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As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa’s diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables.
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 to MedTech Speed to Data.
We have some great shows in store
for you in the next couple of months.
We have Greenlight Guru
coming on in a couple episodes.
This episode we're going to interview
Will DeMore, Senior Mechanical Engineer
here at Key Tech.
We talk about consumables
and when you think about consumables,
it's easy to jump right into high volume,
injection molding, design considerations,
or how you sterilize the product.
But what you really need
to be thinking about these days is
these connected disposables
and how they interface
with the system that it's going to be living in.
What's the interface to the durable?
What's the interface to the digital ecosystem?
We'll talk with Will about integrating sensors
into the disposable and cost.
Cost is king, of course.
So enjoy the show and we'll see you guys soon.
Welcome, everybody, to
the next episode of Key Points.
Andy Rogers, your host here today on the show,
we have Mechanical Engineer Will DeMore.
Will, welcome to the show.
Thank you very much. Happy to be here.
Yeah.
So tell everybody a little bit about yourself.
Sure.
So like you said,
my background is in mechanical engineering.
I went to the University of Maryland
to get my bachelor's degree
and went straight out of there
to come to Key Tech
and been loving it here ever since.
For the last eight years or so,
I'm working on a Master's
Degree in Engineering Management
at Hopkins on the side,
and about one year left in that.
But at Key Tech,
a lot of my experience is in med tech.
Key Tech does a ton of in vitro diagnostics
stuff especially,
but I have a little bit different path
than many of the folks at Key Tech.
And so I
may bring some interesting perspective
on disposables and things like that.
Disposables, that's the topic du jour.
So we want to talk about
disposables, consumables.
And lately,
I know you've worked on on one main project,
here at Key Tech.
I see a lot of other projects coming in the door.
A lot of our customers,
particularly in the medical device market
are developing complex disposals.
That can mean many different things.
They're electrified these days,
and they're increasing in cost.
And the problem
that our clients are seeing
is that they don't have the team in place to add
these complexities into these consumables
that we're going be talking about today.
What we want to learn from you, Will,
and talk about is how to sort of think
about, you know, and change your thinking.
I suppose from classic consumable development
to this new era of complex,
connected consumables.
So what do you think is causing the increase
and the shift away
from your classic
razor blade,
if you will, where it just molded parts
into more complex consumables?
There's obviously a variety of factors
that are contributing to this move
in this direction.
A big thing is, changes in market conditions,
driving down
the cost of things like semiconductors and,
having mass automated production
driving costs down.
And that's allowing the use of those components
a lot more in disposables
because, you know, you don't care quite as much
from a cost perspective about those things
being single use or multi-use,
but not kind of permanent durable components.
Another thing is efforts to reduce
risk generally,
but especially cross-contamination risk.
And so anything that's durable
that's going to be multi-patient use
you're going to need
some kind of reprocessing
that adds risk to your system.
And usually you need to be pretty conservative
about the kinds of reprocessing
that you do on your disposal
or on your
your durable components
that are going to be reused for that.
And that really speaks to the change
in the move to the at home environment,
especially because
hospitals are really set up to be able to do
a lot more in terms of that reprocessing
than someone in an at-home scenario may have.
So that's driving a lot more of the trend
towards disposables for at-home specialty.
There are some other things
that are also contributing to this,
like the demand for
for body worn therapeutics in drug delivery.
It's very common for there
to need to be some kind of a disposable element
between a durable piece and the body.
The body comes in all sorts of different
shapes and sizes
and tends to have different effects on
how a component degrades.
And so a lot of times
it's just easier
and more robust
to make that a component that’s disposable
one important point, I think, to make as we
move into the conversation here, is the distinction
between two categories of disposables
and the big ones that I see
are single use disposables,
the ones that really have
the maximum amount of cost pressure
and have no reprocessing requirements
but are probably the best
they're reducing that risk
and then multi use disposables
which may have some kind of reprocessing requirements.
