Ep14 - Putting a robot in every surgeon’s hands, with Tom Wenchell, CEO RevMedica, and Robert Satti, CTO, RevMedica

Show Notes

Following the data leads to a breakthrough idea in laparoscopic surgery.

Sometimes a technology starts off in one direction, but the data leads developers somewhere else entirely. This is the case for RevMedica, an early-phase medical device company, and manufacturer. 

 

The first product in development at RevMedica is a cybernetic laparoscopic surgical stapler. The development of this device may transform the $4.5B surgical market by matching a reusable power module with a disposable sterile body. But it didn’t exactly start that way.

 

Recently, Tom Wenchell CEO, and Robert Satti CTO, of RevMedica talked with Andy Rogers of KeyTech about how a venture to create a full robotic surgery platform turned into an even better idea, by following the data path.

 

Need to know:

·    Sometimes data can lead you in a new direction. Follow it.

·    Start-ups must learn to do more, with fewer prototypes

·    Data mapping puts performance on view for users and investors

·    There’s a balancing act between development and marketing

 

The nitty-gritty

 

Surgical stapling is a workhorse technology. Staplers are used every day to dissect and/or ligate soft tissue in abdominal and thoracic cavity surgery.

 

Surgical staplers are nothing new. But the mechanical devices – and even the powered devices – have well-known drawbacks. They don’t fit every hand, can be tiring to use, create waste, and rely on the surgeon to feel his or her way around inside the soft tissue.

 

RevMedica’s technology is designed to effectively bridge the gap between the instrument and the surgeon’s hand. It’s a hybrid device, not a full robotic system. It’s designed to give surgeons a tool to make better decisions in the OR and create better patient outcomes. 

Different types of data have shaped each step of the development:

 

Market data drove initial development. As RevMedica Interviewed surgeons, their original concept for a full robotic stapling device fell by the wayside, and the hybrid model began to emerge.

 

Competitive data helped refine and develop the hybrid concept. They looked at entire systems to find inefficiencies in mechanical and powered devices. It became apparent that a hybrid architecture enabled better articulation, smart firing, and a significant competitive advantage: the durable component can remain sterile for multiple procedures. And durable components reduce the waste of “one-and-done” mechanical staplers. This way, RevMedica can provide more value, at a lower cost, without all the bells and whistles or full-on robotics.

 

Ergonomic data from workflows and job functions surrounding the device as well as the way the device works with tissue provided valuable insight. Different aspects of workflow in OR were scored and ranked, then aggregated in spreadsheets and graphs. By making the data visual, RevMedica developers created a useful tool to define user needs, evaluate performance, and demonstrate the viability and value of the technology for investors.

 

Give the episode a listen!

Learn more about RevMedica: https://www.revmedica.com/

What is MedTech Speed to Data?

Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.

Hey everybody, welcome back to

MedTech Speed to Data, A Key Tech podcast.

The latest episode today is with RevMedica.

Got two gentlemen on the line, Tom Wenchell,

and Rob Satti. Gentlemen, welcome to the show.

Thanks.

Yeah, today we're going to be talking

about their powered surgical stapler platform.

And let's just jump right into it, guys.

I would love to know the backstory

I'll start with you, Tom.

The backstory on where did RevMedica come from?

I know you spent many years working in industry,

but just talk a little bit about the background.

Yeah, no.

Great question to start off with, Andy.

So as you know, obviously,

we worked together a little bit

when I was the director of research and development

at Medtronic.

Which back then was probably Covidien.

Rob and I work together on a lot of projects,

and that's where we kind of built the relationship.

He was a go to guy.

And quite honestly, it wasn't until

after I left Medtronic,

Rob had left a little bit before me

that he reached out to me with the idea,

the original concept around RevMedica,

and I got pretty excited about it,

decided to drop what I was doing and go all in,

and started really early on

with just a provisional application.

But I'll let Rob tell you

what was the genesis of the idea that got things going

and then sort of what it's turned into now, which is

quite a far away from that early days.

Yeah, saw a lot of R&D dollars going into full robotic

applications in the surgical suite.

We knew that at least in my opinion,

the world is not going to go to a full robotic

play across the board for all surgeries.

It was needed and required

for some procedures

and also created procedures within itself.

But there was always going to be

a need for technology, innovation in hand instruments.

And from that, Tom and I, conceptualized,

a bunch of different features

to allow surgeons to operate better in the O.R.

And that's really where the initial idea came from,

was knowing that the need

was not going to be a full robotic system,

but something that gave

the surgeon tools to make better decisions

in his current procedures.

Yeah, I love that.

