you who don't know about PTV Medtech, we focus on startups doing design development and manufacturing and and I got in about four years ago prior to pdv Medtech, and I'll talk just briefly about that in just a minute. But prior to that, I've been a global product manager. I was an astrophysicist at the University of California, and I was on the US canoe and kayak team, so done a few things in my life, and quite diverse. And then Phoenix DeVentures, we've been around 24 years. Pdv, Medtech, we've been around 24 years now, 600 products that we've developed, so just a few. And we've probably seen about every major failure, and we've seen successes, with the exception of Inc Edwards. Strategic has bought one of our customers, pretty much every major strategic so we've seen both, both sides of of the coin here, and that's why we want to talk through, you know, what's the best way to look at going from napkin sketch all the way to commercialization and selling? So, so, as I said, PTV MedTech, we got acquired by Indo-MIM. Pass it over to Dave for his intro.
David Chersky 1:44
Dave Chersky, I have about 30 years in med. Device manufacturing, started in endoscopy robotics, airway management, wearables, cardiac surgery, been working with Indo-MIM for the past two years. Indo-MIM is a global manufacturing company specializing in metal injection molding. Been around since 1996 about 4000 people based in Bangalore, India. 25% of their business is in medical device, making 10s of millions of parts for single use, robotic surgery devices, laparoscopic devices, etc. Part of our expansion plan was to build out our vertical and medical and medical and to accomplish that, we partnered with pdv med tech. Closed that transaction in May, and currently in the integration process, my qualifications for being here is 30 years in med, device and lots of startups. I've seen a lot of failure and been part of a lot of failures, but still standing, and that's probably a good thing for for this topic.
Bjoern Von Siemens 3:21
Yeah, I was going to steal your line, but since you did the intro first, and also Michael, my qualification is a similar one. I'm an entrepreneur, an investor in med tech, and originally wanted to be a surgeon. Failed very early on in pursuing that path, but ultimately and came back to surgery in 2010 as a first as an investor and then as an entrepreneur. My company is called Caresyntax and is focused on surgery. We're digitalizing the operating room, creating new work environment for the team and making things more efficient, more easy to use, automating things and connecting before, during and after surgery. So it's a horizontal platform approach. And the use case is for the hospital to become more profitable, more efficient. The second use case, and we have Bruce here, who joined us a couple of years ago, is to enable med tech to do several strategies much more cost efficiently, label extension, lot of off label use in the operating room, with our real world evidence and launch of medical devices post market surveillance. So, yeah, kind of two sided platform. One is the medical device product as well. So we can talk about how that was brought into the market, is being brought into the market, and what would we experienced as, let's say, challenges. Yes And yeah, very, very good to be here and to talk about hopefully more ROI than rip, although there's probably a lot of rip as well.
Bryant Grigsby 5:09
Yep, all right, yeah, so our ROI or rip. So this is meant to be a pretty interactive workshop, right? So we want you all to to ask questions. We can do this one of two ways. We've got kind of three common areas that we see mistakes. If you caught this morning's keynote, it was a very entertaining way of going through a bunch of these different pitfalls, and this a common thing, theme that you'll hear throughout this whole week. It's generally speaking, technology is not the failing part for why the companies fail. My first LSI, this is my seventh. I sat through a lot of pitches and went, Wow, if every one of these technologies succeeded, there would be no disease. Everybody live forever, and everybody would be super, super rich, you know? So seven LSI later, I see a lot of the same companies still pitching for money. So, yeah, so it's clearly the technology is not the not the issue, until we go we can go through these, you know, the technology over the problem, you know, some planning issues that we run into, and then, you know, the timing of spending money. And we've all done a bunch of startups. I think I've done seven startups, or something like that as well. And so we've all been there and have felt the pain and gone through this. So we can do it that way. We've got some warm up slides. Or if you all have questions, I don't know if anybody saw the posting.
Audience Question 6:48
Yeah, you just did on a great subject, seven, seven technology problem. Can you dive into that a little bit?
Bryant Grigsby 6:59
So my very first spam, my very first startup I ever was at. I was VP of it, and we were doing the biometric scanning system, and we had the best technologists in that space so that everybody's got the little RFID cards where you can go and tap. So the guy that invented that was our chief technologist, and we said, Okay, let's take the idea behind that, and instead of having to have this card, put it on your thumb and and so we took all of this software and created a little scanner and went down that path, and we bootstrapped completely. We were running a consulting IT consulting firm at the time, and we slowly pivoted to doing the spin out company. And so the technology was great. Our CEO thought he could leap frog a couple of major steps, and we and this was just like in in med tech. It Back then, this is in the 90s. You could sell much earlier, right? So when, when PTV Medtech started in 2001 you could do a napkin sketch and build a couple of bench tops, get some patents done, and then go sell your company. That was pretty common back then. Nowadays, of course, you have to go all the way through to commercialization, is very rare that you can actually just sell something without commercialization. And so in this, this startup, we did the same thing, where we, we had some IP, had the device, had a couple of demos, and started trying to sell. And actually we had a major strategic that was interested in buying us, but we, we were kind of too big for our own britches and thought we were worth more, and turned down a spectacular deal. About a year later, they ended up pretty much picking up the IP on the bankruptcy market. So that was awesome. So that was my first experience on in a startup.