So cleaning and disinfection
being the big ones there,
but aren't designed for kind of permanent
long term use.
So something like a CPAP mask
where the manufacturer
is going to recommend that you clean that
with soap and water,
especially on some frequency
for extended use.
But you're supposed to throw those
out after 1 to 3 months.
Let's pretend
that you're responsible for designing a body
worn, connected, disposable.
That is going to be used in a home environment.
And this article
that you wrote Will recently, you know, addressed
when you're faced
with a complex disposable development challenge,
the first thing you should do
and where you should focus is the interface.
So the interface between the device and the user,
the device and embedded electronics,
the device in physical space,
and clearly the device and the digital world,
maybe not the metaverse, but, you know,
the digital world at this point.
Yeah, not yet.
So what do you mean
when you say consider the interfaces?
Why do you say that?
The primary reason that I say
that is because in any engineering
development project,
you want to think about your constraints and
and identify areas of maximum complexity.
And in a lot of cases in the kinds of devices
that we design,
the interface between your disposable
and your durable elements
are that only maximum complexity.
And furthermore, a lot of times
and as these medical technologies
get more and more complex,
the disposable may even be the most
the most complex element.
We're finding more and more
that the interfaces are the best place to start,
because you
you typically have the maximum number
of constraints
in those areas,
and then you can kind of fill in the blanks
from there. Right.
So if you if you define your constraints
that where, or you define your interfaces,
where you have all of that complexity,
and you're going to need to spend
probably the largest amount
of your design time
on improving those and making those robust
because they're going to see a lot of cycling
and things like that as well,
which are going to add
to the constraints that you have on that design.
It's best to start there
and then fill in what can often
be the easier stuff in between.
Speaking of constraints, let's talk about
probably the hardest one.
The user.
What should you consider
when you start
thinking about the constraint of the user
or the interface rather with the user
and your device?
For a lot of reasons,
that can be the most complex of these interfaces.
And in my experience,
the reason for that, is really because
in all of your other interfaces
or at least
most of your other kinds of interfaces,
you as the designer have a significant degree
of control over both sides of your interface.
Right?
So from durable to disposable,
you have control over both sides of that.
And on the patient side,
you only have control over one side, your device
or disposable side of that interface.
And you need to account for a very wide variety
in many cases
of, you know, physiological geometry
or other constraints and designing for that user.
And you need to think
very deeply about how a user will interact
with that interface, and ways
in which they could potentially misuse it,
which are going to be,
you know, the most difficult in that space.
So I'm sure later
we'll talk about a variety of ways
that you can make device
to disposable connections more intuitive.
And a lot of
those things are really not on the table for
the disposable to patient interface.
One example of a product
that I spent a lot of my time
on, at Key Tech like you alluded to earlier,
is the CoolStat thermal regulation device
that we developed for CoolTech Medical.
And I remember
in designing the disposable elements for that,
it was relatively early in my time at Key Tech
and I kind of overestimated
the ability of a user to figure out right away,
you know, exactly what I intended with my design.
And I remember one of the founders of Key Tech,
Brian Lipford,
stressing on me that
they're going to put this mask on upside down.
You might think that it looks obvious.
You might think that,
but they're certainly going
to put it on upside down and sure enough,
we proceeded into a user study
partway into that project and, you know,
put this mask in front of people,
ask them to figure out how to put that on
and sure enough, about 40% of the users
put it on upside down.
You need to assume that your users are going
to do all sorts of wild things to
to misuse your device.
And so you need to make it
as intuitive as possible.
And so working with our industrial design team,
I was able to make some small changes
to make that more intuitive
and things that can seem a little too obvious.
But for example, in this case
we added just a sticker that I mask
and that just says the side
arrow points towards your eyes.
So sometimes it can be that simple.
So Will, you mentioned making these devices
as intuitive as possible
so that you don't misuse them.
If you need to add labels, great.
