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