Frequently Asked Questions About Successful Latin America Market Entry Strategies for Medical Device Companies


There’s no question that the medical equipment/devices market in Latin America is growing. Infusion pumps, dialysis equipment, prosthetic heart valves, and cardiac assist devices are projected to grow anywhere from 5% to nearly 14% a year between now and 2021. 25 medical device categories showed impressive gains in eight different countries during 2017. Why so much growth? It could be due to large changes in health conditions that are sweeping the region.

Latin America presents its own set of challenges when it comes to market entry strategies for medical device/equipment companies that may be looking to take advantage of this growth. Here is our advice for companies wanting to take advantage of the growing Latin American medical equipment/devices market.


What are some of the common pitfalls that medical devices companies should look out for when executing market entry strategies in Latin American markets?

There are three major pitfalls to look out for:

  1. Poor selection of a distributor partner. Do your homework on fit, structure, and capabilities.

  2. Entering via distributorship with a plan to build out your own sales force later and then discovering you’re in a legal quagmire trying to extract your product from the distributor.

  3. Not planning and budgeting for the long run; success takes time, investment and continued focus.

If a medical device company opts for building their own local team in a Latin American market, what are some of the key factors they should consider?

These fall into three categories:

  • Market potential: Do your product range and value justify? Is your sector or category growing?

  • Investment: What is your entry strategy and growth projection? What is your break-even point? What are milestone metrics for progress and red flags to watch for?

  • Personnel: Can you hire team members with the right expertise—good experience, proven track record? What are market expectations on compensation? How much will you be constrained by labor laws? And, at the home office level, do you have dedicated support?

What kind of consultants are best suited to help a medical device company navigate the regulatory environments of specific countries in the region?

Before going after an in-country regulatory expert, establish one lead consultant as responsible for the overall regional market entry planning and strategy. You need a person with LATAM-specific device expertise who can see the big regional picture and bring in the right support at the right time.

From there, work with a local in-country regulatory specialist. An experienced specialist can efficiently narrow down to what specific in-country supplemental assistance is needed and likely recommend an experienced resource.

A local regulatory specialist and distributor with in-country reach may be particularly advantageous, especially when first entering the Latin American market and looking to gain traction. This will enable your company to focus on the more strategic elements of the new venture, leaving the local detail to the in-country experts.

Can reimbursement policies be a pitfall when entering a new Latin American medical devices market? If so, what are some of the key challenges to consider?

Reimbursement will be an important factor in any market decision, but it depends on the type of device you’re marketing.

If you’re marketing high-value hospital equipment (e.g., MRI equipment, etc.), you have to determine whether the sector is growing and how does your equipment tie back to their reimbursement (e.g., per procedure, etc.). 

If you’re selling equipment for patient use (e.g., pacemakers, etc.), then it’s critical to understand reimbursement policies in both public and private insurance sectors. You have to be sure that the levels involved are sufficient enough to support your targeted revenue.

How does culturalization come into play when entering a new medical device market in Latin America?

There are two things to keep in mind when first entering Latin America. First, don’t just translate: Adapt to the local market, its buyer preferences, the decision-making process, and the players. Second, use an in-country expert or agency with solid device experience to assist with marketing materials and promotion.

When expanding regionally, make sure to customize materials to the local specific country and market characteristics. Hospital admins and buyers will pick up in an instant if you’re not attuned to their needs and preferences. The differences may be subtle or may be big issues — either way, it creates friction in the market.

Moreover, if materials are already in Spanish, do not assume that they can be used ‘as is’ in every country in the region. Wording and industry usage may be distinct in each country in Latin America. Have translation verification or adaptation done via local resources.

Local Distributor Partners

Should I register my medical device or let my distributor do it (and pay for it) in Colombia?

