we would love to explore having you as a guest on our podcast
We want to know your journey and thoughts on the state of Latin America for Medtech clinical trials
The LATAM Medtech Leaders podcast delivers insightful structured interviews with leaders of medical technology and other life science companies with meaningful experience (or ambitious plans) in clinical research in Latin America. Guests talk about their experiences or ambitious plans in the region and provide a pathway for other leaders to follow so that they can save time, avoid costly mistakes, and benefit patients in Latin America with faster access to medical innovations.
Podcast Description
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, innovative medical technologies sometimes take years to reach these patients.
US and European Medical technology ("Medtech") companies struggle to find a cost-effective first-in-human clinical research center 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.
We realized that a) the majority of US and European small and mid-size Medtech companies fail in their attempt to enter Latin America; b) that these companies have no source of quality, reliable, and actionable information on how to reach the right patients in the region, c) that these companies have a hard time finding an expert to guide them to succeed in the region. As a consequence, patients in Latin America have delayed access to breakthrough and innovative medical technologies.
We decided to create this podcast to fix these problems by becoming part of the solution to accelerate the penetration of breakthrough medical innovations in Latin America.
Our Guests
Our guests are Medtech leaders (i.e., c-suite executives, vice presidents, and directors with responsibilities related to sales, marketing, commercialization, product development, regulatory and clinical affairs) with extensive experience (or ambitious plans) in Latin America. On the podcast, they openly share their stories, experiences, plans, and suggested best practices in the region. During the 30-40 mins of the structured interview, a guest tells his journey to Latin America, his experiences, the good, the bad, the ugly, his plans, and his recommended best practices. This translates into actionable information for listeners. During the interview, the guest addresses important topics ranging from finding an investigator for a clinical trial all the way to obtaining regulatory approvals, and recruiting subjects for their studies.
The Intended Audience
The intended audience of the podcast is decision-makers (i.e., CEOs, presidents, vice presidents, and directors) at developmental and commercial-stage US or European medical technology companies who are looking for best practices, and quality and actionable information to either conduct a first-in-human (FIH) or early feasibility studies in Latin America.
Your Podcast Host
Visit the Podcast Channel on YouTube
Podcast Episodes
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has manufacturing and product development experience, even aiding in developing combination drug-delivery devices, from startups to Fortune 500 companies, and holds a Project Management Professional (PMP) certification. Etienne has managed cross-functional teams for updating legacy products as well as developing new medical devices.
Ruben is the CEO of Alandra Medical. He has dual qualifications in engineering and technology entrepreneurship combined with 16 years of experience in medical device development. Self-motivation, adaptability, trainability, and entrepreneurial drive are his key tools for achieving personal and business goals. Ruben started his career developing hardware and software for medical devices, spending countless hours reading scientific papers, twitching circuits, refining algorithms, and preparing technical reports to deliver products right on time.
Ernesto has 27 years of experience leading healthcare strategies to drive access and expansion for new products, developing value propositions for public and private stakeholders, and assessing global market opportunities for healthcare companies. He has worked for both government agencies and global healthcare companies in roles ranging from strategic marketing and new product development to health economics and reimbursement. Also, Ernesto led several Market Access projects across the US, Europe, Latin America, and the Middle East; Ernesto is the CEO and Founder of ValueConnected.
Dr. Antonio Trujillo is an Associate Professor in the Department of International Health with expertise in health economics, the economics of aging, and applied econometrics. Antonio is the co-director of the Master of Health Science (MHS) in Global Health Economics degree program. He teaches an advanced econometrics course on program impact evaluation using observational data and a course on behavioral economics and public health.
Carlos Medina is a Medical Doctor who works with health technology professionals to help them make the best technology for patient care available across Latin America. Carlos has witnessed the many benefits and risks that come with applying technology to solve health problems and is dedicated to helping others follow the best practices available and avoid the missteps that can derail their health technology problems. He has had the privilege to work with local and international companies across most countries in Latin America, helping them to achieve multi-million sales results and establish lasting and efficient global-local collaborations. He is a Licensed Medical Doctor in Mexico City.
