healthcare & medical industry...global growth opportunities –aging populations, emerging...
TRANSCRIPT
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Healthcare & Medical Industry
Brian PelleyTechnical Specialist – Moldflow & Advanced Manufacturing Technologies
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Applications
Trends & Challenges
Advanced MFG Technologies
Moldflow Case Studies
Edwards Lifesciences
Idex Health & Science
https://thebestschools.org/rankings
AgendaHealthcare & Medical Industry
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ApplicationsTrends & Challenges
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Applications
Equipment & Disposables Diagnostics / Labs Home Healthcare Surgical Devices Implants Dental Prosthetics
Injection / Drug Delivery Blood / Plasma Systems Dialysis Equipment Packaging / labeling Vision Hearing Cable & Connectors Wearables?
Wide Breath
https://www.wired.com
When your activity tracker becomes a personal medical-deviceSeeking FDA https://www.a-dec.com/gallery/dental-equipment
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“The hope is it will improve diagnoses while reducing their costs at the same time.”
IBM's Watson is better at diagnosing cancer than human doctors
Trends
The Internet of Things Artificial Intelligence VR, AR Automation Surgical Devices Implants Reused vs Disposable Metal -2- Plastics Machined -2- Molded
4th Industrial Revolution
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Trends
The Internet of Things Artificial Intelligence VR, AR Automation Surgical Devices Implants Reused vs Disposable Metal -2- Plastics Machined -2- Molded
4th Industrial Revolution
VR Surgery https://www.cnn.com/2016/04/21/health/virtual-reality-cancer-surgery/index.html
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Trends
The Internet of Things Artificial Intelligence VR, AR Automation Surgical Devices Implants Reused vs Disposable Metal -2- Plastics Machined -2- Molded
4th Industrial Revolution
https://en.wikipedia.org/wiki/Da_Vinci_Surgical_System#/media/File:Cmglee_Cambridge_Science_Festival_2015_da_Vinci.jpg
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Projected Growth
0
0.5
1
1.5
2
2.5
3
Implants Procedures (M) Medical Devices On The Rise
https://www.machinedesign.com/medical/analysts-say-medical-devices-are-rise https://www.businessinsider.com/the-11-most-implanted-medical-devices-in-america-2011-7#6-intra-uterine-devices-iuds-6
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Challenges
Material Properties Availability & Quality Short Term Integrity Long Term Integrity
Product Development Validation Short-Cuts Prototype -2-Production
Plastics Design Experience Experience with metals Start-ups with few resources Recognizing Plastics Defect
Plastics
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Challenges
Material Properties Data Availability & Quality Short Term Integrity Long Term Integrity
Product Development Validation Short-Cuts Prototype -2-Production
Plastics Design Experience Experience with metals Start-ups with few resources Recognizing Plastics Defect
Validation & Regulatory Design & Process Validation Class I, II, III…Tracking
Environment Sterilization Tissue / Fluid contact (removed vs
absorbed) Drug flow path exposure
Liability Outsourcing Qualified Suppliers User Experience Engineering
Medical
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Advanced MFGTechnologies
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Process TypesAutodesk Make Up Front Virtual Testing
CFD & FEA
Additive
Fusion 360
Generative
NetFabb
Formative
Inventor
CFDMoldflow
Subtractive
Fusion 360
Power Inspect
PowerMill
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CFD Insight Advanced MFGTechnologies
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Performance of Medical Devices & Equipment
Simulate Thermals & Fluid Flow
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FEA Insight Advanced MFGTechnologies
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Performance of Medical Devices & Equipment
Simulate static stress on the prosthetic socket buckles
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Additive Advanced MFGTechnologies
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Within Medical Porous random latticing. Design porous random lattices for orthopedic implants tailored for osseointegration
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Subtractive Advanced MFGTechnologies
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Enables high precision programming for Swiss-type lathes
Medical CAM Applications
https://youtu.be/3QsUBbDGbo8
https://youtu.be/igmFdJwtGCc
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Moldflow Advanced MFGTechnologies
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How Moldflow Helps
Regulatory & Sustainability
Exploration at a low cost
Identifying Alternative Cost Models
Complex Design Feasibility
Moldflow Challenges
Troubleshooting vs Optimizing Catching & Managing Defects Adding MFG Details Evaluating Variation Sensitivity
Design - Make
AUT-MFG1441_Medical device ebook_en