Our prior guest was with Galen Robotics

and they're also surgeon assist platform.

So the term

I call it just doing some research is cybernetic.

I love that term

is cybernetic laparoscopic surgical stapler.

So just can you remind our audience, you know,

what the state,

what procedures and what organs are these?

Would these staplers be used for.

Laparoscopic stapling,

which is the area

we're targeting with our control module technology.

First, it's a four and a half billion dollar market

it's the workhorse in surgery.

It's used every day.

We invented the first ones

down in the United States Surgical Corporation

when we first figured out

how to automatically load

little staples into plastic cartridges.

So basically these devices are used to simultaneously

adjoin and dissect soft tissue

inside the abdominal cavity, thoracic cavity.

So basically lung, stomach, colon, bowel,

appendix, liver, spleen,

you name it, anything soft tissue staples are used to

to dissect and migrate simultaneously.

And it's about

a three millimeter long instrument

as the length of the device

where all this is happening.

They're fired multiple times

throughout the course of the procedure.

Got it.

So you're in the abdomen laparoscopically

and can you describe just where this product fits

in the market with with on market surgical staplers,

whether they're powered or purely mechanical,

Like how does it compete?

Yeah, absolutely.

So traditional devices out

there were always disposable.

It was when US Surgical had saw

a little company down at Langhorne,

Pennsylvania, called Power Medical

that started with the first robotic arms

like powered platform for stapling devices

they actually then went and purchased that technology.

And it's they still have it on the market today.

It's a reusable system

that has some power functionality.

Ethicon, Johnson and Johnson,

kind of saw that the trend was going towards powered

and they decided

to come up with a device of their own that’s powered

only they opted to go with more of a

disposable powered option.

So they de-featured it,

it doesn't have a lot of bells and whistles,

gets the job done

and really those are the two devices out there

in the powered realm.

And then there's

still the lion's share of products

that are used manually, you know, that require

the surgeon to hand crank and pump through the tissue

with really no feedback other than their own eyes

and their own feedback on their hands.

So I think really what we've come up with

is we're a hybrid model.

We call it a hybrid reusable,

where we've really got the best of both worlds, right?

We've got the advanced features and functionality

to give the surgeons

greater performance,

give them intelligence and feedback and data,

and do it in a way that's sustainable

without interrupting workflows,

without requiring hospital

sterilization processes,

and also reducing the amount of waste

that goes in the incinerator

because ours is again, it's a hybrid, reusable model.

So I think that's where we fit.

We give surgeons what we know they want.

They always want more.

They just don't want to pay for it.

And they certainly want to try

to be as sustainable as they can

without workflow interruptions.

There's definitely a space in the market

for a hybrid option

just based on the research I've done.

So just to be clear, there's, to our audience,

there's a purely mechanical, surgical stapler

that you're gripping and clamping and making staples

along the way.

And then you've got a purely

electromechanical, I guess, but you throw it away,

so you're in-between.

You're providing this battery pack essentially

with sensing and drive

features.

So let's just let's get into the meat of this podcast,

which is the data.

And so I think I caught you guys were part of the

I-Corps program.

So kind of a curveball question for you.

But

the first bit of data I want to talk about

is the market data.

So how did you,

what data did you collect from the market with surveys

or whatever to drive you to this hybrid architecture?

Like how were you convinced with market data?

We get that a lot.

The I-Corps program is part of the NSF.

The instructors actually asked me, we interviewed 135

potential target customers, and surgeons,

and they asked me,

how did you get a surgeon to admit to you

that they don't always know,

you know,

that they need this type of technology

to help them decide how thick the tissue is and

and to make better choices

to end up with better outcomes.

And it really came down to just

walking them through the end of life

with starting with,

you know, when they first scrub in,

when the device gets prepared how do they use it?

What do you like about the current devices?

And then taking them through,

their decision making criteria for

how do they select the staple cartridges?

And really at the end of the day Andy,

every one of them

was honest and open with us and said, you know,

I'm good with this.

You know,

I'm really good at figuring out

what size staple to use

sometimes I guess, but I kind of get it right.

But, you know, it's really a gut feel.

And then when we asked them jeeze, well,

what if you had something more?

What if you had something

that actually indicated to you?

Or better yet, gave you data

that not only tells you

you chose right,

but then also validated

that you got a good result at the end.

Or better yet, you're going to get a good result

when you're done with the firing.

And 10 out of 10 times or 135 out of 135 times

the surgeon resoundingly said, absolutely,

I want that. I need that.

I don't want to pay more for it.

So that was really what we heard.

