Pushing the Limits PPE Design Criteria, March 2-3, 2010

Pushing the Limits - The Next!

Sundaresan J ayaraman, PhD

P rofessor

Georgia Institute of Technology

March 2, 2010

sundaresan.iavaraman® qatech.edu

Overview of Presentation

Respirator Design: Drivers
The Challenges: Design and Real-World
The Opportunity: Creating the Next Avatar
Need for Innovation and Systems Approach
Quality Function Deployment

- User Needs -> Product Design- The Key Steps

Building The House ofiR espirator
The Path Forward

Respirator Design: The Drivers

Preparing for an Influenza Pandemic:
Personal Protective Equipment for Healthcare Workers

--IOM Report, September 2007

The Three Perspectives
•End Users

•Successful Protection
•Comfort

V\dninistratDrs/Piioviclers

•Successful Protection

•End U ser Acceptance

•Cost

•Regulations (e.g., OSHA)

•Manufacturers

•End Users
•Administrators
•Regulations (e.g., NIOSH)

•Trade-Offs - The Balancing Act

The Design Challenges

Ensure Performance

- Efficacy- Ensure Successful Protection During Use

- Avoid Leakage [Crutchfield etal., 1999]

• Fundamental - Occurs When Donned

• Transient- Occurs during Use

Ensure Corrfort

- Enhance Compliance with Usage of Device

Maintain or Reduce Total Cost of Ownership (TCO)

- TCO = Respirator Cost + Fit-Testing Cost + Disposal
Cost + ...

The Real-World Challenges

Limitations of Current Generation of Respirators

- Facial Profiles

• Beard, Children, ...

- Need for Fit-Testing

• C ost, Time, Compliance, ...

- Disposable- Environmental Impact

Potential Shortages (e.g., H1N1 Pandemic)

- Manufacturers Running at Full Clip

- Fortunately, it was, "The Flu Season that Fizzled."

» The Wall Street] ournal, March 2, 2010

Cal/OSHA Recalls 3M 8000 Respirators

California Department of Public Health (CDPH)and
Cal/OSHA

- 3M 8000 - Low Success Rate in Fit-Testing

- CDPH

• Withhold Further Shipments

• Stop Providing them to Healthcare Facilities

While Cal/OSHA is not prohibiting use of the 3M 8000 per
se, it strongly recommends against using this model for
prevention of aerosol transmitted disease and urges
employers, if they decide to issue a respirator of mis model
to any employee, to assure a successfijl fittest with that
employee.

J anuary 2010

The Opportunity

Creating the NextGen Respirarator,
Rather the Next Avatar...

What Does it Mean ...

Push the Limits, The Avatar Way ...
Harness Advancements in Technologies

- Understanding User Needs

- Materials

- Structures

- Manufacturing Methods

Result: The /Respirator (With Apologies to Steve Jobs)

The Design Toolkit

Evidence-based Performance Requirements

I
Will Determine the Choice of

Materials

Structures

Manufacturing Tech.

Will Influence the Properties and Lead to the Design of the

^r

r

\

Respirator

V

J

Gather Evidence from Users

What is Needed: The Twin Catalysts

Innovation

A Systems Approach

Innovation - A Hot-Off-the-Press View

George Buckley on Innovation at 3M

• Innovation: In Tweaks and Snips

- Making Respirators Cheaper

- Manufacturing Process

• Quadrupling in Speed and Efficiency

• Cost-Centric Innovation

• The Box Office Hit - The Oscar J ingle . . .

'The WallStreetjournal, March 1, 2010

Innovation: The Oxygen for Respirator Design

Inspiration
Necessity
Neat
Origin a I
Vaiuabie
Applicable
Timely
Intelligence
Outstanding
Novel FUN!

What are the User's Needs?

Dtgrt* of Protection

Usability

icturability

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Tho Nasds

tiMfiiinmibmiy

DuniDilYiy

Needs are in the Language of the Users - Subjective, Easy to Express

Transforming Needs to Reality

What Does "Usability" Mean?
What Does "Durability" Mean?

Making it Happen: Need for a Systems Approach
Quality Function Deployment (QFD)

Quality Function Deployment

A method for developing a design quality aimed at
satisfying the consumer and then translating the
consumer's demand into design targets and major quality
assurance points to be used throughout the production
phase. -Akao, 1990.

Encompasses The Complete Lifecycle
Subjective Attributes to Quantifiable Parameters
Facilitates the "Engineering" or "Realization" of Needs

The QF D Process

Understand the Needs - The What (Subjective)

Prioritize the Needs- (Scale of 1- 5)
Map Needs to Measurable Parameters - (Metrics)
Assess the Competition - (Benchmarking)
Define the Specifications - (The TargetValues)
Realize the Design - (Materials & Manufacturing Methods)

The Result -> The /Respirator

Applying QFD to Respirator Design ...

