• 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.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.

• Journal of Biomedical Engineering Research
• /
• v.44 no.1
• /
• pp.41-52
• /
• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Archives of Plastic Surgery
• /
• v.48 no.4
• /
• pp.389-391
• /
• 2021

Solo hand surgery is becoming increasingly common, mostly due to a lack of assistants and dedicated operating theatres. The solo hand surgeon faces challenges of proper hand positioning, elevation, and skin flap/tissue retraction. Most commercially available hand retractors or stands do not address all the relevant problems and are not economically feasible for trainee surgeons. The Jain's hand retractor system and stand, described herein, provides solutions to all these problems, and its simple design helps surgeons to reproduce it easily.

• The Journal of Economics, Marketing and Management
• /
• v.6 no.4
• /
• pp.17-27
• /
• 2018

Purpose - As Korea is reaching a post-aged society, the number of chronic illness is increasing, and the demand for rehabilitation medical device is growing. Although there is high potential for the growth in rehabilitation industry, because most of the related companies in Korea are relatively small, lacking capital or R&D resource, it is difficult for them to create an innovative product, and currently most of the high-tech equipments are imported. Therefore a medical device cluster, where business, research, medical institutes and universities may work cooperatively to enhance research development and solve issues is necessary for future development. Research design, data, methodology - In this method we have done a literature review of the rehabilitation industry and industrial cluster. Based on the studies, we have conducted an exploratory factor analysis by studying examples of foreign and domestic medical clusters and drawing success factors in forming a medical cluster. Next based on the studies we have conducted a survey to domestic medical device companies to find their difficulties and needs to form a successful medical device cluster. Results - This paper provides both theoretic review on success factors of forming a medical device cluster and practical analysis using case study and survey. Conclusion - The significance of this paper is that based on the literature review, we have compared actual examples of domestic/foreign medical clusters and drawn difference and coincidence between literature and actual cluster success factor. We were also able to conduct a survey on actual medical device companies and through the results we were able to search difficulties and necessities of medical device companies.

• Journal of Biomedical Engineering Research
• /
• v.42 no.3
• /
• pp.125-142
• /
• 2021

The POCT (point-of-care test) sensing that has been a fast-developing field is expected to be a next generation technology in health care. The POCT sensors for the detection of proteins, small molecules and especially nucleic acids have lately attracted considerable attention. According to the World Health Organization (WHO), the POCT methods are required to follow the ASSURED guidelines (Affordable, Sensitive, Specific, User- friendly, Robust and rapid, Equipment-free, Deliverable to all people who need the test). Recently, several CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) based diagnostic techniques using the sensitive gene recognition function of CRISPR have been reported. CRISPR/Cas (Cas, CRISPR associated protein) systems based detection technology is the most innovative gene analysis technology that is following the ASSURED guidelines. It is being re-emerged as a powerful diagnostic tool that can detect nucleic acids due to its characteristics that enable rapid, sensitive and specific analyses of nucleic acid. The first CRISPR-based diagnosis begins with the discovery of the additional function of Cas13a. The enzymatic cleavage occurs when the conjugate of Cas protein and CRISPR RNA (crRNA) detect a specific complementary sequence of the target sequence. Enzymatic cleavage occurs on not only the target sequence, but also all surrounding non-target single-stranded RNAs. This discovery was immediately utilized as a biosensor, and numerous sensor studies using CRISPR have been reported since then. In this review, the concept of CRISPR, the characteristics of the Cas protein required for CRISPR diagnosis, the current research trends of CRISPR diagnostic technology, and some aspects to be improved in the future are covered.

• Journal of the Korean Medical Association
• /
• v.61 no.12
• /
• pp.702-705
• /
• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• International Journal of Precision Engineering and Manufacturing
• /
• v.7 no.4
• /
• pp.40-46
• /
• 2006

The market of programmable implantable pumps has bound to a monopolistic situation, inducing high device costs, thus making them inaccessible to most patients. Micro-mechanical and medical innovations allow improved performances by reducing the dimensions. This affects the consumption and weight, and, by reducing the number of parts, the cost is also affected. This paper presents the procedure followed to design an innovative implantable drug delivery system. This drug delivery system consists of a low flow pump which shall be implanted in the human body to relieve pain. In comparison to classical known solutions, this pump presents many advantages of high interest in both medical and mechanical terms. The first section of the article describes the specifications which would characterize a perfect delivery system from every points of view. This concerns shape, medication, flow, autonomy, biocompatibility, security and sterilization ability. Afterwards, an overview of existing systems is proposed in a decisional tree. Positive displacement motorized pumps are classified into three main groups: the continuous movement group, the fractioned translation group and the alternative movement group. These systems are described and the different problems which are specific to these mechanisms are presented. Since none of them fully satisfy the specifications, an innovation is justified.. The decisional tree is therefore extended by adding new principles: fractioned refilling and fractioned injection within the fractioned translation movement group, spider guiding system within the alternative translation movement group, rotational bearing guided device and notch hinge guided device in the alternative rotation movement group.

• Current Optics and Photonics
• /
• v.1 no.1
• /
• pp.17-22
• /
• 2017

Mechanical property of tissue is closely related to diseases such as breast cancer, prostate cancer, cirrhosis of the liver, and atherosclerosis. Therefore measurement of tissue mechanical property is important for a better diagnosis. Ultrasound elastography has been developed as a diagnostic modality for a number of diseases that maps mechanical property of tissue. Optical coherence elastography (OCE) has a higher spatial resolution than ultrasound elastography. OCE, therefore, could be a great help for early diagnosis. In this study, we made tissue phantoms and measured their compressive moduli with a rheometer measuring the response to applied force. Uniaxial strain of the tissue phantom was also measured with OCE by using cross-correlation of speckles and compared with the results from the rheometer. In order to compare stiffness of tissue phantoms by OCE, the applied force should be measured in addition to the strain. We, however, did not use a load cell that directly measures the applied force for each sample. Instead, we utilized one silicone film (called as reference phantom) for all OCE measurements that indirectly indicated the amount of the applied force by deformation. Therefore, all measurements were based on displacement, which was natural and effective for image-based elastography such as OCE.

• Journal of Yeungnam Medical Science
• /
• v.41 no.1
• /
• pp.53-55
• /
• 2024

A noncontact sensor field is an innovative device that can detect, measure, or monitor physical properties or conditions without direct physical contact with the subject or object under examination. These sensors use a variety of methods, including electromagnetic, optical, and acoustic technique, to collect information about the target without physical interaction. Noncontact sensors find wide-ranging applications in various fields such as manufacturing, robotics, automobiles, security, environmental monitoring, space industry, agriculture, and entertainment. In particular, they are used in the medical field, where they provide continuous monitoring of patient conditions and offer opportunities in rehabilitation medicine. This article introduces the potential of noncontact sensors in the field of rehabilitation medicine.