Speaker 3 (00:00.322)
Welcome to the first season of the Hard Tech podcast. The Hard Tech podcast is about bringing together innovators, builders, investors and thought leaders all in the world of hard tech. In my background and starting software companies that I've scaled and exited, there's so much content out there for folks building in the software space and not as much in the hardware space. And that's exactly why the Hard Tech podcast exists. This is a super exciting episode, mostly because Grant and I have built a personal relationship with the Waddell Group, a

Medical device focused consulting firm really focused on the project management side of taking products to market I think it's gonna be super interesting of all the relationships we have here at glassboard on the regulatory the QMS side of things We've never met someone or a consulting firm that really focuses on the project management side. I think you guys are really gonna enjoy this

The best.

I'm Bill Davis. I've been with the Waddell Group. Here we go with the Waddell. I've with the Waddell Group since the beginning of the year. I am their vice president of business consultants basically, so I do most of the business development for the company. I also bring a lot of background in the healthcare services arena. So I've been eight or ten years working with health systems on consulting, value-based care.

just moving the bar forward with healthcare systems. And then for my last two years prior to being with Waddell Group, I was helped launch a healthcare tech company. So we had a recruiting side because we all know there's a large deficit in nurses and primary care physicians and specialists. And then we also had a physician compensation side where we had physician compensation software to automate the software for the physicians, which we all know is very complex.

Speaker 2 (01:44.492)
It's amazing how much math has to go in and figure out what they make. You're like, no, this is salary, right? And maybe a per-operation bonus. You're like, no, sweet summer child, it is way worse than that.

So fun fact, we surveyed all the health systems, know, the largest of the health systems, 20,000 people, and 85 % of the health systems are still using Excel spreadsheets to pay their physician.

Well, Tom, how many people still use Excel for project management?

Way more than should

That's a great segue.

Speaker 1 (02:15.246)
So yes, so part of our company does.

And who's our company?

My name is Tom Waddell. The name of the company is Waddell Group. Our tagline is world-class medical device project management. So we're improving that to be world-class project management because we're expanding into healthcare compensation.

Love that.

So.

Speaker 4 (02:43.63)
And actually any healthcare stalled initiatives that we run into, we can help you with. Because Tom has the ability to, you we have several great consultants with us now and we can expand into those arenas as well with my background.

because it's probably 20 or 30 % experience in the healthcare world and then 70 % project management.

just eating your veggies correctly and doing it consistently.

Exactly. think it's really cool because whenever we were first like organizing the podcast and getting to know you guys and we just like reached out we were looking for different growth partners and things like that. Whenever Grant and I originally had the conversation he was like they do project management like wait that's that's really niche and unique.

No one sells just that, right? A lot of people sell regulatory consulting and project management or insert a million other things here, but you guys are like hyper-focused in just project management.

Speaker 1 (03:35.318)
And it's either it's even a little more than that. So it's project management in medical device. Right. And project management in health care is primarily in physicians. So two very narrow niches.

compensation.

And Tom, before we kicked it off, were telling us like about some really interesting stories and projects that you had worked on. think it'd be interesting just like to kick it off on one of the ones you found like the most either the most wounds or battle scars or just like interesting stories that you have.

OK, well, one of the things I do with this, one of reasons probably we haven't grown to be 100 people is I always like to have a project myself. Working in the business versus working on the business. is.

It's really tough to balance, isn't it? They took away my CAD license nine months ago and I still haven't forgiven them.

Speaker 1 (04:28.526)
So I always have a project and what I tell people is I reserve the right to choose the coolest one. So the one I'm actually working on now is for a company called Mitivation. They make products that use infrared and near infrared light to change your body's metabolism in a way that helps particular issues that occur. The one that we're doing.

is to down-regulate your metabolism so that it helps either prevent or recover from something called reperfusion injury. Should I actually probably

I had to ask him twice about what this was the first time.

Okay, re perfusion. So perfusion is blood flow. So if you have a cardiac arrest and you stop having blood flow, you'll eventually die. But it takes a while. So like maybe 1520 minutes. If you get resuscitated within the first few minutes, your cells are there, they were upset, but you know, you they

They get on. They get along with it.

Speaker 1 (05:38.51)
If you're over like five or six minutes, when you get oxygen back, the cells go into this hyper mode. Think of driving a car and running out of gas and your foot goes to the floor, right? And it stays there until you realize you probably should pull it back. But in this analogy, your foot's on the floor, somebody puts gas in and you start up and you just use.

And it stays there.

Speaker 2 (06:05.218)
You run in the car in front of you.

You run into a lot of things probably until you go, I should probably pull back. So the reperfusion injury takes about two hours to get through all of the cascade of damage that this causes. And I won't go into the biochemistry because no one cares.

One of the four of us does care, but I'll ask later at dinner because I don't want to borrow the listeners.

Exactly. And one of the founders is a world renowned human mitochondria expert. So he cares deeply.

So he understands why the mitochondria is the powerhouse of the cell that everyone in my generation learned in school and we don't know why.

Speaker 1 (06:44.334)
And it's actually useful in this case.

Fantastic. So is this academic tech transfer? Where was the original mechanism discovered and how did it become a product? I think that journey is really interesting to talk about.

don't remember who actually did the original discovery of this particular phenomenon of specific wavelengths of light can either increase your metabolism or decrease your metabolism.

I would love to in a flying wall when they first figured this out.

Yes, like, are you kidding me? Light?

