A study on the mechanism and countermeasures of medical devices incidents

( Haizhe Jin ),( Masahiko Munechika ),( Masataka Sano ),( Chisato Kajihara ),( Masaaki Kaneko ),( Fu Guo ) 한국품질경영학회 2015 한국품질경영학회 학술대회 Vol.2015 No.2

Purpose: This study will focus on the human, medical devices and human-computer interactions to analyze the medical devices incidents. Based on the analysis result, this study will suggest the mechanism of medical devices incidents and the countermeasure methods. Approach: In this study, we summarize the mechanism of medical devices incidents through the analysis and research on the cases of medical devices incidents. Mechanism of medical devices incidents will consider the error-process, error-factors and the operating environments. The consideration point is the human, medical devices and human-computer interactions. Based on the explored mechanism of medical incidents, this study will establish the countermeasures through eliminating the error-factors of medical devices incidents. Methods to establish the countermeasures will consider the characteristics of human, features of operating environment and medical devices. In order to ensure the countermeasure``s effect, the countermeasure ideal is by improving the features of operating environment and operating devices to cater human``s characteristics. Findings: Through this study we will present following two: (l) Propose the general mechanism which can summarize the incidents of medical devices, (2) Propose the countermeasures which based on the mechanism and can solve the practical problems. Value of paper: Three aspects of human, devices and the interaction caused the medical devices incidents. In the past research on the medical devices, one or two aspects are considered, but a few of research combine the three aspects. To consider the three aspects and propose the useful mechanism and countermeasure method is one of the value of this paper. Using the practical case to propose scientific result and to solve the practical medical problems is also the value of this paper.

