arsenal products presents the seven ......money toward a repeatable process that can be validated...
TRANSCRIPT
A R S E N A L P R O D U C T S P R E S E N T S
THE SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICE MANUFACTURING
CONTENT
Introduction
Reason 1: Increased Labor Productivity
Reason 2: Improve Device Quality
Reason 3: Reduce Labor Costs
Reason 4: Bridge the Skills Gap
01
02
04
06
Reason 5: Improve Worker Safety
Reason 6: Perform Difficult Processes that Can’t be Done Manually
Reason 7: You Can’t Afford Not to Automate
08
10
12
14
INTRODUCTIONWhile much of the world is moving toward automating
manufacturing processes to remain competitive and re-
duce manufacturing costs, the medical device industry has
been slow to adopt new automation technologies. Today,
the cost of automation and robotics continues to plummet
and medical devices that have been traditionally assem-
bled by hand in low-to-medium volumes (1,000-10,000
units per month) are now ideal candidates for added auto-
mation to increase device margins and throughput.
Why should medical device manufacturers consider automated technologies?
Here are 7 reasons.
01SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
For the past few years, the media has painted
a dismal picture of robotics and automation,
claiming that robots are to blame for sweeping
job losses. While this makes for catchy headlines
intended to attract readers, the reality is that au-
tomation leads to increased productivity of man-
ufacturing workers. More productivity leads to
greater profit and growth. More growth means
more capital deployed and more jobs created.
An April 2017 study called “The Impact of Robots
on Productivity, Employment and Jobs,” by the
International Federation of Robotics, cited that
the “greatest threat to employment is not auto-
mation but an inability to remain competitive.” It
is likely that the companies most at risk for losing
workers are those that become stagnant1 and
can’t remain competitive in the marketplace. The
companies remaining competitive and continu-
ing to grow are actively seeking automation to
make their operations more productive.
The doom and gloom surrounding automation
is misguided in assuming new technologies only
eliminate jobs and fails to account for the addi-
tional jobs created as a result of the emergence
INCREASE LABOR PRODUCTIVITY
of entirely new industries.2 In May of 2017, Jeff
Burnstein, President of the Robotic Industries
Association, gave a presentation at the Kuka
Robotics Annual System Partner Summit. Based
on data collected from the Bureau of Labor and
their own robotic shipment data, the Robotic
Industries Association shows that as robot ship-
ments continue to rise, so do manufacturing
jobs.
Take a common low-to-medium volume med-
ical device assembly clean room. When we
peer into the cleanroom, we typically see op-
erator-attended work cells where devices are
assembled by hand and moved from station to
station. In order to decrease device costs and
increase yield, the solution is automation. But,
automation doesn’t necessarily mean a fully ro-
botic manufacturing line with ultra-fast convey-
02
More Robots. More Jobs.In the United States, from 2010 to 2016:
Sources: US Bureau of Labor Statistics and Robitics Industries Association
New Robot Shipments+136,748Manufacturing Jobs+894,000Unemployment RateDecreased 5.9%
ors shuttling devices at lightning speed. Instead,
an operation would be automated with a series
of individual, tabletop-sized, mechanized tools
with operators loading components to automate
the critical processes down the line. By introduc-
ing individual workstations for adhesive dispens-
ing, curing, cutting, trimming, crimping, forming,
or any other number of actions, we can develop
precise and repeatable individual work cells to
reduce human error and increase productivity.
SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
01
REASO
N 01 | Increase Lab
or Pro
ductivity
USING A 3-AXIS DISPENSING ROBOT FOR ACCURATE PLACEMENT OF TWO-PART EPOXY
PROBLEM A two-part epoxy is applied between
two components and the resulting ep-
oxy bead is inconsistent and not precise
enough to meet specification. The oper-
ator must spend half of his time apply-
ing epoxy and half of his time wiping off
excess epoxy to meet specification. As a
result, the operator has two visual inspec-
tions: one inspection to determine if ex-
cess expoxy needs to be removed, and
one to ensure that excess epoxy is com-
pletely removed.
OUR SOLUTIONBy utilizing a 3-axis robot with integrat-
ed vision and dispensing systems we are
able to accurately place the epoxy within
the required tolerances. Now, the opera-
tor is only required to wipe excess epoxy
from the assembly 5% of the time.
THE RESULTSThe process has an approximate time sav-
ings of 45% per device, leading to nearly
double the throughput. The operator is
now available to pre-mix and pre-load
syringes of epoxy while the machine is
running. Where previously the process
stopped production of units to mix the
epoxy once every thirty minutes, now the
operator is free to mix while the machine
is running.