Speaker 2 (07:13.258)
I was in a project that had thermal therapy and it literally started with a doctor in a copper pipe running through a cat, pouring hot and cold water through a pipe with a funnel.

So the light actually will increase your metabolism or decrease it? Yes. So how do I just go lay under that light right now?

Well, there are a number of advertisements for Juve, J-U-V-V, or something where you lay in a, you lay, they have a big bed, you lay in it and it, that wavelength then increases the metabolism in your skin. So it's skin rejuvenation.

I actually want both directions.

Speaker 2 (07:41.408)
It myths that way of life.

Speaker 4 (07:48.344)
rejuvenation.

And it's lower frequency lights on like UV that damages can. This is.

Got it.

Speaker 1 (07:54.478)
Nope, nope. It's actually 635 nanometers is still near infrared. And 810 nanometers is actually in the infrared band. Those two will increase your metabolism. 750 nanometers and 950 nanometers will actually decrease your metabolism by about 40%.

interesting.

Speaker 2 (08:14.146)
And those are all longer wavelength than UV that damages your skin. I'm trying to that correlation that too much energy damages it. this is the Goldilocks zone.

This actually dumps thermal energy into your cells. there's a rule of thumb is you lose, in skin you lose about 90 % of the energy through one centimeter. So you have to put enough light in there so it can go down about five centimeters. And the therapeutic dose of this light is somewhere in 10 microwatts.

Per square centimeter.

Exactly. So we use the down regulating wavelengths to reduce the metabolism in this period of time of reperfusion where reperfusion injury cascade where it actually will sell, it'll slow the cells down. So they are normal for this period of time. The response only lasts a couple of hours. So we keep this, we keep a headset. The therapy happening for about two hours.

this therapy happening.

Speaker 1 (09:23.546)
And we're using it on small children that have gone through cardiac surgery and then some significant portion of those kids have a cardiac arrest later. And then so they're already in hospital. We'll have the devices right there. We'll be able to get the headsets on them fairly quickly. So we'll know. We'll we'll be able to prove that this works in human beings the same way that we've shown that this works in large.

That's awesome. And again, this is ironic that it's kids because my analogy is ringing to mind is you want to wake up a toddler slowly You don't shock them awake. Otherwise you have a bad time same with these cells You want to wake them up slowly get them back into perfusion slowly

That's a great way to look at it. you want them to be, you want to slow them down. Running, screaming. Yeah. Toddler is perfect. So running, screaming, running into things.

ease him back in the

Speaker 2 (10:16.814)
Yeah, that's awesome. So this, so how do you deliver the light? I think this is my first question is being a primarily mechanical and secondary electrical. How do you get the light in?

All right, we're using class four lasers because there has to be a lot of it. Very dense. We're then delivering the light through glass fiber.

Lots of energy,

Speaker 2 (10:38.082)
Yep, through like a little fiber optic channel.

Right. And then we show we shine that the light coming out of the fiber into some silicone wave guides and it bounces off of the surface the way that it's designed. then so it comes in sideways and then bounces down into the into the skin. All probably 80, 85 degrees.

And so this is all transcutaneous.

Yes, all external. Yep. There's nothing we're not inserting light anywhere.

Thank you.

Speaker 1 (11:13.33)
your nose or ears or you know I suppose we could do something like that but it needs to be diffused enough so that we get enough light in to be able to have a therapeutic dose in the brain for the entire

Yep. you need get enough surface area that's affected at a low enough power. You don't cook the skin. Right. It's all about what is it? The poisons in the dose, not the medicine.

And it's based on the wavelength because if anybody has, for the engineers in your audience, so there is a skin depth per wavelength. So we can put in about an eighth of a watt per centimeter squared for each of the two wavelengths that we're shooting for. We have 32 square centimeters of

Yep, per wavelength.

Speaker 2 (11:58.652)
that you're shooting for.

Speaker 2 (12:03.79)
contact area.

contact area that we put in. One of the fun issues is the hair absorbs this light really readily, so we have to take all the hair off.

You mean this pigmented thing that we have in our head? Yep. It is so crazy how that happens.

It's actually not the pigment, it's the protein. So protein absorbs. Well, any from probably 600 to 1,200, it absorbs.

wavelength of light.

Speaker 2 (12:31.854)
Because it's trying to keep us warm. mean, Heron for it was originally invented to keep us all warm. Doing his job.

So when in this product, this company's journey, did you start working with them? Did you come in sort of midway through? And it's really cool how, obviously, as a PM, you're pretty in-depth on what exactly the product does and how it's being implemented.

A guy who actually got it going and his partner were both at Wayne State in Detroit. Okay. they had a program where they brought in a CEO, what do you call it? Kind of an interim CEO. Oh. and residence kind of program.

Like, like, like a-

God, were they through like a studio?

Speaker 1 (13:13.102)
No, it was through Wayne State.

That's why the university brought in a executive in residence or CEO in residence. Correct. Okay. So this is like a tech transfer project process.

Yes, they were trying to bring this out because it's just really cool. And I knew that CEO and he's like, you know, I can raise money and do what CEOs do, but I can't do the project.

Yep.

Speaker 2 (13:37.602)
Yep, there's a lot of hardware running around.

Right. You need to develop the light. You need to transfer it to something that will actually be able to put the light into someone's head without burning them.

and control it so it never

Control it so never does. So and have safeguards. So we have at least one. Well, there's probably three safety switches in there so that. And then what's the model you're going to use? So razor razor blade. How do you price it? And then infants are probably not the first product we should have gone in.

Yep. How do you price it?

