MedTech sERVICES
LeanLia has tailored services for medical devices and digital health companies looking to enter the U.S. market.
U.S. Product Market Fit Assessment
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Understand the market, dissect the competition, pinpoint industry leaders, and identify growth opportunities.
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Evaluate your value proposition by identify pain points, gather feedback, and confirm adoption factors.
Go-to-Market Strategy & Readiness
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Define your target market, value proposition, pricing, and distribution channels.
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Engage with KOLs and industry players.
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Develop a marketing plan and sales strategy.
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Obtain regulatory clearance.
Ecosystem & Health System Engagement
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Leverage an extensive network of industry leaders, investors, and strategic partners to accelerate market penetration and expansion.
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Access best practices on how to approach large Academic Medical Centers.
Regulatory, Product Implementation, Security
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Define your technology & implementation roadmap.
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Develop a clinical trial and product validation strategy.
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Plan your regulatory strategy.
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Comply with cybersecurity and data privacy requirements.
LeanLia's experts have complementary specialties to provide comprehensive support and strategic guidance, ensuring your success in navigating the complexity of the U.S. healthcare market.
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Audrey Guazzone
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Founder & CEO at LeanLia.
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US Go-to-Market strategist and ecosystem activator.
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Health2Tech event organizer.
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Value definition facilitator at MedTech Innovator.
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Worked at TechStars, MIT, and McKinsey spinoffs.
Apurva Zawar
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Board-certified geriatric specialist and neuro clinician.
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Founder at BeyondRehab.
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Assistant Clinical Professor at UCSF Department of Physical Therapy and Rehabilitation Sc.
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Advancing care through innovative digital solutions.
Rakesh Lal
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Expert in medical device regulatory strategy and clinical trials.
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Founder / Consultant at Rx Device Consulting.
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Experience developing novel medical products and filing 510k applications.
Balint Bene
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MedTech software and cybersecurity expert.
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CEO of Bene Studio.
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Mentor at The Johns Hopkins University School of Medicine, M2D2 IMPACT, and Mount Sinai Innovation Partners Accelerator. ​
Steve Mupenda
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Specialist in Quality Management System (QMS) and Design Control & Risk Management.
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CEO of Spearhead Life Sciences Consulting.
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Former Zimmer Biomet employee.
Sebastien Marque
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Expert in Epidemiology, Biostatistics, and AI with 20+ years of experience bridging academia and industry.
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Advanced innovative clinical designs compliant with European and FDA guidelines.
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CEO, Horiana Corp.