challenges & emerging solutions through micro molding
TRANSCRIPT
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Before We Start
#MDOWebinar
Introducing the Featured Speakers
MODERATOR FEATURED SPEAKER
Nic Abraham Senior Editor Medical Design & Outsourcing
Brian Matachun Director of Technical Sales MTD Micro Molding
Challenges&EmergingSolu2onsthroughMicromolding
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AboutUs…• Experience:40+yearsofminiaturiza4on;toolmakingàmolding• Focus:EngineeringFocuswithaManufacturingObjec4ve
• 4class100kcleanrooms;11self-containedworkcells• 100%Medical• 100%Micro• DevelopmentprogramsàMillionsofproduc4onparts
• Ver5calIntegra5on:• 100%In-housetooling
• Technology:• Con4nuousinvestment
• NecessaryCredits• ISO9001:2008• ISO13485(July2016)• ProcessoroftheYearFinalist2015
MTDIntroduc4on
PartWeight.00000313gms
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TypicalMicro-sizedPartCharacteris4cs
BoneAnchor:40%carbon-filledPEEKovermoldedover.031”stainlessrod
ImplantableTack(Bioresorbable)
Micro-op4clens(Polycarbonate)
Frac4onsofaplas4cpellet~520partsperpellet
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MTD Six Sciences
MaterialSelec4on
Thermoplas5csThermoplas4csarepolymersthatbecomepliableandmoldableaboveaspecifictemperature,andreturnstoasolidstateuponcooling.Anythermoplas5cmaterial,withpropertes5ng,canbeusedforamedicalimplant.
ASELECTIONWEWORKWITH:
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• ABS(AcrylonitrileButadieneStyrene)
• ABS+PC• Acetal(includingBariumSulfate-filledAcetal)
• COC(CyclicOlefinCopolymer)
• COP(CycloOlefinPolymer)
• Hydrogels• LCP(LiquidCrystalPolymer)
• Nylon(PolyamidePA)
• PEBAX(includingBariumSulfate0fillePEBAX)
• PEEK(PolyEtherEtherKeytone)• PEI(PolyEthermide,Ultem)
• PEIK(LinearPolyEthylene)• PELLETHANE
• PBT(PolybutyleneTerephthalate)• PEKK(Polyaryletherjetone,
includingBariumSulfate-filledPEKK)
• PET(PolyEthyleneTeraphthalate)• Polycarbonate(PC,includingPC/
ABSBlendsandGlass-filledPC)
• Polymide
• Polypropylene(PP)• Polysulfone(PSU)• Polyurethane(flexible)• Polyurethane(rigid)• Tecothane• Tecoflex• TPR(ThermoPlas4cRubber)
25oftheMORECOMMONTHERMOPLASTICSRUNatMTDMICROMOLDING:
BioresorbablesBioresorbablematerialsarepopularinmicromedicalapplica4onsasthematerialscandissolve/absorbintothebody.IDEALFOR:
• Medicalbioabosorbableanchors• Implantablestaples• Bioresorbablemicro-plugs• Micro-screws
ASELECTIONWEWORKWITH:
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• PurasorbPLG8531(85/15L-lac4de/glycolidecopolymer)
• PurasorbPLG8218(85/18L-lac4de/glycolidecopolymer)
• PurasorbPLG1017(10/90L-lac4de/glycolidecopolymer)
• PurasorbPDLG5010(50/50DL-lac4de/glycolidecopolymer)
• RESOMERL210S(Poly-L-lac4de)
• RESOMERLR706(Poly-L-lac4de-co-D,L-lac4de)70:30
• RESOMERLR708(Poly-L-lac4de-co-D,L-lac4de)70:30
• RESOMERLR704(Poly-L-lac4de-co-D,L-lac4de)70:30
• RESOMERRG509S(Poly-L-lac4de-co-glycolide)50:50
• P4HB-based(poly-4-hydroxybutyrate)
• PCL-based(polyepson-caprolactone)
• PLGA-based(polylac4de-co-glycolide)
• PLLA-based(Poly-L-Lac4de)
• Other(CustomerProprietaryBioresorbableMaterials)
MaterialSelec4on
• MICRO-FILL:Specializedmicromoldsfortes4ngmaterialflowofdifferentmaterialsandfillers.Thedatafromtheflowtes4ngisu4lizedtopredictfeasibilityofproductfeatureswhenreviewingnewpartdesigns.
• MICRO-FLOW:Micro-Plaquetoevaluateflowofmaterialsintovariousthicknesses.
• MICRO-RUNNER:Atoolingbasedstrategythatexaminesflowproper4esintherunnersystemtoreducescrap.