Speaker 2 (14:17.614)
was actually waiting to ask that and I was gonna do it off the podcast. I was like, man, pediatrics is so hard to start. There's a huge need, but it's a lot of emotional red tape.

And there's a lot of emotional red tape because it's an infant that's now going to have brain damage for its entire life. If, well, if you don't do anything.

If you mess this up That's okay. So you have a need that's already you're gonna do no less damage that's already happened

And we work with a couple of heads of cardiac programs for children's hospitals, which is where we're going to do the. And they're both there. There's nothing that you can't do anything. One of the ways that you can reduce the reperfusion injury is to cool.

clinical.

Speaker 2 (15:04.782)
I was just gonna ask, can you cool them down? But that has little bit of its own damages.

someone enough in two hours so the damage is done. So there is no treatment. So if a child has a cardiac arrest after cardiac surgery and they can't resuscitate them within the first few minutes, they're in big trouble.

big trouble. Yeah, because again, this is that whole

So this is an unmet need.

even though there's an opportunity with this product too. Yes. Wow.

Speaker 1 (15:36.75)
So it's just a heartbreaking issue.

Yeah. And you guys at least have an attempt at making a difference. That's the worst case. In the best case, you have an awesome solution.

We've already proven this works on large animals.

Speaker 2 (15:53.006)
So I'd love to talk about that process in project management is how did you break down the steps? Because again, going from, know that this wavelength of light changes metabolism, awesome science discovery, to, hey, we're selling this and people are paying for it to save their kids' brains during surgery. That's like eating the elephant and no one knows where to stick the fork in. How do you as the program and product manager go through the steps of identifying what are the breadcrumbs that lead us to that whole elephant?

Well, pretty early on, came in, it's like, OK, can we make this? And can we actually inject enough light to do the proof that? Or all the theory was right, and then we set up the studies for doing the animal.

Do the science.

Speaker 2 (16:37.751)
And what animal model were you guys using?

porcine. Yep. Pigs. And it works.

That's awesome. Again, that is.

It's a bimodal distribution. you treat them with the light, they don't. If you don't treat them with the light, it's just massive damage.

And this is what you want to see in animal testing. It's the same thing we've done with the device where we had to go do parts on animal testing. We'd get organs in to test on that we were running some experiments on. it's when you get those night and day results in animal testing, it makes the narrative better. And you can start telling the safety and efficacy challenges in verification in the lab. Hey, if our device failed this way, we saw that it didn't make the therapy work, but it produced no more risk. our device failed and created this other problem.

Speaker 2 (17:28.331)
in our animal model, this is a risk we now have to accept. And I risk acceptance is nothing to talk about.

So far, we don't see any risks. And we put that into our ID submission and the FDA didn't really like us to say that. there's always risks. I'm like.

Now that's awesome.

Speaker 2 (17:45.666)
Yeah, I think your major risk is your device breaks for some reason and what they thought was going to be great therapy doesn't get applied, but it's no worse than before.

How did we choose which therapy to go after first?

Well, yeah, that and how do you how do you go from lab to what was your next engineering test or test and how do you go to clinical like what were those breadcrumbs?

Two really, the two really biggest issues were what, where do we go first? We realized we had seven different opportunities to try this out on human beings. And we, I created a map and said, here's how long it's going to take and the amount of money and tricks. I did. we, we decided that

like a matrix comparing the weight. It's what you have to do to make complex.

Speaker 1 (18:33.806)
For children, we can actually therapeutically help their entire brain. So 95 plus percent of their brains will be therapeutically lightened up. They'll get the therapy. Yes. This also, by the way, so and there's about 30,000 kids that can have this happen with them each year. Not a huge market.

If you look at the number of people more my age that are having cardiac arrests and get brought back

There's about 800,000 people a year in the United States that have a cardiac arrest. Half of them are resuscitated. About 80 % of those people, so 320,000 people have brain damage from.

of some level from resuscitation.

reperfusion injury.

Speaker 3 (19:30.102)
Interesting.

So how soon do you need the device after you've had that event?

It probably will help even if you put it on an hour afterwards.

Okay. It's interesting because it's actually not slowing down. I'm sure, have you guys, let me ask, have you looked at putting on someone the moment of cardiac arrest to slow down their metabolism to keep the cells healthy longer and then also slow them down during reprieve because that seems like the golden ticket. I have heart attack, slow me down.

I'll make a distinction between a heart attack and a cardiac arrest. There is no reperfusion problem if the person has a cardiac arrest and they die. So, and it's pretty fast. The first thing you want to do is get them back. So you have to resuscitate them. You don't want to be messing with some light thing or shape.

Speaker 2 (20:01.176)
Sorry, cardiac arrest.

Speaker 2 (20:21.251)
I've just asked how long do you...

Don't bother. So get them alive and then figure out how to get this headset on them. It's the order of operation. It is an emergency. Someone's dying. get them, get their heart working again. Again, so the big, big, big market is going to be post cardiac arrest.

just get them back.

Speaker 2 (20:30.818)
Got it. That's the order of operation.

Speaker 2 (20:49.518)
therapy.

If you think about it, the same sort of thing happens in stroke.

just gonna ask that.

There's about 700,000 people that have a stroke every year.

or small aneurysms kind of thing.

Speaker 1 (21:01.898)
any situation where they're going to lose blood flow out of the brain and then they'll get it back. So another one will be traumatic brain injury. So I'm walking through the things that we were considering. And then there's probably three or four more.

