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The Power of Plastics
in Healthcare Aran Seminar
April 2017
Christoph Koslowski Senior Sales Development Manager, Healthcare
RFID non-interference
Color coding
Transparency
Radio-opaque or -lucent
Branding ability
Reduce costs
Ergonomical
Reduce weight
Biologically safe Design freedom
Anti-microbial
Stress shielding solution
Imaging friendly
Single-use
Resistant to aggressive chemicals
Bioresorbable
What can plastics do for Healthcare
© 2014 Solvay Specialty Polymers 2
Specialty Polymers Industry Characteristics
• Top tier of plastics pyramid • High-tech material solutions • High barriers to entry • Driving and driven by innovation
• Market and application development • Large variety of markets • High added value • Global
Specialty Polymers Comprehensive Portfolio Aromatics, Fluoropolymers, Barrier Polymers, Performance Compounds
Key Performance Factors
Mechanical performance
Resistance to harsh elements
Broad range of temperatures
Surface properties Lightweighting Fire resistance
© 2012 Solvay Specialty Polymers 5
Turn a PROBLEM into an OPPORTUNITY
How can plastics drive innovation in Healthcare?
© 2017 Solvay Specialty Polymers 6
Solvay Group
Solvay
Planck
Rutherford
Curie
Einstein
Solvay Physics Council, Brussels 1911
Founded in 1863: 150 years of passion and tradition for science
© 2017 Solvay Specialty Polymers 7
Fifth Solvay Physics Council: October 1927
Einstein, after sparring with Niels Bohr and expressing disenchantment with Werner Heisenberg’s Uncertainty Principle :
“I am convinced that God does not throw dice.”
Bohr replied, "Einstein, stop telling God what to do".
© 2017 Solvay Specialty Polymers 8
Pioneering Spirit
• Auguste Piccard: 1884-1962, first man to go 14 miles into the stratosphere in 1931 « The question now is not so much whether humans can go even further afield and populate other planets, but rather how to organize things so that life on Earth becomes more worthy of living. »
Auguste Piccard Jacques Piccard Bertrand Piccard
• Jacques Piccard: 1922-2008, first man in deepest point in the ocean in 1960 « The public has not yet woken up to the extent and seriousness of the problem of pollution. »
• Bertrand Piccard: 1998, first man to circle the Earth non-stop in a hot air balloon «
Adventure in the 21st Century consists of applying human creativity and the pioneering spirit to developing a quality of life which present and future generations have a right to expect. »
© 2017 Solvay Specialty Polymers 9
Solvay and Solar Impulse
• Solar Impulse is the first manned aircraft to fly around the world powered only by solar energy
• Solvay has been Main Partner since 2004
• On July 26, 2016, Solar Impulse landed safely after 43’041 kms in 17 flights that lasted a total duration of 558h 06min.
