[CEO of a company certified as a New Health Technology (NET) by the Korea Health Industry Development Institute] ‘Neudive,’ a company developing digital medical devices and healthcare solutions fo...
Cho Seong-ja, CEO of Neudive
- Development of 'BuddyIn,' a digital medical device that improves social situational awareness and interaction in children and adolescents with Autism Spectrum Disorder (ASD) aged 10 to 18
The biggest competitive advantage is that the therapeutic content was not simply digitized, but developed into a medical device that has undergone clinical trials and verification by regulatory agencies.
- Certified as a New Health Technology (NET) for a technology that structures and implements existing cognitive behavioral therapy and social skills training processes in a digital environment
- Implement the treatment process with mobile-based scenarios and interactive content
Neudive is a company that develops evidence-based digital medical devices and digital healthcare solutions to help children and adolescents with neurovariables, such as autism spectrum disorder, social communication disorder, and ADHD, grow more independently in their daily lives. It was founded in January 2022 by CEO Jo Seong-ja (62).
CEO Cho has been involved in the healthcare industry for a long time, handling new drug clinical trials and regulatory affairs at global pharmaceutical companies such as Pfizer Korea, Janssen Korea, and Lilly Korea. Later, while raising a child with autism spectrum disorder, he came to personally experience the difficulties faced by individuals with the condition and their families in the treatment field.
“Continuous and repetitive intervention is crucial for neurodevelopmental disorders such as autism spectrum disorder and ADHD, but due to a shortage of specialized personnel and the geographical concentration of treatment centers, it is often difficult to receive sufficient necessary treatment. I founded Neudive with the idea that digital technology could solve these problems.”
The flagship item is 'Buddy-in (NDTx-01)'. Buddy-in is a cognitive behavioral therapy (CBT)-based digital medical device developed to improve social situational awareness and interaction in children and adolescents aged 10 to 18 with autism spectrum disorder (ASD) or social communication disorder (SCD).
Previously, improving social skills required receiving cognitive behavioral therapy or social skills training from a specialist in a therapy room. However, access to such in-person professional therapy was difficult due to a shortage of specialists, and there was also the issue of cost, as it required receiving over 20 hours per week at a cost of approximately 50,000 to 100,000 won per session.
Buddy-in has implemented these therapeutic principles in a mobile environment, enabling children and adolescents to practice repeatedly at home and in their daily lives. For instance, it features game-based content designed to address situations such as conversing with friends at school, understanding others' emotions, and choosing appropriate behaviors in social situations.
Social skills training conducted by a professional—rather than the social skills training typically performed in a therapy room—was simulated and gamified to help trainees understand a friend's facial expressions and context and respond appropriately in situations likely to occur at school.
In addition, an important feature is that since usage history, performance results, and compliance are recorded as digital data, guardians and medical staff can check the treatment process and connect it to subsequent medical care. Buddy-in evaluated its efficacy through domestic multi-center clinical trials and, based on this, obtained digital medical device manufacturing certification from the Ministry of Food and Drug Safety in May 2026.
Neudive's greatest competitive advantage is that it did not simply digitize therapeutic content, but developed it as a medical device that has undergone clinical trials and verification by regulatory agencies.
While many digital healthcare services are emerging, clinical efficacy and safety must be proven with objective data to enter actual medical practice. From the early stages, Neudive incorporated feedback into product development not only from medical professionals, cognitive science researchers, developmental rehabilitation and special education experts, and developers, but also from actual patients and their families. Subsequently, we systematically accumulated clinical evidence for the product by conducting exploratory and multi-center confirmatory clinical trials.
The second competitive advantage is the accessibility and repeatability of treatment. While traditional in-person treatment is limited by treatment institutions, specialized personnel, time, and location, digital medical devices enable repetitive training even outside of medical facilities.
The third point is that the treatment process is digitized. By accumulating objective data on usage and outcomes, guardians and medical staff can monitor the progress of treatment, and in the long term, this data can be used to develop more sophisticated treatments tailored to individual characteristics. CEO Cho emphasized, “Neudive’s competitive edge lies in the fact that ‘clinical evidence, digital accessibility, treatment data, and personalization’ are connected as a single structure.”