David Chersky 8:59
So yeah, just to add on to that, I have an example. Surgeon, inventor, thought he had solved one of the major problems that he saw in in the ER. He was a cardiac surgeon, and he saw a problem with intubated patients, and so he invented a device to clear blockages from endotracheal tubes, and with the hypothesis that if you kept the tube open, the patient could wean off the ventilator sooner. And that would be amazing. You wouldn't have to do traches and things like that. So he developed this technology, and the device was very complicated and required, you know, change of methods. And in the ER change of methods in the ICU and. But, you know, he was a little bit, you know, became a little bit blind to that, and fell and just fell in love with the mechanism that he designed because he thought it was so elegant. And, you know, turned out, yes, it did work. But you know, he was blinded to the fact that it was a major change in protocol and hard to get accepted and then also hard to sell against, you know, the incumbent technology. And it took, you know, a lot of money and a lot of years to redirect and redesign and make the product more acceptable to the workflow in in the ICU. And, you know, luckily, we were able to recover. Took us eight or nine years before we could sell the company. But we, you know, we had raised a lot of money, and you know, we're still waiting for our returns, but you know, that was, that was, you know, a really good learning experience for me in having to not only address, you know, does this thing work? Is it an elegant design, but does it meet all the needs of all the customers, not just the patient, you know, not just the science, but, you know, the people who are actually using it? So
Bryant Grigsby 11:33
do we have other questions, or do we want to get some of the warm up slides and kind of hopefully spark some other questions? Okay, so, yeah, the first one is this idea of technology over the problem. It's quite common that you can look at at market push or market pull or technology push, and as as engineers, as doctors, clinicians, they tend to go from a technology push, they have a project that they've been working or a product that they've been working on, because in the or they found they were using x tool, y tool and Z tool, and they want to put it together, because they don't have three hands, and it solved that particular problem. And so they and you see this in it. You see it in med tech, where you fall in love with the technology, and rather than what's the problem to be solved, and there's actually a planning method called when we have, and the idea behind that is, is when you have the solution, not when you're driving the technology. And it comes in multiple different forms, it can come in a slight pivot, can allow you to actually hit your market. You think you've got the solution for your problem, but you're just one surgeon, one clinician, one engineer, one One example of this is we were working on a catheter, and it was taking weeks and weeks to get through creating the design input output document so that we actually understood the specifications. This was was supposed to be about a six or eight week long project to get through that phase. And we were months into it, and we said, All right, let's talk to your key opinion leaders. And they said, Okay, we've got two. We've got the leading surgeons in this space, one at Stanford, one at UCSF. And so we set set the calls up back to back and and. And so we talked to the first surgeon, and they said, Okay, well, in this particular operation, we strap the catheter handle to the leg that gives us access and we can manipulate everything, okay? So you don't actually hold the handle. So then you'd want some way of strapping it like, we never hold the handle. You cannot do the procedure holding the handle like, okay. So we two hour interview, basically going through and understanding the ins and outs of of how they use this. The next day, we talked to the UCSF surgeon. Right off the bat, we never strap the catheter handle the leg, we always hold it. It's impossible to do the surgery. So here we've been spending months trying to figure out the basic understandings of the technology, and their two, two key opinion leaders, had had a different idea of how the technology was going to actually solve the problem. And so, you know, if you're focused on we have to have the catheter handle that's got this button, this function, this that you missed it for half your market, because half the market did it one way, and half the market did in another way. So you had to actually understand what problem you were trying to solve, and that that ended up opening up a whole bag of worms that about six of their major features they didn't really have a good understanding, and so they had to pretty much put the. Project on pause and go back out into the market and do a deep dive on how people were using this technology. Because, you know, it was the patents of existing tech were were coming up, and so they were trying to race to having this product ready to go when the patents expired on the existing tech so they could be first in line for gen two, but they really didn't know where they were going with it.
Audience Question 15:26
Also get a little bit about audio, and probably let's try some questions for us in the audience and with development spending and costs of developer meta build device. And I have one example where a surgeon started collaborating with a very experienced med school device company, and they said, Let's bootstrap this. And then they work on almost a decade of developing a device, and they spend about 400,000 logs on the other side, you have a different approach. And for that tech gate, they spend around 100 million lovers, and they come to a save stage of the what I want to throw in for this, and which is very interesting, and it is what makes it expensive, all the things we don't know and what we have to pay to learn along the way. In one hand, of this, they spent several years not thinking a single thought about regulatory consequences of the technology development. On the other hand, sorry, on the other example, that was with them from the beginning, because they had the experience you have to design for this proper SAR and so and so forth. So I'm going to throw this out there. Is what it makes it sorry, is what makes it expensive, the seas we don't know, and the failures we have to manage.
David Chersky 16:57
Yeah, that's a really great point. Several of my career failures have been along those lines of not considering all the all, all of those things that you need to for example, I joined a group who had developed a wearable device, and they wanted to solve the problem of elder care and remote patient monitoring and things like that. These were software engineers, technologists, you know, people with elder parents who wanted to solve this problem came at it entirely from a technology perspective. Didn't consider, you know, medical, you know, software as a medical device, didn't consider the wearable constraints, didn't consider the regulatory, you know, guidelines. And so they developed this product, and then got to the point where, you know, they had spent millions of dollars, and then discovered, oh, we need to hire, you know, a QA, Ra person. We need to, you know, apply for a 510, K, etc. So, exactly. And that's why, you know, that's why it tends to cost a lot, you know, for people getting into it who haven't experienced those things before, yeah,
Bryant Grigsby 18:37
yep, if you think of it from what's the afterthought? If you have one afterthought, it's not too expensive if you have two afterthoughts, yeah, okay, maybe it might be five times as expensive if you have three afterthoughts, you're probably not going to be in business. You know, you can afford to have one major oops like that, but, but you know, common ones, other ones that Dave didn't bring up in that example are packaging. How's the packaging? And people put packaging at the end and and if you put packaging at the end and you have some sort of oops in it, you're doing your time studies, your shelf life studies, all that well, now you have to extend it out six more months. And if you're putting it at the end, what, when's the most expensive burn rate for you internally, for us, being product developers, the amount of money that you spend with us, it's the same. Whether we do it in six months or we do it over a year and a half, the total is going to be about the same. So if you take a catheter, for example, basic run of the mill catheter, nothing too fancy. It's a million million two for us to develop that. And it doesn't matter if we do it in six months or two years, it's still million million two for a basic catheter. But you as an entrepreneur, especially like in your case that you're talking about the 400,000 pound or 400,000 euro, you. They probably didn't go and hire a chief medical officer, a VP of sales. This that all of a sudden, when you're year three, year four, and you have that staff, you're burning six or $800,000 a month in staff, and now you have to postpone launching your product six more months, and so that that's, you know, it ends up translating to millions of dollars. So that's one of the biggest things that we see, if you skip some of these, these things that are kind of afterthoughts, is, do you have your scale up at the right levels? A lot of people try to jump into high volume production level tools when they're not ready to, and so they end up spending a lot of money on, say, $200,000 in molding tools, when $50,000 in molding tools will get you what you need for the next two years. Because once that product hits the market, you're gonna get feedback, and you're gonna want to change it.
David Chersky 21:00
Yeah, just adding on briefly, I think product focus and strategic focus of how you're going to enter the market plays a big role. So you can, you know, easily get mission creep and increase your expenses simply by not having, you know, cliche, laser targeted plan for entering the market, which also requires prior knowledge and prior understanding of what you're doing.
