Thermoplastic Color Development, Control, and Change...

Thermoplastic

Color Development,

Control, and Change

Management for

Medical Devices

Copyright © RTP Company Page 1 of 13

Thermoplastic Color Development, Control, and Change

Management for Medical Devices

Abstract – Medical devices with plastic components may be required to pass biologic testing,

may be scrutinized for drug interaction, and may need to meet stringent branding requirements

of the manufacturer. This paper provides a technical view as it relates to selecting color for use

in medical devices, guidance on current regulations, plastic formula selection, color control and

change management.

Josh Blackmore

Global Healthcare Manger

Mike Chappell

Color & Additive Marketing Specialist

RTP Company, 580 E. Front St., Winona, Minnesota, USA

Telephone: +1 (507) 454-6900, Internet: www.rtpcompany.com

Table of Contents

I. Importance of Color in Medical Devices ................................................................................................... 2

II. Color Development Criteria for Medical Devices.................................................................................... 2

Medical Devices with Patient Body Contact ............................................................................................ 3

Medical Device Classification .................................................................................................................. 3

Biocompatibility Testing Definitions ........................................................................................................ 5

Medical Devices used for Drug Delivery with Patient and/or Drug Contact ............................................ 5

III. Plastic Formulation Selection, Control and Change Management ......................................................... 5

Color Control for Medical Devices ........................................................................................................... 6

Sterilization Techniques Effect on Color .................................................................................................. 7

IV. Formulation Change Control .................................................................................................................. 8

Measuring Change Using Fourier Transform Infrared Spectroscopy (FTIR)........................................... 8

Formulation Change Management ............................................................................................................ 9

V. Special Effects and Value-Added Options ............................................................................................... 9

Antimicrobial: Value-Added, Masterbatch, and Precolor Technology................................................... 10

VI. Summary and Conclusions ................................................................................................................... 10

VII. References ........................................................................................................................................... 12

VIII. Appendix ............................................................................................................................................ 12

Additional Resources .............................................................................................................................. 12

Selection Check List for Evaluation of Color Compounders for Medical Devices ............................... 13


I. Importance of Color in Medical

Devices

Color is an integral part of our daily lives and is used

to convey vast amounts of information regarding

quality, brand, size, and function coding, and even

convey a sense of how safely a device operates. The

importance of color is recognized by device

manufacturers, consumers, and doctors and nurses,

but each for different reasons.

For doctors and nurses, color plays a more functional

role as they commonly rely on color-coded medical

devices to indicate the size, type and function for split-

second identification during medical emergency and

surgical procedures.

For example, emergency room nurses often report that

color coding helps them find the correct devices

quickly, thus reducing the risk of an error. Color-

coded devices help provide timely and lifesaving care

because healthcare professionals don’t have to

question whether they have the right equipment [1].

Most medical devices were developed for use in

hospital or exam rooms and their main feature was

effective function. Today, aesthetics, branding,

consumer preference and ergonomics are now

topping the list of critical design criteria.

Toothbrushes entered this phase of design more than

10 years ago by applying colors and soft grips to

improve ergonomics and create brand preference.

Now nearly every medical device from drug

injection pens to home blood pressure cuffs that

crossover from institutional to consumer use are

adding features designed to improve patient

acceptance and improve brand recognition.

Leading medical device manufacturers are seeking

to improve the consistency for how their brand

colors are represented and ultimately the value color

produces for their company. As the medical industry

continues to globalize and competition increases, the

importance of a brand identity system becomes more

relevant. The function of a brand identity system is

to encode the brand in people's memory and create a

positive association with the product which

facilitates rapid retrieval from their memory. Color

can have a significant effect on people's perception

of a product or brand [2]. Device manufacturers are

combining branding with insight into consumer

preferences to create medical devices tailored to the

needs of consumers and healthcare professionals.

Although color is considered a “soft science”,

substantial research demonstrates that color is one of

the most powerful tools that can be used to create

brand equity, loyalty and value. Consider the

following statistics: research reveals people make a

subconscious judgment about a person, environment,

or product within 90 seconds of initial viewing and

between 62% and 90% of that assessment is based

on color alone [3]. Additionally, color increases

brand recognition by up to 80% [4].

