Frequently asked questions about the LATAM Medtech Leaders podcast

What's the story behind this podcast?

Julio (bioaccess.™ co-founder, CEO and the podcast host) started getting involved in Medtech thanks to his brother Dr. Pedro Martinez-Clark. Pedro trained at Harvard Medical School/Beth Israel Medical Center as an interventional cardiologist, was a professor at the University of Miami, owns a large cardiology practice in the Miami, FL area, and leads a Medtech incubator in Miami’s Florida International University

While at the University of Miami, Pedro started working with several US Medtech startup companies that were developing structural heart/cardiovascular devices. These companies wanted the University of Miami to facilitate first-in-human clinical trials for them in Latin America. Because of this, Pedro started traveling to Colombia and Paraguay to work with local investigators to gather human clinical data on these devices and discovered Latin America's vast potential for clinical research.

In 2010, Pedro realized that small and mid-sized US and European Medtech companies needed a great deal of help in Latin America with their first-in-human clinical trials and with the commercialization of their innovative medical technologies. That led Pedro to create a company called Interventional Concepts that later morphed and re-branded into what is now bioaccess.™. Julio now lead bioaccess.™ as its CEO while Pedro dedicates his time to his medical practice and other ventures of his own.

Julio realized that patients in Latin America have delayed access to breakthrough and innovative medical technologies; the majority of small and mid-size US and European Medtech companies fail on their attempt to enter Latin America; that these companies have no source of quality, reliable, and actionable information on how to penetrate Latin America, and have no one to guide them to succeed and ensure long-term growth in the region.

Julio decided to create the LATAM Medtech Leaders podcast to fill this void and become part of the solution to accelerate the penetration of breakthrough medical innovations in Latin America. Julio is a recognized medical device expert and his insights on the Medtech industry have been featured on industry-leading publications such as Med Device Online and Clinical Leader

On each episode of the podcast, Julio interviews a Medtech leader (i.e., c-suite executives, vice presidents, and directors with responsibilities related to sales, marketing, commercialization, product development, regulatory and clinical affairs) with meaningful experience conducting first-in-human clinical research or with the commercialization of medical technologies in Latin America.

On the podcast, Medtech leaders with extensive experience in Latin America openly share their stories, experiences, and share their best practices in the region. During 30-40 mins of a structured interview, they speak about how to operationalize a successful first-in-human clinical trial all the way to how to find reputable distributors to ensure medical technology benefit the right patient population in Latin America.

These are some highlights about Julio's work at bioaccess.™:

Why this podcast?

  • Medtech companies struggle to find a cost-effective clinical trial site or to gain market share in Latin America; this prevents patients in Latin America from having faster and easier access to innovative and breakthrough medical technologies.

  • Medtech companies are unfamiliar with Latin America and lack in-house experts who can operationalize successful clinical research, regulatory, or market access strategies in Latin America.

  • Many Medtech companies know very little about the Latin America region and its untapped potential for early-stage/first-in-human clinical research.

  • Many Medtech companies know very little about how to successfully penetrate the Latin American market to get their products sold.

  • There is a life science innovation gap between Latin America and the rest of the world; patients in the region lack easier and faster access to innovative and breakthrough medical technologies.

What problem does this podcast intends to solve?

The LATAM Medtech Leaders podcast intends to close the life science innovation gap between the US, Europe, and patients in Latin America who desperately need innovative and breakthrough medical technologies and sometimes have to wait many years after a medical innovation is released elsewhere in the world.

Latin America is undergoing dramatic demographic and epidemiological changes. Its population is rapidly aging, and there is a worrisome increase in the prevalence of chronic diseases. Despite this, breakthrough and innovative medical technologies sometimes take years to reach these patients. We represent the voices of patients in Latin America so that they can have faster and easier access to the medical technologies that the region desperately needs.

Nobody is bringing Latin America closer to Medtech companies, nor patients closer to medical innovations; so, we decided to do something about it.

Who is this podcast for?

Medtech professionals in leadership positions (i.e., c-suite executives, vice presidents, and directors with responsibilities for sales, marketing, commercialization, product development, regulatory, and clinical affairs) at developmental and commercial stage small or mid-sized US or European medical device or in-vitro diagnostics (IVD) companies that are looking for information and resources to either conduct a first-in-human clinical trial or commercialize their innovations in Latin America to achieve long-term grown in the region.

Who is producing this podcast?

  • Julio G. Martinez-Clark (Host): Julio is CEO and co-founder of bioaccess.™ (www.bioaccessla.com). He has been working with Medtech companies for over 10 years helping them design and implement clinical trial, regulatory and market entry/access strategies in Colombia and other countries in Latin America. Julio worked at the Johns Hopkins University/Hospital on a project to improve the healthcare system in Trinidad & Tobago. Julio is a recognized medical device expert and his insights on the Medtech industry have been featured on articles at industry-leading publications such as Med Device Online and Clinical Leader. Julio has a B.S.E.E. from Saint Thomas University in Colombia, and an M.B.A. from Western New England University in Springfield, MA. Julio spends most of his time in Colombia. Read more.