의료기기분쟁과 분쟁조정제도 ― 독일의 법적 현황을 참고하여 ―

양천수 ( Chun-soo Yang ),우세나 ( Se-na Woo ) 안암법학회 2021 안암 법학 Vol.- No.62

최근 의료기기로 인한 인권침해 등과 같은 의료기기분쟁이 증가하면서 「의료기기법」개정이 검토된다. 오늘날 의료행위에서 의료기기가 차지하는 비중이 높아지면서 의료기기의 결함 문제 및 이로 인해 발생하는 분쟁을 해결하는 것이 중요한 이슈가 된다. 이에 의료기기의 결함으로 발생하는 피해로부터 환자나 이용자를 적절하게 보호할 수 있는 법제를 구축할 필요가 있다. 「의료기기법」개정안은 이러한 문제의식을 고려한 것으로 평가된다. 개정안은 크게 두 가지를 제시한다. 첫째는 제조자의 책임보험 가입을 의무화하는 것이다. 둘째는 분쟁조정제도를 설치하는 것이다. 그러면 이러한 개정안은 타당한가? 이를 검토하기 위해 이 글은 비교법 방법을 원용한다. 특히 이 글은 우리 법체계에 많은 영향을 미친 독일의 법제도, 그중에서도 의료기기의 분쟁조정을 어떻게 규율하는지를 검토한다. 이를 통해 이 글은 다음과 같은 시사점을 획득하였다. 첫째, 독일의료기기법은 의료기기분쟁을 정면에서 규율하는 법적ㆍ제도적 장치는 담고 있지 않다. 둘째, 독일은 우리처럼 의료분쟁을 전담하는 의료분쟁조정법을 갖고 있지 않다. 의료분쟁에 대한 ADR은 민간 주도로 구축되어 있다. 의료조정원이나 감정위원회가 그것이다. 셋째, 의료조정원이나 감정위원회에 대해서는 기본원칙으로 자발성과 비구속성이 적용된다. 넷째, 의료기기분쟁에 대한 ADR로는 독일 조정법에 따른 조정을 언급할 수 있다. 독일 조정법에 의한 조정 역시 철저하게 자율적으로 진행된다. 이 글은 이러한 시사점을 바탕으로 하여 우리의 「의료기기법」개정안을 다음과 같이 평가한다. 우선 책임보험 가입을 의무화하는 개정안은 긍정적으로 평가할 수 있다. 그러나 행정형 분쟁조정제도를 신설하는 것에는 의문을 제기한다. 행정형 분쟁조정제도는 조정의 본래적 취지와 맞지 않는 것으로 보이기 때문이다. 특히 조정을 통해 도출한 합의에 기판력에 준하는 강력한 법적 구속력을 부여하는 것은 문제로 보인다. 물론 그렇다고 해서 법적 구속력을 전적으로 부여하지 않는 것도 바람직하지는 않다. 조정으로 도출한 합의에는 조정제도의 효율성을 제고할 수 있도록 집행력 정도의 법적 구속력을 인정하는 게 적절해 보인다. 아울러 이 글은 법정책적으로는 다음과 같은 방안도 제안한다. 현재 운용 중인 의료분쟁조정제도가 관할하는 대상에 의료기기분쟁을 추가하는 방안이 그것이다. Recently, as medical device disputes such as human rights violations due to medical devices increase, the revision of the Korean 「Medical Devices Act」is being reviewed. As the proportion of medical devices in medical practice today increases, resolving the problem of defects in medical devices and its disputes becomes an important issue. Accordingly, it is necessary to establish a legal system that can adequately protect patients and users from damage caused by defects in medical devices. The amendment to the Korean 「Medical Devices Act」is evaluated to take into account this awareness. The amendment proposes two main things. The first is to oblige the manufacturers of medical devices to buy a liability insurance. The second is to establish a dispute mediation system for the medical device disputes. So, is this amendment valid? To review that question, this article uses the comparative law method. In particular, this article examines the legal system and situation of Germany, which has had a great influence on Korean legal systems, especially how it regulates dispute settlement of medical devices. Through those, this article has obtained the following implications. First, the German 「Medical Devices Act」does not contain legal and institutional mechanisms that govern medical device disputes. Second, German legal systems do not have a medical dispute mediation law dedicated to medical disputes like ours. The ADR on medical disputes is established by the private sector. The ‘Schlichtungsstelle’ or ‘Gutachterkommssion’ are those. Third, ‘Freiwilligkeit’ and ‘Unverbindlichkeit’ are applied as basic principles to the ‘Schlichtungsstelle’ and ‘Gutachterkommssion’. Fourth, the ADR for medical device disputes can refer to the mediation system according to the German mediation law. The mediation under the German mediation law is also ruled by the principle of autonomy. Based on these implications, this article evaluates the amendment of the Korean 「Medical Devices Ac t」as follows. First of all, the amendment which mandates buying a liability insurance can be evaluated positively. However, the establishment of an administrative dispute mediation system should meet questions. This is because the administrative dispute mediation system does not seem to fit the original purpose of the mediation system. In particular, it seems to be a problem to impart a strong legal binding power to agreements reached through a mediation. Of course, the article does not argue that the agreements should have no legal binding power. Instead, it seems appropriate for the author to recognize the legal binding power as executive power to improve the efficiency of the mediation system in agreements reached through a mediation. In addition, this article proposes the following measures for legal policy. This is a propose to add medical device disputes to the subject under the jurisdiction of the medical dispute mediation system currently in operation in Korea.

한방의료기관 의료기기 보유 현황에 대한 조사 연구

박요한(Yo-Han Bak),황대선(Dae-Sun Huang),권진완(Jin-Wan Kwon),신현규(Hyeun-Kyoo Shin) 대한한의학회 2011 대한한의학회지 Vol.32 No.2

동물용 의료기기 기준규격에 대한 고찰

강경묵,김태원,권오륜,박혜정,조수민,김충현,이명헌,문진산,Kang, Kyoung-Mook,Kim, Tae-Won,Kwon, Oh-Ryun,Park, Hea-Jung,Cho, Soo-Min,Kim, Chung-Hyun,Lee, Myoung-Heon,Moon, Jin-San 대한수의학회 2017 大韓獸醫學會誌 Vol.57 No.2

