Shows
The MedTech Podcast#84 Fast-Tracking Clinical Trials with Julio G. Martinez-Clark: LATAM Strategy, FIH Studies & MedTech Market AccessJulio G. Martinez-Clark CEO of Bioaccess and President of IAOCR/GCSA Americas is a MedTech trailblazer helping startups accelerate First-in-Human (FIH) clinical trials across Latin America, with over 20 years of experience spanning healthcare, telecom and venture capitalIn this episode, we unpack why more MedTech companies are turning to LATAM for faster, more cost-effective trial execution. Julio shares how his Miami-based CRO helps deliver 58-day CE mark approvals, his experience supporting 100+ device startups and why time, not money, is the most precious currency for early-stage founders. We also touch on trial quality, regulatory strategy and why he...2025-06-0929 min
21st Century EntrepreneurshipJulio G Martinez-Clark: Why Do U.S. Medtech Trials Go Abroad?Julio G Martinez-Clark is a pioneer in the world of clinical research for medical devices, and we spoke about why so many American innovations never get tested on American soil first. As the founder and CEO of Bioaccess, the only U.S.-based CRO dedicated to first-in-human trials in Latin America, Julio brings an insider’s perspective on how to save medtech startups from trial-related dead ends.Did you know that most U.S. medical device startups look outside the U.S. to test their innovations first? “Because the uncertainty of the FDA, the difficulty of r...2025-04-2213 min
Global Trial Accelerators™José Javier Handal, Chief Medical Officer at MRx SolutionJavier Handal is a Medical Doctor with expertise in clinical research and pharmaceutical industry operations. As the leader of MRx Solution, a Site Management Organization (SMO), he is driving the development of a robust network of research sites across Central America. Javier excels in building strategic partnerships, optimizing operations, and ensuring adherence to international research standards. His proactive mindset, attention to detail, and commitment to excellence enable him to deliver impactful outcomes. Dedicated to advancing healthcare innovation in the region, he leverages leadership, expertise, and collaboration to make significant contributions to clinical research.2025-01-2427 minGlobal Trial Accelerators™Andrew Ortega-Verdaguer, IntelVasc Inc.Today, we have the privilege of speaking with Andrew, a distinguished leader with over 15 years of international experience in marketing, commercial excellence, and business strategy. Throughout his career, he has led large teams at top pharmaceutical and medical device companies, including Novartis, Terumo, and Penumbra Inc. Andrew is a proud graduate of the IGNITE Program at Stanford Graduate School of Business and has also studied at several other prestigious international business schools. His expertise and journey in medical innovation make him a key voice in understanding the challenges and opportunities within the industry. 2025-01-1431 minGlobal Trial Accelerators™Daniel Estay, Founder & CEO at SonoVascular In this episode of LATAM Medtech Leaders, we sit down with Daniel Estay, a seasoned medical technology executive with a wealth of global experience. Daniel shares insights from his journey leading and developing fully integrated businesses across small, mid-sized, and large companies. With extensive expertise in general management, commercial operations, and business development, he offers a unique perspective on navigating the complexities of the medtech industry. We delve into his deep understanding of U.S. and international markets, including the opportunities and challenges of emerging markets in Asia Pacific and Latin America. Whether you're a me...2024-12-0423 minGlobal Trial Accelerators™Paulo Fernandes, C2O Fundador & PrincipalPaulo Fernandes is a distinguished clinical research executive with extensive experience in international clinical trials across various phases and therapeutic areas. With a solid foundation in the CRO industry, he has successfully held roles in project management, start-up, operations management, and business development. Paulo has worked at renowned CROs such as PPD, Covance, and IQVIA. Recently, he structured a healthcare sector start-up for a group of investors, showcasing his entrepreneurial spirit and commitment to high-impact public health initiatives. Additionally, he has 10 years of experience at the Brazilian Association of Clinical Research Organizations, including 4 years as the President of the...2024-10-2425 minGlobal Trial Accelerators™Miriam Serrano, Clinical Research ExpertMiriam is a seasoned professional in Health and Law, specializing in Sanitary Regulation and Clinical Research. With over 20 years of experience, she has a track record in planning and executing global, regional, and local clinical development programs, including Bioequivalence studies and Phase I-IV clinical trials. Her expertise spans Clinical Monitoring, Quality Assurance, Budgeting, Contracts & Payments Control, Clinical Trial Supplies, Master File, Pharmacovigilance, and Regulatory Affairs within both pharmaceutical industries and CROs, at national and international levels. She is recognized in the sector as a key opinion leader and a local expert in regulatory matters. Her leadership and active participation...2024-09-0626 minGlobal Trial Accelerators™Luis Alvarez, CEO and Founder of TheradaptiveLuis is the CEO and Founder of Theradaptive and developed the concept for targeted therapeutic delivery during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. Previously, Luis was the co-founding Deputy Director of the Department of Defense Regenerative Medicine Program and led the department's largest recombinant biologics program through Phase II. Luis was a DARPA Service Chief Fellow and Academy Professor at the United States Military Academy, West Point. Luis received his PhD in Biological Engineering from MIT where he was a Hertz Foundation Fellow.2024-03-0116 min