Bjoern Von Siemens 21:34
Yeah, yeah. And I think it's a, it's a very interesting analogy, also that you spoke about it and tech, because we were coming from a tech background. And in 2020, to 2022, when there was no Interest and Money was free, raised a lot of money and started doing something that, in hindsight, now looks, yeah, looks quite, let's say, unreasonable, and we would, we were scaling into the US market during covid and so obviously, you know, the entire market was the hospitals were occupied dealing with some other problems, so there were no meetings, and so on and so forth, but yet, we had a sales team and everything, let's say, set up successfully, increased our monthly burn rate, and, you know, didn't follow the, let's say, the logical step of actually thinking about what we should do right now, as opposed to what we should do in one year or two years from now, and also making the hard decisions of not doing some things, which is, I think, yeah, one of the hardest things to do in in this space where there's so much improvement potential and so many ways how to things, make things better, and then saying no to to market segments, saying no to to specific customers, and really focusing on what, what can solve a problem today, with a budget available today, that's that was And is for us still, still the key parameters to to make decisions. And I think we fail a lot of time speakers. We're thinking too broadly about things and and, or started too early in in commercialization, when the budget wasn't clear.
Bryant Grigsby 23:41
So can we get a sense of the room on so if we put it in the financial realm, how many of you are seed round companies? How many of you are a round companies? Okay, and then B round or greater. All right, so we've got a decent mix. Obviously, the challenges on each of those is very, very different. Okay, so then how many of you have have had to basically put a major pause in to kind of refocus and re establish and do hit the reset button. Oh, come on, Nik, really that just, just a couple. Don't be shy. All right. Okay, so those of you who raised your hands, what? What was it? So this is supposed to be a workshop interactive so, so what was your What was your reset button? What was the what you need to do.
Audience Question 24:41
We figured out that we had trouble finding venture capital without human data on our
David Chersky 24:49
Yes, that's a really good one in terms of knowing what to do. And you know, plant, maybe this gets into the plan. I think part of it. But in order to raise money, you know, good selling proposition, data is key, right? Like, you know, people get the concept, but they need to see the data. They need to, you know, you need to prove that it works. You need to prove that it makes a difference. You need to prove that it's going to be cheaper. You know, there's a reason to buy it. There's a reason to invest. And a lot of people you know, again, fall in love with the technology and fail to consider the proof that's required out there after you know, everyone close to them has told them what a great idea it is, you know,
Bryant Grigsby 25:46
yeah, and this comes back to the evolution of how med tech acquisitions have happened 15 years ago, getting to your 510 k, you could start going off and selling 10 years ago. Once you've had your 510, K you could go and sell nowadays, if you don't have your market access figured out, if you don't have your commercialization figured out, if you don't have all of your manufacturing de risk, it's very hard to actually go and sell your company. And so if you don't have that path laid out when you go, especially if you're you know, A, B round, it's not as important, and the angel and seed rounds, it's important, but those folks tend to be more riskier investors, and so if you're in the a round or B round, if you don't have at least some sort of line of sight, it's too risky of a proposition for them.
David Chersky 26:35
Yeah, one of the first questions I ask newer companies now is, what's your clinical data plan? What's your you know, what? What's your plan for publications and presentations at major conferences? How are you going to prove this thing works? And because you know, if you're planning to be acquired by a strategic they're going to want to see the quality of data all lined out, not only your IP, not only the market potential, but the quality of the data
Audience Question 27:13
with regard to that on UX or that user experience or human machine or technology drive.
Bryant Grigsby 27:23
Spending in Apple bucks? No, no, no, no, absolutely not. I mean, software is actually one of the places that that really figured it out. You know, we all have phones in our pockets. How much money did Google spend on UX when they wanted to compete against and against iPhone? Does anybody know it's $2 billion just on UX? When? When Android basically got released? So so no, we're not spending enough
Audience Question 27:54
money asking that question. When we speak to searches, we're focused on Saturday, girls days. It's so often we're curious this amazing news day comes out and get from the searches. Yeah, I didn't like it. It wasn't quick enough. I didn't like music. Howard resources have spent you to life, and we had like, Wait yours. Yeah.
Bryant Grigsby 28:19
So our founder, about his third startup in was doing a surgical device, a cautery device, and it was spectacular. Everybody thought it was it was great. They did a bunch of clinicals. Got great, great results. Then they hit the road with it, and the very first hospital that they went to, the Chief of Surgery looked at it and went, nope. They said, whoa, whoa, whoa, whoa, whoa, hold on. Why? And he goes, I'm left handed. And they designed it for right handed people only, and literally killed the company. And it was 10s of millions of dollars developing a spectacular product that, you know, I don't know what the percentage is, 20, 30% or whatever. Left handed, people couldn't use it. They didn't even ask the question.
David Chersky 29:13
And a lot of time, it's not just the surgeons, it's the assistants, it's the nursing staff, anyone who's going to touch this thing or bring it into the system? We need to consider, you know, the ecosystem and and their perspectives. Surgeons may love it, the nurses may hate it. And guess what? The Sir the nurse, if the nurses hate it, they ain't going to buy it.
Bryant Grigsby 29:43
Also, you have to even step back in, as Dave saying, the whole ecosystem. Where is it sitting on the shelf? How big is the shelf? What's the box size that that it fits? What's its replacement do? Does the does the the orderly have to take it out? Of a box, unpack, and then unpack, and then unpack. Okay, that's getting to be a pain in the butt, but so you have to think of that step process all the way through, and with the earlier stage, money being more difficult right now, it's, it's, you have to do that on a more bootstrapping way. It's hard to go out and get the full ecosystem, but this is where, if you've talked to somebody who's brought a project through successfully, more recently, they probably have the understanding of the whole process. If you're talking to, as CARI was saying this morning, somebody who's been at strategics their entire career, they're not going to know the whole ecosystem.
Bjoern Von Siemens 30:48
And I fully agree, the UX thinking hasn't entered into the operating room, really. I mean, the only company that is doing that quite successfully, maybe that two or three, but say Intuitive Surgical, they really just have an amazing user experience. Surgeons now love it. Patients obviously want to be in a robotic surgery and so on and so forth. So you can see the power of that. If you think about it, a lot of the other systems that I see around, we see around, maybe happely, practically good to use, but from a data perspective, and from a, let's say it perspective, it's like you're going back to the 90s or 80s, or even, even worse, in the interoperability terms, so that user experience is, yeah, it's going to prevent a lot of good devices and good ideas from getting into the market, because next generation of surgeons obviously will ask for something else and won't accept it anymore if you have 15 different systems.
