MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, and Quality Assurance support, is pleased to announce its recent acquisition of Vorpal Technologies K.K. This acquisition is an important milestone in MCRA’s globalization as it allows MCRA to provide an expanded service offering to its clients, leveraging the extensive experience and track-record of the highest caliber MedTech consulting firm in Japan. Concurrent with the acquisition, MCRA has announced Samuel Pollard as the General Manager (GM) of Vorpal.
Also Read: Emergo by UL Launches Digital Human Factors Engineering Platform for Medical Device Manufacturers
Founded in 2013 and headquartered in Tokyo, Vorpal is a full-service virtual subsidiary, enabling international MedTech innovators to enter the Japanese market by providing expert guidance and solutions in opportunity assessment, clinical operations, regulatory affairs, reimbursement, quality and safety management, supply chain and commercialization. Over its 9-year history, Vorpal has established itself as the leader in Japan for new category MedTech approvals. With a total of 49 approvals, Vorpal is the market leader in Japan for Class III and Class IV approvals. Recently, Vorpal secured three approvals in a single week to close out a successful 2021, where Vorpal secured seven Class III and Class IV shonin approvals – more than any other consulting firm this year. In addition, Vorpal has secured four new category premium reimbursement listings with an additional four ongoing reimbursement programs, constituting over 5% of new category MedTech reimbursement programs in Japan. Vorpal’s expertise has resulted in the majority of its US-based clients achieving a successful exit through IPO or M&A.
Vorpal also provides Designated Marketing Authorization Holder (D-MAH) services to its clients, which enables foreign manufacturers to comply with legal requirements to market products in Japan while minimizing the initial investment and maintaining control over all strategic options. Key therapeutic areas of expertise include Orthopedics, Cardiology, Imaging, General and Plastic Surgery, Neurology, Urology, ENT, Oncology, Ophthalmology, Dermatology, and Psychiatry. The Vorpal staff consists of bilingual, highly skilled and experienced regulatory, clinical, logistics, quality and reimbursement experts, ensuring clients receive the highest quality strategic advice. MCRA is committed to maintaining the exceptional Vorpal team and continuing to recruit a team of like-minded MedTech experts.
Robert Claar, Co-founder of Vorpal said “Our vision in founding Vorpal was to provide a full-service team of experienced professionals to help medical technology companies through the Japanese clinical, regulatory, and commercialization processes. We are delighted to join the MCRA team to expand our reach and impact in providing patients in Japan and abroad with innovative and proven therapies. Becoming part of MCRA enables Vorpal’s team to expand our capabilities and meet our clients’ needs as the premier portal into Japan for worldwide MedTech innovations.”