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MicroDesign
MicroTechnologies
• Modelvs.Moldedpart• Iden4fyfailuremodes(PFMEA)
• Prototype-bridgetooling–highcavita4onproduc4on• Sontoolingvs.Hardtooling• Exactexecu4onwithworkpieceaccuracyof:
.000042”[~1µ,0.0010668mm]
• Sarix3DEDMmilling
• Allmaintenanceperformedin-house
• EOATin-house–Automa4on
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Micro-EdgeTooling
MicroTooling
• Overmoldingandinsertmolding• Truezero-defect• In-processvisioninspec4on• Screw-overplunger• RJGeDART–sensing&controlintegra4on• Lights-outmanufacturing• Customtrayandpackaging• CustomEndofArmTooling(EOAT)
o Pickandplace
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100%CleanroomMolding
MicroMolding
• Robustvalida4onprocess-standardized• IQ/MT1,MT2,OQ/PQmethodology
• Customin-housefixturing
• Non-contactfullyautomatedOGPmeasurementsystems
• CT-Scanning• GaugeR&R1(analysisoftheeffec4venessofthemeasurementsystem)
• IV,DSC,andTensileTes4ng• Standardcapabilitygoalof1.33Cpk
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MicroMetrologyandTes5ng
1GageRepeatabilityandReproducibility
MicroMetrology
• Reviewingwhatispossible<R.001”.002”wallthicknesses250:1aspectra5osZerodra]
• MicroMedicalApplica4ons:EndoscopyLaparoscopyAbla5onBrachytherapyDrugDeliveryFixa5on
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MicromoldingOpportuni4es
Material:30%GFNylon12Challenge:U4lizethemicromoldingprocesstoinsureapolymerrichsurfacewhichwouldnotallowapossibleelectricalleakpathaswellshutoffondelicatewiringrangingfrom.010”upto.015”.Handling6-8nofdelicatewireassembly.Descrip5on:Electrocauterydeviceusedinanewlaparoscopicplatorm.
CASESTUDY:Stairs
PROBLEM:FailureofAddi5veMfgforRapidPrototyping• 16µlayerthickness&25µstep-over=fuzzyparts• Finishedpartsbrivleandbrokewhenflexed• Notsuitableexceptasamodelfordisplay
SOLUTION:• MTDbuiltasinglecavitytool
• Usefulforprototyping• Acceptableforclinicaltrials• Scalableforproduc4on
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~.040”
~.007X.006”
Eachstair-stepisapprox.diameterofahumanhair
Compe4tor’savempt,using3Dprin4ngtechnologyina“polypropylene-like”prin4nggradepolymer
MTD’smicromoldedacetalpart DetailofMTD’smicromolding
CASESTUDY:BioabsorbableScrew
PROBLEM:• Goal=bioabsorbableproduct• 6+monthsoffailureinthermoplas4c(surrogate)• S4llunabletofillinANYthermoplas4cfilling“violently”
• Lostmarketshare,delayedentrytomarket
SOLUTION:• Uniqueapproachtotooldesigntofill“gently”• MTD4meframe:4weeksPHASEIIRESULT:• Produc2oncapability:over170Kperweek• 7.5%averageIVloss• 38%costreduc2onover4years
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RESCUED
CASESTUDY:DrugDelivery
PROBLEM:• 4piecemanualassembly• Worstplas4cdesignpartever• LeakagebetweenassembledParts• Standardmanufacturingwasnotpossible
• Tolerances• Highcost
SOLUTION:• Moldallcomponentstogetheratonce• MTD4meframe:8weeks• Scalabilitytoproduce50MM• 24/7(lightsout)• Custompackaging• Costreducedby50%• I.D.Cpk=4.5
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RESCUED .0008”WallThickness
• OnlyMolderwhofocusesonMicroMolding• OnlyMicroMolderinNorthAmericasolelyfocusedonMedical
• OnlyMolderinNorthAmericawith3DEDMMillingTechnology
• 90%documentedon4meprojectcomple4on
• 20%ofMTDsuccesseshavebeenFAILURESbyothers
• 30%ofsuccesseshavebeenNOQUOTEDelsewhere
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Differen4ators
Medicalmicromoldingiswhatwedo.Andallwedo.
Material:CarbonFilledPEEKDimensions:MicroOvermoldingovera.031”diameterstainlesssteelrod.Descrip5on:MicroOvermoldingandCarbonFilledPEEKMicroMoldingmaterialswitha400degreeFmoldtemperaturebothpresentmanychallenges.
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Questions?
MODERATOR FEATURED SPEAKER
Nic Abraham Senior Editor Medical Design & Outsourcing [email protected] @NicsMedTechNews
Brian Matachun Director of Technical Sales MTD Micro Molding [email protected] @MTDMircoMolding
#MDOWebinar
q This webinar will be available at www.medicaldesignandoutsourcing.com & email
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