Two pilots flew around the world without fuel
Bertrand Piccard Andre Borschberg
© 2017 Solvay Specialty Polymers 10
Halar® ECTFE Energy capture
Solstick
Energy capture
KetaSpire® PEEK PrimoSpire® SRP
Light weight / metal replacement
Solef® PVDF Energy storage Torlon® AI
Structure
Light weight / metal replacement
Ixef® PARA Radel® PPSU
Fomblin® PFPE Lubrication
TegraCoreTM PPSU Insulation Amodel® PPA
LEDs
OUR SPECIALTY POLYMERS ON BOARD
© 2017 Solvay Specialty Polymers 11
employees 27,000 140 industrial sites
21 major
R&I centers
58 countries
€ 10.9 billion of net
sales
€ 2,284 million of REBITDA
Solvay: A Major Player in Chemicals
• In Top 10 worldwide
• Global presence
• Diversified end-markets
• Sustainable development
• Operational excellence
Our strengths
© 2017 Solvay Specialty Polymers 12
Product Families
Advanced Lightweighting Solutions TegraLite™
• TegraCore™ PPSU Structural Foam
• Films • Composites • Virantage® PESU
Tougheners Biomaterials for Implantable Devices Solviva® Biomaterials
• Eviva® PSU • Veriva® PPSU • Zeniva® PEEK
Cross-linkable Compounds Cogegum® XLPO-HFFR Polidan® PEX/XLPE Polidiemme® XLPO
Films Ajedium™ Films
Fluorinated Elastomers Tecnoflon® FKM
• Base Resistant • Ionic Curable • Low Temperature • Peroxide Curable
Tecnoflon® PFR FFKM Fluorinated Fluids Fomblin® HC PFPE Fomblin® PFPE Lubricants Galden® PFPE Solvera® PFPE Fluoropolymers Algoflon® PTFE
• Dispersions • Fine Coagulated Powders • Granulars • Micronized Powders
Halar® ECTFE Hyflon® PFA & MFA®
Hyflon® AD Hylar® PVDF Hylar® 5000 PVDF for Architectural Coatings Polymist® PTFE Solef® PVDF
Functional Fluids Fluorolink® PFPE Fomblin® PFPE Functional Liquid Crystal Polymers Xydar® LCP Polyamide-imides Torlon® PAI Polyamides, Aromatic Amodel® PPA Ixef® PARA Kalix® HPPA Omnix® HPPA Polyesters, High-performance Lavanta® HPP Polyketones, Aromatic AvaSpire® PAEK KetaSpire® PEEK Polymer Processing Aids Solef® 11010 PVDF Tecnoflon® NM FKM
Polyphenylene, Sulfide Ryton® PPS Polyvinylidene Chloride Diofan® PVDC Ixan® PVDC Extrusion Resins Ixan® PVDC Soluble Powders Sulfone Polymers Acudel® modified PPSU Radel® PPSU Udel® PSU Veradel® PESU Specialty Materials Aquivion® PFSA Hyflon® AD Long Fiber Compounds Solvene® EAP Torlon® AI for Coatings
RFID non-interference
Color coding
Transparency
Radio-opacity
Branding ability
Reduce costs
Ergonomical
Reduce weight
Biologically safe Design freedom
Anti-microbial
Stress shielding solution
Imaging friendly
Single-use
Resistant to aggressive chemicals
Bioresorbable
Driving Innovation Past …. Present …… Future
© 2014 Solvay Specialty Polymers 13
© 2013 Solvay Specialty Polymers 14
Opportunity: Improve Hemodialysis Patient Outcomes
• Saving the lives of kidney dialysis patients since 1995
• Better membranes than cellulose acetate
• More biocompatible • More chemically resistant
during cleaning and disinfecting • Better patient experience
Innovation: PSU (Polysulfone) for Hemodialysis Treatment
Past
Udel® PSU
© 2013 Solvay Specialty Polymers 15
Opportunity: Improve Efficiency for OR Teams
• Improved designs • More ergonomic • Lighter weight • Better organization • Transparent lids • Color coded
Innovation: PPSU (Polyphenylsulfone) for Cases & Trays
Past
Radel® PPSU
© 2013 Solvay Specialty Polymers 16
Opportunity: Improve Efficiency for Surgery
• Alternative to metal • Lighter weight reduces fatigue • Ergonomic for surgeon’s hands • Color coded to decrease
chance of error • Quick visual identification
Innovation: PPSU (Polyphenylsulfone) for Medical Devices & Instruments
Past
Radel® PPSU
Macro Trends
• Aging population
• Increase in treatable diagnoses
• Growing global middle class
• Health of our economies
• Government oversight
• Cost control
Macro forces affecting Healthcare
Present … Future
© 2014 Solvay Specialty Polymers 17
© 2014 Solvay Specialty Polymers 18
Opportunity: Improve Quality of Longer Life
• Alternative to metal • Biocompatible • Radio-lucent • No halo effect during imaging • Modulus similar to cortical bone
Innovation: PEEK (Polyetheretherketone) for Orthopaedic Implants
Present
Zeniva® PEEK
© 2014 Solvay Specialty Polymers 19
Opportunity: Reduce Hospital Acquired Infection Rates
Innovation: PARA (Polyarylamide) for Single-Use Instruments
Present
Ixef® PARA
© 2014 Solvay Specialty Polymers 20
Added Value: Opportunity to Reduce Costs Innovation: PARA (Polyarylamide) for Single-Use Instruments
Reusable Single Use
Sterilization
Packaging
Delivery
Control
Storage
Surgery Ixef® PARA
• A high-performance, specially-formulated polymer
Introducing Ultaire™ AKP
Near net shape disk CNC
machining
Final part
Solvay Dental 360™ Present
RFID non-interference
Color coding
Transparency
Radio-opacity
Branding ability
Reduce costs
Ergonomical
Reduce weight
Biologically safe Design freedom
Anti-microbial
Stress shielding solution
Imaging friendly
Single-use
Resistant to aggressive chemicals
Bioresorbable
Driving Innovation Past …. Present ……
What’s Next?