With this in mind, it is essential that color is

considered early in the medical device development

process to ensure the device appeals to the end-user

aesthetically and represents the brand effectively. As

we have demonstrated, color is an important factor

in many aspects of medical devices, from design to

how the device is used and by whom.

II. Color Development Criteria for

Medical Devices

Once important branding and device acceptance

color influences have been established we turn our

focus to using resins and colorants that are suitable

for the application and will pass the regulatory

testing requirements for safe and effective use. In

2010 the FDA and regulatory bodies around the

world increased their scrutiny of colors as additives

in all materials and are paying special attention to

the biologic testing performed on pigments used in

plastic in an effort to reduce potential safety risks.

To determine what biologic testing is required, you

will need to know what the medical device will be

Excellent example of use of color by the

Coca-Cola Company.

Coca-Cola® and the Contour Bottle are registered trademarks of The Coca-Cola Company.


used for and where it will be sold. Most of the world

follows the International Standards Organization

(ISO) 10993 guidelines for the testing of raw

materials and finished devices, but each country

implements these standards a little differently. Once

you determine which regulatory body has

governance over your device it will be easier to

determine the various biologic tests that will be

required.

Medical Devices with Patient Body Contact

It is important for the design engineer to use plastics

that will pass the required biologic testing of the

finished, molded and assembled device. Plastics

used in medical devices that will be sold in the

United States and have patient contact will follow

the 510(k) #G95-1 Blue Book Memorandum [a].

The basis of this memorandum is the ISO 10993

standard.

The ISO 10993 regulations are essential to

understand because the United States, European

Union, Japan and other countries collaborated to

harmonize various international medical device

regulations resulting in the ISO 10993 standard,

which is the basis for the 510(k) application in the

USA and the CE mark in Europe.

Medical devices with patient body contact are

designated as Class I, II and III in the United States

and Class I, IIA, IIB and III in Europe. In order to

make good choices for the raw materials used in a

medical device you must first understand what

classification will be applied to the device.

Medical Device Classification

The European Union provides MEDDEV 2.4/1 –

rev. 8 PART 2: GUIDELINES FOR THE

CLASSIFICATION OF MEDICAL DEVICES [b],

which is a questionnaire with 18 rules to follow that

result in providing you with a device classification.

The classification allows you to decide the type of

biologic testing that will be required.

In the United States, a similar process is available in

which you answer questions in a decision tree that

flows to the endpoint where you are able to

determine your classification.

The names of these classifications differ slightly, but

the definitions which relate to how the device

contacts the patient and the duration of that contact

are remarkably similar and follow the ISO 10993

guidelines for raw material and finished device

testing.

Both regulatory bodies evaluate a given medical

device by the level of invasiveness or type of contact

(Table 1), as the first step to help prescribe the

biologic tests that will best ensure safe use of the

device. There are often exceptions for device

classification and it is important to refer to the

guidance offered by the appropriate regulatory body.

Once the level of invasiveness is understood, contact

duration must be understood for final determination

of the biologic testing required (Table 2).

Table 2: Contract duration descriptions

US FDA Device Classes

European Union Device Classes

Surface Devices – typical for skin contact

Body Orifice – any natural opening to the body including the surface of the eye ball

Externally Communicating Devices – typical for blood or tissue contact

Surgically Invasive Device – penetrates the surface of the body

Implant Devices – RTP Company does not participate in implant devices

Implantable – totally introduced into the human body

Device Contact Table

US Description

Contact Duration

EU Description

Limited Contact

Less than 24 hours

Transient Contact

Prolonged Contact

24 hours to 30 days

Short Term Contact

Permanent Contact

Greater than 30 days

Long Term Contact

Table 1: Simplified process to determine level of invasiveness


An easy to use chart titled 510(k) Memorandum -

#G95-1 Table 1 Initial Evaluation Tests for

Consideration published on the FDA website

illustrates how to determine what testing will be

required. A colorized version of this chart is shown

as Fig. 1 and provides an overview of the most

commonly required biocompatibility testing related

to patient contact and duration.

For example, it can be determined that a medical

device in contact with circulating blood for a

prolonged time period will likely be required to pass

6 biologic tests and may be required to pass 2 others

as determined by an FDA reviewer (Fig. 1).

Understanding the type of testing required and the

device classification will help the designer to select

raw materials that will pass the required tests.

