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Full text of "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 



WfesjrsjbjJlty 




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 



03 



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Attribute (What) / Parameter (How) 


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Filtration Efficiency 


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Face Seal Leakage 






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Fluid Resistance 








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Comfort 
































B readability 










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P rolonged Use W ithout Discomfort 










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Tightness of Strap 












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Weight 














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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 



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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 


5 




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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