To evaluate the toxicity of ophthalmic drug, the Draize test and Bovine Corneal Opacity and Permeability (BCOP) test commonly used. In Draize test, experimental animals were under stress and pain due to long-term exposure of drug. In addition, regarding physiological functions, animal model is not perfectly reflected a human eye condition. Although some models such as $EpiOcular^{TM}$, HCE model, LabCyte Cornea-Model, and MCTT $HCE^{TM}$ were already presented advanced cornea ex-vivo model to replace animal test. In this sense, cornea tissue structure mimicked ex-vivo toxicity model was fabricated in this study. The corneal epithelial cells (CECs) and keratocytes (CKs) isolated from rabbit eyeball were seeded on non-patterned silk film (n-pSF) and patterned silk film (pSF) at $32,500cells/cm^2$ and $6,500cells/cm^2$. Sequentially, n-pSF and pSF were stacked to mimic a multi-layered stroma structure. The thickness of films was about $15.63{\mu}m$ and the distance of patterns was about $3{\mu}m$. H&E stain was performed to confirm the cell proliferation on silk film. F-actin of CKs was also stained with Phalloidin to observe the cytoskeletal alignment along with patterns of the pSF. In the results, CECs and CKs were shown the good cell attachment on the n-pSF and pSFs. Proliferated cells expressed the specific phenotype of cornea epithelium and stroma. In conclusion, we successfully established the ex-vivo cornea toxicity model to replace the eye irritation tests. In further study, we will set up the human ex-vivo cornea toxicity model and then will evaluate the drug screening efficacy.

An acoustofluidic device using conductive liquid-based electrodes was developed for malaria parasite separation from white blood cells. In this device, the electrode channels filled with a conductive liquid were used to generate standing surface acoustic waves (SSAWs) in a fluidic channel, which can overcome the limitation of conventional patterned metal electrodes. Separation performance of the device was evaluated using fluorescent polystyrene particles with two different sizes (2 and $10{\mu}m$ diameters), which were successfully separated. In addition, a mixture of malaria parasites and white blood cells were also efficiently separated with high purity of ~98% in the CL-SSAW device at the flow rate of $12{\mu}l/min$.

The interbody fusion cage used to replace the degenerative intervertebral disc is largely composed of titanium-based biomaterials and biopolymer materials such as PEEK. Titanium is characterized by osseointergration and biocompatibility, but it is posed that the phenomenon such as subsidence can occur due to high elastic modulus versus bone. On the other hand, PEEK can control the elastic modulus in a similar to bone, but there is a problem that the osseointegration is limited. The purpose of this study was to implement titanium material's stiffness similar to that of bone by applying cellular structure, which is able to change the stiffness. For this purpose, the cellular structure A (BD, Body Diagonal Shape) and structure B (QP, Quadral Pod Shape) with porosity of 50%, 60%, 70% were proposed and the reinforcement structure was suggested for efficient strength reinforcement and the stiffness of each model was evaluated. As a result, the stiffness was reduced by 69~93% compared with Ti6Al4V ELI material, and the stiffness most similar to cortical bone is calculated with the deviation of about 12% in the BD model with 60% porosity. In this study, the interbody fusion cage made of Ti6Al4V ELI material with stiffness similar to cortical bone was implementing by applying cellular structure. Through this, it is considered that the limitation of the metal biomaterial by the high elastic modulus may be alleviated.

Cancer cells are different from normal cells in terms of life cycle, behavior, and growth patterns. Cancer cells can migrate freely in the body through blood vessels and lymph nodes. The cancer cells easily interact with various substrates including extracellular matrix and vessels and they can differentiate in the new environment. However, it is not well known about the adhesion preference of cancer cells on the substrate and the mechanism of their interaction. In this study, we prepared the nano-, micro-patterned substrates using E-beam lithography techniques. MCF-7 cells were tested on the substrates to find out their adhesion preference. The substrates were made by polydimethylsiloxane (PDMS) with specific patterns including pillars with a diameter of 500 nm, 700 nm, $3{\mu}m$ and $5{\mu}m$. MCF-7 cells were seeded on the substrates and incubated for 24 hours. As a result, this study clearly demonstrated that the MCF-7 cells preferred 700 nm patterning.

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

In ultrasound telemedicine, it is important to reduce the size of the data by compressing the ultrasound image when sending it. Ultrasound images can be divided into image context and other information consisting of patient ID, date, and several letters. Between them, ultrasound context is very important information for diagnosis and should be securely preserved as much as possible. In several previous papers, ultrasound compression methods were proposed to compress ultrasound context and other information into different compression parameters. This ultrasound compression method minimized the loss of ultrasound context while greatly compressing other information. This paper proposed the method of automatic segmentation of ultrasound context to overcome the limitation of the previously described ultrasound compression method. This algorithm was designed to robust for various ultrasound device and to enable real-time operation to maintain the benefits of ultrasound imaging machine. The operation time of extracting ultrasound context through the proposed segmentation method was measured, and it took 311.11 ms. In order to optimize the algorithm, the ultrasound context was segmented with down sampled input image. When the resolution of the input image was reduced by half, the computational time was 126.84 ms. When the resolution was reduced by one-third, it took 45.83 ms to segment the ultrasound context. As a result, we verified through experiments that the proposed method works in real time.

We investigated differences in ventricular and hippocampal volumes between CSF tap test (CSFTT) responders and non-responders in idiopathic normal-pressure hydrocephalus (INPH) patients and compared these parameters in INPH patients with that of age- and gender-matched healthy controls. We also evaluated relationships between ventricular and hippocampal volumes and clinical profiles in INPH patients. We enrolled 48 patients with INPH and 29 healthy controls. Ventricular and hippocampal volumes were measured on MRI, including 3-dimensional volumetric images. INPH patients, when compared to healthy controls, had significantly larger ventricular and smaller hippocampal volumes. No difference in ventricular and hippocampal volumes was found between CSFTT responders and non-responders in INPH patients. And hippocampal volumes showed significant negative correlations with Clinical Dementia Rating Scale scores, INPH grading scale cognitive scores, Timed Up and Go Test scores, and Unified Parkinson's Disease Rating Scale motor scores in INPH patients. Volumetric assessment of ventricular and hippocampal regions may have no predictive value in differentiating between CSFTT responders and non-responders in INPH patients. Our findings may help us understand the potential pathophysiology of unique symptoms associated with INPH.

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

Surgical methods and associated precision systems have been developed, but surgical procedures that require precise location and fine manipulation of the lesion remain a limitation. The combination of precision robot manipulation technology and 3D medical image navigation technology overcomes the limitations of minimally invasive surgery (MIS) and enables a more stable and successful operation. Surgical robots are surgical robots such as da Vince, and surgical robots using industrial robotic arms. There are various developments and researches of medical robots. In recent medical robot development, a new type of surgical robot based on an industrial robot arm capable of easily replacing the end effector according to the user's needs is being actively developed at home and abroad. Therefore, in this study, we developed safety and performance evaluation guideline for micro - surgical robots based on open robot platform using general purpose robot arm to help quality control of the medical device.

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.