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About Vorpal Technologies
Vorpal is a full-service virtual subsidiary, enabling international MedTech innovators to enter Japan on their own terms with transparency, confidence and optionality. Vorpal delivers expert solutions in opportunity assessment, clinical development, regulatory affairs, reimbursement, quality and safety management, supply chain and commercialization.
Vorpal Technologies K.K.
3-3-16 Nihonbashi Hongokucho, Chuo-ku, Tokyo , Japan
Regulatory and Reimbursement Strategy
Clinical Trial Management
Health Economics and Market Access
Designated Marketing Authorization Holder (D-MAH) services
Import and Sales of Medical Devices, In-Vitro Diagnostics (IVD)
Distributor Selection and Management
Post Marketing Surveillance (PMS) studies
KOL Relationship Management
Subsidiary Establishment and Business Advisory
We maintain internal and external relationships built on common goals, mutual respect, open communication, trust and teamwork
We approach problems with a positive attitude, acting on needs and opportunities to deliver inspired solutions
We are self-starters who mobilize our knowledge, expertise, diligence, and networks to ensure successful execution
Samuel has over a decade of experience and expertise in biomedical research and the regulatory/clinical space with an extensive background in developing and implementing path-to-market strategies, regulatory submissions, and clinical programs for a wide array of therapeutic technologies in the US, EU, and Japan.
As General Manager of Vorpal Technologies, Sam is passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape.
Previously, Sam served as Director of Regulatory Affairs at MCRA, where he focused on the development of regulatory submissions, design and implementation of clinical trials, and assessment of pre-clinical and clinical data in a wide array of therapeutic areas including orthopedics, cardiovascular, and wound care.
Since joining MCRA in 2013, Sam has developed and reviewed hundreds of regulatory submissions for medical devices including 510(k)s, PMAs, De Novos, and IDEs. In addition, he has developed and reviewed submissions for CDER and CBER products, as well as combination products including IND and pre-IND submissions. He also has many years of international regulatory experience, authoring and reviewing numerous CERs and Technical Files, and assisting with PMDA submissions.
Prior to joining MCRA, Sam worked as a research associate in tissue engineering at the Medical University of South Carolina in Charleston, SC and Clemson University, conducting research in bioprinting and stem cell technology. Sam received his Bachelor of Science in Bioengineering at Clemson University. He is RAC-certified and is an active member of the Regulatory Affairs Professional Society.
Robert E. Claar
Rob Claar co-founded Vorpal Technologies in 2013 to help create solutions for Japan’s device lag and become the premier pathway into Japan for innovative MedTech solutions.
-Vorpal is a full-service virtual subsidiary, enabling overseas medtech innovators to enter Japan on their own terms with transparency, confidence and optionality. Vorpal delivers expert solutions in clinical development, regulatory affairs, reimbursement, quality and safety management, logistics and market development.
-Prior to Vorpal, Rob founded Junicon K.K., a healthcare market research and strategy consulting firm. Junicon now has a global reach with offices in the US and Europe and strong affiliations in all major markets.
-Rob has nearly three decades of experience in healthcare innovation management, opportunity assessment, strategy development and implementation. He is passionate about developing innovative solutions for access to Japan’s healthcare market.
Ben has two decades of experience in healthcare strategy development, marketing, and operations. He commercialized and marketed best-in-class medical products globally and in Japan while at Edwards Lifesciences.
As GM at Vorpal Technologies, he consulted for global healthcare innovators and launched Vorpal Women’s Health, a commercial entity sold in 2017.
His forte and personal mission is creating new businesses for the betterment of patient care. Ben holds an MBA from the University of Southern California.
Hitoshi has 30 years of leadership experience in the life science industry including both large and venture biotech and pharmaceutical companies in executive management, finance, business development, and commercial roles.
Hitoshi’s background as a research scientist and financial professional make him a hands-on manager in biotech startups. He is experienced in private equity fundraising and IPO preparation and holds MBA & USCPA qualifications.