…… Future
© 2014 Solvay Specialty Polymers 22
Opportunity: Improve Osseo-integration of PEEK
• Created in partnership with Georgia Institute of Technology and MedShape
• Provides interconnected, surface porous network
• Promotes bone ingrowth through multiple porous layers
Innovation: Partner with renowned University to create Surface Porous PEEK
Future
© 2014 Solvay Specialty Polymers 23
© 2014 Solvay Specialty Polymers` 24
Opportunity: Flexible PEEK structures
• Custom designed structures • Validated value chain includes
full product traceability • Mechanical Property of fibers
similar to PET fiber • Robust biological safety for
Zeniva PEEK
Innovation: Partner with Secant Medical to offer Zeniva PEEK fabrics and fibers to the implantable devices market`
Future
3D Printing
• Many different techniques exist: SLS, FDM, FFF.…
Selective Laser Sintering (SLS) Fused Filament Fabrication (FFF)
Future
The Power of Plastics in Healthcare
Biocompatible formulations
Provide practitioner comfort
Facilitate creative designs
Control Spread of Infection
Improve patient outcomes
Support new ways of doing things
Improve visual aesthetics
Make old techniques better
Differentiate your company
…… many, many things
© 2014 Solvay Specialty Polymers 26
Coming to Grips with Specifying High Performance Plastics
A Metal Retractor Case Study
Version 1.2
Christoph Koslowski, Solvay Europe
Thanks to our collaborators …
… we value our parters.
Greg Hall, International Business Development
Rob Rice, Development/Design Engineering
Mike Ulanowicz, Sr. Technical Sales Manager
Mike Kell, Sr. Marketing Manager
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Seven Steps from Metal to Plastic
1. Definition of Requirements 2. Conceptual Design 3. Material Selection 4. Engineering Design and Mechanical Simulation 5. DFM/ Process Simulation 6. Prototyping 7. Validation Testing
An alternative retractor’s journey …
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1. Design Requirements • Function • Mechanical Performance • Thermal Performance • Chemical Compatibility • Usage Scenario • Economical Considerations • Regulatory Aspects
→ Qualifiers versus Differentiators
≈ “Need to have, want to have” ≈ “Constraints vs Objectives” ≈ “CTQ’s”, Kano model categories
Voice of Experience: Explicit, Thorough, Detailed
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Requirements – Build a Checklist …
A best practice: An actual written checklist as a guide
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Document Your Findings …
Drill Down: Record/Categorize/Quantify/Clarify
Check List
# Requirement(double click topics to expand / collapse)
CommentsStatus
(double click to change)
1 Function 1.1 What is the function of the part? 1.2 What is the expected lifetime of the part? 1.3 What agency approvals are required? (ISO, UL, FDA, USDA, , USP,
MIL spec)
1.4 Will the part be implanted in humans? If so, biocompatibility is your first concern.
1.5 Will the part be used in an optical system?
2 Environment 2.1 What temperature will the part see? And, for how long? 2.2 What chemicals will the part be exposed to? 2.3 Is moisture resistance necessary? 2.4 Does the part need to be sterilized? With what methods (chemical,
steam, radiation)?
