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It’s hard to talk about medical devices without getting into
what makes them tick. As with so many other products that are
entering the commercial marketplace today, it all starts with elec-
tronics, which play a key role in control management, monitoring
of medical device function, and—most recently—connectivity.
“What’s really neat about electronics today is that so much of it
is computer controlled,” said David Estes, senior systems engineer
at Digicom Electronics, an electronics manufacturing services
provider based in Oakland, California. “And, of course, with
computer control, you have the concept of software. The really
nifty part about software is that it allows the instant customization
of devices to incorporate very finely honed ideas and concepts
and their operation. It also allows for the incorporation of refine-
ments through software updates, just as your phone is updated.
So I think that’s one of the nicest aspects of electronics today.”
Welcome to the new age of smart, connected products, where
the smooth interaction of electronics, software, and hardware
is fast becoming a central design requirement that knows no
boundaries. Wireless technologies that fueled the rise of con-
sumer electronics have quickly spread to the medical device
industry, where they’re reshaping product designs and spurring
new business models. Lux Research, a market research firm
focused on emerging technologies, sees big things ahead for
mobile health (mHealth) devices, projecting eight-fold growth
in the market from $5.1 billion in 2013 to $41.8 billion in 2023.
Rising adoption of clinical vital signs monitoring devices and in
vitro diagnostic (IVD) devices are expected to drive growth in
the mHealth market, according to Lux, which anticipates vital
signs monitoring devices to grow from a $372 million market in
2013 to $16 billion in 2023.
“Consumer devices have seen a lot of hype, but clinical devices
will surpass their consumer counterparts in revenues by 2020,
helped by value-added software services and generally larger
revenue streams,” said Lux Research Associate Nick Kurkjy,
lead author of the report, “mHealth Showdown: Consumer and
Clinical Devices’ Battle for Market Dominance,” released last July.
“Clinical markets will be able to pay much more for comparable
services, especially if a device is able to reduce patient recovery
times or readmission rates, which can lead to outsized cost savings
for the health care provider,” he added in a release from Lux.
Point-of-care diagnostics is spawning its fair share of startups
COVER STORY
Personalized Care Drives
Innovation in Medical Product
Design and Manufacturing
But the more things change, the more they stay the same, as medical device OEMs
hold fast to requirements for quality, reliability, and shorter lead times.
By Mark Shortt
seeking to build a business around, for example, innovative sens-
ing technologies that “bring the device to the patient” wherever
he or she may be. But even if they’ve been fortunate enough to
receive funding to get started, many of the founders of these
companies really don’t have a good understanding of what their
product ultimately needs to do in the marketplace, said John Zeis,
president of the Plastics and Single Use Disposables Business at
Foundry Medical Innovations (FMI), a Carlsbad, Calif.-based
medical and diagnostics device development firm that provides
engineering services and serves as an incubator for cutting edge
medical technology.
“One of the things that we try to really get our customers to
do a good job of, on the front end, is defining what the user’s
needs are and really understanding what need we’re servicing,”
said Zeis in an interview. “We try to guide them towards ‘What are
your user needs and what does this product really need to do?’ as
opposed to, ‘Hey, let’s just make this nice gadget that looks cool
and can diagnose something on a bread board.”
After helping a customer define the user’s needs, FMI will
follow the project all the way through to manufacturing. “We can
make the molds, and then, once we verify that the parts function
Digicom Electronics’ component placement process is geared toward
flexibility, fast changeover, quick setup, and excellent accuracy and
repeatability. Photo courtesy of Digicom Electronics.
60 DESIGN-2-PART magazine • February 2015
properly, we’ll find the critical tolerances
and dimensions, and critical features and
critical functions, and then help spec out
potential manufacturers,” Zeis said. “And
then we’ll work with those manufacturers
to give the product a transition.”
Paul DiPerna, president of the Systems
Engineering and Incubation businesses at
FMI, said that a number of manufactur-
ing improvements, including the growing
reliance on rapid prototyping and 3D
printing technologies, has contributed
to “a strong expectation of getting things
done faster than ever before.” Because of
this, he said, medical device OEMs are
looking for companies that have experi-
ence in completing projects similar to
what they’re trying to accomplish.
“I think the expectation of the length
of the project has gotten very aggressive,”
he said. “A lot of people will come to us
because of our prior expertise, and their
expectation is to hit the ground running.
If you’re working on something in the
diabetes space, you want to be sure that
the company has done other things in
that space. I think that’s a trend, whereas,
before, it was more about your specific
technical expertise. For now, it’s more
about where you’ve been.”
Pia Kumar, director of corporate de-
velopment for Mayfield Plastics, a custom
thermoforming company based in Sutton,
Massachusetts, can vouch for medical
device OEMs’ reliance on suppliers that
have experience in medical manufactur-
ing. Mayfield, which recently completed
a highly cosmetic, complex, multi-piece
housing assembly for a major medical
OEM customer, has more than 40 years
of experience in the industry. The com-
pany has won awards from the Society of
Plastics Engineers (SPE) Thermoforming
Division in multiple categories, including
Best Pressure Formed Parts.
“When a new customer comes to us,
they want to know that they are working
with a company with experience, a com-
pany that understands the highly cosmetic
and functionally exacting requirements
of this market,” said Kumar. “Along with
Mayfield’s track record of successfully
working with major medical device OEMs,
our in-house engineering, design services
and tooling are important differentiators
for customers.” For more on Mayfield
Plastics, see page 96.
DiPerna also said that he’s seeing
a trend toward more entrepreneurial
startups, even among people who are un-
employed. “Nowadays, people say, ‘I could
get a job, I could do some consulting, or I
could start a company. Whereas, 10 years
ago, it was pretty unusual for people to
talk that way; now, it’s almost everybody.
Now that things are improving, there’s a
lot more activity in the air.”
Wireless Medical Devices
Enabling Personalized
Healthcare
Point-of-care products are part of a
rapidly evolving movement in health-
care today toward more personalized
care—an aim enabled and supported by
the pervasive adoption of wireless-based
mobile health (mHealth) devices for
remote monitoring and assessment.
“There are a lot of personalized
care products out there that attempt
to get information onto your Android
or iPhone about everything imagin-
able—your weight, your heart rate, what
you did, where you were,” said DiPerna.