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

트랜스휴머니즘 시대 이식형 의료기기의법적 위험에 대한 연구 - 개인정보보호와 사이버정보보안을 중심으로 -

김성용,정관영 고려대학교 법학연구원 2022 고려법학 Vol.- No.105

이 글은 예상하기 어려울 정도로 빠르게 발전하는 과학기술로부터 비롯된 이른바 트랜스휴머니즘 시대에 접어들게 되면서, 이를 실현할 수단인 이식형 의료기기가 내포하고 있는 개인정보 및 정보보안의 법적 위험에 초점을 맞추었다. 따라서 아직은 현실에서 일어나지 않았거나, 어쩌면 일어날 것 같지 않아서 다소 생소한 느낌이 드는 글로 비춰 질 수 있다. 그럼에도 불구하고 이런 생소한 느낌은 점차 현실화 되어 가고 있다. 다름 아닌 공상과학 영화에서 인간의 신체는 현실과 상상의 경계에서 다양한 가능성으로 비춰지고 있듯, 이제는 현실에서도 실현불가능하게 보였던 일들을 보고, 느끼고 경험하는 시대가 펼쳐지고 있다. 아직은 희박한 가능성이라고 하지만 첨단과학기술은 인간의 유한한 생물학적 조건을 기계와의 흡수․통합으로 탈신체화를 추구하고자 하는 트랜스휴머니즘 사고(思考)에 기여하였다. 그리고 이러한 트랜스휴머니즘적 사고가 현실화될 수 있도록 기여한 이식형 심장 제세동기(implantable cardioverter defibrillators ; ICDs), (체내)이식형 달팽이관(Cochlear Implants), 컴퓨터 의족(의수)(Foot Drop Implants)과 같은 인체 이식형 의료기기는 이상적인 트랜스휴머니즘의 중심에 서게 됐다. 결과적으로 이식형 의료기기는 신체장애로 고통 받는 이들에게 한줄기 희망을 선사하며 인간친화적인 트랜스휴머니즘이 의미하는 것이 무엇인지에 대한 방향을 제시해 주었다. 그렇다면 인간과 기계와의 흡수․통합으로 이상적인 트랜스휴머니즘의 실현 수단으로써 중요한 위치에 있는 이식형 의료기기 수혜자, 즉 이를 이식받은 인간을 어떻게 정의해야 할까? 트랜스휴먼은 자연적·생물학적 존재인 인간과 포스트휴먼으로 알려진 인공지능 사이의 경계쯤으로 정의되고 있는바, 이식형 의료기기를 삽입한 인간이 인간에 가까운 트랜스휴먼인 것인지 아니면 트랜스휴먼에 가까운 인간인 것인지 궁금하다. 아울러 이런 의문으로부터 이식형 의료기기를 이식받은 자는 개인정보보호법상 정보주체로서 보호받을 수 있는 것인지 역시 궁금하다. 앞으로 이식형 의료기기를 이식받게 되는 경우가 점차 증가할 것으로 예상되는 가운데, 지금처럼 한 두 개의 기기를 이식한 경우 외에도, 신체의 1/3, 1/2 또는 신체 대부분을 이식형 의료기기를 내재하고 있는 경우에는 자연적·생물학적 존재가 아닌 새로운 인간 존재로 바라보게 될 가능성은 없는 것인지 의문이다. 바로 모두가 당연하게 생각하는 인간의 개념과 다가올 미래사회의 전혀 새로운 인간의 개념을 논하는 것은 이상적인 트랜스휴머니즘 실현의 수단인 이식형 의료기기가 내포하고 있는 법적 위험을 해결하기 위한 출발점이라고 할 것이다. 현행 개인정보보호법 제2조 제3호에서 밝히고 있는 ‘사람(인간)’에 대한 개념이 정립되지 않는다면 현행법만으로는 이식형 의료기기를 이식받은 자에 대한 정보주체의 법적 권리를 보장할 수 없게 되어 이들의 법적 불안은 계속될 수밖에 없다. 이식형 의료기기는 유무선통신기능이 가능한 디지털 전자기기로 데이터를 생성하고 외부와 송수신이 가능하다. 따라서 환자의 치료 설정 등 많은 개인정보를 포함하고 있는 이식형 의료기기는 데이터의 무결성에 대한 악의적인 변경이 일어날 수 있고, 데이터 기록 및 전송과정에서 환자 정보와 프라이버시를 침해하는 악의적인 공격에 취약하다는 문제를 갖고 있다. 인... As we enter the so-called transhumanism era which stems from unpredictably fast-developing science and technology, this article focuses on the legal risks of personal data and data security of implantable medical devices by means of realizing it. Therefore, it may be seen unrealistic or felt somewhat unfamiliar. As we have seen in science fiction movies, the human body is seen as various possibilities in the boundary between reality and imagination. Although it is still a rare possibility, high-tech technology has contributed to the transhumanistic thinking of pursuing de-bodyization by absorbing and integrating human finite biological conditions with machines. And implantable medical devices such as implantable cardioverter defibrillators(ICDs), cochlear implants and computer prosthetics that helped make this transhuman thinking a reality have become at the center of ideal transhumanism. As a result, the implantable device gave a ray of hope to those suffering from physical disabilities and provided a direction for what ideal transhumanism is. If so, how we define the recipients of implantable medical devices who hold an important position as means of realizing transhumanism through absorption and integration of humans and machines? Transhuman is defined as the boundary between humans, which are natural and biological beings, and posthuman, known as artificial intelligence, so I wonder if the human who inserted the implantable medical device is a transhuman close to a human or a transhuman close to a transhuman. In addition, it is curious whether a person who has received a transplant type medical device can be protected as an data subject under the Personal Data Protection Act. With implantable medical devices expected to increase in the future, it is questionable whether those who 1/3 or 1/2 of the body, or most of the body consist of implantable medical devices will be viewed as a new human being rather than a natural or biological one. Discussing the human concept that everyone takes for granted and the completely new human concept in the future society is a starting point for solving the legal risks of implantable medical devices, which are an ideal means of realizing transhumanism. If a new concept of humans is not established within the scope of interpretation of Article 2, No. 3 "People(Human being)" of the current Personal Data Protection Act, legal anxiety over beneficiaries embedded with implantable medical devices under the current law will continue. Implantable Medical Devices are digital electronic devices that can perform wired and wireless communication functions and can generate data and transmit and receive data from the outside. Thus, implantable medical devices, which contain a lot of personal data, such as setting up patient care, are vulnerable to malicious attacks that violate patient data and privacy during data recording and transmission. As transhumanism and implantable devices which are human aspirations cannot be separated, legal risks such as personal data protection and cyber data security are bound to coexist in the process of realizing ideal transhumanism. The scope of interpretation of Article 2 No. 3 "People(Human being)" of the personal data protection and the security risk under Article 28-2 of the same Act can be said to be the legal risk of implantable medical devices in the process of realizing transhumanism.