And if you go back to really our core

And if you go back to really our core

technology again, because it's this hybrid reusable,

that's at the core of who we are

is you don't have to pay more for it.

You know, we're giving you a better technology

that makes a safer, better decision

making process, better powered,

robotic controls

all that, and we're dropping the cost

we're stripping out the waste

and inefficiencies in the workflows and the waste.

So, you know,

that's really what we heard

loud and clear was that surgeons

absolutely want to innovate.

They're just sick and tired

of getting bells and whistles

that don't really move the needle

that end up ultimately charging

more to their hospitals.

So I understand the

the desire for that functionality

that you're providing.

But I guess I want to talk a little bit more

about the hybrid architecture because,

you know, you're offering that. Yes,

you're going to provide this functionality,

the articulation,

the smart firing and sensing and things like that.

But now you're also going to have to ask them to,

keep the durable, somewhat sterile or,

recharge and things like that.

So I guess, how did you

how did you arrive that

yes, that architecture will work versus

just a purely throwaway

electromechanical architecture.

We wanted to eliminate, you just said something.

You said a dirty word, which is sterility.

But we wanted to eliminate the need for the hospital

to sterilize our durable piece in between procedures.

Really, what we wanted to do is we

we looked at the entire ecosystem from the moment

this product comes in the hospital

to when it gets used.

What it's done being used,

when it gets prepared for the next procedure.

We looked

at the inefficiencies of the current power devices

reusable power or current disposable power devices

and that’s where we've come up with a solution

that completely eliminates

those workflow inefficiencies,

which add up to a lot of extra capital upfront costs.

Inside the hospital,

a lot of extra time

in-central sterile, and in-central sterilization

and quite honestly,

a lot of extra waste with lithium batteries.

So really, we've eliminated

the hurdles

to adopting a reusable, durable platform

with our control module technology.

Now, yes,

you do have to store the control module

somewhere in the central stack.

That is the reusable durable piece.

But there's no sterilization required.

The batteries on our device are interchangeable.

Just got our fifth patent

issued last month for that, as a matter of fact.

So really, it eliminates

any need for any downtime in between procedures.

And you could use our technology from

one instrument to another.

So that was really the answer,

was giving them all that without

putting any undue burden on the hospital

or on any of the employees.

Yeah.

And that was precedence there in the orthopedic suite.

The interface and the interaction of these devices

and the reusable nature.

It's done every day in orthopedics.

We just need to translate it to soft tissue

and we need to understand

what makes the nursing staff

and the hospital staff effective in those procedures.

And deploy it in these soft tissue procedures.

Now, that's important.

Yeah. You've got some sort of heuristic sort of

processes to point to and say look,

there's precedence here.

So you don't need to really wipe down

the module really. It's just the...

Obviously, you know, the module gets wiped down,

but there's no there's no sterilization

and it's a non-sterile component

which is aseptically inserted inside

of the sterile disposable handle.

And then it's sealed inside of that compartment.

So you called earlier a battery pack?

It's a lot more than that.

It's batteries, it's motors,

it’s transmission gearboxes.

And obviously all these sensoring sensors

and electromechanical goodies that are inside there.

You graduated I-Corps, loosely familiar with that

that program.

But OK, so there's a market need and

you kind of

fit that sliver of the market

with the hybrid architecture.

So let's talk a little bit more about, OK,

the market data's been collected.

What, you're looking at each other,

you're both seasoned veterans

at this point in developing these platforms.

What data was most critical for your venture

after you know, kind of getting this market data?

I mean, was it just a functional prototype

or, you know, what were you doing?

What data was most critical?

It was hard for us

to really take our engineering hats off

because we by trade

our engineers Tom has 20 plus years,

I have ten plus years.

And when we went into VOC and the I-Corps was critical

in teaching us this,

we had to look at their workflows

and their job function.

So what we wanted to do

is we wanted to gather the data

that was important to the end user

because that effectively translated to our device

more effectively than us

just talking to them about features.

So we looked at the way that the device interacted

with tissue,

the way that the device interacts

with the workflows in the O.R.

And then we scored them zero through ten

and ranked those different aspects of data based on

where they said it was more important.

And then we aggregated all of that

and put that together in spreadsheets

and visual graphs

to communicate with investors and other users

as to what

we were collecting to make sure

that we were on the right path.

And then that effectively translated

right into our user inputs, into our device.

And those are the pieces of

they actually are the

features now of the device, of the user needs

that is most critical to our device success.

So that was kind of a roundabout way, sorry,

Andy, to take you on a loop there, but it really

we went at 360, we did a 360 on

taking our engineering hats off

going to the users, collecting data from them,

and then translating that into our user specs,

which effectively are engineering specs.