During the late 1980’s to the mid 90’s the United

States Pharmacopeia (USP) Class VI was used as

guidance for biologic testing. It is still referenced

today as a selection criterion for plastic raw

materials. There is some overlap with the biologic

testing required by the USP Class VI and ISO

10993, but they are not identical and the similarities

break down with higher risk devices.

Therefore, the ISO 10993 standard is more

applicable to medical device testing. It should be

noted that it is wise to select raw materials that have

been tested for USP Class VI or ISO 10993 but in

most cases the regulatory body will require that the

finished molded and assembled device be tested to

take into account all the manufacturing steps

required to produce the product.

Fig. 1: FDA Initial Evaluation Tests table where X = test per ISO 10993, and O =additional tests that

may be required in the USA.

Contact Duration

A = Limited

(<24 hours)

B = Prolonged

(24 hours - 30 Days)

C = Permanent

(> 30 Days)

A X X X

B X X X

C X X X

A X X X

B X X X O O O

C X X X O X X O O

A X X X O

B X X X O O O

C X X X O X X O O

A X X X X X

B X X X X O X

C X X O X X X O X X X

A X X X O

B X X O O O X X

C X X O O O X X O X

A X X X X O X

B X X X X O X O X

C X X X X X X O X X X

A X X X O

B X X O O O X X

C X X O O O X X X X

A X X X X X X

B X X X X O X X X

C X X X X X X X X X X X

Type of Body Contact

Implant Devices

Tissue/Bone

Blood

Externally

Communicating

Devices

Blood Path, Indirect

Tissue/Bone/Dentin

Communicating

Circulating Blood

Surface Devices

Skin

Mucosal Membrane

Breached or

Compromised Surfaces

Bio

degra

dation

Biological EffectDevice Categories

Chro

nic

Toxic

ity

Carc

inogenic

ity

Repro

ductive/D

evelo

pm

enta

l

Subchro

nic

Toxic

ity

Genoto

xic

ity

Impla

nta

tion

Hem

ocom

patibili

ty

Cyto

toxic

ity

Sensitiz

ation

Irrita

tion/I

ntr

acuta

neous

Acute

Syste

mic

Toxic

ity


Biocompatibility Testing Definitions

There are many biologic tests that could be

required by a regulatory body depending on

patient contact and duration. The most

commonly required biologic tests by the ISO

10993-1 standard for devices that use plastics

are:

Cytotoxicity – Using cell techniques, these tests

determine the lysis of cells (cell death), the

inhibition of cell growth, and other effects on

cells caused by medical devices, materials

and/or their extracts. Cytotoxicity tests are

described in ISO 10993-5.

Sensitization – These tests estimate the potential

for contact sensitization of medical devices,

materials and/or their extracts, using an

appropriate model. These tests are appropriate

because exposure or contact to even minute

amounts of potential leachables can result in

allergic or sensitization reactions. Sensitization

tests are described in ISO 10993-10.

Irritation – These tests estimate the irritation

potential of medical devices, materials and/or

their extracts, using appropriate sites for implant

tissue such as skin, eye and mucous membrane

in a suitable model. The test(s) performed

should be appropriate for the route (skin, eye,

mucosa) and duration of exposure or contact to

determine irritant effects of devices, materials

and potential leachables. Irritation tests are


Intracutaneous Reactivity – These tests assess

the localized reaction of tissue to medical device

extracts. These test are applicable where

determination of irritation by dermal or mucosal

tests are inappropriate (e.g. medical devices

having access to the blood path). These tests

may also be useful where extractables are

hydrophobic. Intracutaneous reactivity tests are


Systemic Toxicity (acute Toxicity) – These tests

estimate the potential harmful effects of either

single or multiple exposures, during a period of

less than 24 h, to medical devices, materials

and/or their extracts in an animal model. These

tests are appropriate where contact allows

potential absorption of toxic leachables and

degradation products.

Pyrogenicity tests are included to detect

material-mediated pyrogenic reactions of

extracts of medical devices or materials. No

single test can differentiate pyrogenic reactions

that are material-mediated from those due to

endotoxin contamination. Systemic toxicity tests

are described in ISO 10993-11.

Medical Devices used for Drug Delivery with

Patient and/or Drug Contact

If the medical device will be used for drug

delivery, all of the same requirements for patient

contact and duration must be considered, plus

there are additional factors that the designer

must consider.

