• Journal of Biomedical Engineering Research
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• v.36 no.3
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• pp.61-68
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• 2015

In this paper, we studied the effects of intersection angles of the flow-foucusing type droplet generation device inlet channel on droplet diameter using numerical simulation modeling. We modeled different intersection angles with a fixed continuous channel width, dispersed channels width, orifices width, and expansion channels width. Numerical simulations were performed using COMSOL Multiphysics$^{(R)}$ to solve the incompressible Navier-Stokes equations for a two-phase flow in various flow-focusing geometries. Modeling results showed that an increase of the intersection angle causes an increase in the modification of the dispersed flow rate ($v^{\prime}{_d}$), and the increase of the modification of the continuous flow rate ($v^{\prime}{_c}$) obstructs the dispersed phase fluid flow, thereby reducing the droplet diameter. However, the droplet diameter did not decrease, even when the intersection angle increased. The droplet diameter decreased when the intersection angle was less than $90^{\circ}$, increased at an intersection angle of $90^{\circ}$, and decreased when the intersection angle was more than $90^{\circ}$. Furthermore, when the intermediate energy deceased, there was a decrease in the droplet diameter when the intersection angle increased. Therefore, variations in the droplet diameter can be used to change the intersection angle and fluid flow rate.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Korea-Australia Rheology Journal
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• v.19 no.3
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• pp.157-164
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• 2007

Microencapsulation of cells within microfluidic devices enables explicit control of the membrane thickness or cell density, resulting in improved viability of the transplanted cells within an aggressive immune system. In this study, living cells (3T3 and L929 fibroblast cells) are encapsulated within a semi-permeable membrane (calcium crosslinked alginate gel) in two different device designs, a flow focusing and a core-annular flow focusing geometry. These two device designs produce a bead and a long microfibre, respectively. For the alginate bead, an alginate aqueous solution incorporating cells flows through a flow focusing channel and an alginate droplet is formed from the balance of interfacial forces and viscous drag forces resulting from the continuous (oil) phase flowing past the alginate solution. It immediately reacts with an adjacent $CaCl_2$ drop that is extruded into the main flow channel by another flow focusing channel downstream of the site of alginate drop creation. Depending on the flow conditions, monodisperse microbeads of sizes ranging from $50-200\;{\mu}m$ can be produced. In the case of the microfibre, the alginate solution with cells is extruded into a continuous phase of $CaCl_2$ solution. The diameter of alginate fibres produced via this technique can be tightly controlled by changing both flow rates. Cell viability in both forms of alginate encapsulant was confirmed by a LIVE/DEAD cell assay for periods of up to 24 hours post encapsulation.

• Journal of the Korean Society of Visualization
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• v.7 no.2
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• pp.56-63
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• 2010

In this work, a dielectrophoresis-based particle-separation device is developed which is to be used to continuously separate particles in microchannels. We fabricated the particle-separation device with combining the benefits of electrode-based DEP and insulator-based DEP. The DEP forces are generated by an array of electrodes located in both sidewalls of a main channel. According to the magnitude and frequency of electrical signals, particles with different dielectric properties experience different DEP forces, and therefore, continuously move along different streamlines in the main flow channel without need of pre-focusing process. Based on this mechanism, we examined the performance of the device by controlling the trajectory of polystyrene particles. This device is applicable to the investigation of dielectric properties of biological cells as well as the continuous separation of biological cells.

• Transactions of the Korean Society for Noise and Vibration Engineering
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• v.18 no.1
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• pp.11-19
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• 2008

This paper proposes small VCM(voice coil motor) type, auto-focusing and zoom actuators for mobile information devices. In order to meet the large output displacement within small height restriction, the proposed auto-focusing actuator adopts curved suspensions, which are similar to a leaf-spring type suspension of optical disk drives. The sensitivity of design parameters on output displacement and dynamic performance is implemented using ANSYS (3D FEM tool) to determine the optimal geometry and stiffness of the curved suspensions. This paper also investigates a new zoom actuator without a suspension supporting a bobbin. The zoom actuator uses a moving rail and a stoper mechanism by generating rotational force at lens holder. Magnetic flux density of the zoom actuator are calculated by both the FEM and permeance method. Experiments using prototypes of the proposed focusing and zoom models show that both actuators meet the required displacement and performance.

• Korean Chemical Engineering Research
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• v.56 no.5
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• pp.761-766
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• 2018

Droplet-based microfluidic device has led to transformational new approaches in various applications including materials synthesis and high-throughput screening. However, efforts are required to enhance the production rate to industrial scale because of low production rate in a single droplet generator. In here, we present a method for enhancing production rate of monodisperse droplets via parallelization of flow-focusing generators. For this, we fabricated a three-dimensional monolithic elastomer device (3D MED) that has the 3D channel structures in a single layer, using a double-sided imprinting method. We demonstrated that the production rate of monodisperse droplet is increased by controlling the flow rate of continuous and dispersed phases in 3D MED with 8 droplet generators. Thus, we anticipate that this microfluidic system will be used in wide area including microparticle synthesis and screening system via encapsulation of various materials and cells in monodisperse droplets.

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

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2002.11b
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• pp.1015-1021
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• 2002

Optical disk is the media which is used generally in data storage device, but it has a disadvantage in the vibration by spinning and the shock. For overcoming these disadvantage, we must control the optical disk to minimize the focusing error and tacking error. The present study investigates the disk profile for minimizing the focusing error subjected to environmental shock and weight of the disk. In this study, the disk is assumed to be a cantilever beam to determine the disk profile for the minimum displacement as to the shock considering only the first mode. Also, for the optimally determined profile by ADS program this paper recalculate the robust caltilever profile by using orthogonal array and ANOM.

• Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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• 2002.07b
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• pp.992-993
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• 2002

We have fabricated the diffractive optical head(DOH) for optical pick up, which one adaptable to a optical recoding information storage. DOH consists of a focusing grating coupler(FGC) and a solid immersion Jens(SIL). FGC is device that the light converge into a focus by surface lattice. FGC have been studied as a potential application of pick up head for the information storage. In this study, FGC was designed and fabricated to make focus near to possible diffraction limit. We also fabricated recording head combined with SIL. The focus was measured in the range of $1.1{\mu}m$ as near to possible diffraction limit in the FGC having a focusing length of $600{\mu}m$ and a lattice area of 500 * $500{\mu}m$.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2002.11a
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• pp.398.2-398
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• 2002

Optical disk is the media which is used generally in data storage device, but it has a disadvantage in the vibration by the spinning and the shock. For overcoming these disadvantage, we must control the optical disk to minimize the focusing and tracking error. The present study investigates the disk profile fur minimizing the focusing error subjected to environmental shock and weight of the disk. (omitted)