Now, that's

exactly what we were hearing from Galen Robotics

the last go around.

I mean, the user is the customer, right?

So I guess

so were are you taking

nonfunctional prototypes to them?

Or was it mainly just visuals

and maybe just like a disposable competitor product.

Both, we certainly did a lot of both

with the I-Corps

physical prototypes were impossible

it was in the heart of Covid,

it was just a lot of phone interviews

a lot of time with Zoom calls, etc.

But we've also done a lot of wet labs,

both here in the office, in our own lab,

and then also at some

labs in the area as well with surgeons.

And so we constantly do that

to put it in their hands and make sure, look,

when we first started talking

about the ability

to gather data,

and give surgeons a better understanding of the tissue

they're going it to. Sounds great, right?

But until they actually put their hands on it

and feel it,

you know,

that's where you really get the validation

that you that you're going in the right direction.

And that's exactly what we've been doing

pretty frequently throughout the way as well.

So if I may, on the tissue sensing,

can you give a sense for

like how

precise I mean, because the competing products

don't really have much of anything.

It's just a visual inspection so I guess to

what level of detail

are you providing that feedback on the tissue?

Is it just like small, medium, large,

or are you providing more granularity

and that's probably as detailed

as I'll get on that topic.

Yeah, without getting too detailed, we're able to be

very granular across all different patient anatomies

and all different

anatomies that the staplers being applied to.

And that is directly communicated

to the user via

a GUI or an HMI screen, user interface screen.

Excuse me

to throw my engineering words out the window there

through a user interface screen.

And that's done in real time.

So there's no other product on the market

that does it in real time as the surgeons clamping

and ensures that they can safely and effectively

utilize the device and that's really where the patient

aspect of the patient safety aspect comes into play.

Yeah, I think,

I mean, if I could back up to

I mean, one of the things

I think we left out when, about a year

or two years ago, we got something it was announcement

you might have read about, but it was about a 110,000

serious injuries and complications that were

that were not previously reported to the FDA

MAUDE database.

And they came about, they came to the light

and they were all

or most of them

related to surgical stapling issues and complications.

And at the end of the day, when you boil it down

and matter of fact,

the FDA just sent out guidance to all health care

employees back in October of 2021.

Really what it came down to was not understanding

the proper staple size

based on the tissue that you're getting into,

making sure you don't have an obstruction

you know, 110,000.

That's a big number, question

we always get back is yeah, what was the denominator?

Sure.

It's a small percentage,

but it's still a very big number.

And that's why

when we went through those interviews

you really got to walk

the surgeon through every step

and just how do they get that comfort level.

And so that really geared us towards the angle

we want to after with the data

and with the granularity that Rob just mentioned.

In terms of tissue sensing.

What data do you have to collect, a lot of

a lot of folks in your shoes

need to compare their products

to existing products on the market.

So can you talk a little bit

a little bit about,

you know, what bench data you're collecting?

Again, to kind of prove that your product is,

I guess, equivalent

or better than, you know,

competing products on a bench?

You know, because, you know,

start ups,

as you as you're well aware,

there's not enough money to do it

all kind of integrated.

You started with voice of customer

and getting market preference there.

And then maybe you pivot to proving out

these technologies of the product on a bench.

So to talk a little bit about

what you proved on a bench

to compare yourself to competing products now.

So certainly getting the data

and all the customer interviews was important

but let's face it, you know,

we knew what we were going after.

We knew what this technology

was going to enable us to do

and we knew the first thing we needed to do,

which is something

we've both been doing for myself 25 years,

and Rob ten or 15, is form staples

and that was really the first thing that we did

was demonstrated

quite honestly, right off the bat,

our first prototype,

we successfully,

you know, fired staples through tissue.

And that's really what we've been doing

every step of the way

as we go into

the thickest, nastiest tissue on a regular basis.

We just did a lab last week before the holiday,

side by side to make sure that this device is performing.

Because at the end of the day,

that's the most important thing you need to do

is fire staples in all tissue ranges

and cut effectively over and over and over again.

Surgeons are relying,

you know, trust the reliability of it.

So that was definitely our first foray.

And that's the one benchmark

we continuously do things, is compare ourselves

performance wise to the competitors.

So do you think you’ll claim that

are you claiming equivalency?

I mean, there's a 510K

path to market, but the idea that,

Correct.

that over time

you'll be able to show that there's less complications

with your product.

Exactly.

And we've got a lot of support.

We've got, right now,

we're close to a pretty big contract

with a large healthcare group.