“There’s a lot of this information get-
ting to the patient, and there’s a whole
medication adherence field that’s begin-
ning to evolve. It’s in its infancy, as far as
getting people to actually take care of
themselves, as well as take their existing
61February 2015 • www.d2pmagazine.com
therapies. The whole economics of that
is starting to be really understood, and a
lot of the changes in the Affordable Care
[Act] are motivating people to begin to
work in that area. So that’s an area that
I see taking off in the next few years.”
The Center for Disease Control
(CDC) estimates that medication non-
adherence—the problem of patients’ not
taking their prescriptions—is responsible
for adding some $300 billion per year
in costs to the United States healthcare
system, according to Michael Morena,
chief operating officer of AdhereTech, a
small startup company in New York City.
Morena and AdhereTech CEO Josh Stein
started the company two years ago with
the aim of bringing to market a smart,
wireless pill bottle that electronically
reminds patients to take their medica-
tions and provides alerts to caregivers if
doses are missed.
AdhereTech has developed a first
generation Smart Pill Bottle that’s cur-
rently in trials, and is now working with
Intelligent Product Solutions (IPS), a
New York-based product design com-
pany, to develop the next generation
of the product. The second generation
of the product, due out in mid-2015, is
expected to be smaller, less expensive,
and easier to mass manufacture, and to
provide additional user enhancements,
such as longer battery life, a larger cap,
and capacity to hold a higher volume of
medication.
Morena says that medication non-
adherence also represents “about $100
billion a year” in lost revenues for
U.S. pharmaceutical companies, while
contributing to approximately 100,000
deaths a year.
“It’s considered a very large prob-
lem in health care, and the way we’re
approaching it is we’re developing a
cellular, connected smart pill bottle
that is distributed to patients for free
at the pharmacy, so that we can track
their behavior in real time and generate
interventions based on their behavior
or lack of behavior,” Morena said in an
interview. “So when people don’t take
their medication, we can detect that in
real time and generate a reminder. We
can also solicit feedback when people
aren’t taking their meds, and find out
why. There may be reasons other than
forgetfulness. For example, if someone’s
dealing with side effects or financial stress
as a result of their medication, we can
AdhereTech is working with Intelligent Product
Solutions, a New York-based product design
company, to develop the next generation of its
wireless Smart Pill Bottle, which electronically
reminds patients to take their medications
and provides alerts to caregivers if doses are
missed. Photo courtesy of AdhereTech/IPS.
detect when they’re not taking it and
then provide them that information by
connecting them to the right person at
the right time.”
Dana DeMeo, who has been working
directly with AdhereTech as chief techni-
62 DESIGN-2-PART magazine • February 2015
cal officer at Intelligent Product Solutions, calls the AdhereTech
Smart Pill Bottle a unique and novel solution. “It’s an intelli-
gent pill bottle that has electronics inside, and it’s completely
standalone,” DeMeo said. “It has a cellphone radio inside that’s
already pre-configured when you receive it. As a patient, there’s
really no setup that you have to do. You receive a bottle like you
normally would, the prescription’s inside, and the only real dif-
ference to you is that it will occasionally beep and light up to
remind you when to take it. And that’s really it.”
The pill bottle, which requires no syncing or programming,
is designed for simplicity because its users—the least adherent
patients—are the least likely to buy a product, set it up, and help
themselves, Morena said. Rather than trying to sell the product
to them, AdhereTech would rather give them the pill bottle.
“You don’t have to learn how to use it; you don’t have to
worry about how it works, and the reason we make it that way
is we want people to benefit from it right off the bat,” Morena
said. “We don’t want any friction. It comes with the medication
in it; the idea being that when it comes to the patient, they use
it no differently than a regular, standard pill bottle. They open
and close it like a standard pill bottle; they take pills out of it
like a standard pill bottle, and they don’t have to charge it. It
can work for up to 90 days on a full charge, where it will actu-
ally come to the patient fully charged. The idea is that you get
all the benefits without having to do any additional work, and
we see that as our unique approach to solving the problem of
medication non-adherence.”
Mitch Maiman, president of Intelligent Product Solutions,
says that wireless medical devices are an emerging product
category that IPS is well prepared to handle. “One of the ar-
eas where we provide a lot of core competence is in smart and
wirelessly connected devices,” said Maiman. “Because of our
experience, a lot of us having been ex-Symbol, ex-Motorola
people, we have a lot of expertise in wireless communications
in all forms—everything from low level things like ZigBee and
Bluetooth, and near field, up to Wi-Fi and GPS and wide area
radio communications. There’s a lot more things going on, and
you’re seeing them all over the place in terms of connected
devices. This is an area where we have a lot of competence.”
Another consumer electronics trend that’s rolling into the
medical space is the increasing preference for wearable devices
with monitoring capabilities. Maiman also touts IPS’s capabili-
ties in this area. “When you talk about wearable, body mounted
and body worn technology, especially when you get into mis-
sion critical things, like in the medical space, this is where we
have a lot of domain expertise,” Maiman said. “There are a lot
of nuances to designing a wearable device that’s reliable, that
somebody can wear all day long and all night long, that they
can wear in all kinds of conditions—like when it’s 100 degrees
outside and 90 percent relative humidity. We’ve got a lot of
experience in what it takes to make devices that are reliable
over a long period of time, and in wearable devices that work
in those kinds of environments.
“We’ve worked in medication dispensing systems before and
we’ve done work in computer navigation methods for quadriple-
gics, who are unable to manipulate a cursor control, but yet they
need to interact with a computer,” he continued. “We’re doing
work right now on mobile and fixed mounted defibrillators. So
it’s a pretty broad range of products, but the common thread is
that there’s a lot of electronics, and they’re all smart.”
63February 2015 • www.d2pmagazine.com
What to Look for in an
Electronics Manufacturing
Services Provider
Quality, a universal concern across
complex product manufacturing market
segments, is at the top of every medical
device manufacturer’s list of priorities
when selecting an electronics manufac-
turing services (EMS) provider. But it’s
also important to consider the location
of the manufacturer, the degree and
type of service and support that they
provide, and whether or not the person
you interact with is a high-level engineer,
according to a white paper recently
released by Oakland, California-based
Digicom Electronics. The white paper,
“What Medical Device Companies Need to
Consider in Selecting an EMS Company,”
was co-authored by Digicom executives
Mo Ohady, general manager, and David
Estes, engineering specialist.
“Although most EMS companies per-
form the same basic services, every EMS
is different,” explained Ohady in a release
from Digicom Electronics. “You can tell
when you walk into a place, examine the
equipment and processes, and speak to
the people. It’s important to use due
diligence in choosing an EMS company,
but the rewards can be great. A properly
functioning EMS brings decades of experi-
ence and knowledge to embrace and en-
hance the product you want to build in a
time-efficient and cost-effective manner.”
