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2024比利时法兰德斯——小国家，生命科学和医疗器械的强国报告

医药生物2025-01-09孔之昂investinflanders刘***

AI智能总结

Belgium's Flanders Region is a small country with a strong presence in the life science and medical devices sector, serving as the economic heart of Belgium and a key player in the EU. The region accounts for 58% of Belgium's population and 82.4% of its exports. Belgian MedTech companies generate total revenues of €3.2 billion, with €1 billion dedicated to diagnostic imaging. The market is dominated by companies focusing on pre-IV diagnostics, cardiology, neurology, and surgery.

Medical device and IVD companies in Belgium are active in regional headquarters, sales, distribution, manufacturing, and R&D, with 90-95% involved in distribution and 33-33% in R&D. Flanders' research institutes, universities, and spin-off companies apply novel technologies such as sensors, microfluidics, nanotechnology, AI, and 3D printing to medical devices and IVD.

Minimal invasive surgery, including laparoscopic and robotic surgery, is a key focus, with robotic surgery particularly suitable for complex procedures in gastroenterology, gynecology, and urology. The global robotics surgery market is expected to grow at a CAGR of 17.1% from 2018 to 2024, with Europe growing at approximately 16.7%. Belgium is home to the largest robotic surgery training center, ORSI Academy, which offers high-quality training and collaboration with top universities and industry partners.

Flanders has a significant number of potential clients and research centers, with 164 hospitals and 29,206 hospital beds. The region attracts 35,000 medical tourists annually and has strong collaboration between Flanders Make and KU Leuven in research. QbD Group serves as a preferred partner for Chinese companies in Europe for MDR/IVDR regulatory consulting, certification, and clinical studies, covering the full life cycle of medical device regulatory and clinical services.

Flanders Investment and Trade supports companies through matchmaking services, individual support for setting up subsidiaries, and financial incentives. The region offers up to 60% structural funding cash grants, 80% salary tax deductions, and 85% innovation income exemption deductions, along with investment deductions for R&D-related investments and patents.