The drug delivery device must be evaluated to

ensure that the stability and bioavailability of the

drug has not been adversely changed. This is

done once drug toxicity is known and has been

approved for use. Drug delivery evaluations are

done on a case by case basis and include testing

for drug/plastic interaction and plastic/drug

leachability.

To reduce plastic selection errors, and therefore

speed the development process, it is a good idea

to work with a plastics supplier with medical

device experience early in the development

process to add color and/or other value-added

features into the plastics. Key services to look

for include material selection experience across

a wide range of resins, suggestions based on

successful experience, in-house testing of

specific colors and plastics, and the ability to

hold a formulation fixed.

III. Plastic Formulation Selection,

Control and Change Management

Selecting raw materials for medical devices

includes screening them for the ability to pass

ISO 10993 biologic testing. The FDA and EU

place a high demand for information on

colorants used in plastic formulations and

requires a deep understanding of what color

additives will pass the required biologic tests


and perhaps more importantly which ones may

fail. Regulatory bodies have expressed renewed

concern over color additives in plastics over

fears that they may leach out and have adverse

patient reaction or interactions with drug

formulations which alter the drug.

Pre-testing plastics, carriers, pigments and dyes

help to ensure the resulting colored plastic

compound has the ability to pass required

biologic testing on the finished molded and

assembled device. Pre-tested color compounds

should include taking pigments and dyes

through ISO 10993 biocompatibility testing at

an independent lab for part 5, in vitro

cytotoxicity, part 10, irritation and delayed type

hypersensitivity, and part 11, systemic toxicity

[5].

In addition to obtaining a statement of

biocompatibility design engineers should ask

questions to help ensure global availability and

high commercial viability by checking to make

sure large demand exists for these products.

Using pre-tested plastic compounds does not

relieve the OEM from testing the finished

molded and assembled device, as is likely

required by the regulatory body. Using pre-

tested raw materials helps to demonstrate to the

regulatory body a pattern of concern for safety

that was taken during product development. It

will also help to ensure that when testing does

take place, which is usually at the end of the

development, there won’t be any setbacks or

redesign issues which can delay the product

launch schedule.

Color Control for Medical Devices

Good color specifications create boundaries

within a color space that indicate the exact color

desired by OEM’s for medical devices, but are

not too tight to cause excessive rejections.

Numeric color measurement plays an important

role in color control for the plastics compounder

and the molder. By establishing tolerances for

acceptable color, OEMs can help processors,

from raw material to finished parts, achieve

consistent color quality across multiple lots and

manufacturing sites around the world.

Color control tolerances are often driven by the

application. For example, color used to identify

different sizes and types of medical instruments

usually do not have to be as stringent since color

is being used to differentiate one instrument

from another using various colors. Devices

incorporating various polymers of the same

color can require tighter tolerances to maintain

color harmony and devices incorporating brand

colors are often driven by corporate guidelines

using ink on paper.

An important first step in color control is a basic

understanding of color technology, color

measurement and methods available to control

color. Device color can be evaluated visually by

trained colorists or instrumentally with color

measuring devices and software. Visual

evaluation can be limiting because it can be

difficult to communicate or transfer color

information and is usually not a good choice for

consistent color control. A good practice is to

measure color instrumentally and incorporate

visual evaluation in the total color control

process.

The two most common color measuring

instruments are the colorimeter and the

spectrophotometer. Colorimeters are useful for

simple color difference measurements when

both the standard and the trial are made from the

same substrate, the same colorants and using one

illuminant. Spectrophotometers measure the

reflected or transmitted light at specific

wavelengths to provide color difference

measurements as well as take into account gloss

or texture.

Numerous measuring systems have been

developed over the years to quantify color

numerically using color measuring instruments.

These systems require the use of a defined color

space that is usually three dimensional and

provides a means for color specification or

identification and comparison. The most

popular are based on the CIE L*a*b* color

space. In the CIE L*a*b* color space, colors are

identified by their L*, a*, and b* values:


Fig. 2 CIE L*a*b* Visual Difference Example

L* defines the lightness/darkness of a color

a* defines the redness/greenness of a color

b* defines the yellowness/blueness of a color

When a color is measured instrumentally using

the CIE L*a*b* color space, the resulting

numeric coordinates for L*, a*, and b* can be

used to identify a particular color and can also

be used as a quality control tool. In production,

numeric color values from current

manufacturing lots of medical devices can be

compared to stored standard values.

