Science of Skin: Challenges of Long Wear Adhesives

Science of Skin:
Challenges of Long Wear Adhesives
Del R. Lawson, Ph.D.
R&D Manager – 3M Medical Materials and Technologies
3M Critical & Chronic Care Solutions Division

2. All Rights Reserved.19 April 2018© 3M
3M at a glance
▪ Sales in ~200 countries
▪ $31.7 billion in sales
▪ Five business groups
▪ 90,000 3M employees globally
*2016 figures
▪ $1.7 billion invested in R&D
▪ 113,000 patents
▪ 101 straight years of dividends
▪ One of 30 companies on the
Dow Jones Industrial Index
The 3M Carlton Science Center

5© 3M 2018. All Rights Reserved.
Science needs a champion
5
By 2050, the world population is
expected to surpass 9 billion people.
Science will be more important than
ever to address the challenges we face
our world continues to grow.

Supply and demand of
natural resources,
including fossil fuels,
minerals, renewables,
water, and food will
experience a powerful
transformation
A gradual but powerful
shift in the composition,
location, and sheer size
of the Earth’s population
is at the core of nearly
all observable global
trends
Digitization is
fundamentally changing
how businesses and
individuals interact,
make decisions, and
conduct daily
operations
The center of world
economic influence is
transitioning from
dominance of
developed countries
towards an increasingly
multipolar environment
We are facing EPIC opportunities and problems…
Reimagining
natural resources
Shifting
demographics
Digital
transformation
Evolving
economic landscape

+ +
Our people and
collaborative culture
Insights from customers
and the market
46 technology
platforms
How do we apply science to solve problems and improve lives?

Electronics & Energy
Health Care
Consumer
Helping hold planes and cars together
Medical tapes and dressings
Post-it® notes, Scotch® tapes, Command™ strips
Industrial
Safety & Graphics Scotchlite™ reflective material and car wraps
Securing films and other parts of electronic devices
Ad
Adhesives
We apply individual technologies across our businesses…

High-performance window film
Medical dressings
Ad
Adhesives
Fi
Films
FcFlexible
Converting and
Packaging
Pm
Polymer
Processing
Nw
Nonwoven
Materials
Sm
Specialty
Materials
Su
Surface
Modification
Wo
Wound
Management
Ad
Adhesives
Fi
Films
Nt
Nano-
technology
Lm
Light
Management
Filtek™
Dental Adhesives,
Restoratives and Crowns
Am
Advanced
Materials
Ce
Ceramics
NtNano-
technology
Co
Advanced
Composites
Do
Dental and
Ortho Materials
PdParticle and
Dispersion
Processing
Su
Surface
Modification
Bi
Biotech
…and combine them in unique and creative ways
Ad
Adhesives

12. All Rights Reserved.25 April 2018© 3M 3M Confidential.
Chronic disease and pain management require
consistent day-to-day actions, rather
than visits to the doctor to shape outcomes. There is a
growing need for wearable devices
which can remind, warn, encourage, and perhaps
most importantly, supply the patient with innovative
strategies to comply with treatment regimens (and in
some cases, provide that treatment).
Wearables have a unique value
proposition for manufacturers, patients, and
society as a whole in healthcare. Devices have
already found their way into incentivized wellness
programs. Pilots are underway in hospital systems to
replace traditional vital monitoring
with wearable devices.

Science of Skin:
. All Rights Reserved.19 April 2018© 3M
3M.com/MedTech
13
Market Need - Increased Wear Time for Medical Devices
• The essential nature of medical devices is increasing the value associated with
extended wear.
• Extended wear is possible, but the “do no harm” rule still applies.
• How do we insure wear time does not come at the expense of skin injuries?
• How can you select the best options to trial for your medical device applications?
• Best practice – involve your adhesive partner early
• How do we extend our understanding of adhesive performance from the lab to
predict performance in the field?
• Future – what can be done to improve the appearance of devices to reduce the
potential social stigma of wearables?

