ARSENAL PRODUCTS PRESENTS THE SEVEN ......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

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

https://www.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.


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



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


REASO

N 03 | Red

uce Labo

r Co

sts



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


REASO

N 04 | B

ridg

e the Skills Gap



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


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


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




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


REASO

N 07 | Yo

u Can’t A

fford

No

t to A

utom

ate



REFERENCES

1. https://ifr.org/img/office/IFR_The_Impact_of_Robots_on_Employment.pdf

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19. http://www.asse.org/bosc-article-6/

20. https://www.forbes.com/sites/jimlawton/2017/09/21/in-the-race-to-advance-manufacturing-chinas-betting-on-robots/#6db7c1c078cd


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https://www.amazon.com/p/feature/98dnmkwyztuv8ur

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http://www.asse.org/bosc

https://www.forbes.com/sites/jimlawton/2017/09/21/in

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Documents

ARSENAL PRODUCTS PRESENTS THE SEVEN ......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