• Journal of Biomedical Engineering Research
• /
• v.42 no.6
• /
• pp.277-286
• /
• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• Management & Information Systems Review
• /
• v.36 no.1
• /
• pp.181-213
• /
• 2017

According to the aging, the medical device industry is focused as a future promising industry. However, Korea medical device industry is not enough market competitiveness due to a narrow domestic market and a small company structure. This study aims at evaluating medical device priorities following 3 steps. First, we classify the medical device into three hierarchy categories and AHP survey was conducted on 30 experts in order to extract medical device priorities. Second, priority scores of medical device are analysed using AHP and Fuzzy-AHP. Third, a most important medical device is selected by comparing the volume of medical device manufacture and priority scores. As a result, 'dental implant' is the most import medical device, and we suggest a strategy based on a positioning map. The proposed methodology will provide a inspiration for establish of R&D and support policy in the medical device industry.

• Journal of Veterinary Clinics
• /
• v.37 no.1
• /
• pp.15-22
• /
• 2020

This study investigated the effectiveness of radiation safety rules in animal hospital and the awareness and behavior of veterinary radiation workers. With the questionnaires, the data was collected from randomly selected veterinarians in animal hospitals and animal medical imaging centers. Collected data were about radiation device, shielding device, regulations, safety management, education, knowledge, behavior and awareness. Frequency, correlation and multiple regression analysis were performed. The medical devices related with radiation in animal hospital were X-ray (59%), CT (15%), fluoroscopy (12%), mobile X-ray (12%) and others (2%). The number of people using radiation shielding device is high. The answers were low on knowing radiation related regulation and receiving radiation protection education. The group with higher knowledge and awareness shows positive correlation with safety behavior. The increase of use of the radiation related medical devices in veterinary hospital causes the increase of radiation exposure risk. This study suggests that radiation safety management system and policies need to be developed to protect radiation workers and give them correct information and consciousness.

• Journal of Biomedical Engineering Research
• /
• v.38 no.3
• /
• pp.89-94
• /
• 2017

In order to improve national competitiveness through technological research and development, the government puts in R&D budget every year and manages to improve the R&D results. Accordingly, various R&D project management methods have applied for successful advancement of technology and product. TRL is a measurement system developed by NASA to assess the maturity of technology since the 1970s. To apply medical device, the characteristics such as regulation, clinical trials are considered as a significant influence. In this study, we would like to derive PMI(performance measures index) for medical device R&D projects by using TRL and stage-gate model. As a result of this study, it is possible to use the PMI for decision making and evaluation in the R&D projects and believed that the objectivity can be ensured by the approval or certification of regulatory authority.

• Journal of Society of Preventive Korean Medicine
• /
• v.28 no.1
• /
• pp.31-42
• /
• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of Biomedical Engineering Research
• /
• v.38 no.4
• /
• pp.205-210
• /
• 2017

The convergence healthcare industry in Korea has been stalled due to conflicts between stakeholders as well as a supplier-centered industry structure. This situation is caused by the structural contradiction in which the Korean industry has a prolonged conflict structure among stakeholders due to a strong regulation and an institutional inertia from the viewpoint of the sociotechnical system. Therefore, it is necessary to identify new system management plan that enhances social acceptability such as laws, customs and ideas while reducing conflicts between stakeholders. In this study, mainly adapting the stakeholder-oriented autopoiesis and focusing on publicness of healthcare, we propose the rationale and direction for policy making to harmonize various systems within the convergence healthcare industry.

• Journal of Chest Surgery
• /
• v.56 no.2
• /
• pp.147-150
• /
• 2023

A child being supported with an extracorporeal ventricular assist device, such as the Berlin Heart EXCOR (Berlin Heart GmbH, Berlin, Germany), must have at least 2 large cannulae for a long period. Management of cannula wounds is crucial since a cannula forms a track of prosthetic material passing the mediastinum to the heart. Deep wound complications, if they occur, can be troublesome and difficult to control with conventional methods. We applied vacuum-assisted closure to a patient who had Berlin-Heart EXCOR and a gap at the cannulation site. Herein, we describe the technical aspects of management in detail.

• Korean Journal of Veterinary Research
• /
• v.57 no.2
• /
• pp.71-78
• /
• 2017

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.

• Journal of Biomedical Engineering Research
• /
• v.44 no.6
• /
• pp.428-442
• /
• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• Journal of the Korea Safety Management & Science
• /
• v.12 no.3
• /
• pp.37-52
• /
• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).