한방의료기기 사용 현황 및 개발 수요에 대한 조사 연구

남동현(Dong-Hyun Nam) 대한한의학회 2013 대한한의학회지 Vol.34 No.1

State and Subject of Medical Devices Industry at Overseas

Jung Hwa Seo 한국유통과학회 2017 한국유통과학회 학술대회 논문집 Vol.2017 No.-

Most of people do not remind of Who is domestic medical device business? A lot of people that Johnson and Johnson, GE and Philips and other foreign companies belong to medical device company. In fact, local enterprises small place based on world market. Local medical device industry s production has grown up rapidly last 10 years. Sales increased nearly 3 times from trillion and 500 billion KRW in 2004 to 4 trillion and 600 billion KRW in 2014. The production record constantly increased owing to safety and good quality of domestic medical devices. As many as 59% of medical devices made in Korea is exported to 198 countries in the world. Currently, medical device industry in the world has been given considerable attention. Cognition and awareness are very much low. Medical device industry, high income creating industry, is said to next generation industry to increase scale, and Korea does not follow world flow. The industry is given support from the government that is not enough. Korean enterprises have small scale among a lot of global enterprises. Being interested in development of medical devices, the author selected department of IT at college. Medical industry has been nominated to be government-run business and to have much expectation, while medical device industry has not been given reasonable support. The author shall investigate problems and find out solution.