Numerous color difference equations have been

developed based on the CIE L*a*b* color space

that actually improve the correlation between

what is measured instrumentally and how it

corresponds to what is actually perceived by the

human eye. This is why visual evaluation

should always be a part of a good color control

program.

Fig. 2 illustrates a color control scenario with a

numeric limitation in CIE L*a*b* color space of

1.0 unit for L*, a*, and b* along with a color

representation of each. When setting up a color

control program, care should be taken not to

establish color acceptability limits beyond what

is necessary for your usage situation. Depending

on the color difference equation selected, it will

not be unusual to have different limits set for

each variable. It is common to have more color

rejects and returns as well as increased

production costs when using extremely tight

color tolerances.

Color control programs can be very detailed

depending on the color requirements of an

application. For help with setting up a color

control program, ASTM International has

several methods and standard practices for

evaluating color and for establishing color

tolerances and color differences based on visual

evaluations and from instrumental color

measurements [c]. Color measuring instrument

manufacturers can also help with establishing

color controls with the purchase of hardware and

software.

Finally, it is important that standards, measuring

requirements and established tolerances are

communicated and understood throughout your

supply chain for any color control program to be

successful. A good color control program will

also help make the regulatory approval process

easier and less time consuming.

Sterilization Techniques Effect on Color

An issue to be aware of during medical device

development is the effect sterilization may have

on the color of plastic components. The most

commonly used sterilization techniques are

autoclave, ethylene oxide gas (EtO) and

radiation sterilization by either gamma or E-

beam radiation. Each sterilization technique has

an effect on plastic materials that may adversely

affect the color and physical properties. It is

recommended to check color in the finished

CLAB Color Space diagram

CIE L*a*b* Color Space Diagram


assembled state before and after sterilization to

determine the visual and physical effects.

Autoclave - Typical reactions to autoclave may

include hydrolysis, warp and part

distortion/deformation, however, color is usually

not affected.

EtO is often used for heat sensitive polymers

and usually does not cause significant color

change.

Gamma and E-Beam radiation sterilization can

cause cross linking of polymers, chain scission

and yellowing of colors. Although not the

subject of this paper, there are techniques that

knowledgeable color suppliers use to stabilize

colors against radiation.

IV. Formulation Change Control

It is a common practice for plastic compounders

to use resin and pigment equivalents that can be

interchanged based on price and availability.

The key test criteria are typically physical

properties and the ability to match the color

target. Unless you specifically request that the

formulation be held fixed and the compounder

has the ability to track and trace the formulation

in every production lot, you will not have a

secure formula and you may introduce

significant risk to your device and invalidate

your biologic testing.

Once you have selected the color for your device

and have taken it through required biologic, drug

interaction or leachability testing, you must lock

the formulation so that no changes can take

place. This is best accomplished by requesting it

at the beginning of color development.

Otherwise, by not locking your plastic

formulation you will put your device at risk

because all of your test data was performed on a

specific formulation and you may have an

uncontrolled plastic formulation which allows

the supplier to change ingredients.

Measuring Change Using Fourier Transform

Infrared Spectroscopy (FTIR)

Using FTIR test results on a pigment sample

helps us to demonstrate subtle differences in

chemical composition and drive home the need

for formulation control. FTIR is a common

failure analysis technique that provides

information about the chemical bonding or

molecular structure of materials, whether

organic or inorganic. It is used to identify

known and unknown substances present in a

specimen.

The procedure works on the fact that bonds and

groups of bonds vibrate at characteristic

frequencies. A molecule that is exposed to

infrared rays absorbs infrared energy at

frequencies which are characteristic to that

molecule. During FTIR analysis, a spot on the

specimen is subjected to a modulated IR beam.

The specimen's transmittance and reflectance of

the infrared rays at different frequencies is

translated into an IR absorption plot consisting

of reverse peaks. The resulting FTIR spectral

pattern is then analyzed and matched with

known signatures of identified substances in the

FTIR library.