Step One: Define the Requirements (Subjective)

E vide rice Based Performance Requirements

^

Functionality

Protect against
influenza virus
Guard against
contact with
contaminated
fluids and
aerosols

I

i

Usability

Maintain biomechanical
efficiency and sense of touch
and feel
Odor-free

Hypoallergenic
Accommodate wide range of
users (face and body profiles}
Compatability across various
elements of the PPE
ensemble and with other
equipment (e.g., stethoscope)
Non-startling to patients and
families

Facilitates communication with
others (verbal, facial)

T

Comfort and Wearability

• Comfortable — no skin
irritation or pressure
points

• Prolonged use

without discomfort

• Breathable — air
permeable

• Moisture absorbent—
wickability

• Low bulk and weight

• Dimensional stabiltiy

• Easy to put on and
take off (don and doff)

l

Durability

Adequate wear life
Strength — tear,
tensile, burst
Abrasion resistance
Corrosion
resistance

Maintenance and
Reuse

Easy to

decontaminate and

discard disposable

elements

Easy to clean and

replace parts in

reusable PPE

Aesthetics

Variety of styles
and colors
Customizable

Cost

Product cost
Total life-cycle
cost

Minimal environ-
mental impact

Preparing for an Influenza Pandemic:

Personal Protective Equipment for Healthcare Workers

--I0M Report, September 2007

Background; Smart Shirt Research ir> U of the Textile Institute, voL 89, % pp* 44-62, 5998,

Gathering User Needs

Individual Surveys

Focus Groups

Information Gathering Process

- User Profile

- Training

- Using the Device

- Post-Use (Disposal)

- Likes and Dislikes

- Changes to Device

Rank the Needs - Establish Priorities for Design

U

CO

Step One: Define the Requirements

Functionality
(Protection)

• P rovi de a barri er agai nst transfer of

• Microorganisms

• Body Fluids

• Particulate Material

Usability

• Breathable

• P revent F ace Seal L eakage

• Ease of Donning and Doffing

• Reusable after Decontamination and Laundering

• M inimal 1 mpact on J ob Performance

• Does not impair communication

Wearability

• Lightweight

• Comfortable

Shape Conformability
(Dimensional Stability)

• Conform to Desired Facial Shape

• Dimensional Stability during Repeated Use and after Laundering

Durability

• Flexural Endurance

• Mechanical Strength

o Tear

o Tensile/Shear

o Burst

• Abrasion Resistance

Maintainability

• Ease of Care including

• E ase of D econtami nati on

• Ease of Laundering

Manufacturability

• Ease of Fabrication

• Compatible with Standard M anufacturing M achinery

Affordability

• Material Cost

• Manufacturing Cost

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Protection (Functionality)

Filtration Efficiency

X

X

Face Seal Leakage

X

X

X

X

X

Fluid Resistance

X

Comfort

B readability

X

P rolonged Use W ithout Discomfort

X

X

X

X

Tightness of Strap

X

Weight

X

Usability

Range of Facial Profiles

Impairment of Communication

Sweating

Ease of Donning

Ease of Doffing

Duration of Use

Maintenance and Reuse

Ease of Decontamination

Reusability

Durability

Length of Use (Hours/Days)

Cost

Unit Price

Disposal Cost

Aesthetics

Colors

Styles/Shape

Whatto How - A Closer Look

Metrics

Attribute (What) / Parameter (How)

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Protection (Functionality)

Filtration Efficiency

Face Seal Leakage

Fluid Resistance

Comfort

Breathability

Prolonged Use Without Discomfort

Tightness of Strap
Weight

Metrics

BFE (Bacterial Filtration Efficiency) measures the percent efficiency
at which the face mask filters bacteria passing through the mask.

PFE (Particulate Filtration Efficiency) measures the percent efficiency
at which the face mask filters particulate matter passing through the
mask.

AP (B readability) is the pressure drop across a facemask, expressed
in mm water/cm 3 /4. The higher the Delta P, the more difficult the mask
is to breathe through.

Fluid resistance is defined as the ability of a facemask's material
construction to minimize fluids from traveling through the material
and potentially coming into contact with the user of the facemask.
Fluid resistance helps reduce potential exposure to blood and body
fluids caused from splashes, spray or spatter.

