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.

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.

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!

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.

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.

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.

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.

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.