RTP Company used the FTIR analysis technique

to examine two chemical equivalents to

reinforce the need for formulation control and

“no material substitution” services. For this

example, your medical device is colored using

pigment white 6 with a CAS registry number of

13463-67-7, color index number 77891 and its

generic chemical name is titanium dioxide. The

commercial chemical composition of titanium

dioxide can vary due to the variety of surface

treatments used to improve durability, dispersion

and processing performance. RTP Company

tested the same pigment white 6 with CAS

registry number 13463-67-7 from two different

suppliers shown in figure 3 [6].


Formulation Change Management

Having made excellent raw material choices that

have passed your fit, form, and biologic testing

requirements, you’ve made sure the formulas for

your plastic compounds are controlled. But what

happens when change occurs? These changes

typically fall into the following categories:

The OEM changes the location of where the

medical device will be produced or adds

another manufacturing or assembly area.

A supplier has a force majeure situation

occur (such as fire or act of God which

cannot be controlled).

A supplier goes out of business.

The resin, pigment or colorant becomes

discontinued.

The resin, pigment or colorant supplier goes

out of business or has a force majeure

situation

In all these supply disruptions, communication

and the ability to supply from multiple locations

or even globally are key attributes of a quality

medical plastics compounder with a strong

supply chain. Screening questions which can be

asked of the plastic compounder up front will

help to ensure that you develop long term

relationships with a supplier that has the ability

to successfully supply to the medical device

industry.

Does the medical plastics supplier have:

A commitment to the medical industry and

a track record of success?

Multiple manufacturing plants in case one

site experiences force majeure?

A global foot print to accommodate your

growth into other areas of the world?

A solid financial background to reduce the

risk of bankruptcy?

A quality system in place to help you

respond to supply chain issues of

discontinuation and force majeure by

offering change management services?

Change Notification: If a raw material is going

to be discontinued, the change notification

system needs to be capable of determining

where a particular ingredient has been used and

search of all formulations globally for the

purpose of notifying customers of a change and

provide options to pre-order a sufficient

quantity, or evaluate a replacement material.

Change Options: If a raw material has

experienced force majeure or been discontinued,

there may be an option to make a large purchase

to provide more time to qualify new materials or

will there be a need to begin testing new raw

materials right away.

V. Special Effects and Value-Added

Options

Medical devices that have moved from

institutions or doctor’s office into the home

experience new “consumer cross-over” demands

for appealing special effect colors and

ergonomics. Special effect colors that have the

ability to pass ISO 10993 biologic testing are

Metallic Special effects colors available from RTP Company

Fig. 3 FTIR scan demonstrates the differences that can be

found in equivalent pigments from different suppliers.


available for use in medical devices. Devices

moving from metal to plastic and using high

strength-to-weight ratio plastics can be colored

with a metallic color effect with low or no knit

line to provide a similar look. Additional special

effects including granite, marble, sparkle,

fragrance, glow in the dark, and camouflage may

be an appealing design consideration for in-

home medical devices.

Antimicrobial: Value-Added, Masterbatch,

and Precolor Technology

Two popular antimicrobial chemistries

considered for use in medical devices are silane-

based and silver technologies. These

technologies can produce up to a 99% kill rate of

some microorganisms on surfaces including

fungi, and algae depending on polymer

formulation and loading. For medical devices,

efficacy testing is necessary to substantiate any

claim by the OEM. Guidelines for the use of

antimicrobials in medical devices are provided

by the FDA and can be found on their website

[d].

Antimicrobials can be provided in compounds

that incorporate colorants and other necessary

additives as a total package for the molder.

Masterbatches are also available that are

concentrations of the antimicrobial additive

compounded into a carrier resin that is metered

into the molding process at predetermined

levels. Masterbatch (concentrates) carriers can

be unique to specific applications or universal

for use in various polymers. Masterbatches can

also incorporate other additives, fillers, or

colorants necessary for the manufacture of a

device.

VI. Summary and Conclusions Increased regulatory scrutiny placed on colored

plastics from Europe, Japan, United States, and

other countries to pass biologic testing makes

appropriate material and color selection a critical

skill when developing new medical devices.

Additional considerations for branding and

consumer preference must all blend together

with the required fit, form, and biologic testing

to create a functional and attractive medical

device. Understanding the biologic testing needs

of your device is essential to good base resin and

color pigment selection.

Once color has been selected, it is important to

control the raw material formulation and not

allow any changes to the formulation because it

has the potential to invalidate biologic testing

results.