A big part of choosing a supplier in-
volves deciding if you want your product
to be manufactured close to where your
company is located, or close to where
the product will be distributed or sold,
say Ohady and Estes. Factors to consider
when weighing the location of a supplier
include the complexity of the device, the
need for intellectual property protection,
shipping costs and time, and the degree
of supplier involvement that you’ll expect
throughout the manufacturing process.
Manufacturing at a great distance
from home—say, the other side of the
world—can become a problem when a
production issue arises, Estes said in a
phone interview. “If you need to travel
there to resolve the problem because
the expertise to do that just doesn’t exist
at that location, then you’re looking at
maybe a $20,000 trip to travel overseas,
and the delays that that introduces.
And so being local allows a very quick
response to resolve an issue and get on
with production.”
Digicom, because of its location in the
San Francisco Bay area, offers a special ad-
vantage to local OEMs. “We are certified to
California standards, and so when you’re
building medical devices in California,
we are approved of,” Ohady said. “We are
registered with the FDA; that addresses
the U.S. built devices and those that are
distributed throughout the United States.
And the ISO 13485 [certification] tops
it by addressing most of the rest of the
world’s regulatory issues and compliance.”
Ohady got to know his colleague, Da-
vid Estes, when Estes was once a potential
customer of Digicom. At the time, Estes
was doing considerable research as part
of the process of selecting a manufac-
turer for a product that he was helping
to develop. “He has a very rich level of
experience,” Ohady said.
“I can say, from a device manufacturer
point of view, that selecting a manufac-
turer when one has little manufacturing
experience is really daunting,” said Estes.
“It’s very much like going out to buy a car
when you really haven’t driven a car; you
don’t have that experience. And so it’s
critical that you select a manufacturer
that’s willing to accommodate your lack of knowledge and exper-
tise. It almost is like an educational process that occurs between
the manufacturer and the company.
“If the manufacturer is very large and is used to working with
very large companies that have a lot of experience, they may feel
it’s a burden to take on this chore of educating and working with
a customer that’s new to manufacturing,” he continued. “The
advantage for the manufacturer, though, is that it’s a potential
win-win because as one learns new products and overcomes new
problems, this becomes part of the repertoire of the manufac-
turer. And so the manufacturer can actually gain expertise in new
technology by working with new companies.”
Digicom marketing representative Andrea Roberts said it’s
important to work with an experienced engineer who can look at
your boards, box builds, or devices and tell you if your design is
going to work—that is, whether it can be manufactured. During
the prototype phase, experienced engineers can provide ideas
about better ways to manufacture the product, she said. Later,
when you want to build the product in volume, they can tell you
if the prototype can be transferred to volume manufacturing.
“There’s a whole lot that goes into it—the sourcing and the
whole picture of Design for Manufacturability,” she said. “And
that’s why you really need an engineer to work with you, to see
if that design can actually become a reality.”
Quality is much more of a concern with medical devices
because poor quality can directly affect safety and lead to fatal
consequences. It’s important to know what types of inspection
and tests are performed by an EMS provider, whether they have
tracking mechanisms in place, and how clean their printed circuit
boards are, said Ohady. That’s because quality is directly related
to the cleanliness of the boards, an issue that Digicom addresses
in its white paper, “Cleanliness of PCB Assemblies Leads to Medi-
cal Device Reliability.”
In the paper, Ohady and Estes discuss the important role
that cleanliness of electronic components and circuit boards
play in preventing component failure, as well as the benefits of
the company’s Diamond Track Cleaning Process. The process,
part of the company’s Diamond Track Manufacturing program,
employs a proprietary combination of chemicals, temperature,
wash cycles, and timing to render circuit boards extremely clean
and includes stringent test and evaluation procedures.
“Independent tests showed that boards that went through this
[Diamond Track] cleaning process tested 75 percent cleaner than
the 10-2 micrograms/in2
specified by IPC as its highest level of
clean,” they wrote. “In addition, a lab analysis for ion contamina-
tion found zero levels of sodium chloride ion contamination on
the assembled boards.” (The IPC is a global trade association that
serves the printed board and electronics assembly industries.)
The level of cleaning attainable by the Diamond Track process
is said to eliminate failures caused by board contamination and
make products less susceptible to corrosion-induced failures,
reducing the need for maintenance or repair. Medical device
manufacturers that use the process can realize significant cost
savings as a result, according to Ohady and Estes.
“When we’re looking at the devices now being made for the
medical device industry, including all the wireless and implant-
able devices, it is time to take a new look at cleanliness standards
and the processes used in manufacturing to ensure that these
products do not fail,” they wrote.
3D Printed Patient-Specific Implants
Wireless medical devices aren’t the only technology that’s
facilitating the trend toward personalized healthcare. Another
key enabler—one that’s providing some of the most impressive
examples of customization—is 3D printing, now being used to
produce patient-specific implants for reconstructive surgeries of
the skull, face, jaw, spine, hip, knee, foot, and ankle.
But although 3D printing is the most visible step in a process
that reduces lead times, it’s actually part of a larger digital thread
that begins with a medical imaging study—usually a CT scan
or MRI—of the patient’s anatomy. The digital thread includes,
among others, a medical image processing step that builds up a
3D model of the anatomy from the 2.5D representations of the
imaging study. It’s that 3D model of the patient’s unique anatomy
that becomes the basis for 3D printing of a personalized implant.
One of the more interesting companies in the space is 4WEB
Medical, an implant device company headquartered in Frisco,
Texas, that is reported to be the first company to receive FDA
clearance for an additive-manufactured spine implant. Founded
by company president Jessee Hunt, 4WEB Medical has combined
the novel 4WEB geometry—a building block for creating high-
strength, lightweight web structures—with leading edge 3D
printing to develop a proprietary implant platform.
Surgeons have implanted more than 3,000 of the company’s
3D printed,
orthopedic
t r u s s i m -
plants, which
are designed
with a dis-
tinctive open
architecture
that report-
edly allows
for up to 75
percent of the
implant to be
filled with
graft material
to maximize
the incorpo-
ration of bone. The 3D printed implants also have a unique,
roughened surface texture that is said to promote bone adher-
ence and, by increasing coefficient of friction, reduce the pos-
sibility that the implant will move from its original position.
