Medical Devices: Improving Health Care Through a Multidisciplinary Approach PDF
Preview Medical Devices: Improving Health Care Through a Multidisciplinary Approach
Research for Development Carlo Boccato Sergio Cerutti Joerg Vienken Editors Medical Devices Improving Health Care Through a Multidisciplinary Approach Research for Development SeriesEditors EmilioBartezzaghi,Milan,Italy GiampioBracchi,Milan,Italy AdalbertoDelBo,PolitecnicodiMilano,Milan,Italy Ferran Sagarra Trias, Department of Urbanism and Regional Planning, Universitat PolitècnicadeCatalunya,Barcelona,Barcelona,Spain Francesco Stellacci, Supramolecular NanoMaterials and Interfaces Laboratory (SuNMiL), Institute of Materials, Ecole Polytechnique Fédérale de Lausanne (EPFL),Lausanne,Vaud,Switzerland EnricoZio,PolitecnicodiMilano,Milan,Italy EcoleCentraleParis,Paris,France The series Research for Development serves as a vehicle for the presentation and dissemination of complex research and multidisciplinary projects. The published work is dedicated to fostering a high degree of innovation and to the sophisticated demonstrationofnewtechniquesormethods. The aim of the Research for Development series is to promote well-balanced sustainable growth. This might take the form of measurable social and economic outcomes,inadditiontoenvironmentalbenefits,orimprovedefficiencyintheuseof resources;itmightalsoinvolveanoriginalmixofinterventionschemes. ResearchforDevelopmentfocusesonthefollowingtopicsanddisciplines: Urbanregenerationandinfrastructure,Info-mobility,transport,andlogistics,Envi- ronment and the land, Cultural heritage and landscape, Energy, Innovation in processesandtechnologies,Applicationsofchemistry,materials,andnanotechnol- ogies, Material science and biotechnology solutions, Physics results and related applicationsandaerospace,Ongoingtrainingandcontinuingeducation. Fondazione Politecnico di Milano collaborates as a special co-partner in this seriesbysuggestingthemesandevaluatingproposalsfornewvolumes.Researchfor Development addresses researchers, advanced graduate students, and policy and decision-makersaroundtheworldingovernment,industry,andcivilsociety. THESERIESISINDEXEDINSCOPUS Moreinformationaboutthisseriesathttps://link.springer.com/bookseries/13084 (cid:129) (cid:129) Carlo Boccato Sergio Cerutti Joerg Vienken Editors Medical Devices Improving Health Care Through a Multidisciplinary Approach Editors CarloBoccato SergioCerutti Milano,Italy DepartmentofElectronics,Information andBioengineering PolitecnicodiMilano Milano,Italy JoergVienken Usingen,Hessen,Germany ISSN2198-7300 ISSN2198-7319 (electronic) ResearchforDevelopment ISBN978-3-030-85652-6 ISBN978-3-030-85653-3 (eBook) https://doi.org/10.1007/978-3-030-85653-3 ©SpringerNatureSwitzerlandAG2022 Thisworkissubjecttocopyright.AllrightsarereservedbythePublisher,whetherthewholeorpartofthe materialisconcerned,specificallytherightsoftranslation,reprinting,reuseofillustrations,recitation, broadcasting,reproductiononmicrofilmsorinanyotherphysicalway,andtransmissionorinformation storageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodology nowknownorhereafterdeveloped. Theuseofgeneraldescriptivenames,registerednames,trademarks,servicemarks,etc.inthispublication doesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexemptfromtherelevant protectivelawsandregulationsandthereforefreeforgeneraluse. The publisher, the authors, and the editorsare safeto assume that the adviceand informationin this bookarebelievedtobetrueandaccurateatthedateofpublication.Neitherthepublishernortheauthorsor theeditorsgiveawarranty,expressedorimplied,withrespecttothematerialcontainedhereinorforany errorsoromissionsthatmayhavebeenmade.Thepublisherremainsneutralwithregardtojurisdictional claimsinpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSwitzerlandAG. Theregisteredcompanyaddressis:Gewerbestrasse11,6330Cham,Switzerland Foreword Thedevelopmentandapplicationofmedicaldeviceshasalonghistory.Someyears ago,a3000-year-oldwoodentoeprosthesiswasfoundattachedtoafemalemummy inanancientEgyptiangravesite[1].Itisoneoftheoldestprostheticdevicesinthe world’s history and shows both the engineering skills of our ancient ancestors and theirmedicalexperience.Furtherexaminationoftheprosthesishasrevealeddetails about the time from which it came. With technologies like modern microscopy, X-rays and computer imaging, a team of researchers were able to determine the materialsandmethodsusedtomaketheprosthetic.Theyfoundthatthewoodentoe was refitted several times. Based on