'Evertry' Dreaming to Be a Guide in the 'Untapped Territory' SaMD Industry

SaMD Consulting Platform 'Ebeoteurai'
Interview with CEO Shin Jaeyong and CSO Shin Jinwook

New Growth Engines in Medical Industry: 'AI Diagnosis' and 'DTx'
Supporting Full Cycle from Development to Commercialization through Various Foundations

SaMD consulting platform 'Evertly' CEO Jae-Yong Shin (left) and Chief Strategy Officer (CSO) Jin-Wook Shin (Photo by Evertly)

[Asia Economy Reporter Chunhee Lee] Diagnostic assistance through artificial intelligence (AI) and digital therapeutics (DTx) are currently the most promising sectors in the healthcare industry. Both are classified as 'Software as a Medical Device (SaMD).' As a nascent field, many developers face numerous challenges during the process. Existing clinical research organizations (CROs) and consulting firms, also being relatively new in this area, often cannot provide sufficient support.

To overcome these difficulties, we met on the 4th with CEO Jaeyong Shin (Professor of Preventive Medicine at Yonsei University) and Chief Strategy Officer (CSO) Jinwook Shin, who founded Evertly, a specialized consulting platform company that serves as a 'guide' for the SaMD industry, covering the entire development cycle from creation to approval and commercialization.

CEO Shin cited 'frustration' as the reason for founding Evertly. He explained, "Promising companies keep emerging, but most only divide the existing market pie without vertical expansion. I wanted to jump in myself and solve this together."

The two highlighted Evertly's strength as its diverse foundation. CEO Shin said, "Our goal is to build a platform that systematically possesses the necessary depth in each field to approach the SaMD industry and provide various evidences." To this end, he said they secured connections with institutions and companies such as Yonsei University, Severance Hospital, the Digital Health Center, the Biotechnology Holdings Company, and Pi Digital, all under the umbrella of Yonsei University's biotechnology holding company's subsidiary.

CEO Shin stated, "Our immediate goal is to succeed as a clinical research organization (CRO)." He expressed confidence, saying, "Because SaMD products vary widely by product and disease type, it is a niche market where large CROs and our capabilities are not significantly different. Also, being an institution within a university hospital, we are well-equipped to collect evidence."

Shin Jaeyong, CEO of Evertry (Professor at Yonsei University College of Medicine) / Photo by Kim Hyunmin kimhyun81@

So, what are Evertly's unique advantages that can practically benefit SaMD developers? CEO Shin positioned the company as a 'guide to reduce trial and error.' He explained that they assist in setting priorities necessary for actual market entry by analyzing the market and identifying regulatory blind spots. He cited an example from AI diagnostic assistance: "In the U.S., doctors and AI review the same data to determine diagnoses, but in Korea, evaluations are based on how results differ across various hospitals. If development targets only the Korean market, it could lead to significant setbacks. We aim to help reduce such trial and error."

CSO Shin emphasized that they can support the entire development cycle. He said, "If advice is sought separately for development, clinical trials, approval, and commercialization, continuity inevitably suffers. We aim to be a 'facilitator' in the digital healthcare industry by assisting all these stages and connecting what is needed at each step."

Evertly Logo (Photo by Evertly)

With the possibility of the 'first domestic DTx approval' rising within the year, they also stressed the need for concrete strategies for the next phase. CEO Shin said, "What matters in SaMD is not just approval by the Ministry of Food and Drug Safety but how much patients actually use it." He added, "Unlike at the approval stage, for actual market entry, it is necessary to demonstrate how different it is from existing medical technologies and how much innovative economic benefit it can bring to patients." However, he expressed regret, saying, "Such considerations are still often lacking in our industry."

CSO Shin also pointed out, "Many consider overseas expansion, but they should clearly establish their business model before taking on the challenge." He noted, "Many aim for FDA approval, and while we can assist with that, FDA approval itself does not solve everything." He cited Akili Interactive's 'EndeavorRx,' which received FDA approval but has hardly been reimbursed. "After market entry, it is important to prove cost reduction effects through real-world data (RWD), which is not directly linked to FDA approval," he criticized.

CSO Shin proposed 'personal wellness products' as a solution for entering the U.S. market. Instead of obtaining formal SaMD approval, targeting a broader market at a lower threshold in the form of wellness products is possible. He emphasized, "Unlike Korea, the U.S. has poor medical accessibility, so demand is high. Even if digital therapeutics like the weight management program 'Noom' show comparable effects, they have already succeeded with wellness business models and do not attempt FDA approval."

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