Other companies that have achieved prominence in patient-
specific 3D printing include ConforMIS, developers of a propri-
etary iFit Image-to-Implant®
Process (see page 68), 3D Systems–
Medical Modeling, known for its role in integrating 3D printing
into a comprehensive digital thread for personalized medical
implants and surgery, and Oxford Performance Materials, a spe-
cialist in the high performance polymer, PEKK, that has received
4WEB Medical recently announced that surgeons have
implanted over 3,000 of the company’s 3D printed
orthopedic truss implants. Photo courtesy of 4WEB
Medical.
66 DESIGN-2-PART magazine • February 2015
FDA clearance for the manufacture of
patient-specific cranial and facial implants
(see pp. 71, 124, and 150).
Another company, veteran-owned
Osiris Biomed 3D, is preparing to offer
3D printed, patient-specific implants that
it believes can further reduce lead times
to surgery. The company’s proprietary
software is expected to facilitate real-time
production of customized implants from
patients’ medical scans. If approved by the
FDA, the technology reportedly will en-
able surgeons to design and print custom
implants for immediate use in surgery.
Osiris Biomed 3D has applied for a
patent for “single anesthetic reconstruc-
tive surgery,” which, the company says, will
allow a patient to be scanned and a custom
device or implant printed, sterilized, and
surgically implanted “on the operating
table,” all in one surgical procedure. The
company is preparing a highly mobile 3D
printing CONEX (contingency employ-
ment exercise) for the military that can
establish operating suites in a theater of
operations, reducing time to surgery for
wounded soldiers.
In a phone interview, Chief Operating
Officer Christopher Gerstle said that the
company will be initially using an FDM
(Fused Deposition Modeling) process
to ensure that, when starting to build
an implant, the build chamber is sterile
and contains no material from a previ-
ous build. “You’re extruding at very high
temperatures, which are sterile, and what
I refer to as the ‘nest within the box’ is
much more controllable at this point. So
it (FDM) is a good first step for us.”
Quick Response Manufacturing
Cuts Lead Times for Medical
Device OEMs
Gordon Knott had just gotten back
fromtheMD&MshowinSchaumburg,Illi-
nois,lastfallwhenweaskedhimwhattypes
of things the medical device manufactur-
ers who visited his booth wanted to know
about Alexandria Industries’ capabilities
for meeting their needs and solving their
engineering problems.
“The manufacturers we met with
asked about our lead times,” said Knott,
the medical market leader for Alexandria
Industries, a vertically integrated supplier
of engineered, customized aluminum ex-
trusions, as well as precision machining,
plastics molding, finishing, welding, and
assembly services. “Because we use Quick
Response Manufacturing (QRM), we are
able to offer some of the shortest lead
times in the industry, enabling us to com-
pete well with other suppliers.”
Quick Response Manufacturing, used
to cut lead times in all phases of manu-
facturing and office operations, allows
Alexandria to focus on the continuous
improvements of eliminating non-value-
addedwaste,improvingquality,andreduc-
ing cost. Since implementing QRM, the
company has reduced quote times from
12 days to three-to-five days, and extrusion
product lead times from 30 days to as little
as five days, Knott said. Significantly, QRM
has given Alexandria the opportunity to
gain a substantial foothold in markets,
including medical, that value short lead
times.
Medical is one of Alexandria’s prime
markets, accounting for “about 13 to
15 percent” of its total sales, said Patty
Hoffman, the company’s marketing and
communications specialist, in an interview
with D2P. “It’s not our biggest market, but
it’s definitely one of our larger ones, so
it’s a significant industry for us.” That’s
not surprising, given the company’s loca-
tion in Minnesota, one of the nation’s top
states for medical device innovation, and
its proximity to a thriving medtech hub—
Minneapolis/St. Paul—a little more than
67February 2015 • www.d2pmagazine.com
130 miles to the southeast on Interstate 94.
Alexandriamanufacturesawidevariety
of components for the medical industry,
including components for durable and
electro-medical equipment. This includes
structural components for mobile or
stationary diagnostic equipment, moni-
tors, heat sinks, IV poles, medical carts,
structural equipment, X-ray systems, and
CT systems, among others. Knott said that
all of Alexandria’s manufacturing capabili-
ties are well-suited to address the product
development needs of its medical industry
customers, but customers typically choose
the company’s aluminum extrusion, preci-
sion machining, and welding services.
Having partnered with a number of
local medical device makers, Alexandria
Industries has developed a good un-
derstanding of some of the biggest con-
cerns that medical device manufacturers
have—and the constraints that they’re
up against—when attempting to bring a
medicalproducttomarket.Otherthanthe
high cost of bringing a product to market,
medicaldeviceOEMsstrugglewithmanag-
ing their supply base and making sure that
their products are safe to use, Knott said.
“Medical OEMs often need to manage
hundreds of suppliers, which is costly and
time-consuming,” he explained. “Add to
this the increasing trend in mega-mergers
and acquisitions, and an OEM’s supply
basecandoubleortriple.Themoresuppli-
ers, the more time, money, and significant
effort it takes to evaluate, qualify, and keep
a supplier list held to a manageable level.
“Product safety is also a top concern
for medical device OEMs,” he continued.
“Many medical products have movable
parts that interface directly with patients,
and anything that could potentially cause
harm—pinch, stab, or tip over on a pa-
tient—needs to be addressed. Medical
device manufacturers need to make sure
their suppliers know which parts and com-
ponent dimensions are essential to patient
safety and function. They will require that
suppliers identify dimensions that are es-
sential to safety.”
Alexandria’s ability to operate as a
one-stop component shop—a vertically in-
tegrated supplier that offers OEMs a single
source to design, produce, assemble, and
deliver a range of components—has direct
and positive implications for both cost and
lead time, two of the foremost concerns
that medical device companies have when
bringing a product to market. Medical
device OEMs who outsource component
manufacturingfrommultiple—often,hun-
dreds—of suppliers face stiff challenges
in managing these complex relationships
and purchasing processes, which can take
a heavy financial and logistical toll on their
resources. This ultimately slows product
time to market and drives up the cost for
the company.
“Instead of interacting with several
different suppliers, OEMs should find
a supplier who can help simplify their
supply chain needs by offering a range of
complementary manufacturing services so
they can do more of the work for them,”
Knott said. “OEMs should seek a supplier
who also offers value-added services, such
as design engineering assistance and ad-
vanced geometric dimensional accuracy,
to help reduce their time to market even
more.”
