Consulting-Service | サナメディ株式会社

Do you face these challenges?

For Market Entry

■Assess if your technology can become a medical device
■Identify promising therapeutic areas
■Understand regulatory requirements
■Evaluate investment risks
■Build a business roadmap

For Development

■Define regulatory strategy
■Plan FDA submission
■Establish QMS
■Scale manufacturing
■Validate clinical adoption

For Business Expansion

■Develop global expansion strategy
■Explore new opportunities
■Evaluate partnerships, M&A, and investments
■Identify next growth areas

Our support Across the
Medical Device
Development Process

We design tailored support—both comprehensive and customized—based on each client’s situation and needs.

Our Support Model

Integrated Support

Project-based support for specific initiatives

End-to-end, hands-on support from concept through development, regulatory, clinical adoption, commercialization, and growth.　Leveraging our practical experience, we co-design and drive key processes—decision-making, risk management, organizational setup, and execution.　We work closely with stakeholders and external partners to define actions at each stage, ensuring steady and tangible progress.

Targeted Advisory

Expert Review & Issue Structuring

Targeted, short-term support with expert insight and analysis.We address a wide range of topics—from market, regulatory, and technology analysis to business evaluation, PoC review, requirement refinement, and investor materials.We quickly structure key issues and visualize risks, providing clear guidance for next steps. Best suited for companies seeking focused expertise on demand.

Expert Sessions

Embedding Medical Device Thinking

We provide structured sessions that enhance organizational thinking and decision-making through real-world cases. Covering development, regulatory, value design, and commercialization, we deliver practical insights beyond knowledge sharing. We also introduce a cross-functional medical device mindset to enable independent execution. Flexible formats support team building and alignment.

CONSULTING