Bryant Grigsby 32:00
And what we've been seeing more recently is the FDA is requiring more and more data into the UX, you know, again, it's, it's where things are evolving, as when I was at Invisalign and we looked at share a chair, you know, how, how do you get more patients in that chair? But one of the things that we found out is that our dentists were spending more time at night on the iPad, going through and doing approvals and having to click too many extra buttons because we didn't think through some of that UX. And so while, while in their day to day, their in their practice, they were getting that extra full days worth of patients through, they ended up having to do it at night, and that was a problem. So we had to go through and think through all of our, our UX for the entire end to end, processing,
Audience Question 32:52
trainees, the planning, publishing, training into your
Bryant Grigsby 32:58
make or break. Yeah. Yeah. You know, clinician training is make or break, if you so. One example is, there's a catheter that we developed. It's a balloon catheter, and, and, and we say, okay, and you, you have to use x size syringe to inflate the balloon. If you use a big, bigger syringe than that, you're going to end up bursting the balloon. And, and so we it was just part of the instructions. And and surgeons were grabbing whatever syringe they had, putting it on and pop. Pop the balloon. Okay, well, $2,000 counter, toss it out. Pop, do the next one. The even though it was in the note to do that, that specific line of training wasn't talked about, wasn't expressed and so our customer ended up. Their chief medical officer came in, and we worked through a process of of of trying different syringes to find out, you know what, how how small they had to be, or what the threshold was. And then what we ended up just going is, you know what, instead of trying to do that, let's just train the surgeons better. And so as part of the training kit, we then brought out, as part of that kit the syringe that was what we said was the right size, and the distributor said, this is the syringe that you have to use. And after that, 90% of those failures went away.
David Chersky 34:30
Yeah, not saying that. It's easy to do, but, you know, budgeting for adequate labs and discovery is important, depending on, you know, depending on the product, you know, cadaver labs, etc. And during that process, you'll tend to discover some of the UX things, some of the, you know, device performance things. Yeah, and as you get more mature, budgeting for continuing labs and training is important because it's also an important sales mechanism, inviting surgeons to trainings, especially at conferences. It's not cheap, but it can tend to be, you know, a more efficient way of bringing people, you know, in, and it's a selling opportunity as well as a training opportunity.
Bryant Grigsby 35:30
Yeah, we partner with various different universities, you know, Stanford, Biodesign, UCSF, University of Utah. University of Utah is building out a new accelerator incubator space. And as part of that, they have a training area that they've dedicated so that they can bring surgeons in for each of those, the 10 companies that they're incubating, and also so that other people in the ecosystem can rent it out, so that you don't have to go to the hospital to do the training. You can actually go to a simulated hospital environment, and I think that's that's going to be pretty game changing for folks running through that program.
Bjoern Von Siemens 36:10
Couldn't agree more. Do we have any other slides? Another we have more questions
Audience Question 36:18
there given a discussion only about the importance to do I see, so experience. So next slide, someone repeat false or design it the experience. So explain that.
Bjoern Von Siemens 36:30
It's on the slide? Yeah
Bryant Grigsby 36:34
Is it on this one? Okay, yes, yeah, yeah. So this, what we're talking about, is understanding the full experience all the way through. And the specific example I was thinking of was that balloon catheter, when we put that up that so you we've got the whole kit, and actually up at our table, we've got the main catheter kit for that project, when, when it was originally designed, it wasn't thought about. What's the training kit? We have another product that very complicated stint delivery system. And one of the things that we did early on in that project is actually come up with a training kit. And so we made a fake piece of skull about like this, with all of the various different pieces that one would need, so that surgeons could actually go through and get the entire process. And so if you were, if you came, we didn't bring it here, but if you came to our Morgan Hill, Silicon Valley office, you'd see that's actually more up front of a demo piece, the small little syringe catheter piece, it's it's unimpressive, but looking at the training kit and how to get the the surgeon to go through the entire process the way it was intended, there was more focus on that, and that made it a very successful program.
David Chersky 38:04
Yeah, this will address maybe 2.1 is packaging as an afterthought, and the design experience, for example, how is the device going to be presented to the surgical field in its packaging? What's the process of removing the sterile barrier and presenting it to the surgical field. Sometimes that's not even considered until, you know, until the end, but that would be planning for the user experience. You know, not only how is the surgeon going to use it, but how is the or nurse going to unpack it and put it on the table? For example?
Audience Question 38:48
Thing you can do is run called sure and preaching workshops early on, and you get to KOLs in the room, and do the full of fuel is basically all the thing, keep up accelerated option, under friction, the thing, implement option. And you could go through a brace, top all the dose, think right through the experiencer, obviously, for like on the shelf, how easy to unpack it. How's the surgeon really uses in practice, assuming,
David Chersky 39:26
Yeah, that's a great way to put it fuel in friction.
Bryant Grigsby 39:32
Yeah, that sounds that reminds me of the the Six Sigma spaghetti diagram methodology, where you, when you look at from an initial order to when the product is used. What's the path? How does it go through? So does it look like that? Is it Chutes and Ladders going all the way through? And so you kind of map through the full process, where the. Bottlenecks, what are the resistance points? And you know, sales leaders do this. Effective sales leaders do this through the whole process. They go, okay, when I've got a customer in mind, what's the thing that's going to what's the first thing that's going to block them from buying, what's the second thing that's going to block them from buying, what's the third thing? How do I remove those barriers all the way through, are we out of time? I think
David Chersky 40:24
we're just about out of time.
Bryant Grigsby 40:26
Yeah, if you want to keep the conversation going, or if you have any other questions, Nik, our BD manager, he's there, and Dave and I, we've got a table here, and so we're happy to pick this up at lunch or at the table somewhere. So thank you all for coming.
David Chersky 40:42
Thank you guys.
Bjoern Von Siemens 40:43
Thank you.
