After 25+ years in the industry, both in Japan and the States, we decided to share our passion to help provide the best medical technologies to the needed Japanese patients by helping those technologies enter the Japanese market earlier than the norm. Our process is designed to empower you on how to be successful in Japan; from market assessment, regulatory, reimbursement and all the way through to market launch. Talk to us today about how we can prepare and support your takeoff without crash and burn, and put you on a solid track to success and profit as your technology are appreciated in the market.
Our primary service is to help you go direct in Japan, without a handcuffed hand shake with a distributor. If you are direct in the States and not a capx, then you should be direct in Japan, if you want the full focus and attention needed for success. We will shepherd you on all the steps necessary to commercialization not only on regulatory or reimbursement but also on formation of sales, logistics and local entity. Entering a new market is not a cookie cutter. Everyone is different, so we custom fit to your needs. That’s how we ensure your success.
Business mentors are key—that’s why when it comes to client selection, we’re choosy. We want to give each of you the time and guidance you deserve. You need someone who has actually done this before by themselves, not an adviser they hire ad hoc. You need someone that can roll up their sleeves and do the actual work, not just talk about it. Easy to say but hard to do. You need a surrogate country manager who is both bilingual and bi-cultural. Together we’ll create and refine your plan for success. We didn’t get there alone. And neither will you.
Kaye has over 25+ years of experiences working in the medical device industry, uniquely on all aspect of the business; from concept to retirement of products. He has actual hands-on and management experiences in R&D, Regulatory, Reimbursement, and Marketing. He is also a global leader experienced in dealing with companies and markets in North America, Europe, and Asia. He has been described as “All things about Medical Technology.” His most value is in dealing with Japan; a black box for many companies. As well as, in new medical technologies, shepherding the complex maze to commercialization.
Prior to re-engaging back into consulting, Kaye served as Vice President of Asia for Abiomed from April 2010 to June 2015. While at Abiomed, he spearheaded the regulatory challenge of Impella pump catheter into Japan without a local study. He established the brand “Impella” amongst Cardiologist there, built the local entity for commercialization. He also initiated the market entry into China. Abiomed was one of the many companies, Kaye consulted.
From February 2007 to March 2010, he consulted start-ups to Fortune 500s on market access, regulatory, reimbursement, quality system, partner selection, organizational development, business and market development, supply chain as well as stakeholders’ relations focused around Japan. His clienteles were BSI, Phillips, KCI, AMS, Spectranetics, Giving Imaging and Concentric Medical to name a few.
Kaye served as Vice President at Guidant Corporation in Japan (Executive Vice President, Chief Regulatory and Quality Officer and Board Director for Guidant Japan KK) responsible for all Regulatory, Clinical, Quality, Vigilance, Compliance, Quality Systems, and Medical Affairs activities for Japan until he resigned on Nov. 2006. He shepherded the organizational transformation from Japan-centric to a global team. The first half of his 8 years’ tenure with Guidant, Kaye built and managed the Vascular Intervention Business in Japan since its direct operation as Director of Marketing until he was requested to take a leadership role in the regulatory side of the business, to make a turnaround in operations. He was the only one in the Japanese organization successful in reaching a VP level organically.
Prior to Guidant, Kaye worked for Johnson &Johnson Cordis as project manager, product manager, and marketing manager for the Biosense, Cardiology and Endovascular businesses. Before that at Zeon Medical Inc, a Japanese medical device manufacturer, he developed and/or managed a variety of products (except for Orthopedics), as a project manager and product manager.
Kaye began his career as an entrepreneur, co-founding a Part 135 air carrier business from Burbank, California until he moved back to Japan. Kaye grew up in the States and Europe and received a BS and a MS in Bioengineering from University of California, San Diego.
Interestingly, “Kei” in Japanese means “Edify” and “Suke" means “mediate.” In a way, Keisuke was born to be a consultant; Edifying and Mediating Med Tech companies on Japan market entry. He is known as Kaye with an “e” to distinguish between a female name and instead of Keisuke, which is difficult to pronounce.
Considering departing from your distributor and going direct? Are you handcuffed with product approval being a hostage? Why not start new in Japan with a clean slate? We can help you prepare without being noticed.
There are so much information out there nowadays, it is very difficult to know if you have what is in your best interest? A regulation has many different interpretation. You need to have a second opinion to make a sound decision.
MHLW's FOIA records are in Japanese but has less blackouts than ones from the FDA. They are valuable information to understand the predicate devices. We can help you access the approval documents and for Novel devices the PMDA review summary. This will be a 3 to 6 months process depending on how new it is. Executive summary in English can be provided.
Subscription will update you in new product approval, new reimbursement code, new regulations and guidances, and other information you need to know on Japan (coming soon)
Need a review of your patent documents translated in Japanese in term of proper description of technical and medical terminologies?
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