Quality costs decrease as downstream pro-
cesses see less fallout due to a more con-
sistent bead of epoxy. The wiping of the
epoxy can lead to variable results. Reduc-
ing the variability reduces the downstream
scrap rate.
03SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 01 | Increased
Labo
r Prod
uctivity
When we view the effect of automation over the
past several years, we see that instead of leading
to significant job loss as was predicted, automa-
tion actually caused an employment boom and
the creation of entire new industries.
2014
2015
2016
2017
Sources: New York Times, QZ.com, Business Insider, Seattle Times, Statista.com, Amazon. See References 3-15 in Index.
CASE STUDY
Our experience developing tooling has shown
that implementing automation to solve a prod-
uct quality issue typically makes for the fastest
return on investment (ROI) over any other au-
tomation solution. The main reason for repeat
quality problems is a design that was rushed into
production. By skipping over the design for man-
ufacturability process it increases the difficulty
and cost to create a properly validated process.
Once a medical device is in production most
companies are hesitant to change the process
due to regulatory issues and the time and cost
associated with re-validating the process. As a
result, many companies slowly limp along with
nagging problems believing “the next lot will be
better.”
While quality issues sometimes present them-
selves as continuous lingering problems, a qual-
ity issue can also result in the sudden loss of an
entire lot of product. Hopefully, a quality issue is
found at the process step responsible for caus-
ing the problem. It is less desirable is when the
problem is found at final assembly or lot release.
The worst case scenario is when a problem is
found in the field and leads to a recall.
It is often hard to take a step back from a linger-
ing quality problem. A series of small fixes may
have been put in place to help solve the prob-
lem but until the root cause is flushed out it will
continue to absorb time, money, and morale.
Making an effort to invest the time to evaluate
automation options to perform these difficult
operations will have large payoffs later.
There are several reasons to utilize automated
tooling to perform difficult operations in a pre-
cise and repeatable manner. Some of the issues
surrounding quality are easy to quantify and
calculate, but many are a bit more subjective
but no less important.
DEVICE YIELD
Calculating your current yield loss and evaluat-
ing the cost of the lost units will probably be
shocking the first time it is calculated. Putting
money toward a repeatable process that can
be validated and have a high first pass yield
will have a rapid ROI and immediate savings.
Reduced yield loss is an easy way to justify the
upfront capital costs of automated tooling with
a simple calculation.
ENGINEERING COST OF QUALITYAt one company we kept track of hours that went
into Non-Conformance Reports (NCR’s) for failed
components and assembly processes. After a few
months, we were surprised to find that our average
NCR cost $5,000 of engineering and operator time
with meetings, paper work, and material disposi-
tion.
In addition to draining the energy from your opera-
tions, a quality problem can also:
1. Stop the flow of materials at receiving and in-
coming inspection for all materials, including
other non-affected products, as operators
are tied up with handling unexpected issues
2. Interrupt production schedules affecting de-
livery dates
3. Require additional engineering and manage-
ment input for initial review, discussion, and
material disposition
4. Lead to further quality costs (like CAPAs) re-
quiring additional engineering input and fur-
ther operational disruption
5. Create a poor work environment and act as a
02 IMPROVE DEVICE QUALITY
04 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 02 | Im
pro
ve Device Q
uality
05SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
catalyst for employees to seek employment
elsewhere
Knowing the cost of continuous paperwork churn
related to poorly performing processes will also
provide for additional justification of automated
tooling. Raising the first pass yield with automated
tooling will reduce your recurring quality engineer-
ing costs and make the engineers assigned to sort
out non-conformances much happier.
CUSTOMER PERCEPTION OF YOUR COMPANY
Your sales reps in the field are the face of your com-
pany and they want to be able to stand in front of
the customer knowing they have the best oppor-
tunities possible to sell the devices you are manu-
facturing.
Constant, perpetual quality problems or multiple
single quality events can cause your reps to ratio-
nalize the company’s manufacturing choices with
the customer.
They can’t sell well if they can’t trust the product.
Developing reliable automated processes that can
be validated can build the trust they need to in-
crease sales and brand awareness through a dedi-
cation to the highest level of quality.
FEWER COMPLAINTS TO MANAGEThe complaints process for medical device man-
ufacturers can be a tedious and costly exercise.
Developing the proper validated processes can
help reduce complaints in the field and reduce the
overhead required to manage the complaints pro-
cesses. In addition, fewer complaints mean fewer
returned devices to be processed, which also re-
duces overhead and minimizes employee contact
with contaminated, used devices.