And we're going to make a matrix of how much money can we

platform, where should we prove it? And some of them were pretty even with each other. We're like, okay, somebody my age has a cardiac arrest, brain damage. Okay, I've had a really good life.

Baby had cardiac surgery and they're set up to have brain damage for the rest of their life.

It's area area of the curve problem.

Speaker 1 (21:52.922)
Yeah. So we went that way. And said, this needs to be solved. You it's probably not the right one. Corporate.

or even.

Speaker 2 (22:03.271)
to make the most money. But it might be the easiest sale. It might be the easiest to get in market, right? It might be have the biggest need, the biggest error in a company.

as part of it. But again, all of those were somewhat level and we're like, OK, if we're going to be humanitarian.

Yeah, sure. Well, all of things equal. This is our here.

against.

And from like a clarification perspective of like if you start at the pediatric level, is it much easier to then go to the adult level as opposed to starting at the adult and moving back to or is it all the

Speaker 2 (22:26.518)
it's all downhill from there.

Speaker 1 (22:33.064)
From the fun we've had with getting the pediatric devices done and moving forward and getting to the FDA, any of the other pathways look pretty fun. Sure. But I'm not there yet. So when I get through the second one, I'll give you a comparison. Sure. But couldn't be as hard. At the moment, yeah, this is it's a challenge. Sure. it is a yeah, it was a difficult choice to choose which of those.

And this one's probably the smallest market size. again, if we prove this, then everybody's going to say, OK, there's an enormous.

Yeah, time to copy paste this into all the applications.

There's probably five million a year of people just in the US that could have some part of this technology used on them. So it's a very, it's a revolution.

Well, and this is just the first application, right, of the core mechanism. That's the big part, right?

Speaker 1 (23:30.51)
But as a platform, there's probably five million people in the US a year that would have, that it would make sense to have this therapy applied. So yeah, the, it takes a while. You got to get through a clinical, all that.

amazing.

Speaker 2 (23:45.036)
You have to build hardware. I mean, no one's ever taken time to do that.

We built hardware. So that was the first big fun issue to, what are we actually going to treat? Who are we going to actually treat? Not what. Who are we going to treat? then, all right, how are we going to deliver enough light? do that. And getting light out of lasers with two wavelengths can be really interesting.

How do you get it?

Speaker 1 (24:19.727)
There were bunch of challenges with that. had to find the right vendor to make the laser systems.

light piping and everything.

How do you control it enough? Then what's the mechanism of actually getting it from the device sitting over here through light fibers that isn't going to break each time you do that?

or change intensity if it's kinked too many times or it, mean, this is the fun part of engineering.

And then we're going to have a razor blade. So we have 24 glass fibers that have to get connected and put perfectly next to each other. Because if you go like this and you're not transferring the light correctly.

Speaker 2 (24:57.878)
Perfect.

Speaker 2 (25:06.508)
And if they're at an angle, it all bounces back. mean, glass is this weird thing. It'll conduct or bounce light, depending on what angle you hit it.

and the fibers are 100 microns.

just huge bullseyes. Yeah.

Really easy to match those. So the connector development was really fun.

I bet your connector vendor loved you guys.

Speaker 1 (25:28.258)
For some reasons, yes, but we haven't bought a ton of them either.

My joke is they will love you at the end because I'm those are pricey, but I bet during development they loved you guys.

Right. And then the development of the wave guide, you know, how do we have a 40 durometer medical grade silicone? Right. And that actually doesn't have any, it doesn't have a significant number of hotspots so that you actually do burn somebody that would be really bad.

Pouser's light the right ankle most of

Speaker 2 (25:55.542)
or have occlusions in it that end up heating up the wave guide itself because you're hitting all the light.

Yeah, we didn't worry about that one. It's medical grade silicone.

You had a pretty good control process for that. Yeah, because bubbles in that, any even small bubbles that wavelength will bounce light around inside.

Very good.

Speaker 1 (26:17.614)
back to that medical grade. And I haven't seen a bubble yet. That'll be part of the control.

They figured out a process.

Speaker 3 (26:27.799)
go for it now, for free.

So that was pretty early. Who are we going to treat? What's the technology that we're actually going to get there? We really wanted LEDs because the regulations on LEDs are way less than shining class four lasers.

directed at people.

Speaker 1 (26:50.091)
But there wasn't an LED solution. So there is now. We will at some point shift from laser and optics to LEDs with different.

interesting.

Laser knob.

Speaker 2 (27:04.162)
localized light pipes basically.

But that's the decision we made at the time moving forward. And then how do we set this up so not only then do we get the FDA to say yes, but then I'm always looking at what's the end game. We want to make this what everybody at the Kleenex of.

want everyone to want to use it.

Right. Standard of care, I believe.

That's medical term, but it's one of those who's your end buyer versus who's your end user versus who's your end recipient. Right. Right. Because like in medical, this isn't straightforward. When you're building iPhones, I am the buyer, I am the user, I am the everything. When you're selling in medical, someone else is choosing to buy this thing. Someone's actually having to install it and physically use it. And some patient is getting all the benefit. Right. And a payer at an insurance system has figured out how to use the time value of money that this treatment is worth.

Speaker 2 (28:02.86)
all the other treatment we pay later and we'll pay for this.

That's interesting. So there's also a layer of like a business model development as you're doing the product management.

Someone's gotta make money.

We need to make money so that we can continue to expand. The health care system has to have this cost less than it would be if the problem persisted. extra cost for a child to have brain damage throughout their life is over a million dollars. I said over.

I'm shocked it's that low. say area under the curve is a compound interest, hell of a drug.