  • Johanna Barraza (Producer): Johanna studied philosophy at Universidad del Norte in Colombia and now is pursuing her B.A. degree in publishing at Universidad de Buenos Aires. Johanna is based in Buenos Aires, Argentina. Read more.

  • Nicolás McCormick (Audio Engineer): Nicolás is originally from Colombia and now lives in Buenos Aires, Argentina where he is studying audio production and is pursuing his B.A. degree in arts & economics at Universidad de Buenos Aires. Read more.

How will this podcast help you? How might you benefit from listening to this podcast?

  • You will learn how to overcome the hurdles associated with operationalizing a first-in-human clinical trial in Latin America.

  • You will learn how to formulate market access strategies and tactics to successfully commercialize your medical technologies.

What will we offer, include or bring to the table that will help our podcast stand out?

Insightful interviews with Medtech leaders (i.e., c-suite executives, vice presidents, and directors with responsibilities related to sales, marketing, commercialization, product development, regulatory affairs) with meaningful experience conducting first-in-human trials or with the commercialization of their products in Latin America.

Will the podcast interviews be in Spanish or English?

The podcast interviews will be in English, and will be transcribed for easier content consumption. The audio file along with the transcription will be uploaded to the podcast page on our website. Neither the podcast audio file nor the transcript will be translated to Spanish.

What are the questions that you would ask guests in your podcast?

Introduction

  • Welcome to the LATAM Medtech Leaders podcast! This is a weekly conversation with Medtech leaders who have succeeded in Latin America. Here, we deconstruct their past experiences in Latin America and formulate best practices for other leaders to follow.

    We do this in the interest of solving one of Latin America's most pressing needs: Closing the life science innovation gap between the US, Europe, and patients in Latin America who need faster and easier access to innovative and breakthrough medical technologies.

    Today, our guest is {first and last name}.

  • {first name}, it's great to have you here today. Welcome to the show!

  • [Host will introduce the guest and will read its bio].

  • {first name}, could you please briefly tell listeners about your journey to Latin America? How did you get involved with the region?

  • {first name}, what's your overall perception of Latin America as first-in-human clinical trial destination for medical technologies?

  • {first name}, What's your overall perception of Latin America as a market to commercialize medical technologies?

Clinical research (First-In-Human) | Only applicable if the guest has this experience

Let's talk about your practical experience conducting early-stage clinical research for medical technologies in Latin America.

  • In what countries have you been involved in clinical trials in Latin America?

  • What are your thoughts, experiences, and recommended best practices on the following areas:

    • Principal investigator (PI) selection?

    • Clinical research center/site selection?

    • Contract Research Organization (CRO) selection?

    • Regulatory study approval process?

    • Study/site/project management?

    • Shipping and importation of investigational medical devices?

    • Quality of clinical data?

    • Hospital fees/cost savings?

    • Other areas we haven’t mentioned?

Commercialization | Only applicable if the guest has this experience

Let's talk about your practical experience commercializing medical technologies in Latin America.

  • In what countries have you worked in Latin America?

  • Let's speak about market access/go-to market strategy. Did you have a pro-active and well thought-out strategy where you created a market access plan for each country you were planning to enter in Latin America or did you have an opportunistic/reactive approach where you waited for a distributor to contact you?

  • What are your thoughts, experiences, and recommended best practices on the following areas:

    • Obtaining regulatory approvals or market clearance?

    • Distributors

      • Search, due diligence, and selection?

      • Did you have a hands-off management approach where you just sold products to the distributor and let it do the rest on its own, or did you have a hybrid approach where you had a local clinical/sales agent (or even a local office with a country manager) to support the work of the distributor?

    • End-user demand generation?

    • Pricing?

    • Reimbursement?

    • Importation process, duties, etc.?

    • Compliance? What's being your experience with corruption or bribery in the region in light of the Foreign Corrupt Practices Act of 1977 (FCPA)?

    • Other areas we haven't mentioned?

Closing remarks

  • What major trend(s) do you see in Latin America that are relevant to our discussion?

  • Do you have any final thoughts for our listeners? In other words, what would you say to a small of mid-size Medtech company that haven't looked at Latin America (or that is just starting to explore the region) as a clinical trial destination or as a potential market to expand its footprint?

  • Thank you!

What's Med Device Online (MDO)'s support and involvement in this podcast?

MOD is enthusiastic about sharing and promoting content based on the podcast. MDO will turn the podcast transcripts into a regular Q&A on MDO's website. MDO will create a monthly Q&A column after pulling the most informative content from that month’s podcast interviews (presented in, essentially, a roundtable discussion-type format).

When will the the podcast be officially launched?

We are testing audio equipment and lining up guests now. We plan to have our first episode by the end of March 2019, and we will record weekly episodes after that.

I'd like to be a guest on the podcast. Is there a cost associated with me appearing on this podcast?

No. It's totally free of charge for our guests.

I'd like to be a guest in the podcast. How do I contact you about it?

We are glad you are interested in being a guest in our podcast. Please kindly get in contact with our podcast host and CEO, Julio G. Martinez-Clark, to schedule an introductory call to discuss your experience in Latin America and explore the possibility of having you as a guest. Click the button below to select the best day and time that fits your schedule for your call with Julio.