3D 프린팅의료기술과건강보험적용방안 최근논의사례및건강보험관련이슈 건강보험심사평가원겸임수가위원인하대학교부속인하대병원교수박현선
용어정리 3D Printed (Additive Manufactured) 치료재료 3D Printing (Additive Manufacturing) 의료기술
Dimitrios Mitsouras and Peter C. Liacouras; 3D Printing Technologies in F.J. Rybicki, G.T. Grant (eds.), 3D Printing in Medicine, DOI 10.1007/978-3-319-61924-8_2 의료분야 3D Printing Technologies Technology Other common technology names Common material(s) Vat photopolymerization Stereolithography (SLA) Digital light processing(dlp) Continuous digital light processing (CLIP) Material Jetting MultiJet Printing (MJP) Polyjet Epoxy- and acrylic-based polymers Infused polymers Acrylic-based polymers Material Extrusion Fused deposition modeling(fdm) ABS, PLA plastics, composites, metals (rare) Binder Jetting Powder bed fusion Electron beam melting (EBM) Selective laser sintering (SLS) Direct metal laser sintering (DMLS) Selective laser melting (SLM) MultiJet Fusion (MJF) Gypsum, sand, metal (rare) Plastics, synthetic polymers, metal
의료에서 3D printing 이필요한분야 Designing and manufacturing of surgical aid tools, bio-models and implants Designing and manufacturing of various scaffolds for tissue engineering Development of various medical devices and surgical training models Individualization Complex geometries Functional integration Reduced costs Rapid availability Improved patient care Cost-effectiveness for the hospital Weight reduction Javaid M., Haleem A.. Alex J Med (2017), https://doi.org/10.1016/j.ajme.2017.09.003
의료에서 3D printing 실제적용분야 Surgical planning Medical education and training Design and development of devices and instrumentation used in medical Customized implant design Scaffoldings and tissue engineering Prosthetics and orthotics Mechanical bone replicas Forensics Bioprinting Javaid M., Haleem A.. Alex J Med (2017), https://doi.org/10.1016/j.ajme.2017.09.003
의료에서 3D 프린팅사용으로얻는가치 Speed Ease of use Accuracy Personalization Customization Overcoming Complexity Materials 가치 Value = 정확 비용 신속 Cost Javaid M., Haleem A.. Alex J Med (2017), https://doi.org/10.1016/j.ajme.2017.09.003
Complexity & Cost Conventional (Subtractive) manufacturing vs Additive manufacturing Source: Additive Manufacturing Delivers Economies of Scale AND Scope by 3DEO June 07 2017
Traditional vs 3D printing Supply chain 3D printing Idea/ 설계 End User 사용자 Prototype 제작 소매점 Retail 제조 Manufacture 조립 Assembly 물류창고 Warehouse 배분 Distribution Modified from. Impacts of Additive Manufacturing on Supply Chain Flow: A Simulation Approach in Healthcare Industry Çetinkaya, C.; Özceylan, E Logistics 2018, 2, 1; doi:10.3390/logistics2010001
Modified from 3D opportunity for healthcare by Deloitte University press 3D Printing Value Driver in Healthcare Complexity/ Customization High Product Change 정확 High Supply Chain Change Point of Care Supply Chain innovation 신속
3D 프린팅과건강보험 산업발전 비용효과성 보장성강화 안정성 규제 편의성 가치기반 유효성
3D 프린터로제조된의료기기의연도별허가인증신고및등재사항 허가, 인증 24 건 (2017.12 월기준 ) 신고 20 건 (2017.12 월기준 ) 2018.6. 발행 2017 년의료기기허가보고서식품의약처식품의약품안전평가원
3D 프린트방법으로제작된치료재료관리품목기준 구분 기성품 (93) 환자맞춤형 (10) 중분류품목수중분류품목수 급여 (89) C 군 ( 골유합및골절고정용군 ) 36 F 군 ( 척추재료군 ) 11 L 군 ( 일반재료군중치과용재료 ) 42 - CRANIOFACIAL IMPLANTS 2 CRANIOFACIAL IMPLANTS( 맞춤형 ) 7 비급여 (14) 기타관절치환용 재료 ( 골결손대체용 ) 2 흡수성 CRANIOFACIAL IMPLANTS (3D 프린터이용, 환자맞춤형 ) 비흡수성정형용품 (3D 프린터이용, 환자맞춤형 ) 2 1
의료기기시장진입절차