2.5 Is weathering or UV exposure a factor?
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2. Conceptual Designs • Differentiation or Imitation? • New functionality? • “Soft Attributes” – look, feel, sound • What if …? Could we …? The customer wants …
Best Practices: Outside Input - “Think big” Wish Lists - Use Variants
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2. Conceptual Designs
“Designing with Plastics isn’t harder, it’s just different.”
Be sure your designers consider the freedom plastics have to offer.
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3. Material Selection - ABC
Actual Performance Requirements
Match property requirements with potential plastic material candidates. - Materials Databases - Supplier Documentation - Conversion Partners - Outside Specialists - Predicate Devices
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3. Material Selection - ABC
Actual Key Retractor Requirements = Stiffness and Strength
Material Tensile
Strength MPa
Young’s Modulus
GPa
Specific Gravity
Titanium 345 100 4.5
Steel 330 200 7.8
Aluminum 320 70 2.8
Magnesium 225 40 1.8
PARA Ixef® 1022 280 24 1.7
PAEK AvaSpire® AV-651 GF30 162 10 1.5
PEEK KetaSpire® KT-880 GF30 190 11 1.5
PEEK KetaSpire® KT-880 100 3.8 1.3
PPSU Radel® R-5000 70 2.3 1.3
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Biocompatibility Categories per ISO 10993-1
3. Material Selection - ABC
Retractor = Limited exposure, Tissue/Bone/Blood contact.
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Biological risk must be addressed by the device manufacturer. Raw materials chosen are often where evaluation begins.
3. Material Selection - ABC
Biological Safety - Some Supplier Questions:
• Any Policies which support certain healthcare applications, while excluding others?
• Are specific “medical grade” materials offered?
• Is there a long term commitment to the industry?
• How is formulation change handled?
• Available technical, regulatory, processing, design support?
3. Material Selection - ABC
Does your material supplier ”have your back?”
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Single Use Devices • Sterilized once • Cleaning & disinfecting
not required • As-molded properties*
Reusable Devices • Sterilized repeatedly • Cleaned & disinfected
repeatedly • Long-term properties
(3+ years)
Designed for a single procedure.
Engineered to Deliver Long-Life Performance
3. Material Selection - ABC
Life Cycle determines required properties of interest …
*assumes validated sterilization stability
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3. Material Selection - ABC
Compare properties based on targeted Life Cycle …
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4. Engineering Design / Mechanical Simulation
FEA simulation: Begins with “can we get there?”
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
0.00 0.10 0.20 0.30 0.40 0.50 0.60
Deflection (in)
Forc
e (lb
)
Deflection, Real (in)Deflection, FEA, 29,000ksi Modulus (in)Deflection, FEA, 18,000ksi Modulus (in)Deflection, Ixef 1022 (in)
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Iterates through conceptual designs to mechanical models
Design Restriction = Tip Geometry
4. Engineering Design / Mechanical Simulation
44
5. Process and Manufacturing Simulation
• Greatest design change flexibility
• Greatest cost efficiency for smaller quantities
• No parting lines, ejector marks, or flash
• No draft angles required
• Closest tolerances possible
• Lowest component stress
• Fastest turnaround time
• Low or no tooling cost
• Ease of producing features such as threads and undercuts
• Up to 25x lower per part cost
• Part consistency
• Potential to simplify supply chain
• Economy of scale leverage for larger quantities
0 5000 – 10000* 50000+
Parts per year
* Traditional “rule of thumb.”
Machining
or
Molding?
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5. Process and Manufacturing Simulation
• Difficult part design for machining, 7 operations estimated to complete.
• No existing stock shape channel for resins selected
• Resins chosen forfeit 40% of their properties in machined form.
