Former Hedgehog MedTech CEO Hiromi Kawata to Speak! Special Event to Review 4 Years of Digital Health Business Held on August 6 (Thu)

Software Regulation Co., Ltd. (Head Office: Chuo-ku, Tokyo, Representative Director: Eiji Takeda) will hold a special talk event to unravel the trajectory of digital health business development, inviting Ms. Hiromi Kawata, former Representative Director and CEO of Hedgehog MedTech Inc., as a guest. The event will be held in a hybrid format on August 6, 2026.

Background of the Event

In the spring of 2026, Medley Co., Ltd. announced the acquisition of all shares of Hedgehog MedTech Inc., making it a wholly-owned subsidiary.

Hedgehog MedTech Inc. is a startup that has developed businesses in the digital health field for headaches, from operating Japan's largest healthcare app "Zutu-ru" to developing program medical devices (SaMD) for headaches.

With this full subsidiary acquisition, the retirement of Ms. Hiromi Kawata, co-founder and Representative Director CEO, was also announced.

This event provides an opportunity to hear from Ms. Kawata, who has just retired, as a special guest.

Ms. Kawata, who led a SaMD startup with a background as a physician and former Ministry of Health, Labour and Welfare official, will discuss the four-year journey from the founding of Hedgehog MedTech Inc. to joining the Medley Group, and the reality of business development.

This event will be held in a hybrid format, both offline (Nihonbashi, Chuo-ku, Tokyo) and online.

*Online streaming will only cover the first half of the program.

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Event Date and Venue

Date and Time

August 6, 2026 (Thu) 18:00 - 19:00 (Online portion only)

Venue

On-site Venue

Nihonbashi Life Science Hub LSH-C Conference Room (8th Floor)

Nihonbashi Chibagin Mitsui Building 8F, 1-5-5 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-0022

Online

URL will be notified to those who have registered by the day of the event.

Participation Fee

Free

Organizer

Software Regulation

Program Overview

[Common for Online and Offline]

18:00 – 18:05

Introduction

18:05 – 18:30

Challenges in Digital Health Business Development

[Offline Only]

18:30 – 18:50

Review of SaMD Business Development and for Those Aiming for Future Development

18:50 – 19:00

Networking

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Speakers and Panelists

Hiromi Kawata (Guest Speaker)

Former Representative Director CEO / Co-founder, Hedgehog MedTech Inc.

Physician, Ph.D. in Medicine, Industrial Physician. Joined the Ministry of Health, Labour and Welfare in 2014, then Medley Inc. in 2017, where she promoted Government Relations and academic collaborations related to online medical care. From 2020, she was involved in investment screening in the DTx field and the establishment of joint ventures with overseas companies at SoftBank Corp. In October 2021, she co-founded Hedgehog MedTech Inc. and led the development of program medical devices (SaMD) such as therapeutic apps and diagnostic devices in the headache field. She led the launch and expansion of SaMD startups, including the business succession of the headache prediction app "Zutu-ru," while utilizing support programs from NEDO and MEDISO. Retired in 2026 following the full subsidiary acquisition by Medley Co., Ltd. MEDISO, NEDO Advisor.

Eiji Takeda, Representative Director, Software Regulation Co., Ltd.

Has experience in regulatory affairs applications for therapeutic apps at a startup that developed Japan's first therapeutic app. After leaving CureApp, he founded a company to support regulatory affairs applications for program medical devices, and provides comprehensive domestic and international regulatory support for companies developing SaMD, including not only therapeutic apps but also diagnostic AI software.

Regarding Pre-event Questions

Inputting "pre-event questions" is mandatory for event registration.

Please fill in the form fields. They will be addressed during the session on the day.

You can also ask questions through online tools on the day of the event.

*Please note that due to time constraints, we may not be able to answer all questions.

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About Software Regulation Co., Ltd.

Software Regulation Co., Ltd. provides regulatory consulting and support specializing in the development of program medical devices (SaMD), such as therapeutic apps (DTx) and diagnostic AI software. Leveraging its expertise from Japan's first regulatory application and approval of a therapeutic app, the company broadly supports domestic and international regulatory affairs for companies, including startups.

[Company Profile]

Company Name: Software Regulation Co., Ltd.

Location: Nihonbashi Royal Plaza 706, 17-1 Nihonbashi Kabutocho, Chuo-ku, Tokyo

Representative: Eiji Takeda, Representative Director

Established: December 28, 2022 Business Activities: Regulatory support and consulting services related to program medical devices (SaMD), DTx, etc.

Corporate Website: https://software-ra.com/