3D 프린터활용관련유사행위현황 ( 기존기술여부, 신의료기술평가, 치료재료결정신청 ) 연번신청유형 ( 신청일자 ) 신청명칭 3D 유형 1 신의료기술평가신청 (2017.8.1.) 3D 프린터를이용한귀의패턴제작과내시경을이용한두피절개없는측두근막피판거상및동종진피와두피이식을병용한귀재건술 모형제작 2 치료재료결정신청 (2016.8.5.) T&R MESH (PSI), T&R MESH PLUS (PSI) 임플란트 3 치료재료결정신청 (2016.4.29.) MCB 임플란트 4 확인신청 (2016.7.11.) 유방암수술가이드적용 수술용가이드 5 확인신청 (2016.8.22.) 신장수술맞춤형시뮬레이션모델 모형제작 ( 가상수술용 ) 6 확인신청 (2017.9.21.) 환자맞춤형 3차원모형을이용한심장기형질환수술시뮬레이션 모형제작 ( 가상수술용 ) 7 확인신청 (2018.2.7.) 통증조절또는관절보호와교정목적의개인맞춤형 3D 프린팅보조기 / 스플린트제작을위한상하지 3D 이미지분석및설계 보조기 / 스플린트제작
신의료기술의안전성 유효성평가결과고시개정 호, 18.12.4.) ( 보건복지부고시제 2018-258 734. 환자맞춤형 3D 프린팅모형을이용한선천성심장질환수술시뮬레이션 사용목적 : 적절한수술계획수립및방향설정 사용대상 : 개흉으로수술적치료를계획중인선천성심장질환자 시술방법 : 환자의의료영상 (MRI, CT 등 ) 을기반으로 3D 프린팅심장모형을제작하여, 수술전과수술중에육안으로모형을확인하며시뮬레이션을시행함
무엇을어떻게어디까지보상해야하는가? 신의료기술은무엇이고혁신 첨단의료기술은무엇인가? 혁신 첨단의료기술의역할이의료진의편의성을개선하고병원의생산성을향상시키는데국한된다면? 편의성과생산성을넘어효과성까지보인다면? 사회적가치가높은의료기술이란? 산업진흥목적에건강보험진료비를쓰는것도맞는지? 혁신 첨단의료기술은기술뿐의료를함께봐야함.
Anatomical Modelling Flow Map Christensen and Rybicki 3D Printing in Medicine (2017) 3:1 DOI 10.1186/s41205-016-0009-5
잠재가치평가? 2018.9.14
기업 ( 병원 ) 의목표 가치 (Value), 가격 (Price), 원가 (Cost) 이윤 (Profit) 생성 가치 (Value) 생성 환자 ( 소비자 ) Price 2 병원 ( 기업 ) Value Price 1 Value Cost Cost
병원내가치흐름의이해 Doctors, Nurses, Technicians Patient without Value CT, MRI,Lab Medical Equipment, Infrastructure Value Creation Medical Device, Drugs Value Added Patient Hospital Park, Hyeonseon 2018
무엇에대한가치평가인가 치료재료약제 의료 행위 치료결과 환자 경험 Park, Hyeonseon 2018
현재우리의보건의료가치사슬 Producers 의료기기생산자의약품생산자 Payer Fiscal Intermediaries Providers 병원의사약국 정부가입자 건강보험공단건강보험심사평가원 Purchasers 도매상 Downstream Park, Hyeonseon 2018
Modified from Wharton school study 2001 보건의료가치사슬 Healthcare Value Chain 치료결과와경험 보장성 / 지속성 환자에게가치부여 공급망혁신 기술혁신 Payer Fiscal Intermediaries Providers Purchasers Producers 정부가입자 건강보험공단보험회사 병원의사약국 도매상간납업체 의료기기생산자의약품생산자 Downstream Upstream
혁신은어디로부터오는가? Three Enablers of Disruptive Innovation 1. Technology 2. Business Model 3. Commercial Value Network Clayton M Christensen: Innovative Prescription 2009
Modified from 3D opportunity for healthcare by Deloitte University press 3D Printing Value Driver in Healthcare Complexity/ Customization Increase Productivity High Product Change Revolutionize Standard of Care High Supply Chain Change Point of Care Supply Chain innovation Optimized Supply Chain Change How Care is delivered
Modified from 3D opportunity for healthcare by Deloitte University press 3D Printing Healthcare Industry Framework Complexity/ Customization 정확 Path3: Product Evolution 범위의경제 High Product Change Path4: Business Model Evolution High Supply Chain Change Point of Care Supply Chain innovation Path1: Stasis Streamline process Path2: Supply Chain Evolution 규모의경제 신속
International Trends in 3D Printing Use Modified from 3D opportunity for healthcare by Deloitte University press
의료에서 3D 프린팅적용시기업들의어려움 SME Medical AM3DP Annual Report 2018
Potential Scenarios for 3D printing In DRG Source: 3D Printing is Revolutionizing the Medical Devices World, but are Payers Ready? By Ejegul Nuryyeva,, THE EVIDENCE FORUM May 2016
개념설계란? Target 을만드는것
건강보험개념설계 보장성 (Coverage) 지속가능성 (Sustainability) 결과, 경험 (Outcome & Experience) 혁신, 성장 (Innovation & Growth)
개념설계는가치사슬 / 가치흐름을지배하도록 Concept Design Value Chain Value Stream Park, Hyeonseon 2018
가치사슬의이해가필요한이유 가치사슬을지배하는개념설계가이루어지고이에따른실행설계가이루어져야보장성은높고혁신적인의료를통하여소비자에게좋은치료결과와서비스경험을제공하면서의료산업과건강보험은지속적으로성장하고유지될수있다.
감사합니다