• Estimated cost (100 parts) = $145 / part
• Estmated cost (10,000 parts) = $125 / part
• Single tool with insert cavity for multiple handle geometries is possible.
• Up front tooling cost = $38,000
• Estimated cost (100 parts) = $49.00 / part
• Estimated cost (10,000 parts) = $7.50 / part
Chosen: Injection molding with an insert for the handle.
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5. Process and Manufacturing Simulation
Machining is here to stay!
Trends within Orthopedics – Molding/Machining • Molding Strategies Reduce Annual Volumes
• Inserts • Family tools • Common Halves
• Hybrids – designs using both plastics and
metal, often inserts
• Integration of Molding and Machining • Near net shapes • Suppliers moving to offer both processes in
house
• Mold “Center of Bell Curve” Size
Ann
ual Q
uant
ity
47
5. Process and Manufacturing Simulation
Oversimplified: 200+ SKU’s not = 200+ tools …
Recent Case Study on 200+ SKUs of Metal predicate part
• Major orthopedic OEM, reusable device • Predicate metal part $98- each • Molded part cost $23- each • Tooling cost $2MM –> a true commitment to the progam • Demand = 200 parts/year of each SKU
• Predicate metal = $3,920,000/year • Plastic = $920,000/year • Tooling more than paid for itself in the first year
• In addition to cost savings, the OEM gained capacity of 2 full CNC machines for implant manufacture
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5. Process and Manufacturing Simulation
Experienced support can be particularly valuable here …
Considerations specific to plastics and injection molding:
• Gating • Anisotropic (non-uniform) properties, fiber orientation • Knitlines or Weld Lines • Shrinkage/warpage
Many can now be simulated in advance …
49
The simulation favored the handle as injection point …
Injection Molding Simulation
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Prediction of Knit Lines
Handle injection point yields better weld/meld path for flow fronts of molten plastic to rejoin …
The choice of a slotted handle design necessitated a knit line.
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6. Prototyping
Multiple options for prototypes exist :
• Additive Manufacturing* • Stereolithography (SLA) • 3D-Printing • Fused Deposition Modeling (FDM) • Laser Sintering (SLS)
• “Soft” injection molding tool • Pre-production steel tool with cores • Machined samples from stock shapes
*Actively being explored for Orthopedic Short Run Production
Retractor Handle Concepts via SLS
(Paragon)
52
7. Validation Testing
Actual comparative measurements versus incumbent.
Repeat characterization tests using newly produced plastic parts.
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7. Validation Testing … to be continued …
Next step … some actual end user feedback.
Conclusion/Takeaways
• Feasibility of an all plastic retractor can be demonstrated. Next step = desirability.
• Robust capabilities are developing within Orthopedic supply chains to further enable metal replacement. The industry is maturing.
• Regulatory aspects are becoming increasing important, and should be included early in the design stage.
• Healthcare OEM’s have experienced resources to call on to guide them through the metal replacement process.
Wheel reinvention not required ….
Thanks for your attention!
Material Safety Data Sheets (MSDS) are available by emailing us or contacting your sales representative. Always consult the appropriate MSDS before using any of our products .
Neither Solvay Specialty Polymers nor any of its affiliates makes any warranty, express or implied, including merchantability or fitness for use, or accepts any liability in connection with this product, related information or its use. Some applications of which Solvay’s products may be proposed to be used are regulated or restricted by applicable laws and regulations or by national or international standards and in some cases by Solvay’s recommendation, including applications of food/feed, water treatment, medical, pharmaceuticals, and personal care. Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for use in implantable medical devices. Solvay Specialty Polymers does not allow or support the use of any other products in any medical device applications. The user alone must finally determine suitability of any information or products for any contemplated use in compliance with applicable law, the manner of use and whether any patents are infringed. The information and the products are for use by technically skilled persons at their own discretion and risk and does not relate to the use of this product in combination with any other substance or any other process. This is not a license under any patent or other proprietary right.
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© 2013, Solvay Specialty Polymers. All rights reserved.
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