Selecting a color compounder with a long

history of success in the medical device market

is critical as they will have important services

such as pretested ISO 10993 resin and pigment

selections, resin and color advice based on

experience, formulation control, and change

management services. A suggested check list for

screening suppliers is included in the

appendix[e].


Biography

Josh Blackmore is the Global Healthcare

Manager at RTP Company and holds a Bachelor

of Science in Medical Technology from the

Michigan State University and an International

MBA from the University of Notre Dame. He

has over 18 years of experience in the medical

plastics industry and is the co-author of two

additional white papers “Effects of Static on

Plastics Used in Drug Delivery Devices” and

“Effect of Gamma Sterilization on Select TPE

Materials.”

Mike Chappell is the Color and Additive

Marketing Specialist for RTP Company. He has

been with the company for 25 years. During

which he managed the Color Lab at RTP

Company’s South Boston Virginia facility.

About RTP Company

RTP Company is a global compounder of

custom engineered thermoplastics. Private

ownership allows the company to be

independent and unbiased in its selection of

resins and additives while its materials experts

formulate thousands of compounds each year

that meet specific end-use application

requirements.

Thermoplastic compounds can be tailored to

provide multiple property enhancements in a

single material. RTP Company’s customization

capabilities include color, conductivity,

elastomeric, flame retardance, high temperature,

structural, and wear resistant performance.

Headquartered in Winona, Minnesota, RTP

Company operates 12 additional full-service

manufacturing facilities located throughout

North America, Europe, and Asia. Each facility

has complete make-to-order manufacturing,

color lab, product development, and technical

service onsite.


VII. References

[1] Hanson, Scott & Turner, Rachel. “Where Color Meets Clarity.” Medical Device & Diagnostic

Industry, July 2010.

[2] VanAuken, Brad. "Color & Brand Identity." Branding Strategy Insider. 26 July 2007. Web. 03 Feb.

2011. http://www.brandingstrategyinsider.com/2007/07/color-brand-ide.html .

[3] CCICOLOR - Institute for Color Research

[4] University of Loyola, Maryland study

[5] Blackmore, Josh. “Biocompatible Colors for Healthcare Applications”, RTP Company, May 2011.

[6] Podhajny, Richard M. "Phthalo Green: How Can You Tell If It's Always the Same?" Paper, Film &

Foil Converter Magazine. 01 July 2003. Web. 03 Feb. 2011. http://pffc-

online.com/materials/paper_phthalo_green_tell/.

VIII. Appendix

Additional Resources:

[a] 510(k) Memorandum - #G95-1 table 1 Initial Evaluation Tests for Consideration: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080742.htm

US FDA: Device Advice: Comprehensive Regulatory Assistance

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

[b] European medical device guideline for the classification of medical devices:

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

[c] ASTM International: http://www.astm.org/index.shtml

[d] US FDA: Antimicrobials in Medical Devices:

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071380.htm

http://www.brandingstrategyinsider.com/2007/07/color-brand-ide.html

http://pffc-online.com/materials/paper_phthalo_green_tell/

http://pffc-online.com/materials/paper_phthalo_green_tell/

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080742.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

http://www.astm.org/index.shtml

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071380.htm


Selection Check List for Evaluation of

Color Compounders for Medical Devices

Experience and expertise of the organization

o Past history of success in medical devices

o Years of experience in the medical industry

o Products that have been ISO 10993 tested

o Color experience, membership in the Color Marketing Group

o Industry manager responsive to the needs of the medical industry

Knowledge of the organization and support staff

o USA and European regulatory environment.

o Database of known biocompatible resins and additives including color pigments

o Ability to work with any resins system or resins currently commercially available

o Product stewardship department for reporting regulatory compliance

History of the organization

o Years of service

o Technical leadership

o Financial stability

Manufacturing capabilities

o Location of manufacturing plants. Global or regional.

o Capable to handle small to large lot sizes

o Ability to supply precolor and masterbatch

o IT infrastructure and security of data and confidentiality

o Accessibility/flexibility

Quality and change management

o Quality system in place to handle fixed formulations

o Color consistency from plant-to-plant and region-to-region

o System in place to notify of any changes efficiently

o Quality assurance on a physical and appearance level

o Physical audit and outcome of audit

o Quality policy

- APPENDIX E -

Thermoplastic Color Development, Control, and Change...

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