27/03/2017 10CriteriaforChoosingtheRightMaterialsforYourMedicalDeviceDesign

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10 Criteria for Choosing the Right Materials for

Your Medical Device Design
Tue, 05/17/2016 - 10:03am by Cheryl Goodwin, Technical Business Development Manager, Nypro, a
Jabil Company

Materialsselectedforuseinnewmedicaldevices
canhavemajorramificationsthroughouttheproduct DEEPER INSIGHTS
lifecycle,fromdesignthroughtesting,during
regulatoryapprovalsandproduction,andinthe
builduptomarketadoptionandevendisposal.
Ideally,materialssuchasplastics,composites,
elastomersandmetalsarereadilyandconsistently
availablefromthesupplychain.Preferably,the Prototyping and Low-Volume
chosensuppliersdeliverhighquality,outstanding Production for Medical
performanceandsafetyatthetargetpricepoint.And Applications
ofcoursethematerialsshouldenhancedesign
freedom,promoteregulatorycompliance,simplify
manufacturingandappealtoprovidersandpatients
byenablingergonomic,comfortableandaesthetic
solutions.Checkingoffasmanyoftheseboxesaspossiblewhenspecifyingmaterialscan
makeacriticaldifferenceintimetomarketandcommercialsuccess.

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27/03/2017 10CriteriaforChoosingtheRightMaterialsforYourMedicalDeviceDesign

However,giventheinevitabledesignvariablesandtheseeminglyinfinitematerialchoices
available,selectioncanbeexceptionallycomplicatedandtimeconsuming.Thiscomplexity
iscompoundedfordevicecompaniesthatlackdeepmaterialsexpertise,andmaypersuade
designerstogowithwhattheyknowinsteadoftryingsomethingbetter.

Severalcriteriashouldbetakenintoaccountwhenselectingmaterials.Acompetentdesign
andmanufacturingservicespartnercanoftensavetimeandmoneybyhelpingtoavoid
costlymistakes.Suchpartnerscanalsosuggestnewsolutionsthataddressemergingtrends
indevicedesignandhelpachieveproductdifferentiation.

Preferably, the chosen suppliers deliver high quality, outstanding performance and safety at the target price point. And of course the materials
should enhance design freedom, promote regulatory compliance, simplify manufacturing and appeal to providers and patients by enabling

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27/03/2017 10CriteriaforChoosingtheRightMaterialsforYourMedicalDeviceDesign

ergonomic, comfortable and aesthetic solutions.

MaterialsSelectionCriteria

Followingareimportantcriteriatoconsiderwhenevaluatingthesuitabilityofmaterialsfora
medicaldevice.Thesefactorsmustbeviewedthroughthelensofmajortrendsin
healthcare,fromtheagingofthepopulationtothemovetohomebasedcareandthe
increasedemphasisonpreventinghospitalacquiredinfections(HAIs).

1.Availability
Oneofthebaselinerequirementsforanymaterialisconsistentlyreliableavailability.If
quantitiessufficientforcurrentandfutureneedsarenotreadilyavailable,anewdevices
timetomarketandsalespotentialcouldbenegativelyimpacted.Equallyimportant,supplies
shouldbeproducedascloseaspossibletothedevicemanufacturingsitetoavoidhigh
shippingcostsandprovidejustintime(JIT)likedelivery.

Ofcourse,availabilityisanumbrellatermforahostofsupplychainvariables:financial
stabilityandtechnologicalcapabilitiesoftheproducerexistingqualitysystemsandthe
suppliersabilitytoprovidehighqualityassurancelocalorregionalregulationspossible
economicandpoliticaldisruptionsthelistgoeson.Tosucceedinthisarea,device
companiesmaywishtorelyontheexpertiseandinfrastructureofaglobalmanufacturing
partner.Alarge,endtoenddesignandmanufacturerservicescompanyofdiverseproducts
typicallyhasastrong,worldwidesupplychainwithtrustedvendors,awidearrayof
rigorouslytestedmaterials,andtheabilitytomonitorandproactivelymanagesupplier
performance.

2.DesignFlexibility
Materialsareinstrumentaltothedesignfreedomsthatdrivedeviceinnovation.Plastics
alone,forexample,canbemoldedintocomplexshapesorconsolidatedfrommultipleparts
toenablesimpler,moreelegantdesigns.Overmoldingathermoplasticelastomerontoa
rigidplasticsubstratecanprovidebettergriporamorecomfortablefeel.Certainplastics

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27/03/2017 10CriteriaforChoosingtheRightMaterialsforYourMedicalDeviceDesign

andcompositescanfurtherhelpdesignerscreatethinnerwalldevicesthatcombinelight
weightwithstrength.