Executingonitsvisionofbeingasingle
source, vertically-integrated supplier of
“high quality, short lead-time engineered
products,” Alexandria Industries acquired
the plastic injection equipment assets of
a North Dakota-based manufacturer of
injection molded components in 2012.
These assets, as well as TIG and MIG weld-
ing services, were rolled into Alexandria’s
Wheaton, Minn., facility.
Knott also stressed the importance of
evaluating suppliers based on total-cost-
of-purchasing criteria instead of the cost
of the parts. That’s why it’s important to
seek suppliers that combine their manu-
facturing expertise with value-added ser-
vices like ease of purchasing, engineering
assistance, finishing, and assembly, he
said. For more on Alexandria Industries,
see page 74.

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Personalized Care Drives Medical Product Innovation_D2P_Feb15

  • 1. 58 It’s hard to talk about medical devices without getting into what makes them tick. As with so many other products that are entering the commercial marketplace today, it all starts with elec- tronics, which play a key role in control management, monitoring of medical device function, and—most recently—connectivity. “What’s really neat about electronics today is that so much of it is computer controlled,” said David Estes, senior systems engineer at Digicom Electronics, an electronics manufacturing services provider based in Oakland, California. “And, of course, with computer control, you have the concept of software. The really nifty part about software is that it allows the instant customization of devices to incorporate very finely honed ideas and concepts and their operation. It also allows for the incorporation of refine- ments through software updates, just as your phone is updated. So I think that’s one of the nicest aspects of electronics today.” Welcome to the new age of smart, connected products, where the smooth interaction of electronics, software, and hardware is fast becoming a central design requirement that knows no boundaries. Wireless technologies that fueled the rise of con- sumer electronics have quickly spread to the medical device industry, where they’re reshaping product designs and spurring new business models. Lux Research, a market research firm focused on emerging technologies, sees big things ahead for mobile health (mHealth) devices, projecting eight-fold growth in the market from $5.1 billion in 2013 to $41.8 billion in 2023. Rising adoption of clinical vital signs monitoring devices and in vitro diagnostic (IVD) devices are expected to drive growth in the mHealth market, according to Lux, which anticipates vital signs monitoring devices to grow from a $372 million market in 2013 to $16 billion in 2023. “Consumer devices have seen a lot of hype, but clinical devices will surpass their consumer counterparts in revenues by 2020, helped by value-added software services and generally larger revenue streams,” said Lux Research Associate Nick Kurkjy, lead author of the report, “mHealth Showdown: Consumer and Clinical Devices’ Battle for Market Dominance,” released last July. “Clinical markets will be able to pay much more for comparable services, especially if a device is able to reduce patient recovery times or readmission rates, which can lead to outsized cost savings for the health care provider,” he added in a release from Lux. Point-of-care diagnostics is spawning its fair share of startups COVER STORY Personalized Care Drives Innovation in Medical Product Design and Manufacturing But the more things change, the more they stay the same, as medical device OEMs hold fast to requirements for quality, reliability, and shorter lead times. By Mark Shortt seeking to build a business around, for example, innovative sens- ing technologies that “bring the device to the patient” wherever he or she may be. But even if they’ve been fortunate enough to receive funding to get started, many of the founders of these companies really don’t have a good understanding of what their product ultimately needs to do in the marketplace, said John Zeis, president of the Plastics and Single Use Disposables Business at Foundry Medical Innovations (FMI), a Carlsbad, Calif.-based medical and diagnostics device development firm that provides engineering services and serves as an incubator for cutting edge medical technology. “One of the things that we try to really get our customers to do a good job of, on the front end, is defining what the user’s needs are and really understanding what need we’re servicing,” said Zeis in an interview. “We try to guide them towards ‘What are your user needs and what does this product really need to do?’ as opposed to, ‘Hey, let’s just make this nice gadget that looks cool and can diagnose something on a bread board.” After helping a customer define the user’s needs, FMI will follow the project all the way through to manufacturing. “We can make the molds, and then, once we verify that the parts function Digicom Electronics’ component placement process is geared toward flexibility, fast changeover, quick setup, and excellent accuracy and repeatability. Photo courtesy of Digicom Electronics.
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  • 3. 60 DESIGN-2-PART magazine • February 2015 properly, we’ll find the critical tolerances and dimensions, and critical features and critical functions, and then help spec out potential manufacturers,” Zeis said. “And then we’ll work with those manufacturers to give the product a transition.” Paul DiPerna, president of the Systems Engineering and Incubation businesses at FMI, said that a number of manufactur- ing improvements, including the growing reliance on rapid prototyping and 3D printing technologies, has contributed to “a strong expectation of getting things done faster than ever before.” Because of this, he said, medical device OEMs are looking for companies that have experi- ence in completing projects similar to what they’re trying to accomplish. “I think the expectation of the length of the project has gotten very aggressive,” he said. “A lot of people will come to us because of our prior expertise, and their expectation is to hit the ground running. If you’re working on something in the diabetes space, you want to be sure that the company has done other things in that space. I think that’s a trend, whereas, before, it was more about your specific technical expertise. For now, it’s more about where you’ve been.” Pia Kumar, director of corporate de- velopment for Mayfield Plastics, a custom thermoforming company based in Sutton, Massachusetts, can vouch for medical device OEMs’ reliance on suppliers that have experience in medical manufactur- ing. Mayfield, which recently completed a highly cosmetic, complex, multi-piece housing assembly for a major medical OEM customer, has more than 40 years of experience in the industry. The com- pany has won awards from the Society of Plastics Engineers (SPE) Thermoforming Division in multiple categories, including Best Pressure Formed Parts. “When a new customer comes to us, they want to know that they are working with a company with experience, a com- pany that understands the highly cosmetic and functionally exacting requirements of this market,” said Kumar. “Along with Mayfield’s track record of successfully working with major medical device OEMs, our in-house engineering, design services and tooling are important differentiators for customers.” For more on Mayfield Plastics, see page 96. DiPerna also said that he’s seeing a trend toward more entrepreneurial startups, even among people who are un- employed. “Nowadays, people say, ‘I could get a job, I could do some consulting, or I could start a company. Whereas, 10 years ago, it was pretty unusual for people to talk that way; now, it’s almost everybody. Now that things are improving, there’s a lot more activity in the air.” Wireless Medical Devices Enabling Personalized Healthcare Point-of-care products are part of a rapidly evolving movement in health- care today toward more personalized care—an aim enabled and supported by the pervasive adoption of wireless-based mobile health (mHealth) devices for remote monitoring and assessment. “There are a lot of personalized care products out there that attempt to get information onto your Android or iPhone about everything imagin- able—your weight, your heart rate, what you did, where you were,” said DiPerna. “There’s a lot of this information get- ting to the patient, and there’s a whole medication adherence field that’s begin- ning to evolve. It’s in its infancy, as far as getting people to actually take care of themselves, as well as take their existing
