Korea might be lightyears ahead of other countries with developing new digital health technologies. However, the nation falters in timely implementation, raising questions about the practical impact of its advancements. 

Korea approved two digital therapeutics (DTx) devices this year but there has been no news about the market launch since the Ministry of Food and Drug Safety (MFDS) granted the approval for these innovative devices from Aimmed and Welt in February and April this year respectively.

Korea has announced many initiatives to expand the bioindustry but still expresses very conservative views when it is time to implement innovative technologies, which can also be seen with the slow adoption of telemedicine.

What is causing the delay?

WELT-I is an insomnia DTx aimed at delivering treatment to correct psychological, behavioral, and cognitive factors that sustain or worsen insomnia based on cognitive behavioral therapy (CBT). 

Aimmed’s Somzz is a software medical device that also implements CBT to treat insomnia patients by increasing sleep efficiency through sleep habit training, real-time feedback, and behavioral intervention provided by the mobile app for six to nine weeks. 

As the developers of the first approved DTx devices in Korea, both Welt and Aimmed are exploring uncharted territory. 

Even after receiving approval, both companies have to prepare for the pilot project to accumulate real-world evidence of the DTx device, as required by the National Evidence-based Healthcare Collaborating Agency (NECA). 

Welt CEO Sean Kang expressed his frustration with the slow launch saying that it was being delayed as they were required to jump through several hoops to undergo a pilot project. 

“This can take anywhere from one to three years depending on the amount of evidence we can generate within this time,” he explained. 

The pilot project will be conducted with selected hospitals and then later expanded if they generate sufficient evidence. He mentioned that some of the things delaying the launch were the integration of the back end of the DTx with the hospital's electronic medical records (EMR), adapting patients and physicians to the device, and other procedures that were consuming more time than expected. 

“All the extra steps make the product developed for clinical trials feel like a completely different one,” Kang said.

Still, he expects the pilot project to be started earliest at the end of this year or latest, by the first half of next year.

Similarly, Ethan Jung, the head of the DTx business unit at Aimmed, stated that the company is currently working on supplementing the results of the deliberation from NECA after submitting the first research plan. “Subsequently, the revised research plan will be submitted by next Friday, and reviewed by the evaluation committee in early September,” he explained.

How to fast-track the launch of innovative devices?

Korea recently released English guidelines on the review and approval of DTx devices.

The Digital Therapeutics Alliance (DTA) applauded Korea for leading the industry with its regulations and standards. 

However, NECA is now getting in the way of these technologies being used in real-world clinical settings.

This situation often repeats itself. NECA has been previously criticized for its evaluation being redundant and excessive. 

The Yonsei University Health System’s (YUHS) new heavy particle therapy also suffered a delay in launching the device for the first patient treatment this year and many other domestic companies with innovative technologies have also expressed similar struggles. 

While safety should be a key component for evaluating innovative devices, benchmarking policies from countries with experience in launching similar innovative devices should also be considered in the evaluation, experts said.

In particular, Germany has been recognized for its DiGA fast-track system in the DTx industry. The system allows physicians to prescribe digital therapeutic devices through an approval process based on specific evaluation criteria unique to the device and provides insurance reimbursement for a limited time before clinical evidence is established.  

While the Aimmed official acknowledged that Germany has one of the most innovative reimbursement systems, Korea does not need this particular system, he said.

"We just need to find a way for companies to collect real-world data quickly," he explained. "The government is already  making efforts to change this but as the field of DTx is new, the legal and institutional framework is not sufficient."

“I think all the members of the ecosystem, including the government, industry, and medical institutions, have to work together to get innovative devices launched faster.”