Bryant Grigsby 0:05
All right, welcome to ROI or RP. So my name is Bryant Grigsby. I am the CEO of PDV MedTech. So we used to be called Phoenix deventure. So if you've been in the Medtech industry for 2025, years. You've heard of us as PTV Medtech. We sold to into mem this spring, and did a branding change as well. For those of you who don't know about PTV Medtech, we focus on startups doing design development and manufacturing and and I got in about four years ago prior to pdv Medtech, and I'll talk just briefly about that in just a minute. But prior to that, I've been a global product manager. I was an astrophysicist at the University of California, and I was on the US canoe and kayak team, so done a few things in my life, and quite diverse. And then Phoenix DeVentures, we've been around 24 years. Pdv, Medtech, we've been around 24 years now, 600 products that we've developed, so just a few. And we've probably seen about every major failure, and we've seen successes, with the exception of Inc Edwards. Strategic has bought one of our customers, pretty much every major strategic so we've seen both, both sides of of the coin here, and that's why we want to talk through, you know, what's the best way to look at going from napkin sketch all the way to commercialization and selling? So, so, as I said, PTV MedTech, we got acquired by Indo-MIM. Pass it over to Dave for his intro.
David Chersky 1:44
Dave Chersky, I have about 30 years in med. Device manufacturing, started in endoscopy robotics, airway management, wearables, cardiac surgery, been working with Indo-MIM for the past two years. Indo-MIM is a global manufacturing company specializing in metal injection molding. Been around since 1996 about 4000 people based in Bangalore, India. 25% of their business is in medical device, making 10s of millions of parts for single use, robotic surgery devices, laparoscopic devices, etc. Part of our expansion plan was to build out our vertical and medical and medical and to accomplish that, we partnered with pdv med tech. Closed that transaction in May, and currently in the integration process, my qualifications for being here is 30 years in med, device and lots of startups. I've seen a lot of failure and been part of a lot of failures, but still standing, and that's probably a good thing for for this topic.
Bjoern Von Siemens 3:21
Yeah, I was going to steal your line, but since you did the intro first, and also Michael, my qualification is a similar one. I'm an entrepreneur, an investor in med tech, and originally wanted to be a surgeon. Failed very early on in pursuing that path, but ultimately and came back to surgery in 2010 as a first as an investor and then as an entrepreneur. My company is called Caresyntax and is focused on surgery. We're digitalizing the operating room, creating new work environment for the team and making things more efficient, more easy to use, automating things and connecting before, during and after surgery. So it's a horizontal platform approach. And the use case is for the hospital to become more profitable, more efficient. The second use case, and we have Bruce here, who joined us a couple of years ago, is to enable med tech to do several strategies much more cost efficiently, label extension, lot of off label use in the operating room, with our real world evidence and launch of medical devices post market surveillance. So, yeah, kind of two sided platform. One is the medical device product as well. So we can talk about how that was brought into the market, is being brought into the market, and what would we experienced as, let's say, challenges. Yes And yeah, very, very good to be here and to talk about hopefully more ROI than rip, although there's probably a lot of rip as well.
Bryant Grigsby 5:09
Yep, all right, yeah, so our ROI or rip. So this is meant to be a pretty interactive workshop, right? So we want you all to to ask questions. We can do this one of two ways. We've got kind of three common areas that we see mistakes. If you caught this morning's keynote, it was a very entertaining way of going through a bunch of these different pitfalls, and this a common thing, theme that you'll hear throughout this whole week. It's generally speaking, technology is not the failing part for why the companies fail. My first LSI, this is my seventh. I sat through a lot of pitches and went, Wow, if every one of these technologies succeeded, there would be no disease. Everybody live forever, and everybody would be super, super rich, you know? So seven LSI later, I see a lot of the same companies still pitching for money. So, yeah, so it's clearly the technology is not the not the issue, until we go we can go through these, you know, the technology over the problem, you know, some planning issues that we run into, and then, you know, the timing of spending money. And we've all done a bunch of startups. I think I've done seven startups, or something like that as well. And so we've all been there and have felt the pain and gone through this. So we can do it that way. We've got some warm up slides. Or if you all have questions, I don't know if anybody saw the posting.
Audience Question 6:48
Yeah, you just did on a great subject, seven, seven technology problem. Can you dive into that a little bit?
Bryant Grigsby 6:59
So my very first spam, my very first startup I ever was at. I was VP of it, and we were doing the biometric scanning system, and we had the best technologists in that space so that everybody's got the little RFID cards where you can go and tap. So the guy that invented that was our chief technologist, and we said, Okay, let's take the idea behind that, and instead of having to have this card, put it on your thumb and and so we took all of this software and created a little scanner and went down that path, and we bootstrapped completely. We were running a consulting IT consulting firm at the time, and we slowly pivoted to doing the spin out company. And so the technology was great. Our CEO thought he could leap frog a couple of major steps, and we and this was just like in in med tech. It Back then, this is in the 90s. You could sell much earlier, right? So when, when PTV Medtech started in 2001 you could do a napkin sketch and build a couple of bench tops, get some patents done, and then go sell your company. That was pretty common back then. Nowadays, of course, you have to go all the way through to commercialization, is very rare that you can actually just sell something without commercialization. And so in this, this startup, we did the same thing, where we, we had some IP, had the device, had a couple of demos, and started trying to sell. And actually we had a major strategic that was interested in buying us, but we, we were kind of too big for our own britches and thought we were worth more, and turned down a spectacular deal. About a year later, they ended up pretty much picking up the IP on the bankruptcy market. So that was awesome. So that was my first experience on in a startup.