  • 4. 61February 2015 • www.d2pmagazine.com therapies. The whole economics of that is starting to be really understood, and a lot of the changes in the Affordable Care [Act] are motivating people to begin to work in that area. So that’s an area that I see taking off in the next few years.” The Center for Disease Control (CDC) estimates that medication non- adherence—the problem of patients’ not taking their prescriptions—is responsible for adding some $300 billion per year in costs to the United States healthcare system, according to Michael Morena, chief operating officer of AdhereTech, a small startup company in New York City. Morena and AdhereTech CEO Josh Stein started the company two years ago with the aim of bringing to market a smart, wireless pill bottle that electronically reminds patients to take their medica- tions and provides alerts to caregivers if doses are missed. AdhereTech has developed a first generation Smart Pill Bottle that’s cur- rently in trials, and is now working with Intelligent Product Solutions (IPS), a New York-based product design com- pany, to develop the next generation of the product. The second generation of the product, due out in mid-2015, is expected to be smaller, less expensive, and easier to mass manufacture, and to provide additional user enhancements, such as longer battery life, a larger cap, and capacity to hold a higher volume of medication. Morena says that medication non- adherence also represents “about $100 billion a year” in lost revenues for U.S. pharmaceutical companies, while contributing to approximately 100,000 deaths a year. “It’s considered a very large prob- lem in health care, and the way we’re approaching it is we’re developing a cellular, connected smart pill bottle that is distributed to patients for free at the pharmacy, so that we can track their behavior in real time and generate interventions based on their behavior or lack of behavior,” Morena said in an interview. “So when people don’t take their medication, we can detect that in real time and generate a reminder. We can also solicit feedback when people aren’t taking their meds, and find out why. There may be reasons other than forgetfulness. For example, if someone’s dealing with side effects or financial stress as a result of their medication, we can AdhereTech is working with Intelligent Product Solutions, a New York-based product design company, to develop the next generation of its wireless Smart Pill Bottle, which electronically reminds patients to take their medications and provides alerts to caregivers if doses are missed. Photo courtesy of AdhereTech/IPS. detect when they’re not taking it and then provide them that information by connecting them to the right person at the right time.” Dana DeMeo, who has been working directly with AdhereTech as chief techni-
  • 5. 62 DESIGN-2-PART magazine • February 2015 cal officer at Intelligent Product Solutions, calls the AdhereTech Smart Pill Bottle a unique and novel solution. “It’s an intelli- gent pill bottle that has electronics inside, and it’s completely standalone,” DeMeo said. “It has a cellphone radio inside that’s already pre-configured when you receive it. As a patient, there’s really no setup that you have to do. You receive a bottle like you normally would, the prescription’s inside, and the only real dif- ference to you is that it will occasionally beep and light up to remind you when to take it. And that’s really it.” The pill bottle, which requires no syncing or programming, is designed for simplicity because its users—the least adherent patients—are the least likely to buy a product, set it up, and help themselves, Morena said. Rather than trying to sell the product to them, AdhereTech would rather give them the pill bottle. “You don’t have to learn how to use it; you don’t have to worry about how it works, and the reason we make it that way is we want people to benefit from it right off the bat,” Morena said. “We don’t want any friction. It comes with the medication in it; the idea being that when it comes to the patient, they use it no differently than a regular, standard pill bottle. They open and close it like a standard pill bottle; they take pills out of it like a standard pill bottle, and they don’t have to charge it. It can work for up to 90 days on a full charge, where it will actu- ally come to the patient fully charged. The idea is that you get all the benefits without having to do any additional work, and we see that as our unique approach to solving the problem of medication non-adherence.” Mitch Maiman, president of Intelligent Product Solutions, says that wireless medical devices are an emerging product category that IPS is well prepared to handle. “One of the ar- eas where we provide a lot of core competence is in smart and wirelessly connected devices,” said Maiman. “Because of our experience, a lot of us having been ex-Symbol, ex-Motorola people, we have a lot of expertise in wireless communications in all forms—everything from low level things like ZigBee and Bluetooth, and near field, up to Wi-Fi and GPS and wide area radio communications. There’s a lot more things going on, and you’re seeing them all over the place in terms of connected devices. This is an area where we have a lot of competence.” Another consumer electronics trend that’s rolling into the medical space is the increasing preference for wearable devices with monitoring capabilities. Maiman also touts IPS’s capabili- ties in this area. “When you talk about wearable, body mounted and body worn technology, especially when you get into mis- sion critical things, like in the medical space, this is where we have a lot of domain expertise,” Maiman said. “There are a lot of nuances to designing a wearable device that’s reliable, that somebody can wear all day long and all night long, that they can wear in all kinds of conditions—like when it’s 100 degrees outside and 90 percent relative humidity. We’ve got a lot of experience in what it takes to make devices that are reliable over a long period of time, and in wearable devices that work in those kinds of environments. “We’ve worked in medication dispensing systems before and we’ve done work in computer navigation methods for quadriple- gics, who are unable to manipulate a cursor control, but yet they need to interact with a computer,” he continued. “We’re doing work right now on mobile and fixed mounted defibrillators. So it’s a pretty broad range of products, but the common thread is that there’s a lot of electronics, and they’re all smart.”
