24-3차 범부처 첨단 의료기기 연구개발사업 예타조사 최종보고서

◈ 목차

요약······························································································································1

제1장사업개요및조사방법················································································31

제 1절  사업 개요····································································································31

1.사업 추진배경 및 필요성··················································································34

2.사업의 추진경과·································································································35

3.사업 내용·············································································································37

제 2절  조사방법······································································································45

1.항목별 조사방법·································································································45

제2장기초자료분석·······························································································47

제 1절  의료기기 개요·····························································································47

1.의료기기 정의 및 특성······················································································47

2.의료기기 산업의 사회적 환경변화···································································49

제 2절  의료기기 산업 동향···················································································54

1.의료기기 정책 동향····························································································54

2.의료기기 시장 동향····························································································57

3.의료기기 기술 동향····························································································61

제3장과학기술적타당성분석··············································································66

제 1절  문제/이슈 도출의 적절성 ·······································································66

1.문제/이슈 식별 과정의 적절성········································································66

2.과학기술기반 문제/이슈 해결의 중요성 및 필요성······································72

ii  목차

제 2절  사업목표의 적절성·····················································································75

1.사업목표와 해결할 문제/이슈와의 연관성·····················································75

2.사업목표 설정의 적절성····················································································78

3.사업 성과지표의 적절성····················································································80

4.수혜자 표적화의 적절성····················································································83

제 3절  세부활동 및 추진전략의 적절성······························································84

1.세부활동과 사업목표와의 연관성·····································································84

2.세부활동 도출의 적절성····················································································87

3.세부활동별 성과지표의 적절성·······································································100

4.세부활동의 기간 추정과 시간적 선후관계의 적절성···································102

5.추진전략의 적절성····························································································104

제4장정책적타당성분석···················································································110

제 1절  정책의 일관성 및 추진체제····································································110

1.상위계획과의 부합성························································································110

2.사업 추진체제 및 추진의지············································································116

제 2절  사업 추진상의 위험요인··········································································132

1.재원조달 가능성·······························································································132

2.법·제도적 위험요인··························································································135

제5장경제적타당성분석···················································································137

제 1절  비용 추정··································································································137

1.사업계획서 총사업비 개요··············································································137

2.사업계획서의 비용 검토··················································································138

제 2절  경제성 분석·······························································································144

◈본문

제 1 장  사업 개요 및 조사방법

1. 사업 개요

가. 사업 추진배경 및 필요성

□ 추진배경

○ 글로벌 의료기기 산업은 반도체급 대규모·고성장 산업으로 전략적 육성 필요

○ 최근 첨단 디지털 기술과의 융합을 통한 기술적 진보가 빠르게 진행

○ 국제정세의 변화는 의료기기 공급망의 불안정성을 야기

□ 사업 추진 필요성

○ (도전·혁신적 의료기기) 국가 보건의료 도전적인 난제 해결 및 퍼스트무버로의

위상 도약이 가능한 플래그십 의료기기 개발을 위해 도전적·혁신적 대형 R&D

추진 필요

○ (新 유망시장 선점) 첨단기술의 발전으로 신시장 창출이 예상됨에 따라, 국가

성장동력으로써 미래유망 의료기기 산업의 선제적·전략적 육성 필요

○ (보건안보 기술주권 확보) 국가 보건안보 확립을 위해 글로벌 공급망 불안정 시

국민 생명·건강과 직결될 수 있는 필수의료기기 기술주권 확보 필요

○ (의료현장 진입역량 강화) 첨단 의료기기의 신속한 의료현장 진입을 위해 안전성을

담보한 과학적 근거 마련이 필수적이므로 임상연구 및 규제과학기술 개발 필요

나. 사업내용

□ 사업비 : 14,197.51억 원 (국고: 12,454.04억 원, 민자: 1,743.47억 원)

□ 사업기간 : 2026년∼2033년 (8년)

□ 사업비전 및 목표

○ (비전) 의료기기 산업 패러다임 전환을 통한 국가 신성장 동력 확보 및 국민 건강 증진

○ (목표) 첨단 의료기기 개발을 통한 글로벌 신시장 선점 및 보건안보 대응역량 확보

○ (성과목표) ① 세계최초 또는 최고수준 의료기기 개발 7건, ② 매출 100억 원 이상 의료기기 개발 10건, ③ 필수의료기기 국산화 16건 달성, ④ 상급종합병원 의료기기 도립 34건 달성, ⑤ 의료선진국 인허가 획득 및 시장진출 34건

