When you’re trying to add new functionality to existing technology, the data you need won’t be presented on a silver platter. Sometimes, you don’t even know what the right data is until you find it.
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.
Welcome back to MedTech Speed to Data,
a Key Tech podcast.
This is Episode 15 with Rachael Scott,
Senior Electrical Engineer and project manager.
Rachael, welcome to the show.
15! You guys have been busy.
Yeah, 15, yeah.
Very exciting.
What anniversary is this?
Do I get silver? Gold?
What's the 15 year?
I don't know.
You're not near her
Majesty of a platinum jubilee.
So you got 55 more to go to platinum.
Okay. Yeah, yeah.
Thanks for hopping on the show, Rachael.
You've been at Key Tech for a while now.
I have.
You have a lot of lessons to share, I guess.
And also, you're a veteran of the podcast.
Thanks again for coming back on.
Yeah, absolutely.
Thanks for having me.
Yeah.
So today we're talking about
the last episode
or the theme from the last episode.
So the last episode was with RevMedica,
a startup company
in the New England area
with a powered surgical stapler,
a pretty cool architecture, hybrid architecture
where they have a powered,
battery powered sort of base and a disposable
stapler portion
that's pretty novel in that market.
And I think the common theme
from that episode, in my opinion,
was adding new functionality to platforms
that have been on the market,
you know, for a while
and trying to differentiate that way.
So thought you’d be a good guest
to bring on the show
to talk about some of your experience
in that area.
So let's just get right into it.
Let’s do it.
You don't get functionality and sensing
you know, for free, right?
So there's always this question
of how much more will buyers be willing to pay
for this added functionality.
So can you talk a little bit
about your experience of dealing with
the added cost
that comes with adding
sensing, adding functionality?
And I think your experience primarily
is on the disposable side,
but I know you've worked on,
durable and disposable architectures before.
Yeah, absolutely.
I think
what they said in the podcast
rings true, you know,
people want this functionality,
but they don't really want to pay for it.
And especially in kind of, you know, a hospital
kind of marketplace,
you know, cost is often king.
Like that is the driving factor for,
most people, especially in disposables
where you make millions of these
and that's, it's really hard to kind of see
any cost increase, even like cents.
So when you're suddenly adding
sensing technology, which often regards
your processing and battery and,
you know, PCBs and
in like how you're connecting to your sensor,
suddenly it's
trying to keep it down is
is really, really challenging.
So that's something you know, that
we have like
I've worked on a couple of projects where,
you know, we're trying
to find really unique ways to keep costs low
and sometimes, you know,
in one application, you know,
we really we ended up pursuing like
an implementation of a very simple technology
but like tried to kind of
work it into a manufacturing process
that already existed
because every cent counted.
And so we were kind of
we worked up
from all the things
already existed in the industry
and tried to build
a kind of new application around that sensor.
But the cool thing about like
what you know, RevMedica is doing
and some of the flexibility
that having a durable offers
is it allows you to abstract, you know,
some of your big cost players
which are often battery and processing
and make that reusable,
which gives you a lot more flexibility
in the feature set.
You can offer something
because you have that,
you have this box that is the instrument
doesn't need to be replaced.
So you get a lot more freedom, as it were,
to kind of play around
and have more functionality.
That's great.
I mean, there's always this question of
of what goes on the durable
and what goes on the disposable.
Yeah.
It reminds me a lot of the diagnostics market
where you're trying to get that razor blade
cost down really low.
But I thought what was interesting with
with RevMedica is
they were working backwards a little bit from,
you know, the
I mentioned the hybrid architecture,
so their competitors
had a few other disposable products.
And, you know,
there are also some reusable platforms
that have challenges with sterilization.
So I just think it's interesting to kind of
look at your competition,
look at the technologies
that will enable added functionality
and kind of try to fit your product
in between your competition.
And I think they're
they're going to get there.
Yeah. Yeah.
It's a really smart way
of kind of approaching that,
especially from kind of that
that cost aspect
and being able to see
what your competitors have and, you know,
where they might be limited by cost
more of like, by disposable cost
or by functionality, by,
you know, not having these smarts
bridging that gap allows them to try
and be the best of both worlds,
which is, you know, is true in the cost market.