Speaker 1 (28:40.558)
The additional cost for I think the first two months of old person to have reperfusion injury and then brain damage is over $100,000. So the I don't we're not going to get pushback on too hard for selling the razor blade portion of this for something that's you know well less than $100,000.

That's it.

Speaker 2 (29:07.212)
Yeah, a real five figure number is still a steal for them.

Well, and we'll need to provide them a lot of evidence for that, I'm sure. The cost savings, which is what a lot of health care systems look at. Yes. Yes. Yes.

Speaking of healthcare systems, this is a great

Sure, yeah, maybe I could.

They have to, but this is actually going to save a lot of money for the healthcare system.

Speaker 2 (29:31.692)
Yeah, integrated over time.

Bill, back last week, you came in and we were chatting a little bit about that around the healthcare systems, either the capital lost or they're still managing things on spreadsheets. Could you just refresh us on that and dive more into that?

There goes a lot, there's a lot that goes into the physician comp, you know, pay program for doctors and it's constantly changing, which, know, they will only, the fee schedules change, the providers pay structure change, changes. So those expenses are just always ongoing. And as they try to aggregate, you know, for the doctors, you know, what their pay plan is going to be that that's also another problem they're experiencing. And we, you know, there are

compensation systems out there that will automate, you know, SaaS products that will automate and pay these docs. And then it takes a lot of the regulation out because humans aren't entering this data, you know, it's just...

Or the human data that's entered is least fact-checked. Right? Like there are rules that I've like, this doesn't look right. Are you sure?

Speaker 4 (30:35.534)
It's always audited. And so there's a lot lower chance of risk. With the spreadsheets, you have the risk of overpaying providers and you have the risk of underpaying providers. Both are hard to claw back and catch back up.

Well, and underpaying people is a real legal headache. Like when you underpay a human coming from a guy that runs a business, you don't want to do that. You always want to err on overpaying them on accident because if you underpay someone, that's the one place the law has no patience.

Totally. And just to be clear, you talk about like major health care systems using Google Sheets or Excel to pay the doctor.

person.

Are they even advanced enough for Google Sheets? It's assuming they're on G Suite. It's Microsoft 1998. all know. Running on a Windows XP machine that they pirated the 98 software for.

Speaker 4 (31:17.39)
is definitely Microsoft.

Speaker 3 (31:22.799)
Why do you think that the healthcare system is still in that spot? Given, mean, they obviously have the capital to subscribe to any SaaS software they could or what have

and the volume to justify it.

great lead in because that's exactly why we come in. Because the health system is like this giant ship, they're really hard to turn. And they're all siloed, you know, they're in their silos. So to get somebody to understand that they need this software, where they're going to get the return on the return on their investment, two years, three years, instantly. And so there's no reason not to use the software. It's just a matter of getting everybody aligned to make that decision.

And then a lot of the systems I worked with, 10 years ago they had three people in a department working on the physician column. They had 300 doctors. Fast forward to today, they have 3,000 doctors. They still have those three people managing those same. With Excel spreadsheet.

with Excel spreadsheet.

Speaker 2 (32:20.75)
saved locally and then emailed to each other.

So now you're seeing the errors increase, you're seeing everything in the cost increase. So after these systems finally do join with a physician comp automation software, then we can come in and help structure the department moving forward in a practical way that they can actually have structure, break down some of those silos and then.

like a playbook that they all agree to and play from. This weird concept in team building and project management of like, here are the rules of engagement everybody. You're all allowed to be happy or upset based on these rules. And this is how we're gonna manage this. We will make mistakes, but if we have this North Star, we'll at least march in the right direction.

Exactly. So we can come in, help with their software, make sure they're using that to its fullest potential. And then we can also help their department so everybody's working at their highest level instead of taking phone calls from the docs while this is wrong. So they can work at the highest level of their licensure and move forward and be successful. And, you know, we can work with them for six months to a year to make that happen.

It's all about efficiency and scale. You guys are training them, we used to do it Excel because there were three of you and 300 doctors and this was totally manageable. This has now grown into a monster. The new SaaS tool with software we help implement is difficult to wrap your head around it first. It's got lots of options. It can only let you do it their way. You can't do your old tricks you used to do to balance the sheets. You've got to play by the rules. But I promise you, eat your veggies, right? The topic we keep bringing up. If you do it now, you'll be happy and healthy later.

Speaker 4 (33:44.334)
Absolutely, yeah, they're going to be healthy and you know, we know several different vendors that we work with and

I was going to ask like are there specific ones that are better than others or you're like your top three?

There

there are top three that I can you mention that? I'm not going to tell you. Because you there was probably eight to ten that are good. There's a top three that we think you know lead the market and that their software is the safest software out there that's automated well that's gonna work well for large systems. And then you know maybe I might take you to another system if you're 300 docs rather than 20,000.

And you have one person running the system instead of three. Exactly. And this is like unique butterfly. We tell this for everyone. Everyone says, what's a product development journey? I'm like, well, there's a process. It usually goes through these steps. It usually takes somewhere around this time. But every product is unique butterfly. Each company has their unique tech. They have their unique leadership and management style and they have unique market and regulatory needs. And each one is a blend. And what might be poison for one of my clients would be a great fit for another one when I'm introducing software vendors or.

Speaker 2 (34:45.742)
project management vendors, or a fun one to talk about that I'm gonna bring up to you guys. We have a firm locally that does, imagine an actuary, but as a consultant for medical device billing. So they are HavartiRisk, they're here and they go in and down, you know, look at all your clinical data, all your risks, and then go run the actuary science at the backend to help you convince payers what it would save them. So they're, actually I lost our direct operations to them, they stole Tamar from me, they're still great friends.