□ 사업추친체계

○ (주관부처) 과학기술정보통신부, 산업통상자원부, 보건복지부, 식품의약품안전처

○ (전담기관) 한국연구재단, 한국산업기술기획평가원, 한국보건산업진흥원- 동 사업은 사업단(범부처첨단의료기기연구개발사업단) 형태로 운영하고, 주관부처 전문기관-사업단 및 유관기관과의 연계성을 강화하고 사업단을 관리･이사회, 운영위원회와 전문기관협의체 등을 각각 구성･운영 견제할 수 있도록

□ 주요 사업내용

○ (➀ 글로벌 플래그십 의료기기 개발) 최첨단 기술을 통해 기존 의료기기 성능의 한계를 극복하여 글로벌 의료기기 시장 선점과 사회문제 및 의료현장 미충족 수요 해결이 가능한 ‘게임체인저 의료기기’ 개발

○ (➁ 의료기기 코어기술 및 제품개발) 미래 의료기기 시장 선점 및 보건안보 대응역량을 확보하기 위한 의료기기 핵심 기술확보 및 제품 개발

○ (➂ 의료현장 진입역량 강화) 첨단 의료기기의 신속한 의료현장 진입을 위해

안전성을 담보한 과학적 근거 마련을 위한 임상연구 및 규제 과학기술 개발

□ 예산 및 과제계획

○ 내역사업별 소요예산 및 지원과제- (내역사업 1 글로벌 플래그십 의료기기 개발) 총 2,674.5억 원, 14개 과제- (내역사업 2 의료기기 코어기술 및 제품개발) 총 7,453.0억 원, 254개 과제

* 내역사업 2-1 : 미래유망 의료기기 개발 / 내역사업 2-2 : 보건안보 대응 의료기기 개발- (내역사업 3 의료현장 진입 역량 강화) 총 1,846.54억 원, 179개 과제

* 내역사업 3-1 : 의료현장 진입을 위한 임상연구 지원 / 내역사업 3-2 : 맞춤형 규제과학

기술개발

2. 조사방법

1. 항목별 조사방법

가. 과학기술적 타당성 분석

□ 주관부처에서 제출한 기획보고서 내용을 토대로 문제/이슈 도출의 적절성,사업목표의 적절성, 세부활동 및 추진전략의 적절성 등을 조사하여 전체 연구개발사업 계획의 완성도를 분석함

□ 주관부처에서 제출한 기획보고서를 토대로 식별된 문제/이슈가 적절한지 조사함

○ 사전 기획활동을 통해 적절한 문제/이슈를 식별 또는 발굴하였는지, 동 사업을 통해 해결이 가능한지 여부를 검토함

○ 식별된 문제/이슈를 국가적 차원에서 별도의 R&D사업으로 추진할 필요가 있는지,사업의 추진 당위성 등을 검토함

□ 사업목표의 적절성은 동 사업의 추진 필요성이 적절히 제시되어 있는지, 문제/이슈의 해결과 사업목표가 잘 부합되는지 등을 분석함

○ 사업목표와 문제/이슈와의 연관관계, 사업목표를 달성하면 도출된 이슈와 문제가 어떻게, 얼마나 해결될 수 있는지를 분석함

○ 달성하고자 하는 효과를 구체적으로 제시하였는지, 성과지표가 적절히 제시되었는지,사업성과의 활용과 확산을 통해 직접적인 영향을 받는 예상 주체를 적절히 파악하였는지 검토함

□ 사업목표를 달성하기 위한 추진전략 및 추진체계를 적절히 제시하였는지 분석함

○ 세부활동이 사업목표와 논리적으로 연계되는지, 적절한 수준의 세부활동을 도출하여 제시하였는지(세부활동 수요조사, 기획위원회 전문가 구성, 과제규모 및 기간, 수요의 산출 근거 및 논리 등)검토함

○ 세부활동에 대한 성과지표의 적절성, 추진전략의 적절성을 평가함

...................(계속)

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