Yoku Sashida is the CEO & Co-Founder at Kenko Solutions, a company dedicated to managing and developing biomedical projects based on technology. He is responsible for opening economic relationships, capturing technology-based projects, forming work teams to carry out technological development, and administrative and financial accounting. The first product of its own is ecglove, the wearable able to determine the state of the heart in less than 60 seconds.
Luis Santiago is PEGASI's CEO and CTO. By training, he is a social communicator and marketing and public relations professor. By profession, he is a self-taught programmer, technology project manager, and Product Owner, with more than 14 years of experience in the area. He has ventured into banking, IT, and Digital Health. Luis was recognized in 2016 as one of the Young Leaders of the Americas by the American State Department, and in 2020 as one of the 35 Innovators under 35 in Latin America by the MIT Technology Review magazine. He has participated in dozens of international forums and events pointing out the importance of Healthcare digitalization in Latin America.
Dave is the Co-Founder & Executive Chairman at MultiFunctional Imaging, a University of Utah startup company that provides software solutions for improving the efficiency and accessibility of multi-tracer imaging with PET, PET/CT, and PET/MRI scanners. Dolan’s career has been built on successes centering around the commercialization and customer adoption of innovative MedTech products/services. Spanning from Fortune 500 corporations through startups, businesses have benefitted from his track record of success in turning medical device innovation into record growth, high market share, and attractive market valuations.
Josh Cohn has 15 years of experience in the medical device field, rising to National Sales Director of PENTAX Medical, a major endoscope provider. He has a strong history of leading successful sales organizations, building winning strategies, and launching disruptive programs aimed at changing marketplace conventions. As product champion and strategist for all EUS sales, he has attended hundreds of procedures and has established relationships with key opinion leaders, hospital and ASC administrators, and device distributors.
Mr. Bigio is a professor in the biomedical engineering department, responsible for the Senior Capstone Design project. Currently, he is also serving as the department head. He comes to the university after having spent 30 years of professional experience working for large multinationals in different parts of the world, including the development of high technology start-ups in Silicon Valley, commercialization of technology used in large infrastructure projects, and coordinating strategic projects for a multinational consortium. Mr. Bigio clearly understands current challenges and opportunities in the biomedical engineering field. He is very focused on improving the education and skills of graduates in order to provide companies with better employees.
Widy is the Co-Founder and CEO of two technology companies with vast experience ranging from robotics, product design, fabrication, and automation to the electronic assembly of consumer products, food and beverage tech, biotech, medical devices, and pharmaceutical industries. Widy spent 40+ years living in Puerto Rico, and 20+ supporting pharmaceutical, biotechnology, and medical device companies with a presence in multiple Latin American locations. He led an automation firm that exposed him to FDA regulations, manufacturing, and compliance during that time. Today, he leads a medical device company with a unique RPM product to capture biomarkers and allow those to be maintained in a safe digital format for exchange with healthcare professionals or as a personal health tracking system.
Mauricio A. Berdugo, MD, MPH, is currently the Director of Medical Affairs at Humacyte, Inc. Mauricio has worked in different capacities within the CRO, pharma, diagnostics, and biotech industries in the USA and globally, including Latin America, Europe, and Asia over the past 9 years. His clinical and academic research stems from HIV/AIDS, cardiovascular disease, pulmonary disease, renal disease, and orthopedic spine surgery. Mauricio graduated from medical school at the Universidad Evangelica de El Salvador, completed his Master of Public Health degree from Kaplan University, and he is currently pursuing a Fellowship with the American College of Healthcare Executives.
James has more than 25 years of medical device experience and is currently the CEO of Conformal Medical. Prior to joining Conformal, he led Saranas and private companies such as Drawbridge Health, and Aptus Endosystems as their President, CEO, and member of the board of directors. He held a similar role at the publicly traded medical laser company, Cutera from 2017 to 2019. He was part of the management team that led the turn-around at Cyberonics where he was the EVP & Chief Commercial Officer. James spent 17 years at Boston Scientific in various roles and functions including business development, marketing, and general management. Most of his career at Boston Scientific was spent working and living in Europe, Asia, and Latin America. Additionally, Mr. Reinstein has served as a board director for several medical companies, including publicly traded Mainstay Medical in Dublin, Ireland, Pixium-Vision based in Paris, France, and Monteris Medical a privately held company located in Minnesota.