David Chersky 8:59
So yeah, just to add on to that, I have an example. Surgeon, inventor, thought he had solved one of the major problems that he saw in in the ER. He was a cardiac surgeon, and he saw a problem with intubated patients, and so he invented a device to clear blockages from endotracheal tubes, and with the hypothesis that if you kept the tube open, the patient could wean off the ventilator sooner. And that would be amazing. You wouldn't have to do traches and things like that. So he developed this technology, and the device was very complicated and required, you know, change of methods. And in the ER change of methods in the ICU and. But, you know, he was a little bit, you know, became a little bit blind to that, and fell and just fell in love with the mechanism that he designed because he thought it was so elegant. And, you know, turned out, yes, it did work. But you know, he was blinded to the fact that it was a major change in protocol and hard to get accepted and then also hard to sell against, you know, the incumbent technology. And it took, you know, a lot of money and a lot of years to redirect and redesign and make the product more acceptable to the workflow in in the ICU. And, you know, luckily, we were able to recover. Took us eight or nine years before we could sell the company. But we, you know, we had raised a lot of money, and you know, we're still waiting for our returns, but you know, that was, that was, you know, a really good learning experience for me in having to not only address, you know, does this thing work? Is it an elegant design, but does it meet all the needs of all the customers, not just the patient, you know, not just the science, but, you know, the people who are actually using it? So
Bryant Grigsby 11:33
do we have other questions, or do we want to get some of the warm up slides and kind of hopefully spark some other questions? Okay, so, yeah, the first one is this idea of technology over the problem. It's quite common that you can look at at market push or market pull or technology push, and as as engineers, as doctors, clinicians, they tend to go from a technology push, they have a project that they've been working or a product that they've been working on, because in the or they found they were using x tool, y tool and Z tool, and they want to put it together, because they don't have three hands, and it solved that particular problem. And so they and you see this in it. You see it in med tech, where you fall in love with the technology, and rather than what's the problem to be solved, and there's actually a planning method called when we have, and the idea behind that is, is when you have the solution, not when you're driving the technology. And it comes in multiple different forms, it can come in a slight pivot, can allow you to actually hit your market. You think you've got the solution for your problem, but you're just one surgeon, one clinician, one engineer, one One example of this is we were working on a catheter, and it was taking weeks and weeks to get through creating the design input output document so that we actually understood the specifications. This was was supposed to be about a six or eight week long project to get through that phase. And we were months into it, and we said, All right, let's talk to your key opinion leaders. And they said, Okay, we've got two. We've got the leading surgeons in this space, one at Stanford, one at UCSF. And so we set set the calls up back to back and and. And so we talked to the first surgeon, and they said, Okay, well, in this particular operation, we strap the catheter handle to the leg that gives us access and we can manipulate everything, okay? So you don't actually hold the handle. So then you'd want some way of strapping it like, we never hold the handle. You cannot do the procedure holding the handle like, okay. So we two hour interview, basically going through and understanding the ins and outs of of how they use this. The next day, we talked to the UCSF surgeon. Right off the bat, we never strap the catheter handle the leg, we always hold it. It's impossible to do the surgery. So here we've been spending months trying to figure out the basic understandings of the technology, and their two, two key opinion leaders, had had a different idea of how the technology was going to actually solve the problem. And so, you know, if you're focused on we have to have the catheter handle that's got this button, this function, this that you missed it for half your market, because half the market did it one way, and half the market did in another way. So you had to actually understand what problem you were trying to solve, and that that ended up opening up a whole bag of worms that about six of their major features they didn't really have a good understanding, and so they had to pretty much put the. Project on pause and go back out into the market and do a deep dive on how people were using this technology. Because, you know, it was the patents of existing tech were were coming up, and so they were trying to race to having this product ready to go when the patents expired on the existing tech so they could be first in line for gen two, but they really didn't know where they were going with it.
Audience Question 15:26
Also get a little bit about audio, and probably let's try some questions for us in the audience and with development spending and costs of developer meta build device. And I have one example where a surgeon started collaborating with a very experienced med school device company, and they said, Let's bootstrap this. And then they work on almost a decade of developing a device, and they spend about 400,000 logs on the other side, you have a different approach. And for that tech gate, they spend around 100 million lovers, and they come to a save stage of the what I want to throw in for this, and which is very interesting, and it is what makes it expensive, all the things we don't know and what we have to pay to learn along the way. In one hand, of this, they spent several years not thinking a single thought about regulatory consequences of the technology development. On the other hand, sorry, on the other example, that was with them from the beginning, because they had the experience you have to design for this proper SAR and so and so forth. So I'm going to throw this out there. Is what it makes it sorry, is what makes it expensive, the seas we don't know, and the failures we have to manage.
David Chersky 16:57
Yeah, that's a really great point. Several of my career failures have been along those lines of not considering all the all, all of those things that you need to for example, I joined a group who had developed a wearable device, and they wanted to solve the problem of elder care and remote patient monitoring and things like that. These were software engineers, technologists, you know, people with elder parents who wanted to solve this problem came at it entirely from a technology perspective. Didn't consider, you know, medical, you know, software as a medical device, didn't consider the wearable constraints, didn't consider the regulatory, you know, guidelines. And so they developed this product, and then got to the point where, you know, they had spent millions of dollars, and then discovered, oh, we need to hire, you know, a QA, Ra person. We need to, you know, apply for a 510, K, etc. So, exactly. And that's why, you know, that's why it tends to cost a lot, you know, for people getting into it who haven't experienced those things before, yeah,
Bryant Grigsby 18:37
yep, if you think of it from what's the afterthought? If you have one afterthought, it's not too expensive if you have two afterthoughts, yeah, okay, maybe it might be five times as expensive if you have three afterthoughts, you're probably not going to be in business. You know, you can afford to have one major oops like that, but, but you know, common ones, other ones that Dave didn't bring up in that example are packaging. How's the packaging? And people put packaging at the end and and if you put packaging at the end and you have some sort of oops in it, you're doing your time studies, your shelf life studies, all that well, now you have to extend it out six more months. And if you're putting it at the end, what, when's the most expensive burn rate for you internally, for us, being product developers, the amount of money that you spend with us, it's the same. Whether we do it in six months or we do it over a year and a half, the total is going to be about the same. So if you take a catheter, for example, basic run of the mill catheter, nothing too fancy. It's a million million two for us to develop that. And it doesn't matter if we do it in six months or two years, it's still million million two for a basic catheter. But you as an entrepreneur, especially like in your case that you're talking about the 400,000 pound or 400,000 euro, you. They probably didn't go and hire a chief medical officer, a VP of sales. This that all of a sudden, when you're year three, year four, and you have that staff, you're burning six or $800,000 a month in staff, and now you have to postpone launching your product six more months, and so that that's, you know, it ends up translating to millions of dollars. So that's one of the biggest things that we see, if you skip some of these, these things that are kind of afterthoughts, is, do you have your scale up at the right levels? A lot of people try to jump into high volume production level tools when they're not ready to, and so they end up spending a lot of money on, say, $200,000 in molding tools, when $50,000 in molding tools will get you what you need for the next two years. Because once that product hits the market, you're gonna get feedback, and you're gonna want to change it.