So I also think RevMedica did a really good job,
you know, as they should have,
really understanding their customers.
They were part of the I-core program.
And part of that is just doing surveys,
and just paper studies, really
Yeah.
Not even building a prototype.
We don't talk enough about that.
I think here at Key Tech
and even with our customers
like what statistical data
do you have from a survey
that says this feature is viable?
Right.
You can get that for a lot cheaper
than building five prototypes
and getting results that way, so clear there.
But I thought it was interesting that,
you know,
when you're looking
and this is common across
a lot of our customers,
they're adding functionality.
When we asked them
you know,
how does this fit
or how are you improving the workflow?
And the response was,
we are not changing the workflow
really at all.
I mean, they are
you know, requiring some
some wipe down and whatnot.
So they're modifying it some.
But I think just the general mantra of
stick with the workflow is an important one.
So in your experience,
how has that sort of thinking of
don’t change the workflow,
driven some of the product development you’ve done?
It's a huge driver
especially in kind of some of the realm
that, you know, RevMedica is in as well.
And some my experience there,
hospitalists and clinicians are doing,
you know, a thousand things a day
and they really,
you know, and a lot of them
are little things that like
still are so critical in patient safety.
And the way that you start to interact
with those thousand little things,
if you make even a few little changes,
you're kind of disrupting this flow
that people have gotten into for years.
And there's a reason that they work that way.
So it can be a really hard challenge.
And we are regularly kind of faced with
that dilemma of, you know,
like we should
not we're trying not to change it.
We're trying to.
But it does constrain you
when you're truly adding battery and smarts.
There are real,
like real changes to your workflow there.
So it is really about like
how can you do that smartly?
In one application that we worked on,
We kind of investigated actually actively
changing the workflow, in order,
like adding an actuator to a disposable
that kind of forced them, like they couldn't
the user were no longer able
to access something critical
without actuating this thing.
So it kind of forced them to take that step.
But there was a lot of challenges
and we appreciated that battle
we might be up against.
But what we found that
that kind of method,
it did inherently improve the process,
but we didn't know that we like
we thought it might,
but we had to do a lot of work
to kind of justify that change.
And it was a small change.
We're talking,
you know,
a button as opposed to just,
you know, accessing something.
So even something as small as that
you know, we had different reactions
and we had to pay a lot of attention
to how people interact with this device
and what their workflows are.
And that's different across
people, physicians, hospitals,
it's a whole world.
So not changing it is sometimes,
a smoother approach, but it does constrain you.
Right. Yeah, I agree.
I wouldn't want to invest in a company
that says, oh, we're changing the work,
we're doubling the workflow, or,
oh, all you have to do is rely on the clinician
or nurse to,
you know, twist these two knobs
and all of a sudden
your outcomes are improved 20%.
But you have to stick with what people know
because they're going to try to shortcut it.
Right, and then
you have poor acceptance into the market
or you have, just people don't do it.
So, you know,
they don't do the things
that you've implemented.
And so you don’t
get the impact that you're hoping for.
So it's a really tough challenge.
And especially things like batteries
when you're adding smarts
to disposables and to durables
and really changing that process
like fundamentally a battery
kind of forces a workflow change in some way
or if a gear in a purely disposable,
you're kind of thinking about like,
how can I make it?
So the battery is not defining
when the person throws this away
or when the person has to do something
because you don't want your battery
to be defining that.
But in like the durable world,
kind of with what RevMedica is doing,
you have to start thinking about like, OK,
like how often does my battery need to last
for maybe a surgery
or where does this charging station live
and how does that disrupt the normal
workflow of just throwing something away?
So, you know,
that part is like kind of its own
separate workflow analysis.
And sometimes that drives
your battery decisions
even more than the features.
So let's switch gears a little bit here.
So you're talking about RevMedica.
They're adding sensing,
which is just specifically
they're sensing the thickness of the tissue.
And then
they're claiming to apply the stapler force
as a function of
that tissue thickness, which is a novel
is novel functionality for stapling platforms.