Gabriel Alejandro Garza Caro is Co-founder & Managing Director at DocTour who works with international travelers and tourists to solve their health problems during their travel. With innovation in tech & processes, a completely new hybrid model has been created to attend to all travelers’ medical needs. Gabriel believes that empowerment, teamwork, strategic planning, and communication are key fundamentals for startups to develop in order to establish early, the way to success in today’s health tech environment. Gabriel is trained in Business Process Management and in Project and Portfolio Management as a Project Management Officer. For Gabriel, the most rewarding part of his role is the ability to innovate and think out of the box to solve everyday business and market challenges.
Tomás Iglesias is a medical doctor/master in hospital administration/Front-end developer. Tomás is the CEO of Zubia, LATAM's largest digital health marketplace a platform that connects digital health platforms with users that need their services. Currently in 25 countries with more than 400,000 visitors in 10 months from launch, and the co-founder and leader of HealthX, Mexico's largest health-tech community. Tomás is extremely passionate for helping others and connecting health with technology.
Dr. Ethan Russo and Nishi Whiteley have worked together for almost 10 years in efforts to improve the scientific understanding of the endocannabinoid system (ECS) and how the cannabis plant modulates it, assist small and large cannabis companies in product formulation, advise companies on cannabis genetics enhancements, consult on pre-clinical and clinical research design.
“We share a vision of making cannabis better and safer believing in a future in which knowledge of the endocannabinoid system and its therapeutic modulation via the cannabis plant will result in superior highly individualized medicines, aids to wellness, enhanced lifestyles, and novel non-toxic industrial products”.
Thomas Gibson is the co-founder and chief executive officer at MedGlobal Group, a multisided marketplace for the medical industry. After spending 22 years as an executive for healthcare and hospital organizations, Thomas founded MedGlobal Group with his wife, Patricia, recognizing the need to use technology to help solve the challenges of making healthcare equipment, products, and services accessible to the world. Their international platforms combine technology and tools to help connect manufacturers and distributors with global buyers. Thomas and Patricia believe healthcare is more than a business, and we have a responsibility to ensure medical equipment and products are made available to all parts of the world.
Nicholas Focil is the CEO at Fomat Medical Research, a network of research centers based in Oxnard, California. Nicholas graduated in California with a Biochemistry and MBA degree. During his undergrad days, he spent his extra time in a research lab working with a nominated noble laureate performing investigator-initiated studies and publishing weekly articles for a spectrum of publications. Was then recruited by Medtronic MiniMed Diabetes division to do pre-pivotal trials. Thereafter, was recruited for the purpose of managing and expanding Diverse Research Solutions. He then spearheaded the spinoff and expansion of FOMAT Medical Research through both the U.S. and Latin America with current operations in the USA (California and Florida), Ecuador, Colombia, and Peru. With well over a decade of research experience, Nicholas, as the CEO of Fomat Medical Research and proud founding partner of hyperCORE International, continues to innovate and pioneer clinical research in both regions.
Jim Ohneck is the Founder and Chief Executive Officer (CEO) of Epoch Lasers and holds a US patent for his unique Laser Therapy device for treating chronic pain. Jim holds degrees in Business Administration and Electronic Engineering and has thirty-five years of medical device development experience. He is a Fellow of the American Society of Laser Medicine & Surgery (ASLMS), a Member of the International Society of Optics and Photonics and of the International Microelectronic Packaging Association, and an Adjunct Faculty at Notre Dame College in Cleveland, OH where he teaches International Finance and Marketing.
Luís Meireles is currently CEO and co-owner of MDI Industrial a Medical Device Industry in Brazil and a senior consultant for European companies. Luís is Portuguese, Ph.D. in Biotechnology but moved to Brazil, spending the last decade helping to introduce medical devices into Latin America he was responsible for the introduction of Mortara Instruments in Brazil with a successful plan growing from almost zero to one of the market leaders. He was a senior consultant for Hill-Rom visiting almost all countries in Latin America, being perfectly aware of the difficulties of implementing and growing the health market in LATAM, especially in Brazil.
Christian is an entrepreneur and advisor in the bio, pharma, healthcare, and technology sectors with 20 years of strategic advisory, business creation, development, and operational experience. He works with biotech companies and VCs on business development and strategy, with industry on innovation, pipeline, and business development, with institutions on technology transfer & innovation, with governments, institutions, and systems on innovation strategy, policy, and ecosystem development, and has served on biotech, patient organization, and non-profit boards.
