Jorge Franceschi (ホルヘ) Thanks for the comment Ronald. It seems like the big players are Brasil, Mexico, Argentina, and Chile but I am curious as to what are the advantages of one over another. I know Brasil has its own set of complications regarding local labor laws. If you are conducting a meeting there you can't even bring your own IT/Media team. You have to hire the local guy. 😰

Carlos Granada Jorge. We have supported since 2007 medical device companies conducting pre-market and post-market studies in the region. Colombia has a very clear and structured regulatory pathway. Brazil is being changing and getting better. Chile very attractive. Argentina and Mexico also big players. The clinical projects we have supported, have included their results for CE Mark and IDEs. The region is no cheap as we may perceive. To succeed, it is just a matter of strong relationships with the clinical sites, investigators and understanding of each country's culture and environment. A big opportunity to explore. Do not hesitate to reach out if have any need.

Carlos Granada I agree some activities cost less. The real add-value: faster enrollment rates, patient compliance, less competitive trials. Your trial may cost less assuming these activities if you select the right country, the right clinical site and the right PI. No every country is well regulated, and not everyone is well trained and certified to do it, yet.

Jorge Franceschi (ホルヘ) Thank you all for the comments. Carlos I am glad to hear the comments regarding Colombia because I just started some consultant work there and although I am very impressed with the study team it always makes me feel better when someone else has good things to say from their vantage point. I completely agree that qualified and motivated investigators with the right study team will carry a program a long way. If its done right it will cost less in the long run.

Gründlichkeit! I did not know what that was before today but das ist gut! Hopefully I will get an opportunity to reach out to Alfredo soon.

Carlos Granada Jorge feel free to reach out anytime.

Hello, feel free to ask our subsidiary in Brasil to combine advantages from LatAm with certain bullet points of German "Gründlichkeit" - ask Alfredo, the local Manager.

With best regards from Maik Lösel,
Global Marketing
www.burkert.com

Hi Jorge. I agree with a few of the comments which lean towards having development and clinical trials in the US or EU and then manufacturing in LATAM to reduce costs and drive the local supply chain. Another country to heavily consider is Costa Rica, and to review what they have done, as they were one of the first LatAm countries to have high tech US medical device manufacturing move down there and have built an entire industry around it. I have worked there extensively and they have some of the smartest and hard working people I have ever met. But regardless where in LatAm, the FDA regulations are the most critical piece in expediting approvals, and unfortunately, many times it is faster via the US or EU, even though it is more costly. It comes down to time vs. cost and which one is the driving factor, normally it is cost. Feel free to contact me to discuss it further.