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Javier 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.

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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. 

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 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 medtech entrepreneur, investor, or enthusiast, this episode is packed with valuable lessons and strategies for driving success in the ever-evolving healthcare landscape. 

Tune in to explore the future of medtech through Daniel's expert lens!

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Paulo 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 Board of Directors. Paulo holds a specialization in Clinical Pharmacology from USCS, a degree in Pharmacy and Biochemistry from FCF-USP, and training in Business and Project Management from FIA, along with an Executive MBA from INSPER. 

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Miriam 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 in gremial improvement initiatives have been pivotal, building synergies with authorities, academic, and industrial colleagues to further the development and progress of Clinical Research. 

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Luis 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.

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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. 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.

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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. 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 inputs and producing design outputs following state-of-the-art industry standards such as ISO 13485, ISO 14971, IEC 62304 and the IEC 60601 series.

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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.

Ernesto also coordinates the ValueConnected team in applying Artificial Intelligence (AI) and Data Science to address significant unmet needs in healthcare, accelerating the adoption rate of medical technologies that can generate value for patients, payers, and providers. He holds an MBA from the University of Texas at Austin, US, and a Bachelor’s degree in Business Administration from Fundação Armando Ávares Penteado(FAAP), in São Paulo, Brazil.

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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.

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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. He is working on finishing his Master's degree in Information Technology for Healthcare while leading the Medical Devices workgroup of the Mexican HealthTech Association.

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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.

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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.

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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. He is a trusted business leader who draws upon an analytical and data-driven approach with KOLs, advising boards of directors, investors, C-level executives, and other stakeholders in identifying and capitalizing on opportunities to advance each organization’s strategic vision.

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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. 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 success of the organization.

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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. He has been working with the Biomedical engineering students during their senior capstone design project to address two important aspects of their education; help them improve on the ‘soft’ skills that future employers expect from them, and also teach them about how to become entrepreneurs to give them employability alternatives and promote a much-needed activity in our country.

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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.

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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.

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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. James began his professional career with Proctor & Gamble after earning his Bachelor of Arts in Marketing (BA) degree from the Terry College of Business at the University of Georgia in Athens. He also completed graduate studies at INSEAD in Fontainebleau, France.

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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.

Prior to working at DocTour, Gabriel began as a Business Process Consultant and Project Manager at CEMEX, where he collaborated to map, design, and create the new CEMEX’s processes, system, and software and implement it in some European countries and in México. Gabriel holds a University Degree in International Commerce from the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM) in México and a Master's Degree in Economics and Society and Master's Degree in Economics of Territorial Development from the Université Toulouse Capitole in France.

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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 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.

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Dr. Ethan Russo and Nishi Whiteley have worked together for almost 10 years in efforts to:

1. improve the scientific understanding of the endocannabinoid system (ECS) and how the cannabis plant modulates it
2. assist small and large cannabis companies in product formulation
3. advise companies on cannabis genetics enhancements
4. 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”.

Ethan Russo, MD, is a board-certified neurologist, psychopharmacology researcher, and author. He is the Founder and CEO of CannabisResearch.org. Previously, he was Director of Research and Development at the International Cannabis and Cannabinoids Institute (ICCI) based in Prague, Czech Republic. Medical Director of PHYTECS (2015-2017), a biotechnology company researching and developing innovative approaches targeting the human endocannabinoid system, and from 2003-2014, he served as Senior Medical Advisor, medical monitor, and study physician to GW Pharmaceuticals, United Kingdom for numerous Phase I-III clinical trials of Sativex® for alleviation of cancer pain unresponsive to optimized opioid treatment and initial studies of Epidiolex® for intractable epilepsy.

Nishi Whiteley (pronounced Nee-sha), is the co-founder and Chief Operating Officer at CReDO. She has twenty-five-plus years of international business development experience in cannabis, agriculture, wellness, green energy, and food industries. She has had leadership roles on projects in corporate America and for the US Foreign Ag Service in over 10 countries, in startups, a state agency, and non-profits; as well as worked for foreign governments and met with international leaders in Cuba, Mexico, and the Dominican Republic to open trade and advance development programs. She has worked on investment projects in 8 countries.

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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. Our platforms provide sourcing opportunities for both new and used medical products, and we publish a fully-interactive digital magazine focused on the industry. Thomas holds dual BAs in Business Administration and Emergency Management. Thomas received the American Society of Healthcare Engineering Emerging Leader of the Year Award and is the past president of the Florida Healthcare Engineering Association. Thomas and Patricia also operate the Gibson Soto foundation, a nonprofit that helps young women rise from poverty through education.

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Nicholas 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.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 hyper core International, continues to innovate and pioneer clinical research in both regions.

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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.