Science of Skin:
3M.com/MedTech
14
What do you think about when you think about Skin?
Mostly, we take it for granted
• It should be thought of as the elastic “organ” that covers our body
• It is our interface to the world
• Physical, chemical, and microbial barrier
• It protects us from the Sun
• The sense of touch relies on the nerves embedded in our skin
• Receptor for Heat, Cold, Pressure and Pain sensations
• It can repair itself when damaged
• It supports regulation of our body temperature and phosphate/calcium levels

Science of Skin:
3M.com/MedTech
15
Skin structure – layers upon layers with important jobs to do
Stratum
Corneum
Epidermis
Papillary
Dermis
Reticular
Dermis
Hair follicles
Hypodermis

Science of Skin:
3M.com/MedTech
16
Microbiology of the Skin

Science of Skin:
3M.com/MedTech
17
15%
water
70%
water
Water (moisture) management is critical to epidermal function

Science of Skin:
3M.com/MedTech
18
Factors Affecting Skin Adhesion and Wear Time
Key Characteristics of Skin
Human
Skin
Breathing,
Sensitive
Surface
Cell
Renewal
Cycle
Elastic
Surface
Low
Surface
Energy
Rough
Texture
Stratum corneum: 14 days
Epidermis: 28 days
Reversible Stretch up to 50%
25 dynes/cm (Skin)
31 dynes/cm (Polypropylene)
>500 dynes/cm (Stainless)
Hair & Growth
Pores
Skin Wrinkles
Dead Skin Cells
Sweat
Salt
Lotions & Powders
Contaminated
Surface

Science of Skin:
3M.com/MedTech
19
What is a Medical Adhesive Tape?
In the USA, “medical” adhesives, and the tape components created
with them, should be produced under FDA current guidelines for
Good Manufacturing Practices [cGMP]
According to written operating standards that adhere to ISO:13485
Quality Management System guidelines
In a clean facility that has dedicated validated equipment, supply
chain traceability and is regularly audited for compliance
To produce an adhesive tape that has been tested per ISO:10993 for
biocompatibility and is shown to be safe for use on skin.

Science of Skin:
3M.com/MedTech
20
The Evolution of Adhesives Used in Medical Products
1900s 1960s 1990s
Natural Rubber Latex
Adhesives Introduced
Acrylate Adhesives
Introduced
Silicone Adhesives
Introduced
Synthetic Rubber Adhesives
X

Science of Skin:
3M.com/MedTech
21
How Can Medical Adhesives Cause Skin Injury?
A skin injury can occur when the
skin-to-adhesive attachment
is stronger than the skin-to-skin
attachment (Skin Stripping).
skin
adhesive
backing
The unintentional removal of skin layers is one aspect of Medical Adhesive Related Skin Injuries (MARSI)

Science of Skin:
3M.com/MedTech
22
Avoiding skin injuries requires a trade off of adhesive
performance and properties
Skin cell removal visualization
Acrylate Adhesives Silicone Adhesive

Science of Skin:
3M.com/MedTech
23
MARSI Examples – Potential Patient Safety Concern
MacerationIrritant Contact Dermatitis
Allergic Dermatitis
Folliculitis
Tension Injury or BlisterSkin Tear
Skin Stripping

Science of Skin:
3M.com/MedTech
24
Risk Factors for MARSI
Immuno-
suppression
Extremes of age
Skin changes with
sun exposure
Underlying illness
Choice of
Adhesive

Adhering medical devices can be a difficult task. Using
the wrong adhesive could result in unforeseen added
costs and device development delays.
Our goal with Find My Adhesive is to leverage our more
than 50 years of adhesive research and development
expertise to provide a useful tool to design engineers that
helps streamline the adhesive selection process and
improve the device’s overall probability of success. The
interactive, intuitive and efficient tool can assist design
engineers in an oftentimes unexpectedly challenging and
critical part of the medical device design process
FindMyAdhesive.com can help
with adhesive selection

s
3M MedTech Adhesive Evaluations of
Wear Time*
*Wear time results may vary, not a guarantee of performance

3M Confidential.27 19 April 2018. All Rights Reserved.© 3M
In order to develop extended wear solutions,
we started with the products at hand
> 60 Years Experience in Medical Tapes