Since Buddy-In is a digital medical device used based on medical prescriptions rather than a wellness app for general consumers, it requires a different approach from typical app marketing. First, in Korea, we are prioritizing entry into the medical institution prescription market by completing necessary procedures, such as obtaining manufacturing certification from the Ministry of Food and Drug Safety and undergoing the New Medical Technology Assessment. In particular, we plan to expand activities to inform medical professionals and institutions about the product's clinical evidence and practical applications, focusing on child and adolescent psychiatry. At the same time, we are creating opportunities for medical professionals and industry stakeholders to experience the product firsthand through academic conferences and medical and digital health exhibitions.
Overseas markets are also an important goal. We have introduced our products and technologies through global exhibitions such as CES and MEDICA, and are exploring the possibility of joint research and localization with overseas research institutions, including those in Japan. Ultimately, our goal is not simply to sell products, but to create a new digital treatment model that connects medical consultations with home care.
Since its founding, Neudive has been conducting technology development and clinical trials through external investments and government R&D projects. Major external investors included Daewoong Pharmaceutical and Hanol Biopharma, which provided support from the company's early stages, followed by Murex Partners and J&P Medi Partners.
Unlike typical software startups, digital medical device companies require significant time and investment not only for product development but also for clinical trials, regulatory approval, and market entry. On the other hand, once clinical evidence and regulatory frameworks are secured, there is the advantage of being able to leverage this foundation to expand into subsequent products and overseas markets. As BuddyIN has reached the critical stage of obtaining manufacturing certification from the Ministry of Food and Drug Safety (MFDS), we are currently reviewing the attraction of strategic investment to enter the domestic medical market, develop subsequent pipelines, and expand globally. We place great importance not only on simple financial investment but also on collaborating with strategic partners in the pharmaceutical, bio, medical, and digital health sectors who can grow alongside Neudive’s technology.
Neudive has received the New Health Technology (NET) certification from the Ministry of Health and Welfare and the Korea Health Industry Development Institute. This is a government initiative that grants official certification marks to technologies developed for the first time in Korea across seven fields: medical devices, pharmaceuticals, medical science, biotechnology, cosmetics, food, and traditional Korean medicine. The purpose of the NET certification is to identify new technologies developed by domestic companies, research institutes, and universities at an early stage, certify their excellence, and promote their commercialization and technology transfer. Obtaining this certification provides access to various forms of support, including expanded opportunities for cooperation with public institutions and hospitals, additional points when applying for related government projects, and benefits in insurance reimbursement price evaluations.
The core of Neudive's certification lies in its technology that structures and implements existing cognitive behavioral therapy and social skills training processes within a digital environment. “Traditional cognitive behavioral therapy involves a professional evaluating the subject, setting goals, repeating cognitive and behavioral training, and generalizing this to real life.”
Neudive has implemented this therapeutic process through mobile-based scenarios and interactive content. Users repeatedly train to identify the intentions and emotions of others and select appropriate actions while experiencing various social situations. What we consider particularly important is "enabling what is learned in the therapy room to be applied in real life." Therefore, the system is designed not merely to complete on-screen programs, but to allow users to practice with a guardian at home and connect the learning to real life. Furthermore, by continuously recording performance results, we are developing this into a personalized digital therapy technology that adjusts difficulty levels and content according to the performance level of children and adolescents in the future.
The New Health Technology (NET) certification is a system in which the Ministry of Health and Welfare identifies outstanding new technologies developed domestically in the healthcare sector and certifies them after evaluating their excellence and innovativeness. CEO Cho stated, “What is particularly meaningful is that the innovation and technicality of the core technology itself—which implements the proven existing treatment method of cognitive behavioral therapy in a digital environment—was recognized, rather than simply a single application or piece of content.” He added, “There are limitations to explaining the excellence of a technology developed in-house by a startup to the market. In that respect, I believe the NET certification was an important process that allowed us to objectively demonstrate the value of Neudive’s core technology through a credible evaluation.”