But she's over there now helping them scale similar to what Classport's been doing. And they just run a really cool service that they take even nerdier nerds than engineers and actuarial scientists and then apply them fractionally for good. They really like trains even more than we do. It's incredible. But no, it's really cool that they've been able to find this niche that all these early stage med device companies either inside of a large player, right?

like a Metronik or a Striker that are the innovation teams or an actual startup or small to medium business, were struggling to get their point across to the payers because the payers are all talking actuary science. That's all they talk. They only speak risk and the very particular way it's formatted. And they realized, and they were on the other side of the table and realized they be a great service translating from company innovation to risk in a way that was a positive light. And so it really helped this English to English translation, as we say, in a way that became very valuable.

That's pretty awesome.

Yeah. And again, I'm sure you deal with similar things in the project management side of things of you feel like, you know, at least 25 % of your week is telling two people the same thing differently.

Speaker 1 (36:20.014)
Not that high. Thank God.

Juke and SaaS tools that bring that number down.

And Grant, maybe this is a piggyback, maybe it's not. But I know that whenever we first got engaged with these guys, like you were really excited. And I would maybe like to paint the picture on obviously Glass Board is the one that runs like the Hard Tech podcast. And that's a part of it in terms of like how the Waddell group works with Glass Board and like how the because you would think from like a high level project management, although there's project managers on. Yeah, right. But like how does what they what they do is specifically like different and how does it integrate and so on?

We have them.

We project managers.

Speaker 3 (36:55.774)
Like areas that you see opportunity.

tell the story of why I got so excited. So we do project management and over the years we learned that it's way more important than we even thought it was. It is like the multiplier, like the interest rate on your loan. Yes, having borrow more money is more expensive, but the interest rate really turns that knob pretty heavy. Good project management is like having a low interest rate. And we have clients occasionally that are, have trouble getting out of their own way. I think that's the best, kindest way to put it. And we are too close.

to them to tell them what's going on. We're too close. We've been with them since the beginning where we have too casual of a relationship and they feel like, you know, they can fight us on it and it's no big deal. And we'll push back, but we won't get listened to like, no, no, it's fine. We'll do this. And I really need a fresh set of eyes sometimes to come in and manage the project to not only make sure the client knows I'm not just saying this to make more money or to prolong the project, but it really, is the best. This is going to save us later. And sometimes I need my team to get yelled at.

If we're the ones program managing ourselves, like you and I talked about this before, the FOD has started, Cobblers kids have no shoes. How are you managing your own personal to do tasks?

not as good as I am at managing other people. I myself off the hook way too often.

Speaker 2 (38:05.954)
Yep. We have the exact.

Speaker 2 (38:10.872)
Yep. And so that's why I got so excited. It's of these things that it's a human thing and having a third party perspective can both save us from headache from we're the ones causing problems we're not seeing or the client getting a very fresh set of eyes who the person who's not getting paid doing the work is still saying this thing if it's a hard, difficult choice to make today.

Just the idea of project management. One of my former partners used to say, if your project manager makes one good decision, they've paid for themselves completely.

yeah.

If you're burning $100,000 month and your project goes out one more month or two more months, why didn't you have a project?

One more month.

Speaker 2 (38:55.564)
Well, and so let's talk shop. is really fun.

probability of having those big pushouts is way less because you actually know where the problems are going to be along the line.

So by hiring the right team.

Alright.

You actually create a risk register.

Speaker 2 (39:11.624)
I haven't heard that term before. I mean, we talk about risk and risk matrices and risk acceptance, but the term register is ringing for me first.

You have it?

Speaker 1 (39:19.106)
Sure. risk burn down. When are you going to know if this is there or not?

That wrist burn down,

Speaker 2 (39:27.054)
Yeah, yeah. How do you know this is real or not? And how mitigatable is the risk?

Right. And then somebody has to go, hmm, I'm sure we got 80 % of the risks really, because we don't know. And then do a lot of work to go figure out what the other 20 % is. Because if you don't know what the risk is and you don't know how to mitigate it and you then run into it later, bad day.

bad day. Again, FDA doesn't mind if you have a risk and you accept it. They really don't like it when you get surprised.

You know, I think I have a little bit of a correlation. So whenever I was running my first startup all in, I we used an outsource development partner, sort of like Glassboard, but for the software side and built a super close relationship with with the CEO of the software. We would go to Pacers games and things like that. were pretty close, you know, and so on. I was a younger founder. He was like a mentor of mine. They invest in the company and so on. And there would be times where maybe I would have some conviction around where the product should go. And he should. He also had conviction on where the product should go. And we're both, you know,

Obviously I'm paying them to do the work. However, like they're also invested now. So the, you know, both of us succeeding is that the company ultimately succeeding. So it would have been really nice to have a third party PM come in and say, it's probably like, yes, to about 25 % of what you're saying, which was me and about 75 % of what he was saying, which was him. And then bring that together into a more of a concise, I really think that third party aspect really brings a lot of value more specific to like that more interpersonal.

Speaker 2 (40:41.992)
Are you sure about that?

Speaker 3 (40:57.952)
issue that you can come up with. think, kind of just mentioned that, having that outside view because the project management role is so critical, like you just mentioned. One thing goes off, right?

so emotional as much as it's technical in your veggies and making the right risk choices and lists. It's emotional of being able to call a spade a spade or see the future without having the rose colored glasses or the pessimism glasses. The other one I was like, we'll get clients that have way too much pessimism and like we're frozen in action because there may be risks we don't know about. I'm like, well, we're not going to find out until we get there. Got to drive by Braille a little bit.