But, you know, in your experience,
how have you
founded a metric
you know, for a feature
where that hasn't existed before,
you know what I mean?
Like, how do you know what's good enough
Yeah, that's the question
we come up with every time.
You know,
we are trying to add smarts to a platform
or a technology.
It has existed in the market.
You know, you're adding smarts,
but these smarts haven't existed yet.
So you're simultaneously collecting data
and trying to use that data to help
help a clinician make an informed statement
like give viable and helpful feedback,
you know, no one wants to hear.
So you suddenly you're
you're doing exactly what you said.
It's really challenging.
You're saying OK, this force is applied,
but how do you know that force
being applied is acceptable?
Like that data doesn't exist previously.
So it's a really hard challenge.
And we've approached that by,
huge amounts
of trying to get honestly kind of prototypes,
just data
collection prototypes that on already existing
units and just kind of measuring that data in,
you know, in different ways,
like getting it in the hands of users,
getting it in the hands of
even just people to kind of
doing that action
and finding ways to assess that.
But then kind of the other side of the coin is
you do need a professional to assess
whether or not
they would have deemed that good enough
because there is that qualitative element
a lot of the work,
the things that these,
you know, interns are doing
are qualitative in nature.
So it's kind of correlating those two.
So you really need an expert to help you assess
whether or not something was good enough.
That's great.
So let's talk a little bit about adding more
and more sensors.
And I know you worked with a customer that
clearly cost was king.
And the request was let's sense
multiple parameters,
I guess with one sensor,
you know, again, driven by cost.
Can you talk about
doing that or what you think
what your thought process is
when you're trying
to define the right architecture
with clear cost constraints,
with trying to sense multiple things
with one sensor?
It was, I feel like I said this a lot,
it was a real challenge.
But it really is,
I think, you know, kind of understanding
where you are starting.
And I think when you start
with that technology exploration,
it does feel a bit like,
you know, the world is my oyster.
I have so many technologies
that can do, that could accomplish this goal of
this sensing goal
or kind of like the higher level
what you're trying to do.
But where you start to really narrow in is
what of that kind of breadth of technologies,
pressure, optics, magnetics, RFID,
you know, force?
Like, there's so many, you know,
ultrasound, there's
just a myriad of sensing technologies,
you start to get really narrowed down
and it's like which one of those
can kind of cross
into these other sensing goals
that they might have.
So, you know, for example, like,
maybe they want to know
when a device
when someone wants to know
when a device is being used.
But then they also want to know something,
that it's doing its job correctly.
So can you frame those questions
into what is actually happening
when it does its job correctly?
Is there a pressure change?
Is there also like a physical optical barrier,
does like fluid leave
and so you could see a difference in that.
And there's a lot of ways
that like that higher level sensing goal
can be kind of nitpicked down
into different ways you could view it.
And then you start to get this overlap
and you start to see, OK, this technology's
really only going to be really good
at this one thing.
And this technology
is only really going to be good
at this other thing.
And then you start to find the one technology
that might be good at all things,
but you do start to have to assess
your feature set
when you're that cost constrained
because it's really hard
to find one size fits all and does it reliably.
Right, I mean, clearly there's
a lot of applications
where just using cameras, for example,
will sense a lot of things
but you know,
is that the right architecture for,
your workflow, for your cost model,
for your platform?
Yeah.
And then on the flip side of that,
I've also seen
you may recall the GenMark project.
We put a white paper out about using resistors
that are used to sort, of as part of PCR.
You can also use that
for temperature sensing,
like dual modes sort of
electrical components, I guess,
it was one way to do it there.
Yeah, and like one common thing that,
for just an example is like capacitive touch
is something, you see in every single iPhone it
you to detect that someone is using it.
But you know, there's also very commonly
for like liquid level detection.
So kind of looking at
how could you
possibly interact
that single sensing element
to do very different tasks
and that you can kind of apply that process
to all the different type
of sensing technologies.
So our audience is in the business
of commercializing products.
They're short on money,
have a lot to do, RevMedica is no exception.
And one of the themes from that
last interview was needing to pivot
once they started, you know,
getting more market data and end user data,
What's been your experience with pivoting?