As a process is scaling, more workers are re-
quired to ramp up production. But, by using
the appropriate automated processes, scaling
manufacturing can be done by adding addition-
al equipment with a rapid ROI. This reduces the
carrying costs of additional labor and leads to
more profitability and growth.
For medical device companies reliant on oper-
ators for assembly and component processing,
adding a mechanized or automated process can
allow for scalability without the need to add ad-
ditional operators or additional shifts. If a device
can be manufactured with five employees on a
single shift, but additional throughput is needed,
automated tooling can be implemented to re-
duce takt time and gain the additional through-
put. It is often achievable to develop an auto-
mated process that can double the throughput
while also achieving an ROI within a year.
03 REDUCE LABOR COSTS
06 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 03 | Red
uce Labo
r Co
sts
07SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
USING A COMBINED ROBOTIC AND ADHESIVE DISPENSING ROBOT TO DOUBLE THROUGHPUT WHILE REDUCING THE NUMBER OF WORKSTATIONS
PROBLEM When planning for a new manufacturing line, the initial
process called for five operators to perform five separate
adhesive/soldering operations with nine separate pieces of
equipment (three EFD dispensers, three UV cure systems,
and three soldering systems).
Initially, we worked up a proposal as the customer request-
ed: using five separate dedicated workstations to complete
each operation manually. After we met the customer’s re-
quest, we also proposed a second, automated solution.
OUR SOLUTION
For less than the cost of five complete stations, we were
able to propose a solution to utilize a combined robotic
and adhesive dispensing robot to perform all operations
by a single operator at a single station. The robot utilized
a five-station rotary that allowed the operator to perform
each operation in series and utilize a single soldering tool,
single adhesive dispensing system, and a single UV cure
system.
In addition, with the precision and repeatability that the ro-
bot offered, we could shift to fully automated soldering, dis-
pensing, and curing systems to make a far more repeatable
process. By adding less, but higher accuracy equipment, we
also made the process much easier to validate.
The automatic soldering system included an auto-feed, pro-
grammable solder head that applied a known amount of heat
and solder for a known period of time. The dispensing sys-
tems allowed for accurate placement of adhesive in a known
volume. And the UV cure system applied the correct wave-
length of LED light at a known and repeatable distance and
length of time.
RESULTS The ROI on this system became far more attractive than the
five station, completely manual line. Future labor costs were
reduced and throughput was doubled by adding one or two
shifts with one operator each. This eliminated the need to
hire and train five, ten or fifteen people for each shift.
a
CASE STUDY
REASO
N 03 | Red
uce Labo
r Co
sts
05
There is a labor shortage in the United States for
manufacturing workers. To stay competitive in
a global economy American manufacturers are
going to need to leverage technology to bridge
that gap.
Right here in Austin, Texas, there aren’t enough
qualified workers to perform manufacturing jobs.
In a 2017 survey, the Austin Regional Manufactur-
ing Association (ARMA) cited that 93% of Austin
manufacturing companies couldn’t find qualified
workers.16 This puts a huge burden on compa-
nies that have to undergo the cost of training un-
der-qualified workers and then increase salaries
to retain those workers. When considering the
training and retention costs it very quickly makes
sense to offset the skills gap with automation.
The skills gap will be felt by medical device
companies manufacturing devices in the United
States as well as Mexico, Costa Rica, or Puerto
Rico. Companies manufacturing devices domes-
tically will be continually squeezed by investors
to lower operating costs and increase device
margins. Moving toward automation in North
America will help offset the cost to find, train,
and retain workers.
Medical device companies with plans to trans-
fer a device manufacturing line outside of the
U.S., where skilled labor is in even shorter sup-
ply, will also have to handle additional quality
issues as a result of transferring to a remote off-
shore location. The resulting quality costs that
arise from transferring a manual process over-
seas can quickly become overwhelming. Care
taken upfront to automate or mechanize high
skill operations can lead to significant quality
cost reductions that are not prone to operator
variability. Many times a delicate operation has
been performed in the U.S. by the same oper-
ator for many years. After transferring a pro-
cess, quality issues arise when a new operator
doesn’t have quite the same technique as the
original operator.
The non-profit, Reshoring Initiative, published
in their 2017 report that in a 2010-2016 survey
of companies, the numer one reason listed for
moving manufacturing operations back to the
United States was quality issues.17 Product qual-
ity costs need to be considered and accounted
for in the ROI of a tooling purchase.
04 BRIDGE THE SKILLS GAP
08 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 04 | B
ridg
e the Skills Gap
09SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
The skills gap in the united States is huge.