the meticulous construction of the ancient prosthesis, the researchers determined the wearer, a priest's daughter, who wanted the toe to look natural and be comfortable to wear. About 2,500 years later, the famous astronomer Tycho Brahe (1546–1601) profited from a spare part, when he receivedagoldenartificialnoseafterhavinglosthisnoseinanaffairofhonouratmy hometown’s University of Rostock. Some years earlier in 1518 AC, the famous German chevalier Goetz von Berlichingen (1480–1562) and protagonist of the German Peasants war in the beginning of the sixteenth century received an iron artificial hand and could thus continue fighting with the help of such a prosthesis. Theseexamplesillustratethatthehistoryofmedicaldevicesincludingartificialbody spare parts can be rewritten in such a way as engraved in the building of the DepartmentofJusticeinWashington:“Whatispastisprologue!” Medical devices save indisputably lives. Recent years have seen an enormous pushinthedevelopmentofbothnewmedicaldevicesandmedicinaldrugs.Thisis certainly based onan increasedknowledge combined with managerial competence andapressureoriginatingfromdemographicchanges.Theincreaseinthenumberof elderlypeopleandtherelatedlossofbodyfunctionsfurtherstimulatesresearchand application of sophisticated devices with “performance” as a magic word. Perfor- manceofmedicaldevicesiscloselyrelatedtotheirapprovalwhichisaprerequisite of sales and marketing. Medical devices must further reach the affected patient, which explains why logistics, health insurances and financial budgets also play a major role, both in the western hemisphere and in the so-called Third World. The v vi Foreword development of medical device is costly, and thus a return of investment for manufacturers and healthcare providers cannot be neglected. The search for new waysofefficientfinancingallovertheworldis,therefore,achallengeforthecurrent medical device technology. Taken together all these influencing factors can be integratedthrougha“SystemsApproach”[2].Asystemsapproachinmedicaldevice technology bases on the combined efforts of dedicated engineers, physicians and managers for both well performing devices and therapies and to achieve optimal cures for a high quality of life of patients. To my great pleasure, and more than 30 years after the introduction of this keyword, this book perfectly advances the understanding, development and promotion of medical device technology as a “systemsapproach”. This book provides to my knowledge the first comprehensive and well- documentedbookinthefieldofmedicaldevicetechnologybyprovidingengineer- ing, economic and medical rationales for the development and use of medical devices. The collaborative work of the editors and authors brings to you a book whichrepresentsindisputablyaperfectoverviewabouttheactionswhichdetermine theconditionsforprovidingandsustainingmedicaldevices.Ialsowelcomeinthis book the description of tasks of individual stakeholders, not to forget financial aspects and the provision of medical devices in emerging third world countries. I hope that this book will serve as a vehicle for a better understanding of the backgroundandproblemsofmedicaldevicetechnologyandthatinterestedreaders profitfromitswidedissemination. References 1. NerlichA,ZinkA,SzeimiesU,HagedornH(2000)AncientEgyptianprosthesis ofthebigtoe.Lancet356(9248):2176–2179 2. KlinkmannH,FalkenhagenD,StefoniS,BonominiV(1989)Biocompatibility,a SystemsApproach.ContribNephrol70:213–226 HonoraryPresidentofEuropeanSociety HorstKlinkmann forArtificialOrgans,Rostock,Germany Introduction Whytowrite(andpossiblyread)abookentitledMedicalDevices:ImprovingHealth CareThroughaMultidisciplinaryApproach? It is almost a platitude to say that medical devices—with different levels of complexity—arepervasiveintoday’smedicaltreatments.Thetopichasbeenindeed treated by a series of competent authors. This book will outline that a multidisciplinary approach to be applied to the use of medical devices has undoubtable immediate benefits to the patient’s clinical outcome. In addition, this approachcanimprovethevaluecreatedforthehealthcaresystemtobenefitpatients andcommunities. Inaddition, currentdemographic changes,suchastheageing ofthepopulation, andtheincreaseofchronicdiseasesleadingtolong-lastingandrepeatedtreatments, createanadditionalchallengetothesustainabilityofthehealthcaresystems. The use of technology and tools in medicine has a long history. In the industrialised world, a huge number of different devices and equipment have been introduced