David Chersky 21:00
Yeah, just adding on briefly, I think product focus and strategic focus of how you're going to enter the market plays a big role. So you can, you know, easily get mission creep and increase your expenses simply by not having, you know, cliche, laser targeted plan for entering the market, which also requires prior knowledge and prior understanding of what you're doing.
Bjoern Von Siemens 21:34
Yeah, yeah. And I think it's a, it's a very interesting analogy, also that you spoke about it and tech, because we were coming from a tech background. And in 2020, to 2022, when there was no Interest and Money was free, raised a lot of money and started doing something that, in hindsight, now looks, yeah, looks quite, let's say, unreasonable, and we would, we were scaling into the US market during covid and so obviously, you know, the entire market was the hospitals were occupied dealing with some other problems, so there were no meetings, and so on and so forth, but yet, we had a sales team and everything, let's say, set up successfully, increased our monthly burn rate, and, you know, didn't follow the, let's say, the logical step of actually thinking about what we should do right now, as opposed to what we should do in one year or two years from now, and also making the hard decisions of not doing some things, which is, I think, yeah, one of the hardest things to do in in this space where there's so much improvement potential and so many ways how to things, make things better, and then saying no to to market segments, saying no to to specific customers, and really focusing on what, what can solve a problem today, with a budget available today, that's that was And is for us still, still the key parameters to to make decisions. And I think we fail a lot of time speakers. We're thinking too broadly about things and and, or started too early in in commercialization, when the budget wasn't clear.
Bryant Grigsby 23:41
So can we get a sense of the room on so if we put it in the financial realm, how many of you are seed round companies? How many of you are a round companies? Okay, and then B round or greater. All right, so we've got a decent mix. Obviously, the challenges on each of those is very, very different. Okay, so then how many of you have have had to basically put a major pause in to kind of refocus and re establish and do hit the reset button. Oh, come on, Nik, really that just, just a couple. Don't be shy. All right. Okay, so those of you who raised your hands, what? What was it? So this is supposed to be a workshop interactive so, so what was your What was your reset button? What was the what you need to do.
Audience Question 24:41
We figured out that we had trouble finding venture capital without human data on our
David Chersky 24:49
Yes, that's a really good one in terms of knowing what to do. And you know, plant, maybe this gets into the plan. I think part of it. But in order to raise money, you know, good selling proposition, data is key, right? Like, you know, people get the concept, but they need to see the data. They need to, you know, you need to prove that it works. You need to prove that it makes a difference. You need to prove that it's going to be cheaper. You know, there's a reason to buy it. There's a reason to invest. And a lot of people you know, again, fall in love with the technology and fail to consider the proof that's required out there after you know, everyone close to them has told them what a great idea it is, you know,
Bryant Grigsby 25:46
yeah, and this comes back to the evolution of how med tech acquisitions have happened 15 years ago, getting to your 510 k, you could start going off and selling 10 years ago. Once you've had your 510, K you could go and sell nowadays, if you don't have your market access figured out, if you don't have your commercialization figured out, if you don't have all of your manufacturing de risk, it's very hard to actually go and sell your company. And so if you don't have that path laid out when you go, especially if you're you know, A, B round, it's not as important, and the angel and seed rounds, it's important, but those folks tend to be more riskier investors, and so if you're in the a round or B round, if you don't have at least some sort of line of sight, it's too risky of a proposition for them.
David Chersky 26:35
Yeah, one of the first questions I ask newer companies now is, what's your clinical data plan? What's your you know, what? What's your plan for publications and presentations at major conferences? How are you going to prove this thing works? And because you know, if you're planning to be acquired by a strategic they're going to want to see the quality of data all lined out, not only your IP, not only the market potential, but the quality of the data
Audience Question 27:13
with regard to that on UX or that user experience or human machine or technology drive.
Bryant Grigsby 27:23
Spending in Apple bucks? No, no, no, no, absolutely not. I mean, software is actually one of the places that that really figured it out. You know, we all have phones in our pockets. How much money did Google spend on UX when they wanted to compete against and against iPhone? Does anybody know it's $2 billion just on UX? When? When Android basically got released? So so no, we're not spending enough
Audience Question 27:54
money asking that question. When we speak to searches, we're focused on Saturday, girls days. It's so often we're curious this amazing news day comes out and get from the searches. Yeah, I didn't like it. It wasn't quick enough. I didn't like music. Howard resources have spent you to life, and we had like, Wait yours. Yeah.
Bryant Grigsby 28:19
So our founder, about his third startup in was doing a surgical device, a cautery device, and it was spectacular. Everybody thought it was it was great. They did a bunch of clinicals. Got great, great results. Then they hit the road with it, and the very first hospital that they went to, the Chief of Surgery looked at it and went, nope. They said, whoa, whoa, whoa, whoa, whoa, hold on. Why? And he goes, I'm left handed. And they designed it for right handed people only, and literally killed the company. And it was 10s of millions of dollars developing a spectacular product that, you know, I don't know what the percentage is, 20, 30% or whatever. Left handed, people couldn't use it. They didn't even ask the question.
David Chersky 29:13
And a lot of time, it's not just the surgeons, it's the assistants, it's the nursing staff, anyone who's going to touch this thing or bring it into the system? We need to consider, you know, the ecosystem and and their perspectives. Surgeons may love it, the nurses may hate it. And guess what? The Sir the nurse, if the nurses hate it, they ain't going to buy it.
Bryant Grigsby 29:43
Also, you have to even step back in, as Dave saying, the whole ecosystem. Where is it sitting on the shelf? How big is the shelf? What's the box size that that it fits? What's its replacement do? Does the does the the orderly have to take it out? Of a box, unpack, and then unpack, and then unpack. Okay, that's getting to be a pain in the butt, but so you have to think of that step process all the way through, and with the earlier stage, money being more difficult right now, it's, it's, you have to do that on a more bootstrapping way. It's hard to go out and get the full ecosystem, but this is where, if you've talked to somebody who's brought a project through successfully, more recently, they probably have the understanding of the whole process. If you're talking to, as CARI was saying this morning, somebody who's been at strategics their entire career, they're not going to know the whole ecosystem.
