[Good Brain 2022] Making Korea a Global DTx Hub: "Top Technology, Beyond Asia to the World"

DTx Expert Panel Discussion of 6
Concerns About 'Adherence' in Development Process
DTx Expected to Become Commonplace in 5 Years
Domestic Regulations at Global Standards
Reimbursement Important... Prompt Action Needed

On the 21st, at the Westin Chosun Hotel in Jung-gu, Seoul, a panel discussion was held under the moderation of Kim Jae-jin, President of the Korean Society of Digital Therapeutics (Professor at Gangnam Severance Hospital), during the "Good Brain 2022 International Conference" hosted by Asia Economy. From the left: Professor Kim Jae-jin, Kang Sung-min, Co-CEO of Rowan, Kang Sung-ji, CEO of Welt, Kang Young-gyu, Director of Digital Health Regulatory Support Division at the Ministry of Food and Drug Safety, Noh Yoo-heon, Co-CEO of Imocog, Jung Tae-myung, CEO of HipotianC, and Ha Sung-wook, Head of Strategic Planning at KMI Korea Medical Institute. Photo by Kim Hyun-min kimhyun81@

[Asia Economy Reporters Kwanju Lee, Youngwon Kim] The era of 'Digital Therapeutics (DTx)', which treats patients through software such as smartphone applications, has fully opened. In the United States, 20 DTx products have already received approval from the Food and Drug Administration (FDA) and are being used in clinical settings. In South Korea, more than ten companies have entered the confirmatory clinical trial phase, and the first DTx product is expected to be launched this year. As a global IT powerhouse and medical leader, South Korea is highly anticipated to become a new land of opportunity for DTx.

At the 'Good Brain 2022 International Conference' hosted by Asia Economy on the 21st at the Westin Chosun Hotel in Jung-gu, Seoul, a session was held under the theme 'Making Korea the Global DTx Hub,' where CEOs, experts active at the forefront of domestic DTx research and development, and regulatory authorities engaged in in-depth discussions. The panel discussion was chaired by Jaejin Kim, President of the Korean Digital Therapeutics Society and Professor of Psychiatry at Gangnam Severance Hospital, with participants including Sungmin Kang, CEO of Rowan; Sungji Kang, CEO of Welt; Younggyu Kang, Director of Digital Health Regulatory Support Division at the Ministry of Food and Drug Safety; Youheon Noh, CEO of Imocog; Taemyung Jung, CEO of HipotianC; and Sungwook Ha, Head of Strategic Planning at KMI Korea Medical Institute.

On the 21st, at the Westin Chosun Hotel in Jung-gu, Seoul, Kim Jae-jin, President of the Korean Society of Digital Therapeutics (Professor at Gangnam Severance Hospital), is leading a panel discussion at the "Good Brain 2022 International Conference" hosted by Asia Economy. Photo by Kim Hyun-min kimhyun81@

- How do you evaluate the level of South Korea's DTx compared to the global standard?

▲ CEO Sungji Kang: It was natural that DTx received FDA approval in the U.S. around 2017-2018 and gradually spread to other countries. From South Korea's perspective, there was about a three-year gap due to institutional entry, but looking back now, we have closely refined the system and received strong industry support, closing much of the gap. I compare it to electric vehicles. In this paradigm shift, we have the technology and can lead the industry. Although the U.S. leads DTx, by focusing on digital as a keyword, we can certainly lead at least the Asian market.

▲ CEO Youheon Noh: Currently, we are proceeding with product approval, and not many companies worldwide are advancing with dementia DTx. There has been significant progress in Korea. I believe our foundational technology is on par with the U.S. and Europe. We expect meaningful results soon.

▲ CEO Taemyung Jung: However, whether South Korea can become a DTx hub requires deep consideration. The U.S. receives investments worth hundreds of billions of won, but Korea's investment is less than 10 to 20 billion won. The FDA has approved 20 DTx products, but we need to see if the government has policies to make Korea a hub. Government policies and companies' will to become world-class must combine, but as a second-best option, becoming the Asian hub should also be considered.

- What is the most challenging part in the DTx development process?

▲ CEO Sungmin Kang: The biggest concern is user experience and adherence. There's a joke about doctors' misconceptions: doctors think that if they prescribe medicine, patients will take it exactly as directed and come for appointments on time, but many cases are missed. You may have downloaded several health management apps, but even I haven't used one for more than a month. How to improve adherence is the biggest challenge.

▲ Head Sungwook Ha: From a third-party perspective, listening to the concerns of DTx company CEOs, decision-making is difficult because there are no clear answers. Many decisions must be made during development, such as whether to conduct exploratory or confirmatory clinical trials, and whether to start trials in Korea or the U.S. Since this is an emerging industry, sharing know-how through communities is the only way. Although know-how is scarce and the environment is still harsh, once momentum builds, there is hope to grow into a global player.

