'Evertly' Offering 'SaMD Specialized Consulting'
Hosts '1st DTx Workshop'
Advice Such as "Risk Should Be Viewed Differently Depending on Target Disease"
This year is considered a major turning point for the development of the DTx industry, with the release of the first and second domestic digital therapeutics (DTx) devices and the authorities issuing guidelines for applying national health insurance coverage. As research and development (R&D) on subsequent DTx continues, it has been pointed out that smooth development requires a good understanding of the characteristics of DTx, as well as thorough consideration of issues not previously addressed in pharmaceutical and medical device development, such as security and usability.
Han Hyeri, Head of Evertree, is giving a lecture at the 1st DTx Workshop held on the 30th at Yonsei University in Seodaemun-gu, Seoul, hosted by Yonsei University Medical Center and Evertree. [Photo by Lee Chunhee]
At the first DTx Workshop held on the 30th at Yonsei University in Seodaemun-gu, Seoul, hosted by Yonsei University Medical Center and Evertree, Han Hyeri, a manager at Evertree, emphasized in a lecture titled "Regulatory Science (RA) and Quality Assurance (QA) Education for DTx Approval" that "the most important aspect of DTx is evidence-based therapeutic intervention," adding, "DTx can only be recognized if there are clinical practice guidelines and clinical papers." In this regard, while major global regulatory agencies continue attempts to regulate DTx as medical devices, she also pointed out that it is not always appropriate to view them solely as medical devices. She stated, "DTx is a concept that combines medical devices and non-medical devices, including wellness," but emphasized, "Most major countries regulate them as medical devices, and in the medical market, they mostly take the form of SaMD."
Evertree is a software medical device (SaMD) specialized consulting company founded last June by Shin Jaeyong, a professor in the Department of Preventive Medicine at Yonsei University, as a subsidiary of Yonsei University Biohealth Technology Holdings. SaMD is a concept that encompasses not only DTx but also AI diagnostic assistance, which has recently become a mega trend. Although the SaMD development process superficially resembles that of conventional pharmaceuticals or medical devices, many companies are experiencing unexpected trial and error due to numerous differences during development.
On this day, Manager Han mentioned various aspects related to quality along with the unique characteristics of DTx that should be considered during the development process. She conveyed the view that although DTx is generally considered a non-invasive medical device with low risk, it is not necessarily always so. She said, "When risk levels are classified from A to C, DTx is usually made at level B, but DTx managing cardiovascular diseases sometimes requires documentation at the highest level C," adding, "It is important to keep in mind that risk levels may increase depending on the target disease, especially when linked to cardiovascular diseases or cancer."
She also emphasized the importance of security. Manager Han explained, "DTx applications inevitably contain a lot of personal and medical information," and "such leakage scenarios must be set during risk analysis processes." She cited cases where Google’s medical imaging AI development project 'Nightingale' in 2019 and the X-ray data accumulation project in 2020 were thwarted due to security issues, stressing, "Special attention must be paid to this."
Usability was also highlighted as a key factor. While this year marked a hopeful beginning for the domestic DTx industry, it was also a year when dark clouds seemed to gather over the global DTx industry as Pear Therapeutics, a leading player in the U.S., filed for bankruptcy. However, the industry analyzes that the cause was Pear Therapeutics’ app not being user-friendly and the lack of updates to overcome this. Manager Han also agreed, stating, "The main cause was the poor user interface and user experience (UI/UX)," and emphasized, "User-friendliness will be the most critical factor in securing competitiveness in the future."
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