challenges & emerging solutions through micro molding

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q  This webinar will be available afterwards at www.medicaldesignandoutsourcing.com & email

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Before We Start

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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)



•  PurasorbPDLG5010(50/50DL-lac4de/glycolidecopolymer)

•  RESOMERL210S(Poly-L-lac4de)

•  RESOMERLR706(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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