By 2025,3.4 million manufacturing jobs will be needed
Only 1.4 million jobs will be filled
Leaving 2.0 million manufacturingjobs unfilled
REASO
N 04 | B
ridg
e the Skills Gap
05
There is no doubt that there are many inherent
risks to worker safety in manufacturing oper-
ations. There may be health implications to a
variety of workplace hazards, including repeti-
tive tasks, heavy lifting, chemical exposure, and
operating machinery. There are widespread ac-
counts of shoulder issues from manual drilling in
the aerospace industry, carpal tunnel from small,
intricate assembly tasks, and depression for tech-
nicians subjected to monotonous, routine jobs.
Heavy lifting is common in larger scale manufac-
turing like the automotive and aerospace indus-
tries, but it can also be a factor in smaller scale
manufacturing around the warehouse. Moving
raw materials and finished pallets or manipulat-
ing other heavy objects are all operations that
create potential for injury.
Manufacturing workers are twice as likely to
have on-the-job injuries and four times as likely
as office workers to miss days of work due to
injury. In addition, the median days away from
work due to a manufacturing injury is ten days.
Not only does this lead to higher labor costs,
but the burden of workers compensation insur-
ance is twice as expensive as the average of all
other occupations.18
While many of these statistics are geared toward
heavier manufacturing processes, cleanroom as-
sembly of medical devices is not without risk.
As medical device manufacturers consider the
cost of tooling and what can be perceived as ex-
tra costs for safety measures (like light curtains or
area scanners to keep workers safe) they should
consider that the indirect costs of a workplace
05 IMPROVE WORKER SAFETY
10 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 05 | Im
pro
ve Wo
rker Safety Potential Health Risks for Medical Device Manufacturers
OPERATION POTENTIAL HAZARDS AUTOMATED SOLUTIONSINTRICATE ASSEMBLY OF SMALL COMPONENTS
• Carpal tunnel syndrome• Neck and back strain
• Auto feeding and automated assembly of small components • High magnification cameras with large displays for proper operator comfort and less strain
HEAVY LIFTING IN SHIPPING, RECEIVING AND WAREHOUSING
• Back injuries • Neck and back strain
• AGVs for lifting and transporting pallets, racks, and carts• Pallet lifting systems for storage• Robotic pick and place machines for packing and palletizing boxes of finished goods
CATHETER CUTTING, TRIMMING, AND SKIVING
• Injuries from use of sharp blades • Injuries from replacement or maintenance of cutting tools
• Automatic cutting operations that allow an operator to load components to a nest and require both hands to activate tool, keeping hands free of sharp objects• Automatic replacement of sharp objects within tooling at specified maintenance intervals
GRINDING, DEBURRING, AND POLISHING ORTHOPEDIC IMPLANTS
• Contact with large rotating belts and wheels• Strain injuries from repetitive motion • Inhalation hazards of dust and processing chemicals
• 6-axis robotic arms that prevent operator contact with large rotating equipment, apply repeatable and known forces for processing operations, and separate the operators from grinding dust and polishing compounds
SMALL COMPONENT FORMING
• Moving components of forming punch/die tools
• Robotic loading of components• Light curtains to prevent contact with moving tool components• Dual push button activation to eliminate operator contact by punch/die tool
injury are 20 times higher than cost of the injury
itself. A $500 trip to the emergency room to get
stitches for an injury from a cutting blade will ac-
tually cost the company $10,000 in “training and
compensating replacement workers; repairing
damaged property; accident investigation and
implementation of corrective action; schedul-
ing delays and lost productivity; administrative
expense; low employee morale and increased
absenteeism; poor customer and community re-
lations.”19
11SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
CONTACT WITH OBJECT
OVEREXERTION
SLIPS, TRIPS,
AND FALLS
REPETITIVE MOTION
OTHER
CONTACT WITH HARMFUL
SUBSTANCES
40%
24%
19%
8%
3%6%
Top 5 Sources of Injury
114,327TOTAL NUMBER OF INJURIES
Sources: 50% & Key Concern = Travelers IndustryEdge Survey 2012; 38% = Bureau of Labor Safety Statistics 2011; Injuries - National Safety Council Injury Facts 2013 Edition.
REASO
N 05 | Im
pro
ve Wo
rker Safety
There are many examples of operations that are
better suited to automated tools to ensure the
consistency and precision needed for a validat-
ed process. Applying adhesives, laser welding,
torqueing screws, complicated high magnifica-
tion inspections, and soldering are a few pro-
cesses that can benefit from automated tooling.
When processes are dependent on operators to
perform a full range of motion, apply a minimum
force, rely on visual feedback for complicated
operations, or dispense a known amount of
fluid, the cost to ensure a device will function
properly in the field tends to increase. More in-
line inspections may be required or a lot release
test may be necessary to ensure the product
functions properly. It is often difficult to validate
a process that is so dependent on these types
of operator inputs.