  • 6. 63February 2015 • www.d2pmagazine.com What to Look for in an Electronics Manufacturing Services Provider Quality, a universal concern across complex product manufacturing market segments, is at the top of every medical device manufacturer’s list of priorities when selecting an electronics manufac- turing services (EMS) provider. But it’s also important to consider the location of the manufacturer, the degree and type of service and support that they provide, and whether or not the person you interact with is a high-level engineer, according to a white paper recently released by Oakland, California-based Digicom Electronics. The white paper, “What Medical Device Companies Need to Consider in Selecting an EMS Company,” was co-authored by Digicom executives Mo Ohady, general manager, and David Estes, engineering specialist. “Although most EMS companies per- form the same basic services, every EMS is different,” explained Ohady in a release from Digicom Electronics. “You can tell when you walk into a place, examine the equipment and processes, and speak to the people. It’s important to use due diligence in choosing an EMS company, but the rewards can be great. A properly functioning EMS brings decades of experi- ence and knowledge to embrace and en- hance the product you want to build in a time-efficient and cost-effective manner.” A big part of choosing a supplier in- volves deciding if you want your product to be manufactured close to where your company is located, or close to where the product will be distributed or sold, say Ohady and Estes. Factors to consider when weighing the location of a supplier include the complexity of the device, the need for intellectual property protection, shipping costs and time, and the degree of supplier involvement that you’ll expect throughout the manufacturing process. Manufacturing at a great distance from home—say, the other side of the world—can become a problem when a production issue arises, Estes said in a phone interview. “If you need to travel there to resolve the problem because the expertise to do that just doesn’t exist at that location, then you’re looking at maybe a $20,000 trip to travel overseas, and the delays that that introduces. And so being local allows a very quick response to resolve an issue and get on with production.” Digicom, because of its location in the San Francisco Bay area, offers a special ad- vantage to local OEMs. “We are certified to California standards, and so when you’re building medical devices in California, we are approved of,” Ohady said. “We are registered with the FDA; that addresses the U.S. built devices and those that are distributed throughout the United States. And the ISO 13485 [certification] tops it by addressing most of the rest of the world’s regulatory issues and compliance.” Ohady got to know his colleague, Da- vid Estes, when Estes was once a potential customer of Digicom. At the time, Estes was doing considerable research as part of the process of selecting a manufac- turer for a product that he was helping to develop. “He has a very rich level of experience,” Ohady said. “I can say, from a device manufacturer point of view, that selecting a manufac- turer when one has little manufacturing experience is really daunting,” said Estes. “It’s very much like going out to buy a car when you really haven’t driven a car; you don’t have that experience. And so it’s critical that you select a manufacturer
  • 7. that’s willing to accommodate your lack of knowledge and exper- tise. It almost is like an educational process that occurs between the manufacturer and the company. “If the manufacturer is very large and is used to working with very large companies that have a lot of experience, they may feel it’s a burden to take on this chore of educating and working with a customer that’s new to manufacturing,” he continued. “The advantage for the manufacturer, though, is that it’s a potential win-win because as one learns new products and overcomes new problems, this becomes part of the repertoire of the manufac- turer. And so the manufacturer can actually gain expertise in new technology by working with new companies.” Digicom marketing representative Andrea Roberts said it’s important to work with an experienced engineer who can look at your boards, box builds, or devices and tell you if your design is going to work—that is, whether it can be manufactured. During the prototype phase, experienced engineers can provide ideas about better ways to manufacture the product, she said. Later, when you want to build the product in volume, they can tell you if the prototype can be transferred to volume manufacturing. “There’s a whole lot that goes into it—the sourcing and the whole picture of Design for Manufacturability,” she said. “And that’s why you really need an engineer to work with you, to see if that design can actually become a reality.” Quality is much more of a concern with medical devices because poor quality can directly affect safety and lead to fatal consequences. It’s important to know what types of inspection and tests are performed by an EMS provider, whether they have tracking mechanisms in place, and how clean their printed circuit boards are, said Ohady. That’s because quality is directly related to the cleanliness of the boards, an issue that Digicom addresses in its white paper, “Cleanliness of PCB Assemblies Leads to Medi- cal Device Reliability.” In the paper, Ohady and Estes discuss the important role that cleanliness of electronic components and circuit boards play in preventing component failure, as well as the benefits of the company’s Diamond Track Cleaning Process. The process, part of the company’s Diamond Track Manufacturing program, employs a proprietary combination of chemicals, temperature, wash cycles, and timing to render circuit boards extremely clean and includes stringent test and evaluation procedures. “Independent tests showed that boards that went through this [Diamond Track] cleaning process tested 75 percent cleaner than the 10-2 micrograms/in2 specified by IPC as its highest level of clean,” they wrote. “In addition, a lab analysis for ion contamina- tion found zero levels of sodium chloride ion contamination on the assembled boards.” (The IPC is a global trade association that serves the printed board and electronics assembly industries.) The level of cleaning attainable by the Diamond Track process is said to eliminate failures caused by board contamination and make products less susceptible to corrosion-induced failures, reducing the need for maintenance or repair. Medical device manufacturers that use the process can realize significant cost savings as a result, according to Ohady and Estes. “When we’re looking at the devices now being made for the medical device industry, including all the wireless and implant-
  • 8. able devices, it is time to take a new look at cleanliness standards and the processes used in manufacturing to ensure that these products do not fail,” they wrote. 3D Printed Patient-Specific Implants Wireless medical devices aren’t the only technology that’s facilitating the trend toward personalized healthcare. Another key enabler—one that’s providing some of the most impressive examples of customization—is 3D printing, now being used to produce patient-specific implants for reconstructive surgeries of the skull, face, jaw, spine, hip, knee, foot, and ankle. But although 3D printing is the most visible step in a process that reduces lead times, it’s actually part of a larger digital thread that begins with a medical imaging study—usually a CT scan or MRI—of the patient’s anatomy. The digital thread includes, among others, a medical image processing step that builds up a 3D model of the anatomy from the 2.5D representations of the imaging study. It’s that 3D model of the patient’s unique anatomy that becomes the basis for 3D printing of a personalized implant. One of the more interesting companies in the space is 4WEB Medical, an implant device company headquartered in Frisco, Texas, that is reported to be the first company to receive FDA clearance for an additive-manufactured spine implant. Founded by company president Jessee Hunt, 4WEB Medical has combined the novel 4WEB geometry—a building block for creating high- strength, lightweight web structures—with leading edge 3D printing to develop a proprietary implant platform. Surgeons have implanted more than 3,000 of the company’s 3D printed, orthopedic t r u s s i m - plants, which are designed with a dis- tinctive open architecture that report- edly allows for up to 75 percent of the implant to be filled with graft material to maximize the incorpo- ration of bone. The 3D printed implants also have a unique, roughened surface texture that is said to promote bone adher- ence and, by increasing coefficient of friction, reduce the pos- sibility that the implant will move from its original position. Other companies that have achieved prominence in patient- specific 3D printing include ConforMIS, developers of a propri- etary iFit Image-to-Implant® Process (see page 68), 3D Systems– Medical Modeling, known for its role in integrating 3D printing into a comprehensive digital thread for personalized medical implants and surgery, and Oxford Performance Materials, a spe- cialist in the high performance polymer, PEKK, that has received 4WEB Medical recently announced that surgeons have implanted over 3,000 of the company’s 3D printed orthopedic truss implants. Photo courtesy of 4WEB Medical.