When have you had to pivot
or a client has had to pivot
and what are you looking out for
to help make those decisions?
It's really yeah.
What they kind of what they said resonated
and I know from working on a number of projects
where you kind of you're
trying to hit a prototype goal
and you hit that prototype
and then you kind of start to reassess
where you want to go from there.
It can be challenging to do that efficiently
and, you know, cost-effectively.
But I think in my experience,
you know, in order to get to a prototype
you have to make assumptions on date.
You have to make assumptions at the beginning.
You just don't have the luxury
of having every bit of information or,
you know, you're doing research
and development for indefinitely
and you just don't have that luxury.
So you have to make assumptions to hit
to get to that prototype,
to get to that milestone.
And that's important.
That milestone is important
and will teach you a lot of stuff.
So what happens often is
you get to that milestone and you learn a ton.
And sometimes often
you learn that
some of your original assumptions
were not valid
or they're not valid anymore,
or market requirements change,
or kind of as you're learning.
And I think just being open to saying, OK,
I've learned this, I've learned a ton.
And then really revisiting those assumptions,
not continuing to kind of say,
I will modify this prototype
to fix those assumptions at some point
your device can be
one of your biggest constraints.
And I think that's when
sometimes you feel like you've gone
you could have gone too far.
And it's a really hard thing
to make that assessment.
But when, you can often
leverage that knowledge to kind of go
in a different direction
just as quickly
as kind of improving that prototype.
So it's about reassessing that
in my personal experience
I've done, I've kind of
I really like to keep that open mind
and in all projects
because I think it's important
to get to the product
that really is going to be effective.
But one kind of specific example,
you know, in this disposable
unit that we were working on,
we had made an assumption
at the beginning on this technology
that we were going to use to implement
very cheap sensing.
And it would, based on this idea
that they already had this
this technology in manufacturing,
it's used all over the place
and it's used cheaply.
But what we didn't recognize
until we were going into,
you know, feasibility prototyping
and going down that line was that
our very specific application of this
was kind of first of its kind.
And that came with a lot of risk.
It was really just
no one could give us the answers we needed
because it didn't ever been done before.
And there was a lot of R&D
that would have to go into it to
to get to a point where we felt confident.
And I really do
believe we would have gotten there with that
same technology.
After six months
and prototyping and learning
and getting this in the hands of users,
we found there was an alternate
that was relatively inexpensive.
It was a new process to their manufacturing,
but it was not as expensive as we had thought
it could be in the beginning.
So we did end up
pivoting to kind of approaching it that way.
And I think it was the right approach
over kind of
trying to continue down this path
based on the original assumption we had made.
I think the best way to that, I think about,
pivoting or,
this game of product development
and speed to data is
I think you really have to be disciplined
at setting a timeline
like at the end of Q1
we are going to make a decision on the features
we want to explore in the in the next quarter.
You know, like if you're
if you're not disciplined about that, things
just keep bleeding on
and then you're losing track of like, well,
what are we what are we aiming for?
So a lot of times our projects are kind of
artificially sort of limited by,
the scope that we propose in the budget
our clients have.
But I think that's also,
you know, that helps, to really drive
to the data that they need to decide
whether should they pivot
or should they keep going,
should they go to their management and say,
look, this is looking like it will work.
We want to do another three months,
six months, nine months,
assuming this architecture.
Absolutely.
And I think
that's an important
kind of thing that we've learned.
And our clients
or a lot of the projects we worked on yeah.
It's appreciated that, you know,
we can kind of
as a group collectively direct
in each of those directions
just because, you know,
depending on where you need to be.
as you said, like
we got to make decisions at some point.
And sometimes it's really hard.
You have to make those assumptions.
So it's just kind of keeping track of those
and being able to revisit those is really,
really valuable
to the overall trajectory of a project.
Great, all right.
Let's talk about something
very near and dear to your heart.
RevMedica
does claim to be a much more sustainable
platform than their competitors,
with their usable battery power pack
and you're not throwing away
something, you know,
with batteries in it, for example.
