• Journal of Korean Society for Quality Management
• /
• v.46 no.2
• /
• pp.211-224
• /
• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• Journal of Biomedical Engineering Research
• /
• v.42 no.1
• /
• pp.7-17
• /
• 2021

In the case of domestic medical device advertisements, it is possible to proceed with the advertisement after medical device certification, and pre-deliberation is possible based on the medical device technical document. However, there are some medical device advertisements that stakeholders in administrative procedures have no choice but to misunderstand in customs and laws that do not consider users. In addition, medical equipment and the pre-deliberation system were judged to be unconstitutional, and unconstitutional decisions were made in accordance with the principle of prohibiting pre-censorship based on the Constitution. This is because in domestic medical device advertisements, structural contradictions and user damage occur in the central structure of each stakeholder. It is necessary to reestablish stakeholder relationships, increase water solubility from customs and laws, and seek new policy proposals. In this study, we reestablish relationships with stakeholders by applying the Autopoiesis theory, and present the grounds and directions that can prevent hype and misidentified advertisements through the establishment of user-centered policies, and the measures to be taken by the Constitutional Court unconstitutional decision.

• Journal of Biomedical Engineering Research
• /
• v.44 no.4
• /
• pp.264-274
• /
• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• Korea Journal of Hospital Management
• /
• v.23 no.4
• /
• pp.15-25
• /
• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• Journal of Biomedical Engineering Research
• /
• v.39 no.6
• /
• pp.256-267
• /
• 2018

The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

• Journal of Biomedical Engineering Research
• /
• v.43 no.3
• /
• pp.153-160
• /
• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Journal of Biomedical Engineering Research
• /
• v.41 no.6
• /
• pp.256-263
• /
• 2020

The importance of quality control has been emphasized to maintain safety of patients and satisfaction of medical service with medical devices used in clinic. Accordingly, objective evaluation method and standards consistently has been brought up for demand to replace outdated medical devices in appropriate time and to maintain the quality of medical service. Though many studies made suggestions methods to determine what medical devices to be replaced first, these methods were difficult in practice for its complex evaluation criteria and long time to evaluate. Therefore, in this study, a simple evaluation method is developed to identify and prioritize medical devices that are ought to be replaced. For the development of this simple evaluation method, four major characteristics of technology, safety, finance, and user satisfaction, which are considered in clinics to evaluate medical device replacement, and 14 minor attributes are distinctively selected. Each characteristic is assessed in binary form of "YES" or "NO" to minimize its subjective nature. Using this method to evaluate sampled medical devices belonging to four different characteristics, devices are suggested to be replaced in the current financial year or in the following financial year, or re-evaluated by the end of this financial year. Such results of evaluation can amend the subjective nature of existing evaluation method and give objective standards more promptly.

• The Korean Journal of Health Service Management
• /
• v.11 no.3
• /
• pp.129-144
• /
• 2017

Objectives : To review a Tanzanian medical engineering education program and determine improvement measures for the Official Development Assistance (ODA) healthcare projects. Methods : A consultation of the Tanzanian medical engineering education program funded by the National Research Foundation of Korea (NRFK) was reviewed. An on site survey, an environmental analysis, and in-depth interviews were performed. Results : Survey results highlighted a lack of medical device education and the low operating rate of medical equipment. The need to establish educational program was thus confirmed. The expansion of healthcare facilities appeared to be limited within the current medical management system. A master coursework plan for Tanzania medical engineering was developed. Conclusions : The needs of medical engineering education were recognized. A plan and curriculum were developed. The medical engineering education program should be planned and budgeted prior to the ODA healthcare program.

• The Korean Journal of Health Service Management
• /
• v.2 no.1
• /
• pp.28-36
• /
• 2008

The purpose of this study was effect that get to purchase decision-making factor of medical device decision making. A survey of 262 hospitals to 480 hospitals was conducted from December 3, 2007 to January 4, 2008 in the Busan area. The data generated in the survey was analyzed with SPSS/Win version 10.0 and appropriate tests and statistics including t-tests, ANOVA analyses were used. A summary of the actual results of this analysis are as follows : Of the 262 hospitals surveyed 249(95.1%) were male and 13(4.9%) were female, which shows an absolute higher ration of the male respondents. On a question of Medical device purchase sanction rise 50% occupy. CEO of a hospital($4.58{\pm}.80$) is highest at medical device purchase. The highest factor of medical device purchasing is picture quality($4.86{\pm}.37$), after service($4.84{\pm}.40$), cost($4.36{\pm}.75$). Through the results of the above study, Principle and department influence are put than human relations in the medical device purchase decision making.

• Journal of Biomedical Engineering Research
• /
• v.44 no.6
• /
• pp.363-376
• /
• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.