#Japan #healthcare #Tokyo #SaMD #DigitalTherapeutics

SaMD Business Seminar

Learn about the Latest Strategies for SaMD Insurance

On September 10, 2025, a profound seminar will delve into the advancing landscape of Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and medical AI. We are witnessing a surge in the approval of these technologies as medical devices, marking a pivotal moment for their integration within healthcare. However, the crucial aspect that determines their success lies in the insurance strategy, an area often less explored and fraught with hidden complexities.

At this event, we will feature Kohei Takeshita, who holds extensive experience in regulatory assessments at the Pharmaceuticals and Medical Devices Agency (PMDA) and pricing decisions at the Ministry of Health, Labour and Welfare. His insights will cover:
1. Fundamental principles of SaMD insurance strategy
2. Real-world examples of insurance coverage in Japan
3. Current trends and future perspectives

Additionally, we have Eiji Takeda, CEO of Software Regulation Inc., who was responsible for Japan's first regulatory submission of a therapeutic app. He will provide an in-depth look at the realities of insurance coverage, discussing key case studies including:

• - CureApp AUD (an app designed to assist in reducing alcohol consumption)
• - EndoBRAIN-EYE (a program that supports endoscopic image diagnosis)
• - Mirebo
• - Med CBT-i (an app for insomnia disorders)

*Note: Due to time constraints, only select case studies may be discussed.

Who Should Attend?

This seminar is designed for:

• - Individuals interested in deep tech and startup culture
• - Professionals involved in launching or developing businesses in the healthcare sector
• - Anyone curious about trends in digital medicine (DTx, SaMD, etc.)
• - Entrepreneurs, executives, and researchers in healthcare

Event Details

• - Date: September 10, 2025
• - Time: 19:00 - 20:45 JST (Registration deadline: September 9)
• - Format: Hybrid (Zoom & In-Person)
• - Location: Beyond Next Ventures Event Space, 3rd floor, MFPR Nihonbashi Honcho Building, 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023
• - Cost: Free of charge for participants
• - Online Access: Guidance will be provided post-registration.

Important Notes

• - Participation may be subject to limitations due to high demand.
• - Professionals from competing companies or those attending for sales purposes are kindly asked to refrain from joining.
• - No materials will be distributed during the event.

Tentative Schedule

Common for both Online and Offline Attendees:

• - 19:00-19:10: Introduction & Overview of Beyond Next Ventures
• - 19:10-19:30: Basics of Insurance Strategies (Mr. Takeshita)
• - 19:30-20:00: Explanation of SaMD Insurance Case Studies & Q&A (Mr. Takeshita, Mr. Takeda, Mr. Hashizume)

Offline Participant Exclusive:

• - 20:00-20:15: Discussion on Latest Trends
• - 20:15-20:45: Networking Session

Speakers Profile

• - Kohei Takeshita is a lecturer at Tokyo Jikei University School of Medicine’s Advanced Medical Information Technology Research Department. With over four and a half years at PMDA evaluating medical devices comprehensively, he later transitioned to the Ministry of Health, contributing to pricing for various medical products. Currently, he supports innovative ventures in medical IT and device manufacturing.
• - Eiji Takeda, CEO of Software Regulation Inc., has led regulatory submissions for Japan’s first therapeutic apps at CureApp. Post the organization, he founded a company to assist with regulatory affairs in the development of SaMD and AI/ML diagnostic programs, supporting both domestic and international projects.

Organized by: Beyond Next Ventures Inc.

An independent venture capital firm aiming to implement innovative science and technology solutions for global societal challenges, focusing on deep-tech startups during seed stages through incubation and development support.
Learn more about our mission and activities.