Projects
Real-world examples of how we turn partner networks into measurable progress.
Japan–US Market Entry & Expansion
Real-world examples of how we turn partner networks into measurable progress.
- Market entry strategy development
- Partner and distributor search and matching
- Initial market research and feasibility analysis
- Go-to-market planning and execution
Delivered: Market entry strategy, partner search, and initial market research to accelerate cross-border growth.
Market Entry | Medical Device
Delivered: Supported US-based digital health company entering the Japanese market, coordinating PMDA strategy, local partner search, and ecosystem engagement including government and industry associations.
Japan Entry | PMDA
Delivered: Developed and executed FDA regulatory strategy for a digital health platform, including partner matching with regulatory consultants, clinical trial design support, and submission pathway optimization.
Regulatory | Digital Health
Delivered: Connected a Japanese diagnostic device company with US-based KOLs and clinical sites, facilitating clinical validation studies and establishing key relationships for commercialization.
Clinical | KOL Network
Regulatory & Clinical Strategy
Navigate complex regulatory landscapes with expert guidance tailored to healthtech and medtech.
- FDA and PMDA regulatory strategy and planning
- Regulatory and clinical partner identification and matching
- Key Opinion Leader (KOL) and clinical trial partner search
- Medical device Quality Management System (QMS) support
Hands-on Business Development
We don’t just advise—we execute. Our team works alongside yours to drive real business growth.
- Hands-on new business development and deal execution
- Conference and academic event planning and coordination
- Local ecosystem and government support coordination
- Strategic partnership development
Delivered: Identified and negotiated strategic partnerships for a healthtech company, coordinating with academic institutions, hospital networks, and commercial partners to accelerate market penetration.
Partnerships | Business Development
Delivered: Served as external COO for a US-Japan joint venture, providing operational leadership, team coordination, and strategic guidance during critical growth phase with flexible engagement model.
Leadership | Operations
External / Fractional CXO
Access senior leadership expertise without full-time commitment. We serve as your operational partner.
- External COO, CBO, or Head of US engagement
- Third-party management perspective and strategic guidance
- Flexible, part-time engagement models
- Operational leadership and team coordination
PlanEx works with clients, partners, and collaborators across the Japan–US healthtech ecosystem.