| Accelerating AI Digital Medical Device Rapid Productization Project
| Integrated Support for Usability, Clinical Trials, GMP, and Cybersecurity via Dedicated Organization
While technical competition for AI-based digital medical devices is accelerating, the approval and launch processes remain the biggest barriers at the actual market entry stage. In this context, JNPMEDI (CEO Kwon-ho Jung) is drawing industry attention by providing integrated support covering the entire process of digital medical device approval and launch in connection with the government’s ‘AX-Sprint 300’ project.
AX-Sprint 300 is a project for ‘Rapid Productization Support of Advanced AI-based Digital Medical Devices’ promoted by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Medical Device Safety Information (NIDS). It is characterized by providing a one-stop connection for all stages, from identifying AI medical device companies to customized regulatory support and certification/review. Its purpose is to help prepared companies quickly lead to certification, clinical trials, productization, and market entry by systematically supporting regulatory requirements.
In line with the purpose of this project, JNPMEDI plans to play a role in providing practical support for the approval and launch phases, where companies feel the most significant burden during the digital medical device development process. The company operates the ‘MedTech and Globalization Offering Group,’ which is dedicated to the productization of digital medical devices, and is establishing a system to integrally support core factors directly related to licensing, such as Usability, Clinical Trials, GMP (QMS), and Cyber Security.
Seung-mi Lee, Senior Vice President of JNPMEDI, stated, “The core of AX-Sprint 300 is not just technical development, but connecting products that meet approval and certification requirements so they can actually be launched on the market.” She added, “We will systematically organize the regulatory and execution tasks that arise during the digital medical device development process to support companies so they can stably reach the final stage of productization.” Senior VP Lee is currently overseeing the overall digital medical device productization strategy within the dedicated organization.
In the future, JNPMEDI plans to conduct preliminary analysis on essential outputs—such as product and algorithm maturity, regulatory compliance checks, clinical evidence, QMS, and security documents—for companies and medical institutions preparing to participate in AX-Sprint 300. In addition, through an execution-oriented consultation process including verification, testing, and linkage with medical institutions, the company aims to support companies so that their participation in the project leads to actual results.
Meanwhile, JNPMEDI is a digital healthcare company that supports clinical trials, licensing, and overall commercialization through clinical trial data platforms, CRO services, and licensing/business development consulting. It has recently been expanding its scope of cooperation in AI-based digital medical devices and the healthcare sector.
| Accelerating AI Digital Medical Device Rapid Productization Project
| Integrated Support for Usability, Clinical Trials, GMP, and Cybersecurity via Dedicated Organization
While technical competition for AI-based digital medical devices is accelerating, the approval and launch processes remain the biggest barriers at the actual market entry stage. In this context, JNPMEDI (CEO Kwon-ho Jung) is drawing industry attention by providing integrated support covering the entire process of digital medical device approval and launch in connection with the government’s ‘AX-Sprint 300’ project.
AX-Sprint 300 is a project for ‘Rapid Productization Support of Advanced AI-based Digital Medical Devices’ promoted by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Medical Device Safety Information (NIDS). It is characterized by providing a one-stop connection for all stages, from identifying AI medical device companies to customized regulatory support and certification/review. Its purpose is to help prepared companies quickly lead to certification, clinical trials, productization, and market entry by systematically supporting regulatory requirements.
In line with the purpose of this project, JNPMEDI plans to play a role in providing practical support for the approval and launch phases, where companies feel the most significant burden during the digital medical device development process. The company operates the ‘MedTech and Globalization Offering Group,’ which is dedicated to the productization of digital medical devices, and is establishing a system to integrally support core factors directly related to licensing, such as Usability, Clinical Trials, GMP (QMS), and Cyber Security.
Seung-mi Lee, Senior Vice President of JNPMEDI, stated, “The core of AX-Sprint 300 is not just technical development, but connecting products that meet approval and certification requirements so they can actually be launched on the market.” She added, “We will systematically organize the regulatory and execution tasks that arise during the digital medical device development process to support companies so they can stably reach the final stage of productization.” Senior VP Lee is currently overseeing the overall digital medical device productization strategy within the dedicated organization.
In the future, JNPMEDI plans to conduct preliminary analysis on essential outputs—such as product and algorithm maturity, regulatory compliance checks, clinical evidence, QMS, and security documents—for companies and medical institutions preparing to participate in AX-Sprint 300. In addition, through an execution-oriented consultation process including verification, testing, and linkage with medical institutions, the company aims to support companies so that their participation in the project leads to actual results.
Meanwhile, JNPMEDI is a digital healthcare company that supports clinical trials, licensing, and overall commercialization through clinical trial data platforms, CRO services, and licensing/business development consulting. It has recently been expanding its scope of cooperation in AI-based digital medical devices and the healthcare sector.