Build Your Medical Device Business in Japan.
From market strategy to distributor selection and market execution.
Building a business in Japan is what matters.
Japan's medical device market is complex. Regulatory requirements, distribution structures, local business practices, and the right commercial partners all matter. We help international medical device manufacturers move beyond market research — and build a practical path to commercial success in Japan.
Why Japan is difficult to enter.
Challenges international manufacturers face when entering the Japanese market.
Three things we bring to your Japan strategy.
Japan’s medical device market succeeds only when the right product, the right distributor, and the right sales strategy come together. We understand the actual relationships between manufacturers, primary and secondary distributors, regional sales companies, healthcare institutions, KOLs, and procurement departments.
Most market research ends with "the market is large" or "there is opportunity in Japan." Those conclusions don’t sell products. We support the entire arc: market evaluation → entry strategy → distributor identification → partner evaluation → commercial preparation → market execution.
In Japan, meeting many companies matters less than meeting the right person at the right company. We prioritize direct access to executives, business unit leaders, sales leaders, and product owners — the people who can actually decide.
We do not simply introduce distributors.
We evaluate every distributor candidate per product — sales experience, product-category fit, distribution network, sales force capability, hospital relationships, management posture, willingness to invest, and responsiveness to new products.
Three phases from market evaluation to launch.
We do not publish fixed pricing. Every engagement is structured around your product, your target market segment, and where you stand today. Below is how we think about the work.
Strategy is important.
Execution is essential.
A strategy has value only when it can be implemented in the real market.
Not everything you can do. The one seat no one else can fill.
Japan market entry is rarely blocked by a single missing capability. It is blocked when regulatory, distribution, pricing, and execution are each managed by a different party, and no one owns the whole. Our role is to hold the full picture — design the entry program, coordinate every specialist involved, represent your head office’s interests inside Japan, and manage both the decision and the execution as one continuous responsibility.
Go/No-Go assessments, entry-scenario comparisons, partner-candidate comparisons, cost-benefit analysis, risk mapping, a 24-month roadmap, and board- and approval-ready summaries — so your head office decides on one integrated picture, not fragments from multiple vendors.
Monthly steering committees, weekly working sessions, task tracking, RACI ownership, a risk-and-issue log, and a decision log — the operating structure that makes every workstream visible and accountable in one place.
In Japan, regulatory approval, reimbursement listing, and commercial distribution are governed by separate processes with separate stakeholders. We connect PMDA approval strategy, reimbursement design, launch conditions, billing pathways, KOL development, and post-market execution into one coherent plan — so approval, payment, and sales do not stall at the seams between them.
Long-list development, short-list evaluation, role allocation across partners, meeting design, comparison criteria, LOI negotiation points, exclusivity structuring, and exit-clause design — carried through from first search to signed agreement.
Japan entity formation scheme, initial organization design, hiring priorities, the line between outsourced and in-house functions, banking / accounting / legal / general-affairs setup, board and representative-director structure, contracting entity design, and authority allocation between head office and Japan.
We validate proposal scope, clarify cost and responsibility boundaries with regulatory affairs firms, judge whether a CRO or trading company is actually needed, eliminate overlap between vendors, and review deliverable quality — so specialists are managed toward your outcome, not their own scope.
PMDA consultation records, regulatory decision logs, competitor comparison data, partner evaluation records, KOL mapping, reimbursement discussion history, contract-draft comparisons, pricing comparisons, and risk-decision history — retained as an asset that compounds over the life of the program, not lost between vendors.
Indispensability is proven in a crisis, not in calm conditions. When a PMDA review stalls, an additional study is required, a distributor underperforms, a trading company deprioritizes you, a head-office decision is delayed, or reimbursement timing slips after approval — we deliver an alternative course, an impact analysis, a budget revision, a revised schedule, and a vendor replacement plan, immediately.
Overall strategic design for the Japan market entry program.
Introduction order across your product portfolio.
Design of which partner does what, and where responsibility sits.
