For many medical device manufacturers, Latin America represents one of the most exciting growth opportunities in the world. The region is home to more than 665 million people, over 19,000 hospitals, and one of the fastest-growing medical device markets globally, projected to reach $23B USD by 2027

Yet, the same characteristics that make LatAm attractive, rapid demand, fragmented markets, diverse regulatory environments, also make it complex.

Entering the region without precise market intelligence is not a commercial strategy; it is a gamble. The most successful MedTech companies today are approaching LatAm with a new mindset: evidence-based market entry, where decisions are driven by data, validated by in-market insights, and aligned with real buyer behavior.

That is where medikana’s market research and entry strategy becomes indispensable.

Unlocking LatAm: Beyond “How Big Is the Market”

Growth does not come from knowing the size of the opportunity, it comes from knowing where, how, and when to enter.

Our research identifies:

• Which countries offer the fastest, most viable entry paths
  
  
• Where import duties, pricing expectations, or regulations require adaptation
  
  
• How patient behavior and specialist referral dynamics shape demand
  
  
• Which distribution partners are viable, and which are not
  
  
• Where clinical evidence is a differentiator versus where price pressure dominates
  
  

This isn’t theoretical. In the sample output attached to this article, our work quantifies the total and serviceable market opportunity by country and projects commercial value at different penetration rates, mapping opportunity to reality

From “Where Should We Go First” to “How Do We Win There”

The study doesn’t stop at identifying opportunities; it guides pacing and sequencing.

The sample MedTech strategy we delivered recommends a three-tiered phased market entry, balancing:

• Market potential
  
  
• Regulatory complexity
  
  
• Speed to revenue
  
  
• Risk tolerance
  
  

This helps manufacturers avoid the common pitfall of entering the region in the wrong order, where regulatory bottlenecks stall capital, pricing learns come too late, or competitors lock partnerships while you wait.

Actionable strategy begins with prioritization, not every market should be entered first, even if demand exists.

Research That Leads to Action: Not PDFs on a Shelf

Market entry strategy is only valuable if it becomes execution.

Our study provides the foundation for:

• Distributor conversations (with warm introductions from our network)
  
  
• Regulatory planning
  
  
• Pricing positioning
  
  
• Commercial timelines and revenue projections
  

• Clinical messaging and value proposition localization
  
  

We combine data, operator experience, and human intelligence gathered from conversations with pre-vetted distributors across the region, because there is no “proxy” for hearing the market speak in its own voice.

Why Manufacturers Choose medikana Before Their First Step

Because what we deliver isn’t numbers,it’s clarity.

 👉 Clarity on where the opportunity is real
👉 Clarity on how to reduce risk, cost, and time to revenue
👉 Clarity on who your first champions in the region should be
👉 Clarity on what makes your product competitive and what doesn’t

And most importantly:

 A roadmap based on how LatAm really works, not how it looks from abroad

If Latin America Is in Your Growth Plans, Your Strategy Starts Here

Whether you are validating commercial potential, preparing investor-backed expansion, or exploring first distributor partnerships, your go-to-market foundation is the most important investment you’ll make.

Our team sits at the intersection of global MedTech innovation and Latin American commercialization. We have done the early steps many times, so you don’t have to learn them the hard way.

📩 If you are exploring Latin America, let’s discuss how we can support your first strategic step.

Reach out at hello@medikana.io to start the conversation.