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InnovationinMedicalTechnologyandPractice
StanN.Finkelstein,MDFebruary2,2016
InnovationFramework
IdeaGeneration, Invention,Experimentation
KnowledgeManagement
Reduction toPractice
Evaluation
Adoption
Innovation in Pharmaceuticals
Drug Development is a Complex System
Diagram Courtesy of Nancy G. Leveson
InnovationConcepts
• Supplyvs demandsideinitiated• Pushvs pull• Productvs processinnovation• Managingaspectsofinnovationprocess• Disruptiveinnovation• Technology• Organizations• Publicpolicy
Penicillin
• Experimentsin1895-97byItalianandFrenchscientistsmayhavecontributed
• DiscoveryattributedtoAlexanderFlemingin1928inserendipitousobservationthatPenicillum rubens moldhadantimicrobialproperties
• Flemingknowntobeapoorcommunicatorandhisworkwasnottakenseriously
Penicillin
• Limiteduseonpatientswhoheardaboutitandgrewthemoldthemselves
• In1939,AustralianteamledbyHowardFloreyandErnestChainshowedthatthedrugcould
• Curebacterialinfectionsinmiceandpeople• Floreyteamneverpatentedthemedicine,believingthatwouldbeunethical
• DrugwasgreatlyneededforWWIIbattleinjuries,butproductionyieldswerelow
Penicillin
• Progressbychemicalengineers,1942-45producedmillionsofdosesviafermentation
• Supplyconstraintslimitedusagetomilitary• FirstcivilianuseinAustraliain1945• OxfordscientistDorothyHodgkinusedX-raycrystallographytodeterminestructure
Penicillin
• In1957,MITorganicchemistJohnSheehanaccomplishedthefirstchemicalsynthesisofpenicillin
• Sheehanteampatentedthesyntheticprocess• Supplyproblemslargelysolved• ThreeNobelprizesforpenicillinwork:Fleming,FloreyandChain,Hodgkin
MRSAinPittsburghVAHospital
• HospitalintroducedportfolioofinterventionstoreduceMRSAinfectionrates
• “MRSABundle”includednasalsurveillance,contactprecautions,handhygieneandchangein‘institutionalculture’
• 2005-07:nochangeinMRSArated• 2007-10:declinedfrom1.64to0.62infectionsper1000patientdaysisICUs
Managing“IdeaGeneration,Invention…”
• Adequatefunding• Conflictsofinterest• Humansubjects• Otherregulations
Managing“KnowledgeManagement”
• Gatekeeper• Champion
Managing“ReductiontoPractice”
• Technologytransfer• Patentsandcopyrights
Managing“Evaluation”
• FDAregulationsfordrugsanddevices• Technologyassessments• Assessmentofchangeinbehaviororpractice
Managing“Adoption”
• Educationvs promotion• Sourcesofinformation• Socialnetworksandopinionleadership• Overcomingbarrierstoadoption
“DisruptiveInnovation”
• Onceinawhileanewtechnologycomesalongwiththesecharacteristics (Christensen)– Itissimplifyingcomparedtocurrentpractices– Itislesscostly– Initiallynotasgood– Asthetechnologyimproves,itdisruptsthestandardofpractice
InnovationandPublicPolicy• Innearlyeveryindustrynewproductinnovationsinitially
areexpensive,complicated,inaccessibleandrequireskill(Christensen,2008)
• Inmostindustries,technologicalinnovationprovestobecostreducingasprocessinnovationfollowsproductinnovation(Utterback,1978)
• Notobservedinhealthcare,astechnologicalinnovationhasleadtocostinflation(Blume,1992)
• Doctorsneedtoaccessthelatest,mostsophisticatedtechnologiestomeetwhattheyperceivetobetheneedsoftheirpatients(Fuchs,1974)
• Patientsoftenconsideravailabilityoflatestpracticestobeameasureofquality
ClaytonChristensenSeminar“TheInnovator’sPrescription”
• http://video.mit.edu/watch/the-innovators-prescription-a-disruptive-solution-to-the-healthcare-crisis-9380/
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