At the 'Good Brain 2022 International Conference' hosted by Asia Economy on the 21st at the Westin Chosun Hotel in Jung-gu, Seoul, panelists are engaged in discussion. From the left: Seongmin Kang, Co-CEO of Rowan; Seongji Kang, CEO of Welt; Younggyu Kang, Head of Digital Health Regulation Support Division at the Ministry of Food and Drug Safety; Youheon Noh, Co-CEO of Imocog; Taemyung Jeong, CEO of Hipotinc; and Sungwook Ha, Head of Strategic Planning at KMI Korea Medical Institute. Photo by Hyunmin Kim kimhyun81@

- Will DTx truly become a common and important treatment method in the medical market?

▲ CEO Youheon Noh: I definitely expect that to happen. However, I think it will take more than five years to apply the new medical system. Digital therapeutics expand the treatment area while maintaining existing treatment domains. This means the existing medical field will shift to a patient-driven model. Patient-driven care requires significant mindset changes, and patients themselves need time to accept and embrace DTx. As DTx improves and can be effective alone, I expect many people to benefit within 5 to 7 years.

▲ Director Younggyu Kang: In the U.S. and Europe, clinical use is still at an early stage. Many products are being developed, and I believe the outlook will be positive over time. Fair Therapeutics' three DTx products were used about 14,000 times last year. In Germany, about 51,000 cases were registered in the DiGA system. Based on overall data, I think DTx usage will increase.

- DTx can only shine when IT platforms and technology combine with highly specialized medical knowledge. What efforts are needed for convergence between these different fields?

▲ Head Sungwook Ha: Although I don't know all the DTx companies that have completed clinical approval at the Ministry of Food and Drug Safety, roughly the ratio is about 3:7 or 4:6 between medical and IT fields. For people from different fields to understand each other's terminology and run in one direction, leadership that understands both sides is necessary. Especially in this early stage of DTx, leadership from both sides and efforts to reduce risks are essential.

▲ CEO Sungmin Kang: In collaboration with hospitals, there is no resistance to parts different from clinical care. They see it as a good tool to solve problems they wanted to address but couldn't, and actively support companies. The regrettable point is the common misconception in hospitals that patients will follow prescriptions exactly. We need to improve adherence to DTx, but it's difficult to make hospitals understand this.

▲ CEO Taemyung Jung: We need to consider this from a humanities perspective. No one should think their expertise is superior to others. Sometimes doctors think their medical knowledge is superior, or AI experts think they are superior, which hinders collaboration. There are also cases of protesting without understanding regulatory agencies. Respecting different fields is essential for collaboration.

On the 21st, at the Westin Chosun Hotel in Jung-gu, Seoul, a panel discussion was held under the moderation of Kim Jae-jin, President of the Korean Society of Digital Therapeutics (Professor at Gangnam Severance Hospital), during the "Good Brain 2022 International Conference" hosted by Asia Economy. From the left: Professor Kim Jae-jin, Kang Sung-min, Co-CEO of Rowan, Kang Sung-ji, CEO of Welt, Kang Young-gyu, Director of Digital Health Regulatory Support Division at the Ministry of Food and Drug Safety, Noh Yoo-heon, Co-CEO of Imocog, Jung Tae-myung, CEO of HipotianC, and Ha Sung-wook, Head of Strategic Planning at KMI Korea Medical Institute. Photo by Kim Hyun-min kimhyun81@

- How does South Korea's DTx regulatory level compare to other countries?

▲ Director Younggyu Kang: I don't think domestic DTx regulations lag behind those of other countries. Overseas countries apply software medical device guidelines to DTx-related regulations, but in Korea, separate guidelines for DTx were published apart from software medical device guidelines. From that perspective, foreign observers may perceive the Ministry of Food and Drug Safety as a leader in approval. Last week, an FDA official showed interest in the Ministry's guidelines at the International Medical Device Regulators Forum. Although there is no radical regulation like the FDA that allows use without approval, Korea recently enacted the Medical Device Industry Promotion and Innovative Medical Device Support Act, enabling fast-track designation for innovative medical devices. We plan to improve supplementary matters in the future.

▲ CEO Sungji Kang: Until a few years ago, many DTx-related products were released, making it difficult to distinguish quality. When marketing rather than development drives sales, both medical staff and consumers find it hard to choose the right products. Regulation plays a role in protecting companies that do things properly. Also, if overseas countries refer to domestic regulations, domestic companies will face fewer risks and be better protected when responding in those countries.

- Regarding DTx reimbursement, many say the process is too long and complicated. What would be an ideal process?

▲ CEO Taemyung Jung: Personally, I think the long time for DTx reimbursement is less of a concern. I don't think patients will avoid treatment due to costs of around 40,000 to 50,000 won. However, I hope various measures will be taken to speed up the reimbursement process.

▲ Chair Jaejin Kim: No matter how well a drug is made, if the cost exceeds what patients expect, it will be hard to become widespread. That's why reimbursement is important. The domestic review process took 390 days, but in July, digital therapeutic device regulatory improvements were announced and follow-up actions are underway. The review period has been reduced to 80 days, and a Digital Medical Expert Evaluation Committee has been formed at the Health Insurance Review and Assessment Service. We hope products that quickly help patients will be introduced domestically.

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