By Julio G. Martinez-Clark, bioaccess., and Ed Biller
The LATAM Medtech Leaders podcast interviews medtech leaders whose experience in clinical research or commercialization in Latin America can be helpful to their peers. Ideally, details of guests’ triumphs and mishaps can provide a pathway for others to follow — saving their organizations time, avoiding costly mistakes, and benefiting the right patient populations.
As Fransisco Peralta, Principal at Ethos Consulting, LLC, pointed out during his interview, “Latin America is what you make it out to be.”
This article draws on highlights from the first five LATAM Medtech Leaders podcast episodes — including Peralta — touching on topics like commercialization strategy, pricing, and more. Additional guests whose insights have been included are:
How Did You Identify A Commercialization Strategy for Latin America?
Garchow’s initial experience in Latin America started in the 1980s with Baxter peritoneal dialysis products.
“In the eighties, our division at Baxter was the first one to go global and, naturally, we were initially most focused on Europe and North America and Japan. This was because they were large markets and we had direct sales and marketing organizations there. However, Latin America also received focus [for] structural and economic reasons,” explained Garchow.
“The most common form of dialysis is hemodialysis and, in order for hemodialysis to happen, you need to have physical building, you need to put in water, you need to have machines and things like that. So, when I say structural, a lot of Latin American countries had difficulty finding the resources to build these large structures to handle hemodialysis patients. Our peritoneal dialysis products… [were] a home-based therapy… [making] our products perfect for many Latin American countries.”
Examining the market for Bayer’s renal therapies, Garchow reasoned that a “kidney in the U.S. is the same as a kidney in Colombia… so I must admit we didn't spend a ton of time doing market research on the Colombian physician… We pretty much relied on our global understanding of how nephrologists treat the kidney failure.”
While he acknowledged that more calculated planning likely could have helped sales, its absence probably didn’t significantly harm product sales. Garchow concluded that the best approach is “to allow the local country product managers to have enough decision-making flexibility that they can adapt what the global group is selling to meet individual country needs.”
Shrivastava, who guided commercialization efforts for both Medtronic and BTS in Latin America, echoed the fact that country infrastructure must be carefully considered. He used the example of a medical device that was seemingly a good fit for his company’s target market, but ultimately didn’t pan out.
“Sometimes, we need some accessory that's not available. We needed high-pressure argon gas cylinders that get used with a medical device to treat cancer, and it turned out that in many of the Latin American countries, there [were] no high-pressure argon gas cylinders available,” Shrivastava said. “So, they have to use low-pressure gas cylinders then — in the middle of a treatment — they have to change the cylinder. Doctors don't have the luxury to… change the cylinder in the middle of a procedure when they're treating somebody cancer. So, that limited our ability to launch that particular technology.”
In addition to understanding a market’s infrastructure, physician education programs can contribute to successful commercialization in the region, Shrivastava added.
“Many of the doctors are very well trained, [and] there are many… that are ready for receiving training for newer devices and newer technologies that are coming to market,” he said. “So, the companies that are going to Latin America, I think if they can keep this in mind and invest in training local talent, they can see a tremendous opportunity there and growth… for their own products and product use, as well as a benefit to the local patient community.”
Tell Us About the Regulatory Approval Process
“It's hard,” Peralta said. “A lot harder than you would think it needed to be, and it varies; each country, it's a unique identity and the way that they want to do things.”
Still, Perlata said, like anywhere else, Latin American regulators are trying to streamline and simplify their processes, as can be seen in this example Peralta provided:
“In Brazil for example, they changed the good manufacturing practices approval process [to no] longer require that you have a Brazilian inspector come to your facility. [Regulators lacked the resources to meet inspection demand], and it led to a lot of lawsuits, and that ended up delaying some approvals up to four years.”
As of January 2019, Perlata explained, Brazil allows manufacturers to utilize third-party GMP inspections (in Brazil, Boas Prácticas de Manufactura, or BPM). “You need to have somebody in place that understands the many changing rules and laws… [Because, for example], if you think you can’t go into Brazil because it's going to take you four years to get approval, but the reality is you can get it done in six to nine months, then it's a completely different strategy.”