That will help prompt the user
to take certain action.
But in your experience, what are some other ways
you can make devices intuitive and easy to use?
Some things that we use are poka-yoking,
which is basically putting
some kind of a keyed feature
on both sides of your interface
so that it's not possible to place that in,
you know, maybe the incorrect orientation.
Or if you have
two similar interfaces on your device,
you want to make sure that one
element will only fit in one of those two
similar interfaces.
So let's say you have two circular interfaces.
You put a notch on one
and two notches on the other,
something like that.
Another one is color coding
or the use of symbols.
So it seems easy and obvious, but a lot of times
our first instinct is to just design an interface
and expect that it's obvious to the user where
that thing is going to go.
But if you do something simple
like make both sides of the interface red or
put a little symbol on both sides,
the one on your disposable,
for example, and one on your device side.
And the user can kind of easily identify those
and just match them up
in making that connection.
It does an immense amount
to really streamline that process
and make it more intuitive.
The last thing is to take advantage
of what people are used to, right?
So there's a lot of things in
just life in general
that people are doing very repetitively
all the time.
And it makes sense
in the design of medical products
to think about those things and try and relate
your product to those things
that people are used to
so that it's more intuitive
just based on muscle memory,
what they've
spent a lot of time doing in their life.
Yeah.
So how did you reflect that
in your experience on the CoolStat
if you did?
You know, just the mask you put it on, right?
On the CoolStat side,
the two big interfaces other than the mask
which goes straight on the face, that I'll get to in a minute
are a desking cartridge that has some
some media in it that'll dry the air
because that's for delivery of dry.
And that has a circular interface
where you insert the cartridge directly
into the top of the device
and there's a cavity there that’s
the exact size of your disposable cartridge.
And so that's basically
one method of poka-yoking
is to create this volume in your device
that's very obviously intended
for that one elements.
And then on the tube set side,
for the interface between the tube
and the device, there's a custom manifold
that has a specific
rectangular shape with some specific,
you could call it poka-yoked features
on the edges of that, that fit directly
into the front of the device
where there’s a peristaltic pump
to drive the delivery of saline,
which is necessary for that therapy.
And we needed to go
through a couple of iterations
to get that right based on feedback
from user studies,
to make that interface as obvious
as possible
and disambiguate that from the desk and cartridge
and then
in terms of things that people are very used to,
the saline interface, we use a saline spike
that clinical staff
which are the typical operators of this device,
are using for many products
in their time at the hospital.
And so it's something that they're used to.
They're going to know where to put that.
And so we're taking advantage
of what they're used to in that case.
And then on the mask side,
we did some
benchmarking off of existing products
that are very common, like CPAPs
and designed a nasal mask
that takes advantage
of a lot of kinds of features that
people who suffer from sleep apnea are used to.
And even if you don't suffer from sleep apnea,
chances are you, you know, someone who does.
And so you've heard of what a CPAP is.
And the mask is more likely to be intuitive to you
if you've experienced that.
Oh, those are great examples, Will, thanks for that.
So now that we've conquered the user,
we know we know how to design
things that are intuitive and
and match things
that they're, that users are used to dealing with.
Let's switch and start
talking about the next interface
that we mentioned, which is,
the interface of the disposable
to the novel electronics that are powering
these things, are sensing different things.
Things are connected.
So in your experience,
like electrifying these consumables,
what are some of the examples of functionality
that you're seeing added
to traditionally all disposable medical devices?
I think the first place
where electrification of disposables
happened is really in temperature measurement
because the cost of those sensors has been
driven so low by the
ubiquity of temperature sensing
and how little you need
in terms of hardware
to get reliable temperature measurements.
The temperature sensing is a big one.
Measurement of other physiological conditions
in a hospital environment
or otherwise
is also super common for electrified disposables.