Well, and you'll also find engineers either give you wildly aggressive schedules that they're going to be able to do or and you got to know that and the others are the great sandbaggers. You know, they don't want to take any they don't want to take much risk.

They're never gonna hit it.

Speaker 2 (41:44.504)
Well, no, they want to zero risk and this is the worst case scenario and it's going to take a decade to get there. We're only making goldfish.

I can't promise this by this time because here are the five things that can go wrong and I can't predict.

Yeah, and I don't know where they are. It could be a year could be ten years. I don't

So, but you got to come up with something.

Sure, and of course if you want the Goldilocks version of that, just go to Glassport and going to be upscaled.

Speaker 1 (42:09.214)
No, but having somebody that's been through this a few times, okay, you're probably going to be about here.

And you're probably going experience about this much growth throughout the project and the timeline and the cost. Right. Here's what we've seen in this kind of industry. Here's what you don't know at the beginning. Right. The worst case, it goes up by 4x. Best case, it gets to 1.25. Average, it's about 2x what you think it is today. Right. that's, know, insert industry here has their own multiplier curve of, it's always a bell curve. It's always stats. Do you know the team here in town, SCP Software Engineering Professionals? They're a really cool software dev team.

I don't.

They're about 30 years old, 170, 580 people. Raman was on an episode earlier, so make sure to listen to that one. But they've got a really cool Monte Carlo simulation pricing model where they'll do some early sprints to go plan the project and write down their goals and their sprints. And then they relate it to past projects in this big database they've got of, this kind of product, this is the growth we should expect on sprint plans. This is the timeline growth. This is the amount of features that the client doesn't tell it on average. And it's all

and actually.

Speaker 2 (43:13.89)
Here's the average, here's the 1 % outlier on the top, here's the 1 % outlier on the bottom. And they show the client this statistical distribution. We're quoting in the middle, here's where it statistically is, let's get started. And it's such a powerful tool because they're like, hey, this is just data and this is just stats. you're probably not gonna be the top 99th percentile overruns. You're probably not gonna be the bottom 1 % either. Let's plan for standard deviation around the middle here.

So I love that. So the project management things that cause failures in projects, you don't plan it very well. You don't manage it well. And then the last one.

I can't wait for this. mean, scope creep. My favorite part of scope creep is if it's not in the PM's position to control, they're along for the ride. It's my favorite game because you can say scream from the rooftops. This is a terrible idea. This scope creep is going to murder us. And if person in charge says we're going to the top of mountain, you say, captain, you get your bag, you start hiking.

Scope creep.

Speaker 1 (44:20.622)
Well, but you have to tell them.

yeah, in very exquisite detail.

in very exquisite detail and say, you here you go. I always laugh because people are like, well, who makes the most scope creep in a project? Everybody says, well, the marketing group. Of course they do. They they know what the new things are, but they're not. So the engineers like adding their little flavor to everything. Little tiny little changes constantly over project is.

Side quests, we call those side quests.

Speaker 1 (44:52.398)
worse than adding some big feature later. So I mean, maybe it's not worse.

But no, you can at least quantify the big feature before you do it. The little ones are death by a thousand cuts.

Right. So a really great project manager has the definition of the project nailed down.

in Medivice intended use statement.

Here it is. This is what it is and any deviations from that. You can't say you can't make any deviations because the market might come back and say, we have to have that because whatever competitor.

Speaker 2 (45:25.176)
We really need that feature.

And in today's world, I have to add IoT to that thing. That is the current in-med device hot button. I have to add IoT. I have to collect data. I have to run AI on it. And I have to go sell that later. That is currently all I hear.

Actually, I went the exact opposite for the iteration device. So I said, you know, that doesn't even have software and it has firmware.

Yeah, it just has embedded software, yeah.

And if we need to upgrade the firmware, can submit that. And then that will get approved. it doesn't interact. There's no security. There's, you know, know, it's 6-2-3-0-4. You know, it works.

Speaker 2 (46:00.11)
of cybersecurity.

Speaker 2 (46:05.454)
I'm a lot of requests for this. And for us, it is blowing up timelines. But I'm finding markets demanding it. And my clients are willing to go put their money where their mouth is to go get this because it's the future of if it was worth doing, it was worth writing down, which is ironic because it sounds just like the FDA process. If you're going to do this, you should write it down. Right. And that is it's leading to a big what I saw in the consumer electronics market in the teens. Right. know, Nest started it with all the smart thermostat and smart light switch.

light switches and light bulbs and then door locks and you insert everything here. This has come from medical and it's coming fast.

Yes. When is it appropriate? Not not.

not your first product. I think that's the answer is V2 absolutely let's do it but make sure we want to have revenue.

you can have all that fun stuff. yes. So those are some other parts of the game of somebody has to be looking at what's going to cause this thing to fail later down the

Speaker 2 (47:03.138)
It shouldn't be the engineers.

What the regulatory risks? Well, if it's an engineer, they need to be responsible for the schedule. So how many of are that good? But that's what I hire is engineers, but we love the project management portion of it. And that's the responsibility. That's not the engineer.

What in it?