That has a very large surgical innovations team.

They've got a lot of excitement,

as do others as well, around what they can do.

Some of these folks have already done studies

to look at manual staplers, powered staplers

across the different manufacturers

and try to correlate the outcomes,

to leaks, bleeds, complications, et cetera.

And, you know, typically they say, look,

we don't see any differences.

You know, they're all the same.

There's really no impact.

And we say, well, imagine what we can do.

When we recreate that study.

Only now we'll have the actual tissue characteristics.

We'll have the tissue,

you know, dynamics related to the stapler

that we can start to correlate that to.

And I think we're going to learn some things

and just from,

you know, anecdotally from the interviews

and talking with the surgeons right off the bat,

they kind of say, you know,

if I had this, I might develop a different standard

for how I do some of my procedures

if I actually had the data to support that.

So, yeah,

I think we will

we'll find some improvements

and really on all those,

on bleeds, on leaks, and on complications.

Got it. Very good. All right.

So just just to pause real quick,

we jumped right into it.

But just to remind our audience, so RevMedica,

you're developing a staple pack, right?

A power.

Am I right there?

Well, it's not a staple pack.

We're developing a control module technology, and

it provides the

robotic functionality inside of a handheld instrument.

And our first device that we're going after

is a powered laparoscopic stapler.

So really,

the core of the company is the control

module technology that provides the intelligence

the power functionality in a non-sterile fashion.

And that’s what enables us to really add

all these features and benefits

in a sustainable package.

So just backtracking a little bit.

So key decisions you made at the company,

you mentioned that, in a prior interview,

there were lots of pivots early on

before deciding on the architecture

that you're talking about now.

There was the robotic potentially

integrating into a surgical robotic platform

or developing your own.

I guess.

What data did you ultimately collect to drive

the decision and the architecture you have today?

Was it just a little bit of everything

plus time to market or what was it?

No, well.

You know, it was really only one pivot.

You know, the original concept

that Rob came with was a robotic application.

And quite honestly,

it was through that process of patenting

and doing that

first prototype

and it was a stapler for a robotic application.

That was when we had the aha moment and we realized

the opportunity of this control module technology

and what it can enable us to do

inside of a handheld device.

And that's when we decided

to go full fast on a handheld stapler

we still have the robotic application.

Matter of fact, we've filed subsequent

applications in the robotic space

to apply our control module technology too.

But really that was the pivot was from

that initial concept that we didn't throw it away.

We're really leveraging that IP and then some,

in the current robotic

handheld platform we're working on today.

Got it.

So talking a little bit more about the handheld

architecture,

I think I know the answer to this question, but

did you consider like a complete

refresh on how the surgeon interacts

with the hand tool?

Because now, you've got a GUI

right there on the on the hand piece,

you know, it's heavier than maybe

the obviously it's heavier

than the purely mechanical architecture, but

just talk a little bit more

about the design of that human machine

sort of interface

where you're trying to keep it

the same as what's on the market,

or could you see it as an opportunity

to differentiate.

That was one of the goals initially was

although we were improving clinical workflows,

for example, the workflows in the operating room,

we didn't want to interfere with any of the

clinicians workflows or the surgical workflows.

So the approach that thoracic surgeon

cardiothoracic takes in a lobectomy.

We wanted to take that same exact approach.

We didn't want to have a high barrier to entry,

and training and retraining surgeons

to create a different procedure.

We knew that, I've been burned by that in the past.

It's difficult.

It makes being adopted in the hospital

that much harder.

We wanted to ensure that this device

did not affect their surgical workflow at all.

While affecting their outcomes

and their confidence in the procedure.

Yeah,

Andy if I could just add one of the other big things

that we focused on, also though.

We wanted to be simpler you know, we wanted

to really simplify the ease of use for the surgeons.

And we also made a big effort,

and I think we've done a really great job

this thing fits a size six hand

and we made a big focused effort to make sure

that all the extra buttons and features

we've added to this thing, one, they're intuitive

and it doesn't take

you know, multiple cases to get comfortable with.

And two, that anybody can use it and pick it up.

And then I think, you know, secondly,

this is digging a little bit into the

into the engineering side of it.

But we also wanted to use common sense

and use mechanical,

you know, mechanical stops

and mechanical features and functions

to eliminate relying solely on software

for every click of this device as well,

which is definitely helped out tremendously.

At this point in your development program.

How often are you putting

prototypes in the hands of surgeons?

Clearly early on,

you're in clinics probably weekly.

But at this point, how often are you

are you putting it in front of clinicians?