Mona Oliveira is one of the creators and founders of the startup BIOLINKER, which in 2019 was awarded as one of the TOP 500 best startups in the world in the area of biotechnology for the project she coordinates. Double Ph.D. in Biochemistry and Nanotechnology from USP (Brazil) and IJS (Slovenia). During her academic career, she has accumulated awards and honors for performance and scientific excellence, publishing in annals and journals of international renown. Currently, he is Co-CEO of BIOLINKER acting in scientific operations and negotiations.
Steve Scalia is the President of Tanner Pharma Group, a 20-year-old specialist pharmaceutical services provider headquartered in Charlotte, NC USA with offices in the United Kingdom, Brazil, Switzerland, and Ireland. Tanner provides a portfolio of service offerings focused on improving global access to medicines worldwide. In his role, Steve leads the company’s business activities with oversight of the commercial divisions, cross-functional departments, the Corporate Governance Team, and the Senior Management Team.
Jacobo Luchtan is the CEO and Co-Founder at HelloDoctor, a Mexican startup providing data-driven telehealth services. They operate in more than 10 Latin American countries and have successful cases with patients from each. They created a neutral bridge that connects patients and healthcare practitioners where they can provide online consultations, digital recipes, online pharmacies, track their medical records, and more.
For over 30 years Alvaro has been advising people and companies on Intellectual Property and Regulatory Affairs, developing strategies for companies to comply with the regulations and protect their assets. Alvaro has an extensive international experience with greater emphasis on the countries of America.
Jay Nadkarni is a Business Consultant and Adviser to Life Science companies with Ambiance Ventures in Pennsylvania. Jay is also Managing Partner at Molecule Market OU in Estonia which serves Europe. Jay has 20+ years of experience in multiple therapeutic areas in Product Development, Licensing, and Global Marketing. He is an industry expert with unique abilities to validate and bridge market needs with pragmatic solutions and offer actionable proposals for measuring returns on investment.
Motivated professional with more than 15 years experience on diagnostic and research multinational companies at marketing, scientific support and training, and commercial and management roles with experience in selling reagents, instruments, and services in research and clinical markets; organizing events/conferences/symposiums; giving training sessions and talks on scientific and corporate meetings; managing importation, promotion and sales operations in Brazil and managing distributors in Latin America.
Twelve years’ academic experience on research in virology and molecular biology and holder of a Ph.D. in Science (emphasis on Molecular Virology) issued by the University of São Paulo - USP and Post-Doc also in Molecular Virology completed at Campinas State University - UNICAMP.
Thomas Grandell is the CEO and founder of Etsimo Healthcare Ltd, a Finnish company providing data-driven healthcare solutions to its customers with the help of AI and machine learning. Thomas strongly believes that the key to transforming healthcare lies in combining data, technology, and empathy. Thomas has an M.Sc Econ and has been an entrepreneur all his life. Thomas puts innovative thoughts and technologies to work to enable new ways of doing things, making the experience either faster, more cost-effective, better, or easier, or preferably all of these at the same time.
Chief Executive Officer and Founder of a successful cutting-edge healthcare business spanning four countries on two continents. Additional experience includes asset management and investment banking in the UK and Switzerland and an MBA from the University of Oxford. Expertise in strategy, innovation, investment, scale-ups and business development.
Humãnus Regenerative Medicine is a group of companies based in Argentina, Paraguay, and Uruguay. It is the first company to introduce adipose-derived stem cells therapies in Argentina & Paraguay.
Jón I. Bergsteinsson, M.Sc. in Biomedical Engineering, is the founder of SMART-TRIAL, which was acquired by Greenlight Guru in 2022, where he helps MedTech companies bridge the gap between their devices and clinical data. Jón served as the CTO of SMART-TRIAL from 2013 to 2017, where he paved the way for the platform’s quality standards, data security, and compliance. Since 2017, Jón has been leading SMART-TRIAL's commercial operations. With a solid technical background and ten years of experience in MedTech and the clinical space, Jón is mainly occupied with sharing valuable insights and know-how with the rest of the industry.