Madoka Makishima

Madoka Makishima has over 25 years of experience in the healthcare industry. She began her career as a nurse, gaining five years of clinical experience before transitioning to a medical device manufacturer, where she worked as a Clinical Education Consultant specializing in sterilizers and disinfectants. She later joined a global medical device company, where she spent 15 years in regulatory affairs and an additional 5 years in Government Affairs & Market Access.
 

She has experience with Shonin approval and Ninsho certification applications for Class I to Class IV medical devices, including neurosurgical implants, orthopedic implants, endovascular embolization materials, minimally invasive surgical instruments (endoscopy), and pain management devices. She also served as Vice Chair of the Regulatory Affairs Committee at the European Business Council (EBC), contributing to working groups and policy reform proposals related to regulatory operations.
 

Since 2024, Madoka has been leading Market Access initiatives at Vorpal Technologies where she secures insurance coverage for Category C devices and submits proposals for medical technology assessments. She has also participated in industry-wide discussions on medical service fee revisions through her involvement with medical device industry associations.