Regulatory PressuresCost PressuresSustainability
Digital
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The Prototypes were flat…………… ¯\_(ツ)_/¯
Patient Monitoring
Differential
Shrinkage
Rendered with Fusion 360 Rendered with Fusion 360
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Required top face flatness tolerance within 0.15mm
Medical Valve Assembly
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Unfilled Material bows 0.64mm
30% GF Material bows 0.19mm
15% GF + Mineral
bows 0.08mm
Material Comparison
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Healthcare & Medical Industry
Robert PozzoTool Engineer
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Internal use only
Our History Founded by Miles “Lowell” Edwards in 1958
– Inventor and visionary, held 60+ patents
Trusted partner with physicians to introduce innovative medical devices– Albert Starr, Jeremy Swan, William Ganz,
Thomas Fogarty, Alain Carpentier, Delos Cosgrove, Alain Cribier
Company evolution– 1958 Edwards Laboratories– 1968 American Hospital Supply– 1985 Baxter International– April 2000 Edwards Lifesciences (NYSE:EW)
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Internal use only
Investing to transform patient experience and extend leadership
Global growth opportunities– Aging populations, emerging markets
Transcatheter therapies expand treatment options– Clinical evidence, new technologies extend leadership positions– Focused on procedural success
Global growth opportunities– Untreated patient populations– Moderate and low-risk patients may seek treatment longer-term
Surgical & Transcatheter Heart Valve
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Internal use only
Multiple THV growth opportunities– Expanded indications and device innovations– New interventional platforms including mitral
Transformation of Valve Surgery– MIS platforms potential to be standard of care– Innovative options for younger patients
Critical Care expansion– Non-invasive technology increases penetration– Pioneering smart monitoring innovations
Expansion in emerging markets
Edwards’ Growth Primarily Fueled by Innovation
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Medical MoldingCase Studies
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Internal use only
Predetermine weld lines formations to incorporate features
Weld Line Prediction Study
Material: Sabic, Lexan HPX8R (High flow PC 35 MFR)Processing Temperature: 581° FMold Temperature: 180° F
Challenges:• Nominal and Thick Wall Sections• Over-Molded Wire Will Have Pull
Force and Torsion Requirements
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Internal use only
Core pins to support Main Core Pull from deflection will also be vented to atmosphere.
Placement of the core pins is predetermined by the weld lines formation prediction.
Weld Line Prediction Study
Vent to Atmosphere
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Internal use only
Predetermine weld line formations to incorporate features
Weld Line Prediction Study
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Internal use only
Material: Solvay Udell P1700 (PSU)Processing Temperature: 675° FMold Temperature: 300° F
Shrinkage Void Mitigation
Challenges:• Nominal and Thick Wall Sections• Over-Molded Wire Will Have Pull
Force and Torsion Requirements
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Internal use only
Shrinkage Void MitigationObservation:Heat Concentrated in Thick Areas Created a Void After Pack and Hold Causing Wire to Slip Out.
Processing Was Not Successful In Removing The Void. Temperature Variations and Profile Injection Helped Reduce The Void, But No Significant Change.
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Internal use only
Shrinkage Void Mitigation
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Internal use only
Shrinkage Void Mitigation
Approach A:Adding Material to The Wire To Reduce Material Wall Thickness Thus Removing Concentrated Heat and Shrinkage.Different Wire Configurations Were Evaluated
Wire With a Larger Step To Add Material and a Groove To Prevent Rotational Movement
Air Trap Identified During Flow Analysis.
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Internal use only
Shrinkage Void Mitigation
Approach B:Adding Material to The Wire To Reduce Material Wall Thickness Thus Removing Concentrated Heat and Shrinkage.Different Wire Configurations Were Evaluated
Wire With a Larger Step To Add Material and a Hole Thru To Prevent Rotational Movement
Trapped Air Preventing Fill
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Internal use only
Shrinkage Void Mitigation
Approach B:Weld Line Formation Identifies Trapped Air Pocket in the Wire Hole.
Weld Line Formation
Vent / Back Pressure
Unfilled Cavity predicted
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Internal use only
Shrinkage Void Mitigation
Approach C:Adding Material to The Wire To Reduce Material Wall Thickness Thus Removing Concentrated Heat and Shrinkage.
Wire With a Larger Step To Add Material and Two Flats To Prevent Rotational Movement
Larger Head Diameter Was Used. Heat Concentration Was Lowered Thus Reducing Heat Void Significantly.
