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U.S. Healthtech Market Services

Expanding into the U.S. healthcare market is complex, expensive, and relationship-driven. Companies often invest in U.S. expansion before validating the commercial evidence needed for success.

LeanLia helps digital health and medtech companies de-risk that process: first by validating the commercial path to success, then by acting as a hands-on U.S. partner to execute and grow.

Validation Sprint

A structured, low-risk engagement to answer the most important commercial questions
before committing significant resources.
Every sprint is tailored to the company’s stage, objectives, and existing market evidence.
U.S. Commercial Readiness Assessment​ 
  • For: companies that need to understand whether their U.S. strategy is credible for the next milestone—market entry, fundraising, partnerships, or commercialization.
  • Focus: gaps, priorities, evidence needs, and next steps.
U.S. Market Validation & Development
  • For: companies that need direct U.S. market input to validate and refine their strategy.
  • Focus: value proposition validation, target customers, buyer dynamics, adoption, reimbursement, KOLs, and go-to-market.
Outcome: A clear view of the strongest U.S. opportunity and the priority actions
needed to move forward with customers, partners, or investors.
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U.S. Liaison & Market Execution

Beyond validation, LeanLia can act as your U.S. extension, supporting execution without the need to build a full local team.

Business development & partnerships

Customer pilots & program management

U.S. subsidiary setup & operations
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Areas of support

LeanLia combines multiple capabilities to support both validation and execution in the U.S. market
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Market Strategy & Expansion Planning

  • Assess U.S. market fit, competitor landscape, and growth opportunities.

  • Understand customer needs, adoption drivers, and value proposition alignment.

  • Evaluate expansion readiness and develop your Go-To-Market strategy

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Partnerships & Stakeholder Engagement

  • Map and engage Key Opinion Leaders (KOLs), health systems, and investors.

  • Leverage our global network to accelerate collaboration and market penetration.

  • Support academic and clinical partnerships for validation and adoption.

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Regulatory, Product Implementation, Security

  • Clarify FDA pathways, regulatory strategy, and clinical trial planning.

  • Ensure cybersecurity, data privacy, and compliance requirements are met.

  • Turn clinical and market data into credible evidence for adoption and reimbursement.

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Fractional & On-the-Ground Execution

  • Part-time U.S. business development and local representation.

  • Support for trade missions, conferences, and U.S. market initiatives.

  • Hands-on execution of go-to-market, operational, and expansion projects.

Flexible Ways To ENGAGE

In addition to structured sprints and ongoing support, LeanLia offers modular services tailored to specific needs—allowing you to engage where it matters most.
U.S. Market Entry Assessment

Check your readiness for the U.S. market

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U.S. Market Opportunity Snapshot

Discover market trends and growth potential.

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FDA Pathway Identification

Define your regulatory path to device clearance.

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Customer Discovery Starter

Uncover user needs, pain points, and adoption factors

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KOL & Health System Engagement

Engage with Key Opinion Leaders & Heath Systems

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Evidence Generation & Market Access

Turn data into impact and influence adoption

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U.S. HealthTech Market Advisory

Benefit from industry experts advice

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U.S. Business Development

Part-time liaison or focused execution during U.S. trip

cLIENT tESTIMonials

Trusted by international healthtech innovators

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Alexandre Boulanger, CEO & Co-Founder of Metyos, Co-Founder of Wandercraft
Paris, France
"Always highly responsive, Audrey was perfectly able to carry out for us a mission to set up a US medical board, a key factor in the development of Metyos. Her strategic vision, clear understanding of our needs, excellent network and interpersonal skills enabled her to successfully complete this mission within a controlled timeframe, as well as providing us with valuable introductions to key players in the US."

Curated EXPERT Network

LeanLia works with a curated network of U.S. healthcare experts to support targeted questions and decisions throughout your market entry.

We bring in the right expertise—only when needed—to complement validation and execution.
Our network includes:
  • Clinical experts: Feedback on workflows, adoption, and clinical value
  • Regulatory & FDA specialists: Guidance on pathway, risks, and timelines
  • Health system and payer advisorsInsights into purchasing, reimbursement, and market access
  • Commercial operatorsSupport for partnerships and go-to-market execution
 
Hands-On Practitioners
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Audrey Guazzone

U.S. Go-to-Market Strategist & Ecosystem Activator

New York City

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Rakesh Lal

FDA Strategy &

Medtech Product Expert

Boston

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Nicolas Saint Arnaud

AI, Data, and

Investment Advisor

San Francisco

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Sebastien Marque

Clinical Study Design &

AI Expert

San Francisco

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Balint Bene

MedTech Software and Cybersecurity Expert

Boston

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Stephan Grynwajc

Lawyer in IP, Tech, Privacy Law (France, UK, Canada, U.S.)

New York City

Steve Mupenda Quality Medical Devices

Steve Mupenda

Specialist in Quality Management System (QMS) & Design Control.

Montreal

Strategic Advisory Network

Examples include:

 

  • Advisor in Medicare, Pediatrics, Acute & Primary Care Innovation (CVS Health and Aetna, ex- Boston Children's Hospital)

  • Advisor in Renal Care Innovation and Operations (ex-Strive Health, DaVita)

  • ​Advisor in Real-World Data Insights and Analytics (Clarivate, ex-OMNY Health, Clarify Health Solutions, Komodo Health)

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