Speaker 2 (47:21.038)
Well, they're not the individual contributor engineer. That's where I'm going is is in we inside Glassport, even within a project have different roles that you may be an individual contributor on another project. Sure. But if you're PMing this one, you shouldn't be an individual contributor on it. Right. Yeah. It's interesting as we got, you know, I got older in my role here in Glassport, we got bigger. I there's a big difference between management leadership. And those are totally different skills that I didn't realize are unrelated. And I am terrible at management.

Yeah, that's really smart.

Speaker 2 (47:47.896)
halfway okay at leadership, think. People tend to want to go do stuff. But management, I'm so bad at. It's wild. And we have Sean, who's our chief COO here at Glassboard, and he is so darn good at managing people and making them enjoy the process. And it's this difference that is in project management. You actually need to simultaneously play leader, that you're getting everyone rallied behind the idea, and they're following you into the darkness because they trust that you've got everyone's best interests at heart, even if you disagree with them on Tuesday.

being modest.

Speaker 2 (48:16.534)
And you also still have to become the manager and that's got to be a really tough role to fill both. How do you hire for that?

I have a that that wasn't a rhetorical question.

No, no, no, that was like, I want to take notes the rest of the time for all the listeners do too.

All right. I only hire people that have managed enough projects to have blown one up.

That's a, it's not that hard in hardware, but yeah.

Speaker 1 (48:42.99)
Well, even software, if you get in through there and and you extend out way beyond where you were supposed to go, that's a failure. Yeah. So the people that I hire need to understand that you have to define the project really well. You have to manage the Pajeebers out of it to make sure the planning and everything goes the way it's supposed to go. And then, and you got to manage the scope. And the way I find that out is I ask them about their best project.

and I asked them about their worst problem.

And you want to hear the real horror story on the worst one. You want to hear the real gates of Hades.

I want to hear from both of them. I want to hear what they learned. So for the best one, part of this was luck. I landed the very best project team I've ever had.

My client was very clear with all their needs.

Speaker 1 (49:32.074)
Yeah, and they were responsive, you know, I had these issues and they were solved within days and then the ones that just completely blew up What did you learn? So if people are If people are honest, here's what I contributed to this

Yeah, here's how I didn't fix the thing I should have fixed.

And even for the great ones, it's like, you know, I probably had 10 % for this. had the dream project team and the dream management that went this way. Over here, yeah, I made these three decisions that were disaster. And it took us six months to clean this up.

Yep.

Speaker 2 (50:13.662)
Or I didn't catch this thing that I should have caught. And we all do that, right? And it's one of these things that it can be discipline. It can be emotional. There's 101 reasons that you might miss something in PM or management that it like, it's not a straightforward of I didn't check in every week. is. I liked the engineers so much. I trusted their enthusiasm. They'd solve this critical problem instead of calling a spade a spade and say, hey, it's too late. got to this feature.

On one of my disasters, had two parts of a project that were both equally, could be a problem. And for one, this guy was really awesome. This engineer was spectacular. And the other, the group that was working over here was just, they were a train wreck waiting to happen. So I spent 90 % of my time over here working to make sure that the train wreck didn't

And you kept them on the rails.

I kept them on the rails. was. And this over here blew up.

because he still needed some touch.

Speaker 1 (51:16.174)
He needed 25%, not 10. I learned that one. No matter how good this person is, they're still the engineer and they're doing engineering stuff and they're not watching. Or if they freeze. As it should be. They're not doing your job. You got to do your job.

and their heads down.

Speaker 2 (51:38.972)
that's interesting. My worst one that's very similar. My worst one that's so similar to that is I was the engineer and the PM and I had client I really liked and we were life-saving technology, just the coolest medical technology ever. And if the project had been going to that point at rocket speed, I knew the client before they found this technology, another tech transfer out of university. So my contact became the EIR in residence and became the CEO. And I like this guy.

That was hard. It was just, my God, that was hard.

Speaker 2 (52:07.95)
and we start working on it and we go from first check to start development to functional animal testing that works in I think six weeks. Like I just had, we got lucky that the concept idea worked and I built this prototype that did the thing and they put it into a cat on Thursday and it did the thing. So raised a bunch of money. And the next couple of phases go really well, go through, get some SBIR funding, phase ones and phase twos. But all of a sudden, right before human clinical, we get some rubber that starts meeting the road.

some engineering challenges that I was convinced we could solve with time and money. this is my first lesson, asymptotal approach to solution, where you don't actually, once you solve the core math all the way down, there's never a solution. But you're really close. You're only off by like 10%, but you're not gonna make your metric. But you didn't understand the core complexity of insert complex system here, that every week you could make 10 % progress towards your goal from where you were.

but you're never going to get there because AspimTotal sucks. And so you keep telling yourself and your client, like, you're going to make it, we're going to get there, it's going to be fine. And the timeline starts really getting tight. And I finally had to call it and it was still, it was just too late to the relationship. And like all on me, my PM, I was the engineer and very first lesson in modeling AspimTotal approach. So you can catch it one, you know, one iteration loop in or two, not, man, we are now so close, but we're still in.

Just start, you know, start, start modeling that decreasing approach percentage. And that is something I model all the time. We have any hard physics we're working on now. Graph this.

Yeah, that's the kind of response that I want to. I think you've proven your worth in that particular realm.

Speaker 2 (53:49.998)
so I get hired.

Speaker 2 (53:56.472)
But again, you only get that by bruises.

I think the thing I'm walking away with this is when you win, it's we when you lose, it's me. that, everybody. This is the Hard Tech podcast. Thank you so much for joining us. We'll see you guys next week.

that's good.

Speaker 2 (54:12.334)
everyone. Thanks so much.