to the medical field to support diagnosis, therapy and rehabilitation. In recent years, this trend has provoked the development of new devices. When considering the current concept of personalised medicine, new ideas and models areurgentlyneeded. The increasing use of highly sophisticated medical devices, such as MRI, PET-SPECT, and artificial organs, may increase the cost for treatment. This may also be due to the raised therapeutic expectations which will also lead to a higher demandforreimbursementbythecommunity. Fortheabovereasons,thequestforvalueandimprovementofefficiencyinhealth care has become a hot topic in this field. The complexity of a technology-based healthcaresystem,however,requireslookingatitfromdifferentperspectives.This means to consider a systems’ approach for the application of medical devices, depending not only on the condition of the patient. This approach also involves medical science, environmental conditions, engineering, organisational, normative andeconomicaspects. vii viii Introduction Value creation HPO operation Theory of & Management Innovation Medical devices Selection of Quality in Technology Healthcare Performance Optimisation Fig.1 Topicalclustersinrelationtomedicaldevices,whichwillbeaddressedinthefollowing chapters(HPO—HealthcareProviderOrganisation) This multi-perspective view is the objective of this book. It will show that a consistentandmultidisciplinarymanagementofmedicaldevicesoffersanimportant supportforhealthcareinstitutions.Thesubjectofmedicaldevicesgoestogetherwith atleastsixtopicalclusters,asrepresentedinFig.1. Theseclustersunderlinethemultidisciplinarynatureoftheapplicationofmedical devicesandareatthebasisofthequestionsarisingintheeverydaylifeofoperators anddecisionmakers: (cid:129) Whatisthemeaningofvalueinhealthcare? (cid:129) How can the healthcare system and organisations pursue the value, quality and sustainabilityofcare? (cid:129) Howtodecideaboutthebestapplicablemedicaltechnology? (cid:129) Howtocontrolthequalityandsafetyoftheapplicationofmedicaltechnology? (cid:129) How can a Healthcare Provider Organisation (HPO) optimise its performance withtheuseofmedicaldevicesandequipment? (cid:129) Whatistheroleofinnovationinhealthcare(medicaldevices)? Inthefollowing,thisbookwillprovidepossibleanswerstotheabovequestions. They are based on the experience gained in academia, in both research and healthcare institutions as well as in industry. This book further aims to support decision makers (engineers, caregivers and administrators) in deciding on opera- tional and strategic movements when dealing with complex medical devices. We hope that this work can make a contribution to the quest for the increasing quality andefficiencyinhealthcareforthebenefitofthepatientandthecommunity. Introduction ix I. Opening Thoughts Promise and role of technology Innovation III. Engineering IV. Economics in II. Definitions & Operations Healthcare & Regulations Applications of medical devices Economic perspective Standards & Regulations Risk management Technology assessment Life cycle ICT Reimbursement strategies V. Problems & Opportunities Sustainability Low-income countries Ethical issues Where we are and where we are going Fig.2 Structureofthebookshowingtheroadmaptoguidethereaderalongamultidisciplinary tour(ICT—InformationandCommunicationTechnology) Figure2showstheroadmapfollowedinthebooktoguidethereaderalongthis multidisciplinarytour. Part I provides an introduction of the overall topic presenting the author’s considerations on what are the potential improvements that medical devices and equipmentcanbring tohealthcare (Chap.1),whichisalso seeninanapproachto individualised therapies (Chap. 2). But in our society technology is almost a syno- nymofinnovation,thisiswhyweadded(Chap.3)anexaminationoftheinnovation theoryinmedicaltechnology. PartIIclarifiessomebasicdefinitionsandprovidesanoverviewofthestandards and regulations applied in the field (Chap. 4) and presents (Chap. 5) the typical lifecycle of a medical device to show what are the main issues to consider when dealingwiththesedevices,alwayskeepingtheeffectivenessofthetherapyandthe patients’(andoperators’)safetyinmind.Inthischapterthedevelopmentofacardiac arrhythmiamonitorispresentedasacasestudy. PartIIIdescribessomeoftheimportantpointsthathealthcareinstitutionsshould consider when operating the medical devices. Chapter 6 analyses the impact of medical devices in a generic healthcare provider organisation and gives some
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