Now, even things like consumer products
like vaporizers,
which obviously is not a medical products,
but because they are so commonly used,
these disposable vaporizers,
they're driving down
the cost of things like
disposable batteries, disposable circuit components,
that go into those disposable
temperature measure sensors.
And then I've also seen flow sensors,
memory chips on products such as EEPROM chips
and things where maybe you have a variety
of different disposables that look very similar.
One example of a product
that Key Tech has spent time
working on that uses something like that,
is a product for combinational drug therapy.
And in that case,
you've got a variety of things
that may fit together
and that look very similar,
but you don't want the user
to have to think very hard about
what is in each one of those
and how they fit together.
And so if you can put some intelligence
in your disposable,
that makes it easy to identify by the durable
part of the device
that can really streamline
the process and reduce risk
for what you're trying to design.
So those are some examples of functionality
that are being added to consumables.
But you know,
the topic we're covering today is the interface.
So when you talk about,
these functions are being added,
these components are being added.
But what is it about the interface
between the disposable
and these electronics
that you need to look out for?
So it's really a different
kind of electrical connection
than what we as engineers are used to
in other areas of our devices.
So the most common thing on
the inside of a device is a PCB mounted connector
that goes directly
to your electromechanical component.
But those kinds of connectors
that are going to be board mounted,
are typically not appropriate
for the kinds of interfaces to disposables
that we're talking about here.
And so you need to think about different
things like how the user will interact
with that connection,
whether it is easy to hold in their hand,
easy to manipulate.
The number of connections involved.
You may need just
two conductors for something
like a temperature sensor.
You may need four conductors
if you are, for example,
driving some piezoelectronic element
and you want to have some sensor alongside that,
to either you know, sense the presence of liquid,
or just get a continuity check to sense
for the presence
of that disposable connected to your product.
There's a good example of a product
that I've been working on very recently,
in that we're using a piezoelectric
misting transducer to mist some saline.
And in that case we have four conductors.
And so that has driven us away from,
you know, something like, for example,
a pin and socket connector,
where if you've got four connectors,
there are some difficulties with tolerancing
among those different pins.
And so you typically want something
with a little bit more compliance
or that has those four connectors
kind of in the same annular design.
So something like an audio jack or an amp jack
is something that we may end up using for that
just because it's one connection
that the user needs to insert, but it has four
conductors along
the OD of that connector.
Some other constraints
that you're going to think about in
that case are things like ingress protection.
Your internal connections
are not going to need
the same kind of ingress protection
that you have in the outside of the device.
Cost pressures,
which are going to be different
for your single use disposables
versus your multi-use disposables,
but there's a lot more cost pressure
for something that's disposable
than there would be for some of those
inside the device connections.
And then cleanability,
especially in a multi-use disposable case.
You may need to wash that disposable
with soap and water a few times
before you replace it.
And so it can't be something
that's going to corrode in that case
Great, those are all, yeah.
It makes you wonder
why you want to add all this complexity
to these consumables,
because you're just introducing,
you know, these compounding effects
of functionality and interfaces,
particularly on the electronics side.
So we're both mechanical engineers.
Let's talk about more of like,
you know, the physical interface.
And some of the prior examples
did touch on physical interfaces.
But, you know, now that,
there's this anatomy of, yes,
consumables, they're complex.
They do interface at times with a durable
that's reused.
But you know, talk a little bit
about the physical interface rather,
of durable and disposable devices.
There's a few things that we think about
and create optimizing those physical interfaces.
One is sealing.
If you're manipulating a fluid,
whether it's
a liquid or a gas, maybe saline, or air
as in that CoolStat case,
you want to make sure
that you're getting a reliable seal
in that connection,
which can be difficult
for something that will see a lot of cycles.
And so you need something
that's not going to wear over time
in a way that's going to negatively affect that.
Or maybe you put your compliant component
on the disposable side,
let's say it's an o-ring,
and you have more robust,
rigid components on the device side.
That's a great way
to achieve one of those connections
in a single use case.
