ETRI WEBZINE

VOL.70 September 2022

SPECIAL

ETRI Leads International Standardization
of Medical 3D Printing and 3D Scanning

- Prepared 5 essential international standards for
the development of patient-tailored medical devices
- Established 3D scanning standard working group,
leading the next generation of data-based biohealth

ETRI researchers are taking the lead in developing international standards for medical 3D printing and 3D scanning, which are essential for creating customized medical devices for each patient. If this standard is developed, it is expected to be of great help in promoting public health, revitalizing the related medical equipment industry, and spreading digital twins and metaverse.

The Electronics and Telecommunications Research Institute (ETRI) announced that three new international standard development tasks for 『Medical Image Based Medical 3D Printing Modeling』 were approved and a working group for 3D scanning standard development was also established. Two related international standards, which began development in 2019, are about to be finalized. It is the result of the full-cycle medical device R&D project of all ministries.

This has further strengthened Korea's leadership in international standards for medical 3D printing and 3D scanning, and is evaluated to have laid the foundation for a leap forward as a global digital powerhouse by laying the foundation for expansion into construction, manufacturing, national defense, aviation, culture and art, and reverse engineering.

The three newly adopted standardization items are ▲Standard evaluation process for precision/accuracy evaluation in the manufacturing process of medical 3D printing implants based on standard CT images ▲Precision/accuracy error evaluation method in the human tissue segmentation stage and 3D modeling stage ▲ the standard operating procedure for creating a data set

The three standardized items newly adopted this time are ▲Standard evaluation process for precision/accuracy evaluation in the manufacturing process of medical 3D printing implants based on standard CT image ▲Precision/accuracy error evaluation method in the human tissue segmentation stage and 3D modeling stage ▲Information about standard operating procedure for creating dataset.

Medical 3D printing is a technology that uses the patient's medical image information to make customized surgical devices, implantable medical devices, and pre-simulation tools. It is used to make implants and prostheses that fit the patient's facial skeleton.

Until now, to prepare medical equipment suitable for the patient's condition, printing models had to be made by hand. This is because it is not easy to clearly distinguish the tissue parts in the image. It took a long time to produce, so there were many restrictions in an urgent situation, and it was difficult to use data from other medical staff because there was no standard plan.

When this standard is completed, the research team expects to be able to evaluate the precision/accuracy with standardized procedures and methods for medical 3D printing modeling software, which will be of great help in domestic and overseas medical 3D printing software licensing.

The design time can also be reduced from 24 hours to around 3 hours.

Comprehensive quality control is also easy. Above all, when commercialized, it is expected to help establish a new medical paradigm, such as predicting treatment effects and prescribing optimal drug through virtual simulation based on personal health data.

Experts from the US FDA, RSNA, and DICOM are also expected to participate in this standardization work, so it is expected to have a big ripple effect on the medical and related industries.

The researchers have been developing standards for surgical 3D printing modeling and artificial intelligence-based automation since 2019, and are set to enact two standards at the end of this year. The three new proposals this time contain an additional precision/accuracy core evaluation system and method.

ETRI was able to achieve this result by working with JongHong Jeon, Principal Researcher at the Intelligent Information Standards Lab, and Byoung Nam Lee, an Research Fellow of the Open Source Center, along with Professor Kyuwon Shim and Hwiyoung Kim of Yonsei University, Helen Hong of Seoul Women's University, and Se-myung Jang, Director of Coreline Soft. In particular, the joint research team developed more than 700 CT medical image learning/experimental datasets in the skull, orbit, and mandible for standard development and validation, and published more than 7 international conference papers on the results of AI-based segmentation and 3D modeling performance evaluation.

In addition, ETRI established a working group (AHG-3) for the development of 3D scanning standards and held its first meeting on the 16th. The working group will discover international standard issues linking 3D scanning and 3D printing in the future, develop technical reports and establish an international standardization roadmap.

Kim Hyung-jun, head of ETRI’s Intelligent Convergence Research Institute, said, “It is very meaningful to develop more than 5 medical 3D printings essential for patient-tailored medical care led by Korea, establish a 3D scanning group, and lead the core international standards that can lead to digital twins and metaverse.”

Dr. Lee Byung-nam, chairman of the International Standards Working Group (WG12), said, “We will further strengthen cooperation with other relevant international standardization organizations to accelerate international competitiveness of platform technology standards, focusing on JTC 1/WG12.”

Based on this achievement, ETRI is planning to expand international standards to cover various industrial fields by collecting additional opinions from industry-academic institutions related to medical 3D printing and 3D scanning.

ETRI has been promoting the establishment of a committee to lead the international standardization of 3D printing and scanning since 2015, and established Working Group (WG) 12 in August 2018 and is leading the international standardization of the medical field by collaborating with domestic and foreign experts.