Science of Skin:
3M.com/MedTech
28
• In-house wear studies and analysis
• Select 3M MedTech portfolio and experimental samples
• Intended to screen wear time performance and skin health
• 3M employees
• Healthy Volunteers
• Wash to prep skin
• Clip Excess Hair
• 3 replicates typical
• Record activity
3M Internal Wear Time Studies

Science of Skin:
3M.com/MedTech
29
• Target: >80% survival
• Showered, no hot tubs
• Active Adults
• Recorded Activity
Wear Time Performance over 8 Days

Science of Skin:
3M.com/MedTech
30
Extended Wear Study – 21 days
• Select 3M MedTech tapes based on best performers in the 8 day study
• Included experimental Gentle to Skin and long wear samples
• 3M employees
• Healthy Volunteers
• Wash to prep skin
• 3 replicates
• Record activity
• Tape only, no device

Science of Skin:
3M.com/MedTech
31
Wear Time Performance over 21 Days

Science of Skin:
3M.com/MedTech
32
Evaluation of Skin Irritation at 10 and 21 days
The skin was graded
following these guidelines:
0=No redness (of the skin)
1=Slight redness, barely perceptible
2=Definite redness
3=Severe redness (well defined) with
edema
4=Extreme response with edema (swelling)

Science of Skin:
3M.com/MedTech
33
Pain Response upon Removal of Tapes at 10 and 21 days
4.6
4.3
4.3
5.2
6.7
3.3
3.3
4.5
3.3
4.1
0 10 20 30 40 50 60 70 80 90 100
[03] 1776
[04] 9834
[05] 9873H
[06] 9841
[10] 1533L
Pain Score (0-100mm)
Pain Upon Removal
(mean ± standard error)
Day 21 Day 10
No pain zone: May
have tugging or
pulling sensation Very Painful

s
Extended Wear Tape – Interesting…
But what about medical devices?

Science of Skin:
3M.com/MedTech
35
Wear time study with Occlusive Device
• Purpose to understand performance and skin health with device
• Device locations – Abdomen and Chest
• Experimental adhesives with Polyurethane backing
• Samples with and without skirt (extended edge)
Antenna
Top Protective Layer
Adhesive Tape
Assembly DCT
EMI Shielding Tape
Assembly DCT
Stick-to-Skin Adhesive

Science of Skin:
3M.com/MedTech
36
Images of Occlusive Plate Study
Lift score of “1” 15 day - chest15 day - abdomen

Science of Skin:
3M.com/MedTech
37
Effect of “Skirt” on Wear Time
Hypothesis: Skirt transforms
failure from peel to shear

3MTM
4076 Extended Wear Medical Tape
• Polycarbonate “Device”
Footprint: 30mm x 46mm
Thickness: 3mm
Weight: 4 grams
• 3MTM
9889 device attachment • 16 - 3M Healthy volunteers, 8 devices/subject
• Average miles walked: 70 miles
• Activity tracked - only restriction hot tubs
• # 5,6 & 11 were most active with highest
recorded intensity minutes
• #4,6 & 7 swam
• #5 trained for and ran a 1/2 marathon
• #11 ran daily
• #12 harvested corn
*
Day 14
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
PercentAttached
Subject Number
Percent of Devices Attached - Day 14
(3MTM
4076, Mock Device)

Science of Skin:
3M.com/MedTech
39
Summary
• Skin is a dynamic interface and highly individualized
• Adhesive use can be a patient safety concern; important to prevent MARSI
• Lab tests, combined with predictive models of wear time remain elusive
• Clinical studies remain the most reliable predictor of performance on skin
• Think about TAPE/ADHESIVES earlier in the design process
• Example: An extended edge/skirt can improve wear time
• 3M MedTech Tape Constructions have demonstrated extended wear time*
• Improved Tape Constructions and trials are under development

Science of Skin:
Special thanks to Dr. Pat Parks (3M Medical Officer), Diana Eitzman and Marcia
Cartier for their pioneering work on the 3M Science of Skin and clinical trials, along
with the entire 3M MedTech R&D team.

www.3M.com/MedTech
www.Findmyadhesive.com
3M Medical Materials & Technologies

Adhesion is a property of the system.
Skin is a part of that system.
IV Securements Tapes and Adhesives Biomedical Electrodes

Science of Skin: Challenges of Long Wear Adhesives

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