Can you just share any of we didn't
talk about that much in the episode, but
can you just
you lead the sustainability
sort of initiative, Key Tech Green.
Can you just talk a little bit about,
either what's going on here at Key Tech,
or kind of just your thoughts
as you look at projects
when thinking about sustainability.
Yeah, absolutely.
It's certainly near and dear to my heart.
So, you know,
Key Tech Green, which is something I kind of,
a fellow,
you know,
group of people at Key Tech right now
is we're trying to look across the board
at sustainability both, you know,
how are we ourselves
wasting a lot and shipping too much
and do we really need
overnight shipping
every time we get a McMaster box
to also like how can we encourage
and build designs
that are just as effective
but not creating as much waste?
And that's something that
we're starting to think about more
and I feel like
I have noticed
as I've been looking at newer projects
in recent years, I have felt this kind of shift
a little bit more into that is a
that is a question on people's minds.
And I'm really excited about that.
I'm really excited that this seems to be,
you know, not just,
oh, it would be nice, but like,
some people are coming to us with
this must be a durable component.
I can't move to a disposable
and things like that
to try and reduce this waste.
And so I'm just really excited
like this is a kind of a
an input that are coming to us from clients
more and more.
So it's really exciting to see RevMedica
kind of take that and, you know, build
that as a platform pro,
you know, and a selling point.
And I do see kind of,
that's a really exciting thing for,
the medical industry, which is,
got a lot of disposables across it.
When I hear sustainability,
I put my entrepreneur hat on
and I think like,
you know, any product out there,
how can you make this product, this workflow,
this user experience
more sustainable, you know, sustainable,
like the real definition of sustainability,
like environmental sustainability,
not necessarily
a sustainable,
you know, burn rate or something like that.
But if you look at any product with that lens,
all of a sudden
this whole world of sort of ideas,
come about.
I think.
So I think we’re going to be seeing more platforms
that are pushing sustainability like RevMedica
Maybe it's not necessarily a step change,
but it's an equal product
but if you can show that, or prove that,
the approach is more sustainable,
I think you will get more customers.
And it's not just the product
it's the whole supply chain.
Yeah, to get there.
That's my challenge to all
12 listeners of you out there.
Is to think of products
in a more sustainable light
and you might find some ideas there.
Yeah.
Well, hey, any other any other
high level thoughts on
adding functionality to on market products?
I mean, that's
where innovation comes from, I guess.
But just any other thoughts.
I think kind of covered a lot of them.
But really that it
it feels like
there's so much power in knowledge
and there's so much power in that feedback
that, you know,
we're just starting to touch the surface,
like what RevMedica
is trying to do
with providing feedback to users.
There's just so much power in it
and our processes and things.
But that kind of path to the market
and the kind of the,
the major things is
like getting it into workflow
that people already feel comfortable
with or disrupting the workflow
in only positive ways
is a really big challenge and then,
you know,
having something to compare to
is really hard.
So I think those are just the main takeaways.
But it's really exciting to see.
And I think you know,
the more we have
that capability to just
see what's going on,
I think it can only be better.
Yeah.
I mean, I think that it's a similar story
to like the surgical robots that are out there
where you're getting these products
with additional sensing out in the field
and there's a market for it.
But what they're really doing
is that, you know,
they're collecting all this data
that will then inform
even more features
and better outcomes and things like that.
So I think we're like,
I’m trying to think of a not a web 3.0 analogy,
but, you know, product development
probably 5.0 at this point.
But like, you know what I mean?
We're getting the electronics out there
that didn't exist before.
And then there's going to be
this whole other wave of,
you know,
machine learning,
artificial intelligence layered
on top of these products, guiding users
to perform their procedures,
you know, just better.
Yeah, no.
And that's a really awesome direction.
And it's just it's going to take time,
as you said, to kind of
we're getting the sensors in there
to collect the data.
And even if these first implementations,
because we are trying to do both,
assess and provide the data,
I think iteration is going to be important.
But yeah, that next gen is coming
and it's going to come in
and it's going to,
you know, really help,
I think with that quantitative measurement also.
Awesome.
OK, thanks, everybody.
That's it for episode 15. Talk to you soon.