The Cost of Misalignment
In the MedTech industry, the most expensive waste is developing a product for a market that won't pay for it. Entering a new market involves navigating three disconnected hurdles. Failing to align them is the primary cause of the 'Valley of Death'.
Regulatory Traps
Underestimating the complexity and nuances of local approvals (e.g., MFDS, FDA, CE marking).
The Reimbursement Gap
Gaining market clearance but failing to secure insurance coverage or proper reimbursement coding.
Clinical Mismatch
Solving a problem that local clinicians, procurement teams, or hospital systems do not value or prioritize.
The Leanabl Insight
We view Market Entry as the first and most critical step in your Value Stream. A validated strategy eliminates the immense waste of trial-and-error development and submission cycles.
The Leanabl 360° Feasibility Assessment
We apply Lean principles to assess the holistic viability of your product in a target market, providing a clear Go/No-Go decision matrix based on four critical pillars.
Commercial Viability
Market size modeling (TAM/SAM/SOM), competitor benchmarking, and pricing analysis.
Outcome:
Validated revenue potential in your target region.
Regulatory Reality
Regulatory pathway assessment, predicate device identification, and specialized expertise (e.g., Korea MFDS).
Outcome:
A realistic timeline to market approval.
Market Access & Reimbursement
National insurance analysis (HIRA, CPT codes) and reimbursement landscape evaluation.
Outcome:
A clear path to payment and profitability.
User Validation
Voice of Customer (VOC) interviews with Key Opinion Leaders (KOLs) and willingness-to-pay verification.
Outcome:
Confirmation of clinical utility and product-market fit.
More Than a Report. A Decision-Making Engine.
We engage as an extension of your team. Our delivery format is designed to ensure you understand the 'Why' behind every recommendation.
Collaborative Engagement
Kick-off Workshop (90 min)
Deep dive into goals & scope (Virtual/In-person).
Bi-Weekly Milestone Syncs
Agile check-ins to share interim findings.
Expert Interviews
We interview KOLs, Regulators, and Payers; you get the insights.
Tangible Deliverables
The Strategic Feasibility Report
50+ pages of analysis with an Executive Summary.
Source Data Transparency
All references and raw interview notes provided.
The Go/No-Go Decision Matrix
A visual scorecard evaluating risks vs. rewards.
Final Handover
Executive Presentation (60 min)
Strategic briefing for leadership & investors.
Action-Oriented
Focus on 'Next Steps,' not just past data.
Q&A Session
Dedicated time to address specific strategic concerns.
Your Market Entry Roadmap
You walk away with more than data. You get a strategic plan to execute with confidence.
The Feasibility Report
A data-backed assessment of your target market's potential, risks, and opportunities.
The Go/No-Go Matrix
Clear, actionable recommendations on investment risks and strategic milestones.
Regulatory & Launch Timeline
An integrated schedule merging submission milestones with commercial launch activities.
Why Choose Leanabl?
Integrated Perspective
We don't view Regulation and Marketing in silos. Our approach ensures your regulatory strategy serves your commercial goals from day one.
Local Expertise, Global Standards
Specialized, on-the-ground expertise in high-barrier markets like Korea, paired with a deep understanding of FDA and EU standards.
Just-in-Time Intelligence
We focus on the critical data you need now to make the next decision, avoiding costly analysis paralysis and focusing on lean execution.
Is This Service Right For You?
Our Market Entry Strategy service is designed for:
- MedTech innovators planning their first or next market entry.
- Foreign manufacturers navigating the complex Korean or wider Asian markets.
- Venture capital and private equity firms conducting due diligence on potential investments.
Eliminate Uncertainty. Validate Your Vision.
Schedule a discovery call to discuss your target market and validation needs.