Other things that you like to think about
are users like to have some kind of haptic feedback
in making those connections.
And so maybe you want to use something like detents,
or similar spring loaded elements
to get your disposable,
to kind of snap into place when you place it.
Because the absence of that haptic feedback
can sometimes make users worry
that they haven't placed it correctly,
even if they have.
And so that's important to think about,
even if it doesn't seem immediately necessary
when you're first kicking off your design.
Another thing that you like that
we like to think about is
potential for cross-contamination, especially in
a device
that is specifically designed for multi-user use.
That's where things like reprocessing
or maybe if you have a device
that is for multiple users on the durable side.
But as a single use disposable,
you just make sure that you've got
an appropriate amount of filtration
between your durable and your disposable,
such that any kind of backflow from user
and let’s say in the CoolStat case
backflow from breathing into that nasal mask.
You want to make sure that anything
bacterial or viral, that could reach
the device is going to be filtered out
on the way over there.
Another thing that you want to think about
is the frequency of connection.
So you need a different level of reliability
and compliance
in something that is going to be cycled daily,
versus something that's going to be cycled,
you know, replaced every six months.
So frequency of a connection
is definitely a huge area that
you want to study
before you proceed into detail design.
The last interface
I want to talk about is the digital interface.
And I think the digital interface
really is a culmination of the prior three.
The use case, the user,
the electrical
interface to the electronics interface
on the disposable
and then clearly the mechanical
physical interface to a durable.
And all three of those combined really
are enabling the use case
of course, and the products used.
But now
with the advent of at home and smartphone enabled
devices, you know those three interfaces
then create that fourth digital interface.
So clearly you have to pair, your pairing,
or you're using RFID, you're taking pictures
to bridge from the physical
to the digital world.
And I know you've been working on a project
now where the product is app enabled.
Are there any, what is the most critical part of the
digital physical interface in your experience?
Well, I think the projects slightly differently
and saying, you know,
where can you get the most value
from the digitization
of the modern world
in medical product development?
And you touched on it in saying that there’s
a big move towards at-home medical products now.
And everyone has pretty much, for the most part,
a smartphone in their pocket now.
So they've got significant computing power
already prepaid and in their pocket and ready to go.
And for a lot of products,
you can get a ton of value out of that
for relatively little investment compared
to what you may have needed to do,
to get similar amount of connectivity,
you know, a decade or two ago.
And so, you know,
one product that I'm working on right now
is for an at-home therapy treatment
for an acute medical condition.
So it occurs
you take the device out and you use it,
and we're developing a mobile app for that.
That may include things like instructions
for use, use tracking, to know whether you're
running low on disposables
or something like that.
Download of device data both for improvement
over the long term.
If the client can use that data to study,
use cases, and consider improvements to the product.
And so it's
if these devices are already in your
in your pocket,
all you need to do is add
some kind of wireless
connectivity capability to your device.
And then, you know, that $600 smartphone can do
a lot of the work
for you in sending a lot of useful data
up to the cloud
where it could be accessed by the manufacturer
of the device.
It’s super valuable to both the
supplier of the device and the user.
So, you know,
there's a lot of opportunity
there to optimize the experience
for the user and add detailed instructions
or explanations of what's going on
with the device, at any given time.
You may be progress tracking through your
use of the device or something like that.
And at the same time,
the supplier is getting a lot of value
with all the data that they can record
from the use and encouragement of the user
to go ahead and get more disposables
when they need some,
which obviously is good for
that supplier's business.
Yeah, those are great examples.
And I would say, you know,
these are interesting times
when you consider, you know,
interface to the digital world.
When you describe the projects you’re on,
it's clear that you're designing the consumable
with the digital experience in mind,
you know, at the same time.
But there are other products out there
that have been on the market.
Let’s call it, lateral flow, diagnostic test strips,
been on the market for decades,
and now people are adding
the digital interface
on top of it, just taking pictures
of the lateral flow strip.