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Internal use only
Shrinkage Void Mitigation
Ideal Scene:If Feasible, The Core-Out Option Is The Optimum Solution. Not An Option On This Project
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Health Care & Medical Industry
Gabe HillAssociate Product Development Engineer
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© 2016 IDEX Health & Science
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Introduction
45
Three divisions:• Fluid & Metering• Health & Science
• Analytical Instruments• Automotive• Food & Pharmaceuticals• Industrial• Life Sciences• Medical & Dental• Semiconductor &
Electronics• Fire & Safety
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Chromatography
46
Typical analytical chromatography system (Agilent 1290)
Example chromatograph
• Separation of substances into their components
• Quantification of components • Ranging from sample volumes of µL
(Analytical) up to Liters (Industrial)• Result quality based on:
• Sample prep• Procedure development• System performance
• Column efficiency• System volume• Solvent performance
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Solvent Degasser Overview
47
Vacuum Pump
Solvent
Porous Tubing
Chromatography System
Degasser Bulkhead
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Degasser Bulkhead Overview
48
Part Functions:• Fluidic connections
• 1/4”-28 Flat-bottom
• 10-32 Cone Port• System mounting
• M3 bolt hole• Bracket
alignment• Vacuum Seal
• O-ring seat• Tank alignment
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Current State
Moldflow Density Result: shows low density (4% decrease) in thick sections. Mold contact freezes outer material first while inside continues to contract creating voids
Thick sections in current design results in voids. These voids periodically result in mechanical failure
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Proposed Design Changes
50
Design Changes:• Reduce mounting flange
thickness• Remove material around ¼-20
port bosses and replace with ribbing
Results:• Reduce wall thickness• Reduce overall part height• Reduce shot size (cycle time)
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Design #1
51
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PPS PEEK
Existing
Re-Design
Moldflow Density Comparison
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Material DesignDensity
Max Min Δ Δ (%)
PPS Existing 1.642 1.574 0.068 4%
PPS New 1.656 1.629 0.027 2%
PEEK Existing 1.274 1.175 0.099 8%
PEEK New 1.28 1.255 0.025 2%
Quantified Density Results
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Gate Freeze Visualization
Gate Frozen (.050”x125”)T<3.7 seconds
Thick sections still molten
• Gate is too small for current part thickness• Thickness should be closer to %70 of
nominal wall thickness
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Gate Freeze Time
55
.05”x.125”(Current Gate).125”x.125”
1.0 second
3.3 seconds
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Time to Reach Ejection Temperature (400 °F)
56
.125”x.125”.05”x.125”(Current Gate)
Gate Size Comparison
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• Gate increased 2.5X from standard • Parts molded with standard
process• X-ray section analysis to
determine differences (attribute data for comparison)
• Void content reduced by increasing gate size
• Voids still present with modified gate and standard process
Gate Modification
Comparison of Standard vs. Modified
Standard Gate (X-ray image from 1/4/19)
Modified Gate (X-ray image from 4/2/19)
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Volumetric Shrinkage & Velocity
58
Volumetric Shrinkage Velocity During Solidification
Areas with Highest Volumetric Shrinkage
Velocity directions as high shrink areas are freezing
Arrows pointing towards wall indicate voids
Arrows pointing towards center indicate sink
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• DOE utilized modified gate (0.125” x 0.125”)
• Factors – Injection speed, hold pressure, nozzle temperature
• Samples were X-ray imaged for porosity analysis
• ImageJ software utilized to quantify void content
• Void content observed in all runs
Process DOE Results
3 Factor, 2 Level, Full Factorial, with Center Run
0
2
4
6
8
10
12
14
16
18
1 2 3 4 5 6 7 8 9
Void
Con
tent
(%)
DOE Run
DOE Data Summary
Processed X-ray image (Run 9)
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Process DOE Results - Images
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Run 1 Run 2 Run 3 Run 5
Run 6 Run 7 Run 8 Run 9
Run 4
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Moldflow DOE Results
• 95% Confidence Interval (p<0.05)• Random and homogeneous residuals• Predictive equation
• Injection Speed (A) is not significant outside of interaction terms
• All other factors are significant• Minimum void content with:
• High injection speed• High hold pressure• Low nozzle temperature
Coefficients Standard Error t Stat P-valueIntercept 11.5400 0.2276 50.6995 0.0000A -0.1148 0.2414 -0.4757 0.6397B -1.2602 0.2414 -5.2198 0.0000C 1.6027 0.2414 6.6384 0.0000AB 0.7683 0.2414 3.1825 0.0049AC 1.9190 0.2414 7.9487 0.0000BC 0.9693 0.2414 4.0151 0.0007ABC 0.3660 0.2414 1.5160 0.1460
Intercept 11.53996A 1B -1.26017 1C 1.602667 -1AB 0.768333AC 1.919BC 0.969333
Prediction Equation
Predicted Result6.55712963
Excel Regression Analysis
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• Optimum process condition is: high injection speed, high hold pressure, low nozzle temperature
Moldflow DOE Results
3 Factor, 2 Level, Full Factorial, with Center Run
![Page 63: Healthcare & Medical Industry...Global growth opportunities –Aging populations, emerging markets Transcatheter therapies expand treatment options –Clinical evidence, new technologies](https://reader033.vdocuments.site/reader033/viewer/2022051511/600c61781435d5129d422501/html5/thumbnails/63.jpg)
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