Guidelines on Transparency with Medical Institutions, etc.
July 1, 2022
Vorpal Technologies K.K.
Article 1 (Purpose)
In accordance with Transparency Guidelines with Medical Institutions in the Medical Device Industry established by the Japan Federation of Medical Devices Associations (hereinafter referred to as the "Transparency Guidelines"), Vorpal Technologies K.K. will disclose funding information to medical institutions, etc. in order to ensure that our corporate activities are highly ethical and that our relations with medical institutions, etc. are transparent.
Article 2 (Method of Disclosure)
We will disclose the funding we have made to healthcare providers through our website for the prior year's one-year funding after the close of the year's financial results. The funding provided through us by our clients shall be handled by individual clients in accordance with individual guidelines, etc., and shall not be included in the scope of our disclosure.
Article 3 (Subject to Disclosure)
The object and contents of the information to be disclosed shall be as follows.
1.Research and development expenses, etc.
Include costs of tests, studies, reports, and investigations (clinical studies, clinical trials, post-marketing studies, reports on defective/infected cases, post-marketing investigations, etc.) conducted under various guidelines including public regulations such as ministerial ordinances under the Clinical Research Law and the Pharmaceuticals and Medical Devices Law
・Joint research expenditure: Name of the facility to which the product is provided: ○○ cases, ○○ yen
・Outsourced research expenses: Name of the facility to which the project is to be provided: ○○ cases, ○○ yen
・Clinical trial expenses: Name of the facility to which the product is to be provided: ○○○○ yen
・Post-marketing clinical trial expenses: Name of the facility to which the product is to be provided: ○○ cases, ○○ yen
・Expenses for reporting defects and infectious diseases: Name of facility to which information is provided: ○○ cases, ○○ yen
・Post-marketing surveillance expenses: Name of the facility to which the product is to be provided: ○○ cases, ○○ yen
・Other R&D expenses-Name of facilities to be provided: ○○ cases, ○○ yen
2.Grants-in-Aid for Scientific Research
Includes scholarships, general donations, and donations from academic societies and joint sponsorship of academic societies to support the promotion of medical technology and research subsidies.
・Scholarship donation ••○○ University ○○ Classroom: ○○ case ○○ yen
・General donations: ○○○ University (○○ Foundation): ○○ case ○○ yen
・Donations from academic societies: The ○○ Society (○○ Regional Society, ○○○ Workshop): ○○ case ○○ yen
・Joint sponsorship fee…○○ seminar for the ○○○ Society: ○○ case ○○ yen
3.Materials for writing manuscripts, etc.
Expenses related to the outsourcing of business, such as lectures, draft writing, and consulting, for the provision of information on the proper use of in-house medical devices are included.
・Instructor's fees: ○○○ University (○○ Hospital) ○○○ Department Professor (General Manager): ○○ case ○○ yen
・Writing materials, supervisory fees, Professor ○○○ at ○○ University (○○ Hospital) and Professor ○○○ (Department Manager): ○○ case ○○ yen
・Consulting, etc. Consignment Fee: Professor ○○○ at ○○ University (○○ Hospital) and Professor ○○○ at ○○ Department (General Manager): ○○ case ○○ yen
Expenses for lectures, simulated practical guidance, briefings, etc. required for the proper use and safe use of the Company's medical devices for medical professionals are included.
・Lecture fee: Annual number and total amount
・Briefing expenses: Number and total amount per year
・Annual total amount of expenses for provision of medical and medical engineering-related literature, etc.
Expenses such as hospitality as social courtesy will be included.
・Expenses for hospitality: Annual total
This provision shall be effective as of July 1, 2022.
Funding to Medical Institutions, etc. from January 1, 2021 to December 31, 2021
R&D expenses, etc. Not applicable.
Grants-in-Aid for Scientific Research Not applicable.
Materials for writing manuscripts, etc. Not applicable.
Information-related expenses Not applicable.
Other (Hospitality expenses, etc.) Not applicable.