Thechallenge,however,isthatthereisahugenumberofplasticchemistriesand
compounds,anddesignersmayneedassistancefromamaterialsreferencedatabaseora
knowledgeablepartnertofindthemostappropriatecandidatesespeciallywiththe
emergenceofnextgenerationtechnologiessuchasconductivepolymers,nanopolymersand
shapememorymaterials.Althoughstickingwithsomethingtriedandtruemaysavetime,it
canalsomeanmissingoutonacompetitiveadvantageorevenabreakthroughdesign.

3.CostperUnit
Materialcostsareacriticalaspectofanymedicaldevice.Butcompaniesneedtolook
beyondthesimplepriceofaplasticormetaltoassessitstruelifecyclecosts.Different
materialscanraiseorreducecostsbyaffectingdownstreamfactors,suchas:

Amountrequiredperdevice,whichisinfluencedbymaterialdensity,wallthickness
andpartconsolidation
Additivesneededor,incasessuchaspolymerswithmoldedincolor,notrequired
Easeandspeedofmanufacturingduetorequiredsecondaryoperationsora
materialssuitabilityforhighvolumeproduction
Transportcostsforshippingweightordistance

Itisimportanttoconsiderhoweachcandidatematerialcanaddorreducetheunitcostofa
devicethroughoutthefulllifecycle.Sometimesamoreexpensive,higherperforming
materialcanactuallysavemoneyinthelongrun.

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Materials are instrumental to the design freedoms that drive device innovation.

4.PerformanceProperties
Centraltothematerialselectionprocessismatchingperformancecapabilitiestodevice
specifications.Performancecapabilitiescanrangefrommechanicalproperties,suchas
strength,flexuralmodulusandhightemperatureresistancetochemicalresistance,
particularlyexposuretoharshantibacterialcleanersusedtocombatHAIs.Theyalsoinclude
thedemandsofcommonusagescenarios,includingresistancetobreaking/crackingfrom
impact.Somematerialsareinherentlystrong,flexibleorchemicallyresistant,whileothers
canbeenhancedwithadditivesorreinforcedwithfillersorglassfiber.

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5.RegulatoryCompliance
Althoughregulatorybodiescertifythesafetyandefficacyoffinishedmedicaldevicesrather
thantheircomponentmaterials,adetailedmasteraccessfileforacertainmaterialcan
oftenhelpsmooththeroadtodeviceapproval.Amanufacturingpartnerwithadedicated
regulatorypracticecanhelpdevicecompaniesidentifymedicalgradeplastics,elastomers
andcompositesthatmeetU.S.FDAandUSPClassVIrequirements,aswellasthosefor
internationalregulations.

6.Biocompatibility
Biocompatibilityisultimatelyafunctionofacompleteddevice,soitencompassesallofits
components,assemblyprocessesandoveralldesign.However,thoughtfulmaterialselection
canhelpensuretheoverallbiocompatibilityofafinishedproduct.

Eachmaterialshouldundergobiocompatibilityassessmentusingcharacterization
techniques.Thecompleterangeoftestingconductedaspartofabiocompatibility
assessmentisdetailedinthestandardISO109931:2009.However,indeterminingwhich
specificteststoconduct,specialconsiderationisgiventohowamedicaldevicewillactually
beusedandthedegreeanddurationofcontactbetweenthedeviceandthepatient.This
canbeacomplexandlengthyprocess,andmisstepscanleadtodelaysintheproduct
developmentcycle.

Anendtoendmanufacturingpartnercanhelpidentifythetestingrequiredandthe
appropriatetimeinthedevelopmentprocesstoexecutethesetests.Thetimingshouldbe
consideredasafactorinoveralltimetomarket,weighingitagainsttherisktoleranceofthe
project.Thepartnerofchoiceshouldalsobecapableofmonitoringcertifiedthirdpartylabs
usedtoconducttesting.

Evenwhenmaterialsincorporatedintoamedicaldevicehavebeenassessedfortheir
biocompatibility,newriskscanbeintroducedthroughmanufacturingandpostproduction
processesthatcanhaveanadverseeffectonthedevice.Propercleanroomassemblyand
hygieneprocesseshelptolowertheserisks.

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7.AestheticsandUsability
Thetrendstowardhomebasedcaredeliveryandconsumerhealthmonitoringdevicesare
compellingdevicemanufacturerstopaycloseattentiontoappearanceandeaseofuse.
Devicesusedbypatientsorfamilymemberswithoutdirectclinicalsupervisionmayrequire
specialmodifications,suchasimprovedergonomicsorgrip.Forexample,theuseofcolor,
specialeffectsandtexturecanhelppatientsunderstandandfollowcorrectusage
parameters.Lightweightmaterialsincreasedeviceportability,oftenwithoutcompromising
strengthordurability.

