Even amid social distancing due to COVID-19, it appears that the world co-operates with one another for public health issues. Health Kyunghyang, the first media company to operate a multilingual edition, rapidly delivers domestic health and worldwide medical news. This year, we went one step further, preparing a particular article called 'Medical Discussion with World Scholars.' From the latest treatment methods for numerous diseases to the direction of health care development in line with future medicine, we will communicate with renowned health and medical scholars at home and abroad to provide readers with a broader range of information. The eighth theme is 'Digital Therapeutics.' You will be informed of the diverse opinions of scholars from different countries at a glance. < Editor's Note>
Recently, as digital therapeutics (DTx) has become more active, the government is actively presenting assorted support and training measures and guidelines for approval review. In fact, in March of last year, by including 'digital therapy' in 30 promising technologies for the post-Corona 19 era, high-level hospitals and companies are putting effort into its expansion and commercialization. Accordingly, the relevant contents were summarized based on the ‘2021 Yonsei Global DTx (Digital Treatment Device) Symposium'.
Participants in this discussion were ▲Professor Sangkyu Lee, Department of Preventive Medicine, Yonsei University ▲Park Jihoon, Medical Device Program Director (PD), Korea Institute of Industrial Technology and Evaluation ▲IEC TC62 Secretary Regina Geierhofer ▲Eric Heckler, University of California, San Diego, USA Professor ▲ Magan Coder, Vice President of Policy, Digital Therapy Equipment Alliance (DTA).
■Discussion Main Issues
Digital therapeutics refers to software medical devices employed to prevent, manage, and treat diseases or disorders. Patients were suffering from poor treatment for certain diseases, such as chronic diseases and neurological and mental diseases, which are rapidly increasing due to the aging of the population. Digital therapeutics are rapidly evolving as an alternative to supplement this insufficient treatment area. The global digital therapeutics market extended at an average annual rate of 26.7% to $2.117.8 billion (KRW 2.497 trillion) last year. In 2025, it is expected to reach US$ 6.94.6 billion (KRW 8,139.8 billion). However, it appears still challenging to develop and commercialize it due to inadequate laws and systems.
- The current state of development of digital therapeutics in each country.
Professor Sang-Gyu Lee of Korea: Digital therapy is attracting attention as a new solution encompassing treatment, management, and prevention in the non-face-to-face era. Most domestic medical devices lag in the global market, but digital therapeutics do not.
Currently, it is being actively developed in the field of ▲Central nervous system diseases that are difficult to develop new drugs such as dementia, Alzheimer's, and ADHD (attention deficit and hyperactivity disorder) ▲Chronic diseases that can have therapeutic effects through behavior modification include cancer, high blood pressure, diabetes, and respiratory diseases, and ▲Neuropsychiatry includes smoking cessation, drug addiction, depression, insomnia, autism, etc. So it is vital first to secure the source technology. Accordingly, general tertiary hospitals are continuing various researches in connection with companies by opening digital treatment centers and research centers.
Korea Program Director Park Ji-hoon (after this referred to as Park Ji-hoon): The healthcare delivery system has changed due to the COVID-19 pandemic. Currently, the Ministry of Trade, Industry, and Energy actively supports the nation's new growth industries in R&D fields such as alcoholism, insomnia, corona blue and depression, panic disorder, smoking cessation, orthostatic hypotension, and eating disorders. Among them, the development of alcoholism and insomnia is the fastest.
In addition, as a result of a survey of the Korea Digital Health Industry Association, there are a total of 23 digital therapeutic pipelines. Development domains include mental health 43.5%, age group 21.7%, chronic disease 17.4%, pain, physical activity 4.3%, and other 13%. However, most are still in the early stages.
- Companies around the world are taking the lead in developing digital therapeutics. Any hardships in the field?
Megan Coder, Vice President of Policy: The Digital Therapeutic Devices Alliance is a non-profit association of more than 70 member companies worldwide. Currently, all companies, including associations, pursue a principle in common. ▲ Digital treatment application method in clinical field ▲ Patient personal information security ▲ Design/manufacturing guarantee application principle ▲ Clinical trial format required outside the development stage ▲ Product regulatory review method ▲ Clinical evaluation period, etc.
The target of digital therapeutics has recently gone beyond chronic diseases to cancer. Although digital therapy does not instantly treat cancer, it plays an essential role in minimizing side effects and optimizing drug therapy. In simple terms, 'telemedicine' and 'customized medical care' are achievable with digital therapeutics.
This is very innovative for patients with limited access to health care. Cancer treatment using digital therapeutics shows a substantial difference from traditional therapy in that it provides a variety of information to clinicians, patients, and caregivers. Early next year, our association will announce a digital therapy value evaluation and integrated guide.
Professor Eric Heckler: The limitations of digital therapeutics presently under development are clear. We expected various treatment options to be provided in the early stages of development, but it was challenging to apply digital therapeutics to the medical field. Moreover, the new treatment was neglected by patients due to the inconvenience of use.
This is because of the absence of communication between the developing company and the medical field. Therefore, what is needed now is a change in clinical methods. For digital therapeutics to be commercialized in the future, the dependence on randomized trials (RCT) should be reduced, and the partnership between companies and researchers should be solidified. A few years ago, a paper on 'Comparison of weight-loss treatment using wearable technology' was published. This study conducted for 12 months showed the problems of the randomized trial: The patient's details cannot be comprehended, and proper sampling is challenging to be completed as participation in the test may be lowered. Therefore, a separate clinical track that can adequately prove the efficacy and effect is required.
- Efforts for the successful settlement of digital therapeutics.
IEC TC62 Secretary Regina Geirhofer: Now, digital therapeutics are small in software medical devices, but they have excellent growth potential. The concern is that safety and reliability have not yet been sufficiently ascertained. Therefore, international standardization work is critical. Take, for example, a therapeutic game for children with attention deficit disorder (ADHD). Without the standardized standard, it will cost a lot of time and money to illustrate the effects to parents who want to reduce their children's computer time. Therefore, IEC is currently focusing on verifying ▲information system ▲safety ▲ethics that the general public can easily understand.
Ji-Hoon Park: Korea persists in supporting digital treatment source technologies' development, demonstration, and commercialization. Support for a total of four years encloses ▲ 'Advancement of the mechanism of action' in the 1st year, ▲ 'Elaboration of business model' in the 2nd year, ▲ 'Clinical effect verification' in the 3rd year, ▲ and 'Licensing and commercialization support' in the 4th year. In the first year, with clinical experts and advisors' participation, we concentrated on devising excellent products through the mechanism of action verification and advanced support. In addition, we are in the middle of installing safety, effectiveness, and economic indicators so that digital therapeutics can be directly applied to the medical field. Next year, we plan to lead the global market by vigorously intercommunicating with overseas experts.