Yeah, actually, today

nowadays it's more with upgrades of software,

different screen interfaces,

different functionalities of the device

that the more

the performance of the device evolves and improves

you know, probably every month

at least, we just had one probably last month.

We'll be doing one again the end of this week.

We're going to put it in a clinician's hands.

Certainly when we get this partnership

I mentioned with this healthcare institute,

we're probably going to be sending devices

down there blindly

that we'll send down that

they'll be able to have it their disposal

to do whatever they like to

and give us feedback on it.

We'll continue to do that.

So, you know, I think it's important.

I think at this point now, it's really,

getting into the robustness of the device

and the reliability of the system overall

to find out what they really like and don't like.

And I continue, you know,

I see us continuing to do that.

You know, probably at minimum every month,

some some touch point

based on the latest performance of the device.

You know, we've really built up

a good relationship, though,

with our advisors where we text and call them weekly.

You know, any time one of us thinks of something

or we want to make a little update

before we do any of that, we always bounce it off.

Five to ten guys and gals

to just get their opinion on things.

So Rob, where are you in development?

Are you under design controls now

or are you still kind of pre design control ready?

Getting close to locking?

Yeah, great question.

So Tom, myself coming from big corporate,

we would have been under much stricter

design controls at this point.

We've kind of changed our thought there

and we're under quote unquote

loose design controls

at the end of feasibility.

We have basic traceability of all of our components.

Rev controls on all designs, software and so forth,

but we don't officially have a QMS stood up fully.

So we're in this pseudo design controlled design

change phase

where we don't want to lock ourselves in

from a development standpoint.

We want to be able to be nimble

and change things on the fly.

But also at the end of the day,

if we need to draw a line in the sand today,

we’d be able to and say,

this is a device moving forward

we're going to validate everything as is.

And so we've chosen that approach to make sure

that we ensure nimbleness

while not burning ourselves in the long run.

I think that's a great strategy.

So what are you waiting for

to lock design controls?

And I'm asking

mainly because our audience,

they're all in the same boat.

They're all, you know,

they have functional prototypes and,

you know, kind of always continually fundraising.

They're like, what are you waiting for?

So Tom, and I have a lot of experience

with these tools specifically

because we have so much experience in this field.

So we're lucky with that.

So we understand what our long lead time tools are.

So we've entered design freeze

for those long lead times and kicked off those tools,

and we're staying flexible on software interface,

the system level architecture

so that when we get to the time where we start

to validate officially,

that will be when we will lock everything down.

But right now, as we're waiting for

these long lead tools to come in,

we're still updating software

and the way the device interacts

certain angle on certain things.

So where there's really no discrete

answer I could give you, it's

I guess we'll know it when we know it,

but we're waiting for

for the final design

when all these long tools come in.

I got it, so you want to integrate those in

and kind of do a final test before locking the design.

Correct.

That's helpful.

So can you talk a little bit about how you,

how and why you have structured your team

the way you have?

And I don't know the answer to the question

about how your team structure,

but maybe just Tom, if I may, like

when the company started to roughly

where you are today, like what does that look like?

A lot of Rob and I obviously doing everything to start,

but we've also been really fortunate.

Rob mentioned our advisors, clinical advisors.

Sure, they were great.

But beyond that,

we brought on some other advisors for some key areas

that could really help us

both from brainpower, but also physical contributions

with an early prototypes of early parts and,

stuff to really get this thing up off the ground

to show somebody.

So that was big.

I think early on it was really just Rob and I,

and everybody else was pretty much virtual,

and we paid them assigned as advisors, et cetera.

We've evolved obviously as we've raised more money.

You know, last year, we had

three engineering interns,

one we've kept on full-time.

We've got, advisors and contract

electrical engineers that are working for us,

software engineers, multiple software engineers,

legal intellectual property consultants, et cetera.

So really, regulatory quality, you name it.

So we've really put together

a really solid virtual team

that believe in what we're doing.

I think that’s the most important thing

is finding somebody that you want to work with,

but then that they want to work with you.

And we've done that.

And really it's, pretty much virtual.

Besides what we're doing here.

at 175 Forpath Rd.

between Rob, myself, and our mechanical engineer.

Yeah.

I think that's one way to do it,

you know, the virtual model

and that's a lean and mean way

to do it, particularly

with you guys being experienced in the market.

It makes sense.

I can imagine for other founders, CEOs

with just the idea

but not the engineering background

that they would need to,

make more kind of significant hires.

But I imagine

eventually you're going to want to bring on

a more substantial internal team, is that right?

Absolutely, and that goes back to your

your QMS, your earlier

design control question as well.