Difficult processing operations are challenging
to quantify during initial device development
and there is usually not enough time spent on
process development to ensure a proper vali-
dation. Engaging with an experienced tooling
integrator early in the process to identify and
solve any issues that are difficult to accomplish
manually will save significant time, money, and
frustration once the product is released.
06 PERFORM DIFFICULT PROCESSES THAT CANNOT BE DONE MANUALLY
REASO
N 06 | Perfo
rm D
ifficult Processes that C
annot b
e Do
ne Manually
12 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
13SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
ROBOTIC DIPPING: ACHIEVING A CONSISTENT SWIRL
PROBLEM A contract device manufacturer had a process in place for
many years making a dipped silicone component. Over
time as the sales of the device grew, shifts were added until
the units were made 24 hours a day. The manufacturer had
poor yields (70%) that were overcome until now by making
as many components as possible. By running three shifts at
a 70% yield they were able to deliver all the components
necessary. However, as sales continued to grow they finally
reached a point where they had to add additional capacity
to meet demand.
OUR SOLUTIONAlready experienced with dipped dispersion manufactur-
ing, we were able to propose fresh ideas to increase the
throughput of the device along with methods to signifi-
cantly increase the yield of the device.
With a 6-axis robot we were able to triple the throughput of
the component and reduce the operation from three shifts
to two. The articulated motion of the robot arm performed
the slow entry, proper swirl motion, and returned the man-
drels back to a vertical position which lead to a more con-
sistent wall thickness.
A racking system populated with the proper number of man-
drels ensured that the mandrels received the correct amount
of devolatilization time between each of the three dipping
cycles. The proper number of racks also allowed for the prop-
er timing to allow the robot to dip continuously. This eliminat-
ed operator errors due to manual labeling of the current dip
cycle and incorrect wall thicknesses to be discovered later in
the process due to an incorrect number of dips.
A viscometer regularly monitored the viscosity of the disper-
sion and could add additional solvent when necessary. This,
combined with a lid over the dispersion that remained sealed
for 95% of the dipping process, led to a more consistent vis-
cosity of the dispersion throughout the day and ultimately a
consistent wall thickness. Yield moved from 70% to 82%.
RESULTS With the combination of the labor savings of moving from
three shifts to two, quality savings from fewer NCRs and
significantly less scrap, and increased sales due to higher
throughput and more saleable units, we were able to provide
an ROI in 4 months (months, not years!) for a full robotic dip-
ping solution.
CASE STUDY
As medical device manufacturers consider op-
tions to increase margins and improve device
quality, it is often difficult to truly value and as-
sess the ROI for aspects that are out of your
direct control, and thus, are not accounted for.
There are a few items to consider when evaluat-
ing the return on an automation project:
OVERSEAS MANUFACTURING WILL GET
CHEAPER
Overseas manufacturing will continue to be-
come cheaper over time. Foreign companies
are leading the charge in the development and
implementation of robotics and automation. The
Chinese government announced their “Made in
China 2025” plan, where they intend to build,
buy, and put robots to work. China acquired
75,000 robots in 2015, installed 90,000 new ro-
bots in 2016, and plans to develop the technol-
ogy to build 100,000 more robots by 2020. The
Chinese have recognized that their quality stan-
dards must increase and they see robotics as
the pathway to reach those higher quality stan-
dards.20
YOUR COMPETITORS ARE AUTOMATING
As the price of robotics and automation con-
tinues to drastically decrease, more and more
medical device manufacturers will rely on auto-
mated assembly techniques that will become
the future standard. Your U.S. based compet-
itors will continue to look for ways to reduce
costs and become more profitable by imple-
menting these techniques. Not following suit
will leave you scrambling to catch up.
CASH ON THE TABLE
Right now, you are likely leaving money on the
table by not getting started with automation.
Robot and automation costs continue to plum-
met and by not taking advantage of and acting
on strong, rapid ROIs for automated tooling,
your future growth opportunities will be limited.
LEVERAGE TECHNOLOGY
There is value in leveraging the implementa-
tion of new technologies and associating your
brand with high tech manufacturing processes.
Customers will see this as an investment in qual-
ity and efficiency and employees will feel proud
to be part of a high tech, growth-oriented com-
pany.
07 YOU CAN’T AFFORD NOT TO AUTOMATE
14 SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
REASO
N 07 | Yo
u Can’t A
fford
No
t to A
utom
ate
15SEVEN BENEFITS OF AUTOMATING MEDICAL DEVICES | ARSENALPRODUCTS.COM
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