MassMassachachuusesettstts InInssttiittuutte of Technole of TechnoloogygyHaHarvarvarrd Md Meedicadicall SScchohoololBrBrigighaham am annddWWoomemenn’’s Hs HoossppitalitalVA BVA Boossttonon HeHealalthcthcaare Sre Syysstteemm2.782J/3.961J/BEH.451J/HST524J2.782J/3.961J/BEH.451J/HST524JDESIGN OF MEDICALDESIGN OF MEDICAL DEVICES/IMPLANTSDEVICES/IMPLANTSOverviewOverviewM. SpectoM. Spectorr, Ph.D., Ph.D. 2.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplants••••••Design of a novel implantable device that has aDesign of a novel implantable device that has a reasonable expectatreasonable expectation of wion of woorking:rking:––not an incremental improvementnot an incremental improvement in an existinin an existingg devicedevice ––no need fabricate the deviceno need fabricate the device––document should be sufficidocument should be sufficient foent for a patent disclosurr a patent disclosureeNot to use a thesis topic or a project on wNot to use a thesis topic or a project on whhicich you are alyou are already wready woorkingrkingNot a class in wNot a class in wrriting aiting a ““business planbusiness plan””Page 12.7822.782 DesignDesignof Medicalof Medical DeviDevices/ces/IImplantsmplants••••••Description/diagram of the deviceDescription/diagram of the device––DimensionsDimensions––Materials of fabricationMaterials of fabrication––AA working model is not neceworking model is not necessary, but may be possiblessary, but may be possible––Computer simulation is not necessary, but may be possibleComputer simulation is not necessary, but may be possibleDescription of howDescription of how the device is to functionthe device is to functionDiagram of the device in its site of implantationDiagram of the device in its site of implantation––Description of hoDescription of howw the implant is to be fixed to the hosthe implant is to be fixed to the hosttissue/organtissue/organ––Instrumentation for implantationInstrumentation for implantation (if an essential feature o(if an essential feature ofthe device)the device)2.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplantsPatent OptionsPatent Options••Students are free toStudents are free to pursupursue a patent on theie a patent on their owown (at their own (at their own expense)n expense)••Can approach the Patent Office at MIT toCan approach the Patent Office at MIT to determine if the Instdetermine if the Institute has an interest initute has an interest in obtaining a patentobtaining a patent––1/3 to1/3 to inventor(sinventor(s))––1/3 to inventors1/3 to inventors’’departmentdepartment––1/3 to Institute1/3 to InstitutePage 2Page 32.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplantsExercise in EngiExercise in Engineerinneeringg DesignDesign••EngineeringEngineering••ScienceScience••TechnologyTechnology2.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplantsExercise in EngiExercise in Engineerinneeringg DesignDesign••EngineeringEngineering––MakMakiing a product for the human goodng a product for the human goodusing existing kusing existing knnoowwledgeledge••ScienceScience––Process of acquiring newProcess of acquiring newknowknowledgeledge••TechnologyTechnology––Means of producing the productMeans of producing the productPage 42.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplants••••••••Approach towApproach towaard the Designrd the DesignDiscuss possible design topicDiscuss possible design topicss in classin class––Personal medicaPersonal medical experiencesl experiences––InformatioInformation from the median from the media––Intuit/braIntuit/braininstormstormStudents join to form design teams (3Students join to form design teams (3--4/team)4/team)Consultations wConsultations wiith Professors Yannas and Spectorth Professors Yannas and SpectorConsultations wConsultations wiith cliniciansth clinicians2.782 Design of Medical2.782 Design of Medical DeviDevices/ces/IImplantsmplants••Oral presentationsOral presentations––PoPowerPointwerPoint••ReportsReports––Microsoft Word doMicrosoft Word documencumenttssPage 5Permanent ReplacementPermanent Replacement Devices/ProsthesesDevices/ProsthesesAbsorbable Scaffolds for TissueAbsorbable Scaffolds for TissueEngineering/RegenerationEngineering/RegenerationPermanent Replacement versus Regeneration Figures removed due to copyright restrictions. Fixation plate and screws Total knee replacement prosthesis Total hip replacement prosthesis Anorganic trabecular bone as a bone graft substitute material Collagen-GAG Scaffold Biomaterials as Medical Devices Multicomponent Medical Devices Figures removed due to copyright restrictions. Page 6Collagen-GAG Regeneration Templates Figures removed due to copyright restrictions. See Swerdlow, Joel L. "Unmasking Skin." National Geographic (November 2002). WAITING LIST FOR ORGANSWAITING LIST FOR ORGANSSciSci. Registry of Transplant Recipients. Registry of Transplant RecipientsNo. onNo. on wawaitingitingNo.No. who dwho diied oned onlist as of 6/30/01list as of 6/30/01list 7/list 7/1/001/00--6/30/016/30/01KidneyKidney49,86049,8602,8372,837LiverLiver18,08918,0891,7991,799PancreasPancreas9769762323KidneyKidney--PancreasPancreas2,5872,587220220HeartHeart4,2004,200608608LungLung3,7983,798497497HeartHeart--LuLungng2222223535IntestineIntestine1701702424AllAll79,90279,9026,0436,043wwwwww.ww.ww.ww.ustustustustrrrraaaannnnsplasplasplasplant.nt.nt.nt.oooorgrgrgrgNY TimesNY Times,, 3/13/100//0022Page 7ERAS OF (ORTHOPEDIC) SURGERYERAS OF (ORTHOPEDIC) SURGERY19201920--19701970Age of DevicesAge of Devices19701970--Age of BiomaterialsAge of Biomaterials20002000--Age of Tissue EngineeringAge of Tissue Engineering20102010--Age of Gene Therapy (?)Age of Gene Therapy (?)ERAS OF (ORTHOPEDIC) SURGERAS OF (ORTHOPEDIC) SURGERYERY19201920--19701970Age of DevicesAge of Devices--Fracture fixationFracture fixation--Joint replacemenJoint replacementt--Spine instrumentationSpine instrumentation19701970--Age of BiomaterialsAge of Biomaterials--Hydroxyapatite coatings for TJAHydroxyapatite coatings for TJA--Bone graft substitute materialsBone graft substitute materialsPage 8ERAS OF (ORTHOPEDIC) SURGERAS OF (ORTHOPEDIC) SURGERYERY20002000--Age of Tissue EngineeringAge of Tissue Engineering--Porous absorbable materials toPorous