Research topic: EU MDR and its effects on the commercialization plans of small and mid-size Medtech companies
The new medical device regulation (MDR) in the European Union (EU) (aka “EU MDR") has increased the barriers to entry in the EU. This is apparently making Medtech companies look at other alternative markets (e.g., Latin America, Middle East, Asia) more favorably for their commercial activities.
Below, you will find some background information about myself, and the questions that I am asking the Medtech leaders I am interviewing for my upcoming article.
My brother Pedro trained at Harvard Medical School/Beth Israel Medical Center as an interventional cardiologists, was a professor at the University of Miami, owns a large practice in the Miami, FL area, and leads a Medtech incubator in Miami’s Florida International University.
In 2010, Pedro realized that US Medtech companies needed help in Latin America with their first-in-human trials and with market access/commercialization of their devices. That led us to create our organization (bioaccess.™), and that led me to write about early-stage clinical research and market access topics with a special focus on Latin America —I realized that nobody was writing good insightful articles about this.
An article that CenterWatch wrote about our work in Colombia (Interventional Concepts was our previous company name).
I host a podcast titled "LATAM Medtech Leaders: A weekly conversation with Medtech leaders who have succeeded in Latin America."
The future implementation of the EU MDR has increased the barriers to entry in the European Union (EU), and apparently more Medtech companies are looking to other alternative markets (e.g., US, Asia, Latin America) to first initiate their commercial activities. These are some of the questions that come to mind around the topic (you don’t have to share confidential information):
In light of the rigorosity of the EU MDR, are US Medtech companies still considering the EU as their first commercial market before they seek FDA approval?
If yours (or a company that is a client of yours) is a medical device design, development, and commercialization company, what’s been your (or their) company experience with the EU MDR?
How has the EU MDR affected your company’s (or a company that is a client of yours) first-in-man or commercialization strategy?
Are Medtech companies considering now other alternative markets to the EU where they can start generating revenue faster? If so, is Latin America one of those markets?
What are your general thoughts on early-stage clinical trials or selling medical devices in Latin America?
What’s been your practical experience conducting early-stage clinical trials or selling medical devices in Latin America?
Have you heard about the Pacific Alliance in Latin America? (An economic trade bloc with Mexico, Colombia, Peru, and Chile that will create a single regulatory market to make it easier for Pharma and Medtech companies to commercialize their products).
Conference call instructions
Here are the instructions to connect to our interview call. The call will be recorded, transcribed, edited for clarity, and uploaded to our blog. Please follow these recommendations to ensure a successful call:
Make certain you are in a quiet place without background noise.
Make certain you have a good cell phone signal or a high-quality internet connection to the conference bridge.
Please consider wearing a headset to avoid echo during the call.