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/