Welt: "Securing Real Data Essential for DTx Growth... Foundation for Competitiveness Established"

Interview with Kang Sung-ji, CEO of Welt

Ministry of Health and Welfare's 'Integrated Review of Innovative Medical Devices'
Welt's 'PillowRx' Selected

"DTx Evolves Through Securing RWD"
"To Maximize System Impact, Fee System Must Also Be Integrated"

Kang Sung-ji, CEO of Welt (Photo by Welt)

[Asia Economy Reporter Chunhee Lee] Digital therapeutics (DTx) devices selected as innovative medical devices are expected to see their commercialization process, which previously took over a year, drastically shortened to 80 days. This institutional support for rapid commercialization is anticipated to be a significant boon for the DTx industry, which has long been thirsty for such measures.

Kang Sung-ji, CEO of Welt, defined DTx in an interview with Asia Economy on the 23rd as "software as a medical device (SaMD) that evolves based on real-world data (RWD) tailored to each individual patient," and predicted that the Ministry of Health and Welfare's introduction of an integrated review and evaluation system for innovative medical devices will greatly aid the growth of the DTx industry. He added, "Since SaMD can simplify refined verification, it is necessary instead to secure RWD through rapid launch and develop based on that. It is significant that a market-friendly system to enhance global competitiveness has been established through policy."

Recently, the Ministry of Health and Welfare unified the existing innovative technology medical device system, which required separate processes such as medical device approval by the Ministry of Food and Drug Safety (up to 80 days) and innovative medical technology evaluation by the Korea Health Industry Development Institute (up to 250 days), into an integrated review and evaluation system for innovative medical devices. The prescribed period previously totaled about 390 days, exceeding one year, and if delays occurred in the middle, it could take several years until final launch. However, going forward, once designated as an innovative medical device, commercialization will be possible within a significantly shortened timeframe.

Welt’s chronic insomnia improvement DTx, 'PillowRx,' was selected as an innovative medical device along with AimMed’s insomnia DTx 'Somz' through this integrated review and evaluation system. Currently, PillowRx is undergoing the medical device approval process by the Ministry of Food and Drug Safety, and once approved, it can enter the market as early as 30 days after approval following the notification procedure that begins simultaneously.

Welt's chronic insomnia improvement DTx 'PillowRx' (Photo by Welt)

Regarding the review process for PillowRx under this system, CEO Kang said, "There was some burden as the steps that would have been taken sequentially were done all at once," but added, "I prepared diligently, believing that graduating sooner would lead to better outcomes."

However, concerning the commercialization schedule of PillowRx, he emphasized that "the clinical environment does not seem mature enough for doctors and patients to smoothly utilize DTx," and that even if approval by the Ministry of Food and Drug Safety is granted, they will not rush into commercialization. He said, "Looking at cases like Fair Therapeutics and Akili Interactive in the U.S., market entry for DTx is not an easy issue," and added, "We are deeply considering how to create a structure for the company to grow in a virtuous cycle after entering the market."

CEO Kang also did not hold back suggestions to enhance the effectiveness of the system. He said, "Germany’s 'Digital Health Application program (DiGA),' which is similar to the integrated review system for innovative medical devices, includes reimbursement within the system," and added, "Ultimately, since the most important thing is the pathway for use in the field, for the system to have more explosive power, the reimbursement aspect should also be included in the system." He further explained, "The government’s approval stage focuses on safety and efficacy, but when entering the market, user convenience and cost-effectiveness become the battleground, so it would be better if system improvements consider these factors."

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