You know, we could go on

design control now, but,

it's just that much more that Rob and I and

and our engineer Dawson would have to do that.

Really, we don't have time for

I mean, other than keeping the controls

loosely, as Rob defined, you know,

and that's why

those additional resources

which we've got planned to bring in the fall,

you know, to really help us manage

all the components, manage

all the suppliers, manage the QMS, the testing,

et cetera.

So yeah, certainly we've got plans

for expanding as we move forward.

But this point, it's worked.

And like I said, we're really fortunate

with the external team.

We've got that really have been able to

deliver for us whenever we've needed them to.

So I'm not going to let you guys off that easy

with the competitive products question.

So this one comes from one of our senior

project managers.

And can you just describe the benefits

of being able to tissue sense and articulate?

Right, which is what you're claiming with

the downsides of, having batteries

and that additional user burden

compared to the purely mechanical option,

which I imagine is cheaper maybe on a

on a per product basis, but just

describe those benefits and why they're

you should use your product

versus purely mechanical one?

One less complication that should be...

Pay for itself.

All that matters.

You know, really just one less complication.

And we know we can do that.

I can go on and on, but you know in the waste

with the current mechanical devices

we even eliminate a lot of that.

but really, you know, most people

we talked to, smaller handed surgeons,

they can't use it.

They can't use it.

They're asking for power devices

specifically for their procedures

or their bariatric weight loss programs

because they can't use the purely manual device.

You know, one surgeon said it best.

He said, you know what,

somebody's got to take the da Vinci robot,

and boil it down into a handheld stapler,

because so far nobody's been able to really do it right.

And when they do, we're all going to switch to it.

And I think that's really what it comes down to.

Nobody's done it right yet.

And I think that's what we're doing here.

Yeah, I definitely, under appreciate

the challenges with a purely mechanical stapler.

Also, you know, just general fatigue.

I'm sure that's part of the equation, too, right?

Like time and time again, you know,

just after a long day,

I don’t know how many cases the surgeons

are going through a day.

But it's just, I’m sure,

it would be nice

to have a powered stapler at your hand

rather than having to squeeze it time and time again.

Absolutely.

So my next question, Tom, for you,

like we've talked a lot

about your initial commercial product,

a handheld powered laparoscopic stapler.

Can you talk a little bit

about what the future

might hold beyond that initial launch,

for your company RevMedica?

Yeah. Absolutely.

I think that's really the value of RevMedica

is in that platform control module technology

and the ability

for us to feed multiple devices,

not just handheld staplers,

obviously, you know, circular staplers,

open instruments,

hand instruments, energy based devices, et cetera.

We can apply that to.

But, even outside of soft tissue

surgery, we've got some applications

and some ideas and concepts that we're pursuing.

But one of the biggest areas

that really excites us also

and I know everybody's got a robot.

Everybody's getting into robotics.

We're looking at doing it,

leveraging our same control module technology

to really be again, a hybrid,

of a laparoscopic robotic assisted bedside

type of robotic platform.

And we've got a real strong patent portfolio

into that direction.

We just got 40 claims

in a search report that were found to be patentable

but still have a ways to go before we get them issued.

But it's a great start

and certainly looks promising.

So, but certainly, yeah,

we want to round out

and put a robot in everybody's hands

and they want to build our own bedside robot assisted

robot for surgeons, for laparoscopy as well.

Yeah, that's a great soundbite.

You put a robot in everybody's hands.

because when you talk to most people about

surgical robotics or medical robotics,

they just think of the da Vinci.

But it seems like the future is actually more

the cybernetic play here

where you're helping a surgeon do their job

more effectively than necessarily

replace that surgeon.

All right.

So yeah. So are there other

lightning round questions for you?

So kind of an oldie but a goodie.

So,

what was the most challenging part

or what has been the most challenging part

of this endeavor for you both?

And how did you overcome it?

Yeah, so technical or personal.

Aside from the pandemic or going

without a paycheck, that kind of stuff.

You know, we all know that that exists.

But aside from that.

Yeah, yeah, yeah.

No, I think, you know, I think it was

I mentioned, you know,

we needed to build that first one

and how we're going to do that

without a paycheck, without funding.

We got really creative.

And like I said, we partnered up

with some great people to get that first one.

But then, you know, it's the frustrations.

I'm coming from Medtronic, I had,

$20 million a year budgets

in teams of engineers to do everything.

And now it was Rob and I and, we get,

instead of, you know, the first 100

would get one.

And we had to make

a lot of decisions based on that first one,

you know, as we kind of stepwise,

move things along.