Flanders is the largest region and economic heart of Belgium in the center of EU.法兰德斯位于欧盟的中心，是比利时最大的地区和经济中心 BelgianMedTechcompanieshavetotalrevenueof3.2billionEURofwhich1billionEURindiagnosticimaging比利时医疗科技公司的总收入为32亿欧元，其中10亿欧元用于诊断成像 Barcoisamarketleaderofhigh-endmedicaldisplaysinChinaandhasestablishedafirst-classR&DandmanufacturingfacilityinSuzhou巴可是中国高端医疗显示器的市场领导者，在苏州建立了一流的研发和制造设施 MedicalDeviceandIVDcompaniespresentinBelgiumareactiveasRegionalHeadquarters, Salesand Distribution,Manufacturing and R&D医疗器械和体外诊断公司多在比利时设立区域总部、销售和分销、制造和研发团队 Flanders'ResearchInstitutes,UniversitiesandSpin-offcompaniesapplynoveltechnologiestoMedical DevicesandIVD法兰德斯的研究所、大学和衍生公司将新技术应用于医疗器械和体外诊断 Minimalinvasive surgery is applied to reducepatients'health risksintraditionalopensurgery Open surgery is the traditional surgicalapproach.Surgeon makes a large incision using ascalpel (e.g., 8-10 cm fora removal of prostate)Surgeon operates the affectedbodystructuresdirectlythroughthis incision Description Keyapplicationareas In Europe,double-digitgrowthisexpectedforroboticsurgery Despitebeingamarket steered bytheUSA, Europeis expectedtogrowapproximately in linewith themarketgrowth rateParticularly,reimbursementlimitations (i.e., high cost perprocedures) and measurestowards centralization of certaincomplex procedures (e.g.,Switzerland) are limiting thegrowthUSwill remaintheworld'slargestmarketforroboticsurgerysystems-It is expectedto continueto bethemajor growth driver Current developments suggest a trend towards robotic surgery Flanders is home to the largest robotic surgery training center, ORSl academy法兰德斯是最大的机器人手术培训中心ORSI学院的所在地 1 3Orsi Academy is an open,inclusivecenterwithafocusoncollaboration:.peer-to peerapproach.top'KeyOpinionLeadersinpartnerhospitals 5Orsi Academy hasaccesstoavarietyofdifferent trainingmodels:.Virtual (simulated).Porcine,canine,chickencadavers.Human cadavers 2Orsi offers highquality training in fullcollaboration withpartners and industry 4Orsi Academy isparentedbythetwotopuniversitiesinBelgium::Universityof Ghent.University ofLeuven Orsi is a centerofsurgicalinnovationandexpertise,whereindustry,clinicalandacademicpartnersworkingtogetherwiththe purposeofimprovingbestpractices in minimallyinvasivesurgery(Mis) CourseCalendarhttps://www.orsi-online.com ORSIAcademyconnectsRoboticSurgeryCompanieswithKOLSurgeons forTraining and Universities for Clinical Validation Visit ofthe Royal Collegeof Surgeons of Englandpanel to Orsi Academy ORsiAcademy's currenttechnologypartners Orsi'spartners:OrsiAcademyis an inclusive platform whereallinnovativecompaniesarewelcome. Recent case Studyfrom Japan: Medicaroid HinotoriMedicaroid is working on the CE marking ofconformity of the hinotorim according to MDR(2017/745).Afterofficial regulatoryapprovalandcertification in Europe, hands-on training at the skillslab of Orsi Academywill officially launch. Visit of Medtronic Surgical Robots President Marinari Kashif Ikram -Head of Vascular Robotics at Siemens Healthineers Our training robot systems comprise five Intuitive da Vinci robots Our CEo Prof. Dr.Alex Mottrie was already given the honour oftesting out the robot:"OrsiAcademy is an inclusive platformwhereall innovative companiesarewelcome,It is ourmissiontoimprovesurgerythroughimprovedtechnologybutmostofallthrough a novel and revolutionary training methodology. It isonly through safeand effective trainingthat we can lowercomplication rates and make surgery safer." Flanders houses a significant numberof potential clientsand research centerswhocouldbenefitfromsurgical robotstoperformcomplexsurgeries Proximitytoclientsandresearch Total of164hospitalsinBelgium,with inFlanders:49 general hospitals and 4 university hospitals,representing29.206hospitalbeds39hospitalsforrevalidation/mentalhealthAhealthawarepopulation:20.2% of population is above 65 (above EUaverage)60.3% of population has average to high healthliteracyFlanders is a top destination for medical tourism:Belgiumattracts35000medicaltouristsannually5universitiesandresearchcentersinBelgium:Incl.VUB Brubotics Human Robotics ResearchCenter4StrategicResearchCentersinthefieldofmicro-and nano-electronics, biotech and manufacturingStrong collaboration between Flanders Makeand KULeuven at research level ...aswellasaccesstoc.150.000hospital bedsandmultipleuniversityhospitalswithina2hoursdrive QbDGroupispreferredpartnerforChinesecompaniesinEuropeforMDR/IVDRregulatoryconsulting,certification&clinicalstudiesQbD集团是中国企业在欧洲MDR/IVDR监管咨询、认证和临床研究的首选合作伙伴 QbD groupcovers thefull life cycle inmedical device regulatory& clinical servicesQbD集团涵盖医疗器械监管和临床服务的全生命周期 Verification&validation ProcessdevelopmentEquipmentQualificationProcess ValidationQAsupportSoftware validationTechnical Documentation ProjectManagementSitemgmt,andmonitoringClinical regulatory (EC/IRB, CA)Safety mgmt, and medicalmonitoringData managementStatistiesMedical WritingQA and compllance consultingSupply management(Core) lab management Production supportQ

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