  • 9. 66 DESIGN-2-PART magazine • February 2015 FDA clearance for the manufacture of patient-specific cranial and facial implants (see pp. 71, 124, and 150). Another company, veteran-owned Osiris Biomed 3D, is preparing to offer 3D printed, patient-specific implants that it believes can further reduce lead times to surgery. The company’s proprietary software is expected to facilitate real-time production of customized implants from patients’ medical scans. If approved by the FDA, the technology reportedly will en- able surgeons to design and print custom implants for immediate use in surgery. Osiris Biomed 3D has applied for a patent for “single anesthetic reconstruc- tive surgery,” which, the company says, will allow a patient to be scanned and a custom device or implant printed, sterilized, and surgically implanted “on the operating table,” all in one surgical procedure. The company is preparing a highly mobile 3D printing CONEX (contingency employ- ment exercise) for the military that can establish operating suites in a theater of operations, reducing time to surgery for wounded soldiers. In a phone interview, Chief Operating Officer Christopher Gerstle said that the company will be initially using an FDM (Fused Deposition Modeling) process to ensure that, when starting to build an implant, the build chamber is sterile and contains no material from a previ- ous build. “You’re extruding at very high temperatures, which are sterile, and what I refer to as the ‘nest within the box’ is much more controllable at this point. So it (FDM) is a good first step for us.” Quick Response Manufacturing Cuts Lead Times for Medical Device OEMs Gordon Knott had just gotten back fromtheMD&MshowinSchaumburg,Illi- nois,lastfallwhenweaskedhimwhattypes of things the medical device manufactur- ers who visited his booth wanted to know about Alexandria Industries’ capabilities for meeting their needs and solving their engineering problems. “The manufacturers we met with asked about our lead times,” said Knott, the medical market leader for Alexandria Industries, a vertically integrated supplier of engineered, customized aluminum ex- trusions, as well as precision machining, plastics molding, finishing, welding, and assembly services. “Because we use Quick Response Manufacturing (QRM), we are able to offer some of the shortest lead times in the industry, enabling us to com- pete well with other suppliers.” Quick Response Manufacturing, used to cut lead times in all phases of manu- facturing and office operations, allows Alexandria to focus on the continuous improvements of eliminating non-value- addedwaste,improvingquality,andreduc- ing cost. Since implementing QRM, the company has reduced quote times from 12 days to three-to-five days, and extrusion product lead times from 30 days to as little as five days, Knott said. Significantly, QRM has given Alexandria the opportunity to gain a substantial foothold in markets, including medical, that value short lead times. Medical is one of Alexandria’s prime markets, accounting for “about 13 to 15 percent” of its total sales, said Patty Hoffman, the company’s marketing and communications specialist, in an interview with D2P. “It’s not our biggest market, but it’s definitely one of our larger ones, so it’s a significant industry for us.” That’s not surprising, given the company’s loca- tion in Minnesota, one of the nation’s top states for medical device innovation, and its proximity to a thriving medtech hub— Minneapolis/St. Paul—a little more than
  • 10. 67February 2015 • www.d2pmagazine.com 130 miles to the southeast on Interstate 94. Alexandriamanufacturesawidevariety of components for the medical industry, including components for durable and electro-medical equipment. This includes structural components for mobile or stationary diagnostic equipment, moni- tors, heat sinks, IV poles, medical carts, structural equipment, X-ray systems, and CT systems, among others. Knott said that all of Alexandria’s manufacturing capabili- ties are well-suited to address the product development needs of its medical industry customers, but customers typically choose the company’s aluminum extrusion, preci- sion machining, and welding services. Having partnered with a number of local medical device makers, Alexandria Industries has developed a good un- derstanding of some of the biggest con- cerns that medical device manufacturers have—and the constraints that they’re up against—when attempting to bring a medicalproducttomarket.Otherthanthe high cost of bringing a product to market, medicaldeviceOEMsstrugglewithmanag- ing their supply base and making sure that their products are safe to use, Knott said. “Medical OEMs often need to manage hundreds of suppliers, which is costly and time-consuming,” he explained. “Add to this the increasing trend in mega-mergers and acquisitions, and an OEM’s supply basecandoubleortriple.Themoresuppli- ers, the more time, money, and significant effort it takes to evaluate, qualify, and keep a supplier list held to a manageable level. “Product safety is also a top concern for medical device OEMs,” he continued. “Many medical products have movable parts that interface directly with patients, and anything that could potentially cause harm—pinch, stab, or tip over on a pa- tient—needs to be addressed. Medical device manufacturers need to make sure their suppliers know which parts and com- ponent dimensions are essential to patient safety and function. They will require that suppliers identify dimensions that are es- sential to safety.” Alexandria’s ability to operate as a one-stop component shop—a vertically in- tegrated supplier that offers OEMs a single source to design, produce, assemble, and deliver a range of components—has direct and positive implications for both cost and lead time, two of the foremost concerns that medical device companies have when bringing a product to market. Medical device OEMs who outsource component manufacturingfrommultiple—often,hun- dreds—of suppliers face stiff challenges in managing these complex relationships and purchasing processes, which can take a heavy financial and logistical toll on their resources. This ultimately slows product time to market and drives up the cost for the company. “Instead of interacting with several different suppliers, OEMs should find a supplier who can help simplify their supply chain needs by offering a range of complementary manufacturing services so they can do more of the work for them,” Knott said. “OEMs should seek a supplier who also offers value-added services, such as design engineering assistance and ad- vanced geometric dimensional accuracy, to help reduce their time to market even more.” Executingonitsvisionofbeingasingle source, vertically-integrated supplier of “high quality, short lead-time engineered products,” Alexandria Industries acquired the plastic injection equipment assets of a North Dakota-based manufacturer of injection molded components in 2012. These assets, as well as TIG and MIG weld- ing services, were rolled into Alexandria’s Wheaton, Minn., facility. Knott also stressed the importance of evaluating suppliers based on total-cost- of-purchasing criteria instead of the cost of the parts. That’s why it’s important to seek suppliers that combine their manu- facturing expertise with value-added ser- vices like ease of purchasing, engineering assistance, finishing, and assembly, he said. For more on Alexandria Industries, see page 74.