So

luckily, things have improved

and we've been able to increase the numbers

to get better data and better testing.

But I'll tell you what

we're doing inside of this little,

two by two by four brick

it's never been done before.

there's all the analysis

and equations in the world, but nothing replaces,

the real world application and usage of this thing.

And and we've been learning every step of the way.

As you were answering, it brought up another question.

I think it would be really valuable

to hear your response,

so at KeyTech, just to sympathize

a little bit, you know, we're always,

either writing a proposal

for like a minimum viable prototype like the one or,

you know, an end to end.

But you talked about

instead of building

100 prototypes, you would only build one.

That's all you had funding for.

And then you said you'd make a lot of decisions

with that one prototype.

Can you describe, like

the mode of your product development?

Was it very much like you build the one prototype

and then start another sprint

or was it kind of take that prototype

and just kind of like

make iterative changes all along the way

and all of a sudden you're two years into it?

How did you structure like,

I don't know, maybe the early

the first two years of that kind of cycle?

Yeah, the first two big iterations in the product

were two big sprints it was make one product

that does exactly what we wanted to do

and then get a lot of learnings off of that

and like the next month or so,

get all the user feedback and then do another sprint

and make all the improvements.

And then from that product,

we iterated and made better

to meet all the inputs that we wanted to meet.

So we would change the different mechanisms

as needed in different ways

to improve on them and to perfect them.

So I think it was a combination of both

two big sprints and then iterations after that.

Yeah, two long sprints.

I like that.

I was a middle distance runner in college, so,

800 meters is just a long sprint.

Would you do that differently?

It's hard to say.

We got a lot of learnings off

of those two big sprints.

And when I say two big sprints,

it wasn't with lack of talking to users

at the same time.

We were talking to users throughout.

I think if in a perfect world

and Tom alluded to the fact when we were at Medtronic,

we had a huge budget to work with.

In a perfect world,

we probably would have had a lot

of different prototypes

to get a lot of learnings off of that.

And then gone from there.

But we weren't able to continuously iterate

week after week

and get a lot of little learnings

once we got to that one form factor that we knew

was good

and knew that we could get a lot of learnings.

So I really do like the combination personally.

Tom, I don't know if you want to weigh in at all

but it gave us a good mixture

of getting to a final form factor

that when you get some substantive feedback from

and then allowing ourselves

the nimbleness

to refine those features to get even better.

Yeah, I guess the only thing I'd add

is we realized, you know Andy, in a startup world,

you know, you don't have the funding.

Sometimes you just have to do

you have to make decisions

based on hitting milestones, showing progress.

And in that case,

that was a couple of those long sprints.

we knew that we needed to get a device

in a surgeon’s hands to get feedback

that we can throw it out there

to our investors, current investors and new investors

to let them know that we're making progress.

You know, they don't want to hear that.

we haven't done another device.

We haven't made any updates.

Nobody's seen anything new, you know.

So I think that's part of it.

You're always torn in a startup world between,

how much do you dot, the I's and cross the T’s

early on,

you know, versus making the decision

based on what you've got for runway

and making a decision to get the most bang

for your buck

or the biggest splash with what money you've got,

whether that be patents.

You know, we've got a lot of patents,

obviously, or prototypes.

And we chose those couple of big sprints with prototypes.

And it's proven out well for us.

Yeah, and to put things into perspective

prepping for some of our big labs

could have taken us a month like a team,

a month of time to do.

And that really took away from us getting on the CAD

or us doing some prints or us doing

some internal benchtop testing

that would have progressed the product.

So it was a balancing act

of hitting those meaningful milestones

and inflection points and showcasing the product

at Tom's point.

That was probably the biggest obstacle.

I actually think

taking us away

from doing the actual engineering side of things

and then going out there

and doing the marketing side at the same time.

Well, hey, congrats on the success to date, gentlemen.

Tom and Rob,

and we could talk

all afternoon here

about different ways to to prototype,

but I hadn't really put much thought

into like the long sprint model.

I mean, that's basically, pre alpha, pre beta,

even developing like pre design control.

But it's

it's in the startup mentality

where you kind of have to not do everything

but just do enough

to get an integrated prototype put together.

And it's not three months and it's not a year.

It's more like a six month sort of longer sprint.

So, you know,

it’s good to hear that worked for you guys.

That was it for my end.

So, gentlemen, thanks again for your time.

You're going to be Internet famous now.

So thanks again, guys.

Andy, thank you so much.

Great,running into you a couple of weeks ago.

Appreciate the opportunity.

Yeah. All right.

Take care, guys.

Thank you. Nice to meet you.