You should register your medical device under your company's name and pay for the registration process. This way, you will own the registration and have total control over it. This is what the US Department of Commerce has to say about it: 

"It is strongly recommended that U.S. companies process the registration under their name and not under the local distributor's name or else the U.S. company will not be able to change or add distributors during the lifetime of the registration, which is 10 years." —

Don't be tempted to let your distributor take control of the registration process and pay for it. You will likely regret it later. 

What should companies consider when looking for the right partner to handle sales and distribution for them?

You may want to start off by asking three key questions:

  • How important are you to them?

  • Are they already calling on the right customers, departments and purchasing groups?

  • What is their track record in representing other companies?

In addition, you want to have a thorough in-country background, due diligence work done before you sign a contract with a distributor. You need to gather insights such as reputational analysis, coverage, background checks and do your due diligence. 

How important is product fit when considering a local distributor or sales team?

Product fit is the starting point for any evaluation. While there is likely no such thing as a perfect partner, here are some factors to assess:

  • Are they handling complementary products?

  • Does bringing in your product add value for them (e.g., make their sales force more productive)?

  • Are they selling to the sector and buyers of greatest importance for you?

  • Do they currently cover the geography that you need to reach (e.g., major cities across a country)

Create your own checklist for the ‘ideal partner’ in as much detail as possible before starting to look at partner candidates. Include both concrete and less tangible factors. An example of concrete measures: Make sure they do not handle/promote directly competitive products. Less tangible but important: Do you feel that you can work well with the lead people within the organization, particularly sales management?

Developing a list of potential distributors can be complicated, particularly when operating in fragmented markets. Seek the help of a local expert who has the tools and experience necessary to cast a wide net of potential distributors and also drill down onto each one in order to make sure you get the right fit.

Are there objective ways to evaluate a local company’s sales abilities to get a sense of how well they would do with a product?

Here are some considerations:

  • What’s the ‘word on the street’? Via industry or local chamber contacts, learn all you can about what they’ve done with other products/companies. To the extent possible, verify numbers and growth figures.

  • If you have a good set of criteria for an existing sales force, start with that. Ask the candidate company for a job description and how their reps are evaluated (and compensated). Match this against your own standards, but understand that there may be legitimate differences in measures/expectations.

What should companies ask for in legal agreements with local partners? What should they avoid when it comes to these agreements?

  • Include key performance indicators (KPI) with both incentives and triggers for change.

  • Work with local counsel to make sure that your agreement is comprehensive and is enforceable in that country’s legal system.

  • Be sure your agreement does not tie you so closely with the distributor that you cannot make future changes.

Market Potential

Obviously, there are large, well-established medical device markets in Latin America that people in the industry know very well, such as Brazil, Argentina, and Mexico. Are there other markets in the region with strong potential that haven’t really been leveraged as they should be? 

There are three markets that come to mind, each of which is interesting for different reasons.

First, Chile has a large middle class, well-established healthcare systems and also has seen rapid market growth in medical equipment.

Colombia is now in a period of accelerating growth as it comes out of the long FARC conflict era. This has opened up significant market potential with both immediate and long-term opportunities. In addition, quality healthcare is becoming a hallmark in Colombia.

Costa Rica (and more broadly Central America) is another interesting market. Costa Rica is a generally smaller market but quite accessible and posting strong growth. It also features a good level of education, less corruption than some neighboring countries and significant U.S. influence in the system.

Overall, the smaller markets have been somewhat neglected as companies focus on the big three). In many sectors, there will be less competition and a higher average selling price (ASP).

If you’re new to the LATAM space, these smaller markets may be a place to get your feet wet without running as much risk. Make a mistake here, and it’s not earthshaking. However, making a mistake in a big market could seriously impact regional potential.

About The Author

Julio G. Martinez-Clark is CEO of bioaccess, a U.S.-based contract research, regulatory, and market access consulting company focused on Latin America. Julio holds a bachelor’s degree in electrical engineering (B.S.E.E.), and a master’s degree in business administration (M.B.A.).


Source: Global Health Intelligence (interview with Dorothy Erlanger), Julio G. Martinez-Clark