He added, “The most significant benefit is securing objective credibility for the technology.” He continued, “Especially in the field of digital medical devices, there is a clear difference between having a good idea and possessing technology with actual medical value. Having had the novelty, inventiveness, and technicality of our technology objectively evaluated during the New Health Technology (NET) certification process serves as a crucial foundation of trust when collaborating with medical institutions, pharmaceutical companies, investment firms, and overseas partners. Furthermore, it enables priority purchasing when supplying to national agencies, local governments, and public enterprises through the Public Procurement Service. It also holds great significance internally for the company. Startups must constantly verify whether they are heading in the right direction while developing new technologies. Having the innovativeness and growth potential of our technology evaluated by external experts has given the R&D team considerable confidence. Moving forward, we plan to pursue entry into the medical institution prescription market, business cooperation with pharmaceutical and healthcare companies, follow-up product development, and expansion into overseas markets, all based on the combined foundation of the NET certification and the Ministry of Food and Drug Safety manufacturing certification. Ultimately, I believe the certification itself is not the final goal, but rather a foundation of trust to deliver excellent technology to actual patients and their families.”
One of the characteristics of Neudive is that it is a multidisciplinary organization combining medicine, science, content, and software. CEO Cho stated, “To create digital medical devices, neither developers nor medical professionals alone are sufficient,” adding, “Products must be created by people with diverse expertise, such as personnel who understand clinical practice and regulations, researchers in cognitive science and neurodevelopment, content planners, UX/UI designers, and software developers.”
In particular, Neudive incorporates the opinions of experts not only from actual clinical settings but also from specialists in developmental rehabilitation and special education into its products, and collaborates with external research institutions such as the Korea Brain Research Institute and researchers from university hospitals. What we consider important is not merely creating technically superior products, but developing products that children and families can actually use and that can be utilized in medical settings. Therefore, we aim to be an organization that reflects the perspectives of medical, scientific, and IT fields, as well as actual users, starting from the research and development stage.
Regarding future plans, CEO Cho stated, “Our short-term goal is to ensure that Buddyin, which has received manufacturing certification from the Ministry of Food and Drug Safety, is prescribed in actual medical settings and delivered to children, adolescents, and their families in need.” He added, “Our next goal is to expand our product portfolio based on the clinical and regulatory experience, as well as digital therapeutic technology, accumulated by Buddyin.”
“We are currently developing follow-up digital solutions to improve the executive and cognitive functions necessary for children and adolescents with neurodevelopmental disorders, such as ADHD, as well as those with autism spectrum disorder. In the long term, we aim to evolve into a personalized digital therapy platform that moves away from providing treatment programs uniformly to everyone. Instead, we analyze user performance data and characteristics to determine 'who to provide what treatment, and at what level of difficulty.' Our ultimate goal does not remain confined to the domestic market. The issue of accessibility to treatment for neurodevelopmental disorders, including autism spectrum disorder and ADHD, is a common global concern. To our knowledge, Buddy In is currently the only instance where a digital medical device for interventional purposes in the field of autism spectrum disorder has received certification from regulatory authorities such as the Ministry of Food and Drug Safety. We hope that digital medical devices developed with Korea’s excellent technology and verified through clinical trials will expand into overseas markets and benefit many children and adolescents with autism spectrum disorder in other countries. Our goal is to grow into a global digital healthcare company in the field of neurodiversity that is recognized internationally, based on the clinical evidence, technology, and regulatory experience Neudive has accumulated in Korea. When starting Neudive, the most What we considered important was not the technology itself. 'Bringing treatment, previously only possible in a specialist therapy room, into the daily lives of children'—this is the problem Neudive aims to solve, and it remains our unchanging goal.
Date of Establishment: January 2022
Main Business: Development of digital medical devices for brain disorders such as autism spectrum disorder and ADHD
Achievements: Buddy-In received certification from the regulatory authority (MFDS) as the world's first digital medical device for autism spectrum disorder intervention (May 2026), won an Innovation Award at CES 2025, received certification as a New Health Technology from the Ministry of Health and Welfare (2025), and was designated as an Innovative Medical Device by the MFDS (2025); Buddy-Step completed exploratory clinical trials with the MFDS and advanced to the 'i-Mind Exploration Team' contest jointly organized by Hyundai Marine & Fire Insurance, Save the Children, and Severance Hospital.
Reporter Lee Jin -ho jinho2323@hankyung.com
