Approval of Two International Standards Proposals for Customized Medical Device Development

ETRI researchers are holding a skull model for medical simulation made using a 3D printer. From the left, Dr. Byeongnam Lee of ETRI, Dr. Jongheung Jeon of ETRI.

ETRI researchers are holding a skull model for medical simulation made using a 3D printer. From the left, Dr. Byeongnam Lee of ETRI, Dr. Jongheung Jeon of ETRI.

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[Asia Economy Reporter Han Jinju] Domestic researchers are embarking on the development of international standards that enable the creation of customized medical devices using artificial intelligence (AI) and 3D printing technology.


On the 28th, the Electronics and Telecommunications Research Institute (ETRI) announced that two newly proposed international standardization items regarding "Medical 3D Printing Modeling Based on Medical Imaging," submitted last month on the 25th, have been finally approved.


The adopted standardization items include ▲ requirements for producing medical 3D printer implants based on CT images and the empty space of the skull (orbit) images ▲ procedures for segmenting different human tissues necessary during the manufacturing process.


Medical 3D printing refers to technology that uses a patient's medical imaging information to custom-make surgical medical devices or implantable medical devices. Until now, preparing medical equipment tailored to the patient's condition required manually creating printing models. There were issues such as difficulty in distinguishing tissue areas in the images and long production times.


The research team is developing standards for automating the process of creating 3D printing models using deep learning. Experts from the U.S. Food and Drug Administration (FDA), the Radiological Society of North America (RSNA), and the Digital Imaging and Communications in Medicine (DICOM) standard are also expected to participate in the proposed standardization work.


Kang Shingak, Director of the Standards Research Division at ETRI, said, "It is very meaningful that we have created a case leading the development of international standards for convergent medical 3D printing combined with AI technology, led by South Korea."


ETRI explained, "Since 2018, we have been able to achieve results through collaboration centered on Senior Researcher Jeon Jonghong of ETRI, Professor Shim Kyuwon of Yonsei University, and Professor Hong Helen of Seoul Women's University."


The joint research team developed over 500 sets of CT medical imaging learning and experimental data for the orbital bone area to develop and verify the standards, and published more than five international conference papers on AI-based segmentation experiment results.


Based on research experience in developing 3D scanning and 3D printing authoring and editing tools, as well as bio and electronic device 3D printing technologies, ETRI has been striving since 2015 to establish a committee capable of leading international standardization of 3D printing and scanning. Through this, Working Group (WG) 12, which approved these standardization items, was established in August 2018, and it is leading international standardization in the medical field in cooperation with domestic and international experts.


Dr. Lee Byungnam of ETRI, chair of the international standard Working Group (WG12), said, "To accelerate the development of international standards for medical 3D printing, we will further strengthen cooperation with related international standardization organizations in dentistry, orthopedics, medical AI, and medical imaging centered on WG12."


The joint research team plans to apply deep learning technology to "3D reconstruction" and "3D format conversion" in the future to create additional international standards that enable precise automatic modeling without distortion or loss.



ETRI plans to incorporate additional opinions from domestic industry-academia-research sectors related to medical AI and medical 3D printing through this achievement to reflect solutions for technical issues.


This content was produced with the assistance of AI translation services.

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