What Hurdles Exist Relevant to Corruption or Political Instability?
Infante, who has spent the past 20 years operating in international markets, including Latin America, said that uncertainty in the region can stem from a number of areas, including changing governments, volatility in exchange rates, and shifting regulations. That said, no matter a medtech’s market of interest, “there is always going [to be] this uncertainty, there's always going to be this volatility, and you have to be able to manage it… you have to do it for the long term, and you have to be able to adjust your presence, adjust your resources according to a situation.”
Infante compared the Latin American Market to a roller coaster, complete with ups and downs: “There's always a better day; there's always a country that is better than the others; there are new waves of technology coming into the countries; there's a growing patient population. So… keep cool, don't lose sight of your strategy, and make sound decisions.”
Regarding corruption, Infante warns companies to carefully understand and abide by the Foreign Corrupt Practices Act (FCPA), a U.S. regulation that basically holds accountable companies doing business in Latin America for all corrupt practices. The FCPA holds companies accountable not just for the corruption within its own ranks, but accountable for corruption involving the company’s distributors, agents, or anybody acting on its behalf.
“Healthcare is particularly sensitive to exposure to FCPA,” Infante explained. “You'll have to make sure that [whether] you're operating directly or indirectly a distributor, you are compliant with all the regulations, that you can demonstrate that you have a solid compliance program, that you're training your distributors, that you are training your employees, that you're monitoring what's going on in the market.”
Pinning blame on a third-party distributor or claiming that a given government or aspect of a market is inherently corrupt is not a viable defense, Infante warns. Companies must “be able to demonstrate to the [U.S.] government, if ever you run into problems, that you have done everything that is reasonably within your reach to avoid this… and that you have taken swift action to stop it when you find out that something actually did happen.”
Tell Us About Pricing and Reimbursement
Beck has sold medical devices in almost every country in Latin America and South America and, though he pointedly states he is not a reimbursement expert, he offered some insights on pricing strategy and reimbursement in those markets.
Latin America is, from a pure sales price perspective, a lesser market than, say, the U.S. or Europe. However, the latter markets may require a huge sales organization, as well as equally large overhead costs. “[If I’m] using a really effective distributor in Latin America, my profit still is higher than in the United States,” Beck points out.
“Lots of companies typically [go] more for the high revenue. I actually [look] more at cost-effectiveness, and this is where my pricing or reimbursement comes in place. If I can sell easily, if my devices sell very fast because I have the right distributor in the place who really wants to sell my device, then my device stays [at a maximum] six months on a shelf, and my profit is much higher than in other countries.”
Beck stated, for the sake of example, that his device reimbursement may be 20 percent less in Latin America than in the U.S., but other factors mitigate that drop-off.
“Again… when I can sell my devices very cost effective for having the right distributor in place, there's barely any shipping costs to Latin America. Everything is very fast. I still would make more profits versus a higher reimbursement… in the United States. Ideally, I am looking … to [sell] devices that already have a reimbursement code,” Beck said.
In closing, he noted that the impact of any import/export tax, or value added tax (VAT), depends on how a medtech is structured for reimbursement (i.e., certain countries also ask for import tax that must be calculated against a company’s revenue and profit).
This has been just a sampling of the discussions regularly taking place on the LATAM Medtech Leaders podcast. Keep an eye out for the next “informational roundup” from experts who’ve found success in Latin America, and whose experiences can guide your company. In the meantime, you can subscribe to the LATAM Medtech Leaders podcast or read transcripts from the interviews here.
About The Authors
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 is the host of the LATAM Medtech Leaders podcast and holds a bachelor’s degree in electrical engineering (B.S.E.E.), and a master’s degree in business administration (M.B.A.).
Ed Biller is the editorial director for and Med Device Online, RF Globalnet, and Photonics Online, in addition to penning articles for each site and working with VertMarkets' vendor partners to produce insightful content. Prior to joining VertMarkets in 2015, Ed worked as a reporter for the Butler Eagle in Butler, Pa., and as a writer/editor for Dick Jones Communications, a niche public relations firm serving higher education institutions. He holds a B.A. in journalism from Penn State University, where he was a columnist for The Daily Collegian.