Bjoern Von Siemens 30:48
And I fully agree, the UX thinking hasn't entered into the operating room, really. I mean, the only company that is doing that quite successfully, maybe that two or three, but say Intuitive Surgical, they really just have an amazing user experience. Surgeons now love it. Patients obviously want to be in a robotic surgery and so on and so forth. So you can see the power of that. If you think about it, a lot of the other systems that I see around, we see around, maybe happely, practically good to use, but from a data perspective, and from a, let's say it perspective, it's like you're going back to the 90s or 80s, or even, even worse, in the interoperability terms, so that user experience is, yeah, it's going to prevent a lot of good devices and good ideas from getting into the market, because next generation of surgeons obviously will ask for something else and won't accept it anymore if you have 15 different systems.
Bryant Grigsby 32:00
And what we've been seeing more recently is the FDA is requiring more and more data into the UX, you know, again, it's, it's where things are evolving, as when I was at Invisalign and we looked at share a chair, you know, how, how do you get more patients in that chair? But one of the things that we found out is that our dentists were spending more time at night on the iPad, going through and doing approvals and having to click too many extra buttons because we didn't think through some of that UX. And so while, while in their day to day, their in their practice, they were getting that extra full days worth of patients through, they ended up having to do it at night, and that was a problem. So we had to go through and think through all of our, our UX for the entire end to end, processing,
Audience Question 32:52
trainees, the planning, publishing, training into your
Bryant Grigsby 32:58
make or break. Yeah. Yeah. You know, clinician training is make or break, if you so. One example is, there's a catheter that we developed. It's a balloon catheter, and, and, and we say, okay, and you, you have to use x size syringe to inflate the balloon. If you use a big, bigger syringe than that, you're going to end up bursting the balloon. And, and so we it was just part of the instructions. And and surgeons were grabbing whatever syringe they had, putting it on and pop. Pop the balloon. Okay, well, $2,000 counter, toss it out. Pop, do the next one. The even though it was in the note to do that, that specific line of training wasn't talked about, wasn't expressed and so our customer ended up. Their chief medical officer came in, and we worked through a process of of of trying different syringes to find out, you know what, how how small they had to be, or what the threshold was. And then what we ended up just going is, you know what, instead of trying to do that, let's just train the surgeons better. And so as part of the training kit, we then brought out, as part of that kit the syringe that was what we said was the right size, and the distributor said, this is the syringe that you have to use. And after that, 90% of those failures went away.
David Chersky 34:30
Yeah, not saying that. It's easy to do, but, you know, budgeting for adequate labs and discovery is important, depending on, you know, depending on the product, you know, cadaver labs, etc. And during that process, you'll tend to discover some of the UX things, some of the, you know, device performance things. Yeah, and as you get more mature, budgeting for continuing labs and training is important because it's also an important sales mechanism, inviting surgeons to trainings, especially at conferences. It's not cheap, but it can tend to be, you know, a more efficient way of bringing people, you know, in, and it's a selling opportunity as well as a training opportunity.
Bryant Grigsby 35:30
Yeah, we partner with various different universities, you know, Stanford, Biodesign, UCSF, University of Utah. University of Utah is building out a new accelerator incubator space. And as part of that, they have a training area that they've dedicated so that they can bring surgeons in for each of those, the 10 companies that they're incubating, and also so that other people in the ecosystem can rent it out, so that you don't have to go to the hospital to do the training. You can actually go to a simulated hospital environment, and I think that's that's going to be pretty game changing for folks running through that program.
Bjoern Von Siemens 36:10
Couldn't agree more. Do we have any other slides? Another we have more questions
Audience Question 36:18
there given a discussion only about the importance to do I see, so experience. So next slide, someone repeat false or design it the experience. So explain that.
Bjoern Von Siemens 36:30
It's on the slide? Yeah
Bryant Grigsby 36:34
Is it on this one? Okay, yes, yeah, yeah. So this, what we're talking about, is understanding the full experience all the way through. And the specific example I was thinking of was that balloon catheter, when we put that up that so you we've got the whole kit, and actually up at our table, we've got the main catheter kit for that project, when, when it was originally designed, it wasn't thought about. What's the training kit? We have another product that very complicated stint delivery system. And one of the things that we did early on in that project is actually come up with a training kit. And so we made a fake piece of skull about like this, with all of the various different pieces that one would need, so that surgeons could actually go through and get the entire process. And so if you were, if you came, we didn't bring it here, but if you came to our Morgan Hill, Silicon Valley office, you'd see that's actually more up front of a demo piece, the small little syringe catheter piece, it's it's unimpressive, but looking at the training kit and how to get the the surgeon to go through the entire process the way it was intended, there was more focus on that, and that made it a very successful program.
David Chersky 38:04
Yeah, this will address maybe 2.1 is packaging as an afterthought, and the design experience, for example, how is the device going to be presented to the surgical field in its packaging? What's the process of removing the sterile barrier and presenting it to the surgical field. Sometimes that's not even considered until, you know, until the end, but that would be planning for the user experience. You know, not only how is the surgeon going to use it, but how is the or nurse going to unpack it and put it on the table? For example?
Audience Question 38:48
Thing you can do is run called sure and preaching workshops early on, and you get to KOLs in the room, and do the full of fuel is basically all the thing, keep up accelerated option, under friction, the thing, implement option. And you could go through a brace, top all the dose, think right through the experiencer, obviously, for like on the shelf, how easy to unpack it. How's the surgeon really uses in practice, assuming,
David Chersky 39:26
Yeah, that's a great way to put it fuel in friction.
Bryant Grigsby 39:32
Yeah, that sounds that reminds me of the the Six Sigma spaghetti diagram methodology, where you, when you look at from an initial order to when the product is used. What's the path? How does it go through? So does it look like that? Is it Chutes and Ladders going all the way through? And so you kind of map through the full process, where the. Bottlenecks, what are the resistance points? And you know, sales leaders do this. Effective sales leaders do this through the whole process. They go, okay, when I've got a customer in mind, what's the thing that's going to what's the first thing that's going to block them from buying, what's the second thing that's going to block them from buying, what's the third thing? How do I remove those barriers all the way through, are we out of time? I think
David Chersky 40:24
we're just about out of time.
Bryant Grigsby 40:26
Yeah, if you want to keep the conversation going, or if you have any other questions, Nik, our BD manager, he's there, and Dave and I, we've got a table here, and so we're happy to pick this up at lunch or at the table somewhere. So thank you all for coming.
David Chersky 40:42
Thank you guys.
Bjoern Von Siemens 40:43
Thank you.
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