Amanufacturingpartnerwithexperienceinconsumergoods,suchasconsumerelectronics,
canbringvaluableexpertisetomaterialsselectionforusability,aestheticsand
miniaturization.Often,theconsumersectorisaheadofthehealthcareindustryinitsuseof
advancedmaterialtechnologies.Theseinnovationscanoftenbetransferredtomedical
deviceapplications.

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To reduce the prevalence of HAIs, hospitals use aggressive disinfectants such as alcohol, bleach and peroxide as well as sterilization methods
including autoclaving, gas plasma and Ethylene oxide (EtO). Repeated exposure can cause many plastic medical devices to craze or crack, lose
critical properties or change color.

8.ManufacturingEfficiency
Themanufacturingprocessofferssignificantopportunitiesforcostsavingsandproductivity
gainsiftherightmaterialsarechosen.Theabilitytousehighvolumeand/orintegrated
processes,suchastwoshotinjectionmolding,canlowersystemcostsandenablerapid
scaleup.Anotherkeyopportunityinvolvesminimizingsecondaryoperations,suchas
assembly,curing,polishingandpainting.Forexample,resinswithstandardorcustomized
moldedincolorsandeffectsareavailablefrommanysuppliers.

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Manufacturingefficiencyisoftenacorecompetencyoflargedesignandmanufacturing
servicescompaniesthatproduceverylargevolumesundertighttimeandbudget
constraints.Theyarewellversedindrivingoutunnecessarycoststhroughtheuseof
innovativematerials,technologiesandprocesses.Inaddition,thesepartnershavethe
abilitytodesign(ormodify)productsforassemblyandmanufacturingtechniquesakey
stepinaproductsindustrialization.

9.SterilizationandCleaning
ToreducetheprevalenceofHAIs,hospitalsuseaggressivedisinfectantssuchasalcohol,
bleachandperoxideaswellassterilizationmethodsincludingautoclaving,gasplasma
andEthyleneoxide(EtO).Repeatedexposurecancausemanyplasticmedicaldevicesto
crazeorcrack,losecriticalpropertiesorchangecolor.Asanalternative,metaloffers
excellentresistancetoharshcleanersandvarioussterilizationtechniques,buthasa
numberofotherdrawbacks,includingincreasedweightanddesignrestrictions.Designers
seekingthemiddlegroundcanconsidersemicrystallinepolymerssuchaspolypropylene,
polyethyleneandpolyamides,whicharelighterandmoremoldablethanmetalsandoffer
betterchemicalresistancethanamorphouspolymerssuchaspolycarbonateand
acrylonitrilebutadienestyrene.

10.Sustainability
Thesustainabilityofmedicaldevicescomesintoplayprimarilyduringdesign,manufacture
anddisposal.Materialselectionaffectsallthesestagesofthelifecycle.Inthedesignphase,
sustainabilityconsiderationsincludestrategiessuchastheuseoflowerdensitymaterials,
reducedneedforfillers,broaderpartconsolidationanddowngauging.Manufacturing
processescanalsobetweakedtoreduceenergyandwateruse,orlowerscrapgeneration
orvolatilesreleasedfromsecondarypaintingandadhesives.So,inadditiontofindingthe
mostcosteffectiveorhighestperformingmaterial,devicemakersshouldalsoevaluatehow
itmustbeprocessed.Endoflifeisanotherstagewherematerialsselectioncancontribute
tosustainability.Forinstance,areadilyrecyclablematerialandavoidanceofproblematic
additivessuchashalogenatedflameretardantscanfacilitatedisposal.

Conclusion
Materialsaffectamedicaldevicesperformance,appearance,cost,durabilityand

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sustainabilityandcansignificantlycontributetothespeedofcommercializationandmarket
success.Butmaterialselectioncanalsopresenthugechallengesduetothesheervarietyof
optionsthatmustbeevaluatedagainstrigorouscriteria.Designersandbrandownerscan
streamlinetheselectionprocessandreducetheriskofcostlymistakesbytappingthe
expertiseofamanufacturingpartnerwithmaterialsexperienceandastrongandreliable
supplychain.

Reference
PhysicalandChemicalCharacterization:TheFirstStageinAssessingtheBiocompatibilityof
MedicalDeviceMaterials.UnderwritersLaboratories.http://library.ul.com/wp
content/uploads/sites/40/2015/02/UL_WP_Final_TheFirstStageinAssessingthe
BiocompatabilityofMedicalDeviceMaterials_v10_HR2.pdf

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