Global Trial Accelerators™Etienne Nichols, Medical Device GuruEtienne 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. His expansive knowledge, experience, and passion for medical devices are evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market.2023-02-2331 min
Global Trial Accelerators™Ruben Gaitan Ortiz, CEO at Alandra MedicalRuben 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. In a nutshell, his experience as an engineer revolves around developing Class I and II active and sterile medical devices (bio-instrumentation and software); this includes defining design...2023-02-1636 min
Global Trial Accelerators™Ernesto M. Nogueira, CEO at ValueConnectedErnesto 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.Ernesto also coordinates the ValueConnected team in applying Artificial Intelligence (AI) and Data Science...2023-02-0932 min
Global Trial Accelerators™Antonio Trujillo, Ph.D, Health Economist & ProfessorDr. 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.2023-01-2637 minGlobal Trial Accelerators™Carlos Medina, CRO Mexico, Central America, and Caribbean at Hasten LLCCarlos 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...2023-01-1937 min
Global Trial Accelerators™Yoku Sashida, CEO & Co Founder at Kenko SolutionsYoku 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.2023-01-1233 min
Global Trial Accelerators™Luis Santiago, CEO at PEGASILuis 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...2023-01-0530 min
Global Trial Accelerators™Dave Dolan, Co-Founder & Executive Chairman at MultiFunctional ImagingDave 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. He is a trusted business leader who draws upon an analytical and data-driven ap...2022-12-1524 minGlobal Trial Accelerators™Josh Cohn, Chief Commercial Officer at EndoSoundJosh 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. In his current role as CCO, Josh will be responsible for the pre-and post-commercialization Sales and Marketing strategy designed to ensure the integrated commercial...2022-12-0827 min
Global Trial Accelerators™David Bigio, Department Head of Biomedical Engineering at Universidad de los AndesMr. 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...2022-12-0142 min
Global Trial Accelerators™Widy Medina, CEO & Co-Founder at TelebionixWidy 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...2022-11-2437 min
Global Trial Accelerators™Mauricio Berdugo, Director of Medical Affairs at HumacyteMauricio 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.2022-11-1729 min
Global Trial Accelerators™James Reinstein, President & Chief Executive Officer at Conformal MedicalJames 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...2022-11-1033 min
Global Trial Accelerators™Gabriel Garza, Co-founder & Managing Director at DocTourGabriel 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...2022-11-0339 min
Global Trial Accelerators™Tomás Iglesias, CEO at ZubiaTomás 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 highly passionate about helping others and connecting health with technology. In 2020, created LATAM's most used COVID-19 suspected case self-assessment platform, reaching 194 countries, 24 million users, and generation 2,500 telemedicine consultations per day.2022-10-2134 min
Global Trial Accelerators™Ethan Russo, CEO at CannabisResearch.org & Nishi Whiteley, Chief Operating Officer at CReDODr. 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 itassist small and large cannabis companies in product formulationadvise companies on cannabis genetics enhancementsconsult 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”.2022-10-0730 min
Global Trial Accelerators™Thomas Gibson, CEO & Co-founder at MedGlobal GroupThomas 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...2022-09-3029 min
Global Trial Accelerators™Nicholas Focil, CEO at Fomat Medical ResearchNicholas Focil is the CEO at Fomat Medical Research, a network of research centers based in Oxnard, California. Nicholas graduated from 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...2022-09-1631 min
Global Trial Accelerators™James Ohneck, CEO & Founder at Epoch LasersJim 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.2022-09-0227 min
Global Trial Accelerators™Luís Meireles, CEO & Co-Owner at MDILuís 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 ma...2022-08-3134 min
Global Trial Accelerators™Christian Suojanen, CEO at Broadreach GlobalChristian 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.He led a turn-around of Europe’s largest biotech association which he represented among the BIO "Heads of Associations" group, was the lead advisor, dialogue mo...2022-08-2030 min
Global Trial Accelerators™Mona Oliveira, Founder and Co-CEO at BIOLINKERMona 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. After three years of foundation, BIOLINKER was approved for several accelerations and closed contracts...2022-08-0632 min