국내 인ㆍ허가 온열의료기기 기술 현황 조사 및 분석

임수란 ( Su-ran Lim ),박정환 ( Jung-hwan Park ),박지연 ( Ji-yeun Park ),김송이 ( Song-yi Kim ) 경락경혈학회 2023 Korean Journal of Acupuncture Vol.40 No.4

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled Regulations on Medical Device Items and Rating by Item” from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms heat and heating. Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.

의료기기의 시판 후 안전관리 및 실사용 데이터 기반 환자 등록 연구를 위한 「의료기기법」법적 근거 고려사항 도출

김윤지,황유나,권지연,김성민 한국에프디시규제과학회 2023 FDC법제연구 Vol.18 No.2

시판 후 안전관리를 위한 실사용 데이터 기반 환자 등록 연구는 실제 임상 환경의 특성을 반영하여 환자의 안전 과 의료기기의 안전성 및 유효성을 보장하기 위해 중요성이 높아지고 있다. 국내에서는 의료기기를 대상으로 재평가, 시 판 후 조사, 추적관리대상 의료기기, 부작용 관리 등의 시판 후 안전관리 제도가「의료기기법」에 근거하여 실시 중이 다. 해당 제도들은 시판된 의료기기를 대상으로 의료기기 사용 도중 발생하는 부작용 등의 안전성 정보를 분석 및 평가 하여 국민의 안전을 목적으로 국가의 주도하에 실시된다. 하지만, 의료기기 안전관리를 위한 환자 특성, 건강 결과 등을 포함한 임상 정보와 의료기기의 실사용 데이터(UDI, 제품 특성, 안전성 및 유효성 관련 실사용 데이터)를 통합한 환자 등 록 연구는 미흡하다. 따라서 본 연구의 목적은 한국과 미국의 유관 법령의 비교 분석을 통해 의료기기 시판 후 안전관리 를 위해 환자 등록 연구가 가능한 국가 주도 레지스트리의 구축에 대한 필요성 및 법적 근거 마련 시 고려사항을 제안 하는 것이다. 이와 관련하여 미국, 유럽은 정부 주도하에 시판 후 안전관리 연구 환경을 DARWINEU, NESTcc와 같은 데 이터 네트워크 형태로 구축하였으며, 이를 통해 획득된 데이터를 활용하여 시판 후 안전관리 연구를 하고 있다. 반면, 국 내의 경우 의료보험 측면에서 의료기술 평가를 위한 협회, 제조업체 등 민간 주도 레지스트리 기반의 환자 등록 연구가 이루어지고 있다. 또한「의료기기 부작용 등 안전성 정보 관리에 관한 규정」에서 명시하고 있는 이상사례 보고의 목 적은 문제 발생 시에 의료진, 환자, 제조업체에서 정해진 양식을 통해 매뉴얼적으로 보고하도록 범위가 제한되어 있다. 한국과 미국의 시판 후 안전관리 및 환자등록연구를 위한 유관 법령을 분석한 결과,「의료기기법」상 규제 레지스트리 구축의 범위 및 관리 주체, 절차 마련 시 고려사항을 제안하였다. 본 연구의 결과는 의료기기의 시판 후 안전관리 및 환 자등록연구의 실시를 위해 향후 「의료기기법」에 추가가 필요한 법적 근거 마련에 활용될 수 있을 것으로 기대된다 Real world Data based patient-registry studies for post-marketing safety control are becoming increasingly important to ensure patient safety and the safety and effectiveness of medical devices by reflecting the characteristics of the actual clinical environment. In Korea, a post-marketing safety control system (re-evaluation, re-examination, medical devices subject to tracking and control, adverse event reporting) is being implemented based on the「Medical Devices Act」. The systems are implemented under the lead of the government for the purpose of public safety by analyzing and evaluating safety information such as side effects that occur while using medical devices on the market. However, patient –registry studies for medical device safety control that integrate clinical information, including patient characteristics and health outcomes, and real world data (UDI, medical device’s characteristics, safety and effectiveness real world data) of medical devices are insufficient. Therefore, the purpose of this study is to propose the necessity of establishing a government-led registry that can conduct patient-registry study for safety control after marketing through comparative analysis of related laws in Korea and the US. In this regard, the US and Europe established a post-marketing safety control study environment under the lead of the government in the form of data networks such as DARWINEU and NESTcc. Using the data obtained from them, post-marketing safety control study is being conducted, On the other hand, in Korea, privateled registry based patient-registry studies such as associations and manufacturers for medical technology evaluation are being conducted in terms of health insurance. In addition, the purpose of adverse events reporting stipulated in the「Regulations on Safety Information Management (Side Effects of Medical Devices)」is limited to manual reporting by medical staff, patients, and manufacturers in the event of a problem. As a result of analyzing relevant laws and regulations for post-marketing safety control and patient-registry study in Korea and the US, this study proposed the considerations, including the scope, management subjects, and procedures for establishing a regulatory registry, needed to the「Medical Devices Act」. Th e results of th is study are expected to be used to prepare legal grounds that need to be added to the Medical Devices Act in the future for postmarketing safety control of medical devices and patient-registry study.