Source: The Basics of Surgical Mask Selection

ByDianneRawson, RN, MA
3M Corporation

Characteristics of the Face-Seal Interface

Shape Conformance (Flexibility)

Slip Resistance

Shock Absorption

Vibration Resistance

Comfort

Texture

Hypo-Allergenic

Easy to Put On, Stay in Place -> Prevent Leakage

Step Three: Assess the Competition (Benchmarking)

10 = Always; 5 = Sometimes; 1

= Never

Attribute

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Protection (Functionality)

Filtration Efficiency

Face Seal Leakage

Fluid Resistance

Comfort

Breathability

Prolonged Use Without Discomfort

Tightness of Strap

Weight

Usability

Range of Facial Profiles

Impairment of Communication

Sweating

Ease of Donning

Ease of Doffing

Duration of Use

Styles of Filtering Facepiece Respirators

Duck-
Kimberly-Clark

Flat-fold
3M 9211

Flat-fold
MSA

<i>

w

Cup
Gerson 2747

Fan-fold
Alpha-Protech

Surgical N95
Moldex3100

Surgical Mask
Kimberly-Clark

Step Four: Define the Specifications

Respirator Attributes and Design Metrics

Based on the Comparative Analysis and Benchmarking data, enter the Ideal and Acceptable Values for

each Metric; provide the link to the path forward/action plan to address this design attribute.

Metric

Unit of Measure

Ideal Value

Acceptable Value

Path Forward - What will be done?

Particulate Filtration Efficiency

%

%

Degree of Leakage

%

Fluid Resistance

Pressure Drop (• P)

in

Force Exerted by Straps

N

Mass of Respirator

oz

Moisture Absorption (Wickability)

%

Shape Conformance

Slip Resistance

Vibration Resistance

Shock Absorption

Time to Put Mask On

sec

Time to Take Mask Off

sec

Length of Use

hr

Step 5: Bring It All Together

Requirements.

Translate Into

M ask Performance R equirements

Functionality

Usability

Wearability

Shape Conformability

bl

Durability

M aintainability

M anufacturability

Affordability

Properties

Materials &

A re Achieved Through Fabrication By Applying These

Desired Properties

Barrier Properties
•Resistance to Transmission of

•M icroorganisms

•Particulates

•Fluids
Comfort Properties
•Hand

•Air Permeability
•M oistu re Absorption
•Stretchability
•Bending Rigidity
•Weight

•Tensile Strength & Modulus
•Form- Fitting
•M anufacturability
•Cost

Lead To

Design

bi

•Barrier Component (BC)
•Comfort Component (CC)
•Form-Fitting Component (FFC)

Technologies

> Design Parameters

Materials

Design Parameters

Barrier Component (BC)
•Polypropylene Filter M edia
•Electrostatic Charged Filters
•Textile Fibers

Filter Density
Filter Composition

C omfort C omponent (C C )
•M eraklon (Polypropylene)
•M icrodenier Polyester Blend

Fiber Length, Fineness,
Strength, Elongation,
M oisture Absorption, Density,
Friction, Cross-Sectional Shape

F orm-F ittinci C omponent (FFC)

Strength, Elongation, Fineness,
Creep/Elastic Recovery

Manufacturing Technologies

Design Parameters

Novel

"w

Warp/Weft Density, Weave Structure,
Warp/Weft Yarn Count

p

Nonwoven

^w

M att Density, Type of Bonding

p

Mask Assembly

Design Parameters

Cutting, Sewing Straps,
Filter Integration

^w

Number of Layers, Lay-up Orientation,
Filter-Structure Composition

p

Building The House of /Respirator

Product Characteristics

Customer
Needs

Relationships

Competitive
Analysis

Performance
Targets

Concept to Market: Making it Happen

The Key Design Drivers

Evidence-Based User Requirements Analysis

n

Design Realization

n

Field Use and Evaluation

11

Market Introduction

Post-Market Surveillance

An Integrated View: Coming Together

Effectiveness

Articulation of Need

End User

Insurance
Company

Administrators .

/Respirator

,..-y f -..

Improved Quality of Life

Public Policy

CostAdvantage

Commercializing
Company

Enhanced Convenience

Technology Success Factors

Success of Product in Market Depends on:

- Effectiveness in Understanding User's Needs and Meeting Them

- Reduction in Cost of Current Solutions to be Supplanted

- Improvement in the Quality of Service or Performance

- Enhancement of the User's Convenience

- Adoption of Innovation - E.M. Rogers

• Is there a Relative Advantage?

• Does it Ensure Compatibility?

• Degree of Complexity

• Observability: Opportunity to Observe the Product in Use

• Trialability: Opportunity to test or try outthe Product

- Apple's Newton - A Failure :: iPAD - A Success (Before its Birth)!

The Path Forward

Innovation & Systems Approach: Critical for Success

Goal: Ideal Design for the Optimal Cost

Modular Design- Product Flexibility

Breakthrough Thinking - Important for Making
Significant Progress in Respiratory Protection

The Engineering Design Paradigm = Creative +
Structured Thinking

"Doing Well by Doing Good"

Acknowledgments

Institute of Medicine Committees
Learning and Discussions - Critical to Thinking
Fellow Members for their Observations!
NPPTL