So, you know,
when we talk about the interface,
there's another layer here of like
when do you add
this interface on, is it
after you launch your disposable or,
you know, slightly more complex disposable
and get it out?
Or do you do it in parallel from the get go?
And I think there, you know,
we're not going to get into the strategy here
in this episode.
But, you know,
there are different ways
to go about doing it,
I guess is my point there that I'm seeing in the market.
Absolutely.
And it really depends on the volumes
for initial launch and things like that
as to when you make those investments
like anything in a medical product.
But there are plenty of cases
where it makes sense to invest
in that early and others
where you do that much further down the line
and add something like a QR code, you know,
for example, like those lateral flow test strips
to be able to track results on the cloud.
Yeah, but I loved your response, which was,
where's the value,
you know, where can you add the most value?
And I think that applies,
you know, for all the other topics
we've brought up here, it's like,
do you want to add a battery to this disposable
and add cents?
If you're doing 10 million of these products
a year, you know, every penny matters.
So, where is the value that you're
adding and is it worth it?
We've talked about designing
for considering the interfaces
and being a soon to be master.
I believe in project management, right?
Technical project management.
Yeah. That's what your degree is. Yeah.
So yeah, congrats.
Being a good project manager,
let's talk about, you know, the best
trait of a manager is predicting the future.
So what are
some of the common pitfalls
that you've seen developing consumables,
particularly these complex consumables,
that you as a project manager
try to look out for? And how do you do that?
Yeah, that's exactly right.
The most important thing
as a manager is to take a risk based approach
and think about
what kinds of things could go wrong
from a programmatic perspective,
from a use perspective,
especially in terms of safety.
And to try and head those off in your design,
so in terms of programmatic, or cost,
to our clients,
one of the big pitfalls that I've seen is
a de-emphasis or too little emphassis on
what it's going to cost
to assembele a medical disposable and,
focusing on driving down BOM cost
while allowing the cost of assembly
to to increase and so design for assembly
is exceptionally important.
It's not going to be worth it to shave
$2 off the BOM cost
if it adds ten minutes to the assembly time.
And you know
that labor expense of doing the assembly,
especially in something
that's designed for medium volumes,
where it's not going to make sense
to do some mass automated production.
Yet, you really want to focus on
what it's going to take to assemble
on simplifying that process, both in terms
of reducing assembly time, and reducing scrap.
Because if you need to throw out
a significant portion
that's going to bring the price
of that disposable up.
And then on the at home environment side,
you want to prioritize risk over things
like aesthetics, especially.
But sometimes you need to make tradeoffs
in terms of usability and cost
because in the at-home environment,
especially if users only getting partial
or no support from insurance or a given product,
you hope to get that support from insurance.
It’s important to make sure you're thinking critically
about whether the user is going to prefer some cost
reduction versus some
minor improvement to usability,
and making sure that you're thinking
about those things correctly.
And then finally, the last
and most important thing in terms of risk
is thinking about any possible way to reduce
safety risk in the design
of a disposable element.
And sometimes that's really going to push you
towards a single use disposable,
especially for something that has fluids in it.
You certainly wouldn't
use a single disposable over multiple patients
in the at-home environment
or even in a clinical setting,
unless it's easily sterilized.
And so focusing on that risk reduction
is certainly the biggest piece.
Yeah, risk based approach is the way to go.
We talked about developing consumables,
why they're getting more complex.
They're moving from hospitals to home.
You're adding connectivity,
adding novel sensing, powering them,
challenging user environments
in the home environment.
So considering all of these interfaces is key.
We talked about,
looking for the value
in the digital physical interface.
Where can you add the most value
with connecting these things
to a smartphone
or whatever you're connecting to
and then clearly thinking about,
preventing these pitfalls
and thinking about the risks at a time
as a project manager
I think are all great
tips that we've talked about today.
Will, thanks for your time.
Thanks for having me, been a pleasure.