Comparative materials that support your board and leadership decisions.
The operating structure that keeps every workstream visible and on track.
One coherent plan across approval, pricing, and sales.
End-to-end management of partner search through negotiation.
Support for establishing and operating your Japan legal entity.
Governance over specialist firms and program spend.
Deal structure design through to exit-clause planning.
Institutional memory retained across the life of the program.
Rapid re-planning when conditions on the ground change.
Your path to Japan.
A single continuous engagement, structured as six sequential steps. You know at every stage what has been done, what comes next, and what the outcome will be.
Naoya Takahashi
Naoya Takahashi is a MedTech business leader and ecosystem builder with over 25 years of cross-functional experience across sales, product management, marketing, and business development in the global medical-device industry. He is currently the founder and principal of JNY TAKAHASHI Medical Advisory, where he advises medical-device and digital-dental companies on Japan market entry, commercial expansion, and cross-border growth strategies.
At the heart of his practice is a simple premise: bringing an overseas MedTech product into Japan — or scaling a Japanese business into new therapy areas — requires more than translation. It requires deep operating knowledge of the local market, an understanding of how products are adapted, sold, and supported in the field, and trusted relationships across clinicians, distributors, and academia. Naoya has repeatedly built that bridge, from scratch, across multiple therapy areas.
He began in ophthalmology as a Sales Specialist for glaucoma diagnostic devices at JFC Sales Plan (2000–2004). He then moved to BD (Becton, Dickinson and Company), one of the largest global MedTech companies, as a Senior Regional Sales Manager (2004–2008), followed by a Senior Product Support Specialist role at Fisher & Paykel Healthcare focused on respiratory care and home-care devices (2008–2010). In 2010 he joined JUNKEN MEDICAL as a Product Manager for blood-purification systems and circuit products destined for the Chinese market, giving him hands-on PM experience in Asia-to-Asia commercial export. From 2013 to 2018, as Marketing Strategy Manager at Dentalead, he led go-to-market strategy for dental bone-regeneration biomaterials and delivered numerous lectures on biomaterials at dental schools across Japan. He then served as Business Development Manager at 3Shape, the Danish digital-dentistry company, leading commercialization of 3D dental scanners in Japan (2018–2022). From October 2022 to June 2026, he founded and served as President and Representative Director of Aidite Japan K.K., the Japanese subsidiary of Aidite (Qinhuangdao) Technology Co., Ltd., a global digital-dentistry leader.
The advisory serves overseas MedTech and digital-dental companies planning or expanding their Japan business, as well as established Japanese manufacturers seeking growth into adjacent therapy areas.
Market research, regulatory and distribution landscaping, partner identification, business planning, and end-to-end execution of Japan subsidiary launches.
Portfolio strategy, localization, and product lifecycle guidance drawing on multi-therapy-area PM experience.
Channel architecture, key-account management, hiring, and cross-border strategy for companies targeting Japan and wider Asia.
Partnerships with medical and dental schools and professional societies, building KOL groups, and curriculum design.
Naoya has carried products from R&D and PM through regulatory, launch, and lifecycle across ophthalmology, diabetes care, respiratory care, blood purification, dental biomaterials, and digital dentistry.
He has held PM responsibility for products built for the Chinese market, and now leads the Japanese entity of a Chinese-headquartered global company, giving him a perspective most Japan-focused advisors lack.
In 2022 he personally founded Aidite Japan K.K. in Tokyo from scratch, an execution record that defines how he works with clients — strategy and operations hand-in-hand.
Naoya holds a Bachelor's degree in Law from Nihon University (Japan) and studied at Brigham Young University in the United States.
We work with manufacturers who are serious about Japan.
Not every international medical device company should enter Japan, and not every one who wants to should do it now. We choose our engagements carefully — with partners who see Japan as a market to build, not to sample.
Let's discuss your opportunity in Japan.
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We'll be in touch within two business days to discuss your Japan opportunity in detail.