의료기기 분야의 아이디어 발상원리 및 효용성에 관한 연구 : IDEA Medical & Health 입상작을 중심으로

연주한,도성정 한국창업학회 2019 한국창업학회지 Vol.14 No.4

최근 의료기기 산업은 사람들의 치료와 건강을 위하여 매우 중요해지고 있으나 의료기기 산업의 발전을 위한 아이디어 발상 원리와 세부적인 고객의 정의에 관한 연구는 매우 부족한 상황이다. 본 연구에서는 의료기기 산업의 아이디어 발상원리와 세부적인 고객을 도출하기 위하여 BCC 사고도구를 이용하여 IDEA 디자인 어워드 medical & health 분야의 5년간의 입상작들을 분석하였다. 또한 의료기기들이 고객에게 어떠한 효용성을 제공하고 있는지를 알아보았다. 그 결과 의료기기 제품들에서도 다른 산업들과 동일하게 속성의존, 결합 코드의 적용빈도가 가장 높게 도출되었으며, 다른 산업과는 다르게 분리코드가 의료기기 제품에서는 활발히 적용되었다. 연구대상인 IDEA 디자인 어워드 의료기기분야의 주요고객으로 의사, 환자, 약사 및 간호사로 도출되었으며 이러한 고객을 위하여 제공하고 있는 효용 지렛대의 요소는 기능성과 사용성으로 도출 되었다. Recently, medical device industry is getting more important for people's cure and health. However, research on detailed customer definition and inventive thinking principle of medical device industry is very limited. Hence, in order to study the principle of inventive thinking principle in the medical device industry, 63 products of the IDEA design award winning for medical & health were analyzed by using BCC (Business Creativity Codes) along with the real customers of the medical device. In addition, we analyzed the utility of medical device that affected customers. The main results of this study are as follows. First, the principles of attribute dependency and combination are most frequently applied in the medical device industry as in other industries. Second, the division principle that is not actively applied in other industries has actively been applied in the medical device industry. These results indicate the characteristics of the medical device industry that require more accurate diagnosis and cure. Third, the major customers of medical device are analyzed to be doctors, patients, pharmacists and nurses. Fourth, the utility levers of medical device were found to be functionality and usability. This result suggests that the medical device industry had better perform activities that improve the functionality and usability of the product for more accurate diagnosis and cure.