Medtech companies struggle to find a cost-effective clinical trial site or to gain market share in Latin America. The LATAM Medtech Leaders podcast delivers insightful interviews with leaders of medical technology companies with meaningful experience conducting first-in-man trials or with the commercialization of their medical devices in Latin America. They talk about their experiences in the region and provide a pathway for other leaders to follow so that they can save time and avoid costly mistakes.
Luiz Levy, Director & Quality and Regulatory Affairs at Emergo
Luiz Levy has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment, and disposables subject to INMETRO Certification. Luiz’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 16/2013, ISO 13485:2016, Directive 93/42/EEC, Regulation (EU) 2017/745, FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device Single audit program; performing multiple local and foreign (US, Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; compiling clinical evaluation reports and compiling and peer-reviewing market access reports.
As Director, Quality and Regulatory Affairs, Luiz has peer-reviewed more than 300 regulatory filings and reports, conducted multiple onsite audits on local and foreign manufactures, performed internal audits, and performed or reviewed more than 350 classifications/technical files of healthcare products, attended strategic meetings with ANVISA to help Agency on the final draft of new regulations (RDCs). Luiz is the designated Health Manager for Emergo’s Brazil Registration Holder services, and he additionally managers Emergo Brazil’s RDC 16/2013 quality system. Prior to Emergo, Luiz held RA/QA positions at CPL Medicals, Goen3, and Medics.
Mitchell Parrish, President at H Clinical
Mitchell is the President of H Clinical, the leader in decentralized trial and home health services for clinical trials across Latin America. With a 15-year passion for enabling clinical research, supporting life sciences, and transforming organizations, Mitchell is responsible for H Clinical’s strategy, business activities, and operations. Prior to H Clinical, Mitchell served as Managing Director, Everglade Rx, Executive VP & General Counsel, Advarra, and Associate Attorney, K&L Gates. Mitchell is on the Board of Directors for Life Science Washington, Faculty for RAPS, and a former Steering Committee Member for Harvard MRCT. He is a published author on FDA regulations and a frequent speaker on technology in clinical research.
Chris Sedgwick, Americas Trade Specialist at the Illinois Department of Commerce and Economic Opportunity Office of Trade and Investment
Chris Sedgwick is the Americas Trade Specialist at the Illinois Department of Commerce and Economic Opportunity Office of Trade and Investment. He has lived in Chicago for 9 years. Born in Los Angeles, he attended California State University Northridge where he received his Bachelor of Arts in French. As a student, he participated in the Junior Year Abroad program at the University of Aix-en-Provence in France. He later went on to receive his MBA from the Thunderbird Graduate School of Global Management in Glendale, AZ.
After a few years in the freight forwarding and customs brokerage business, Chris went on to a career in international sales for a variety of industrial manufacturing companies in the reinforced plastics, welding, specialty and medical gas, and personal protection equipment industries.
Daniel Uzbelger Feldman, CEO & Co-Founder at Real Time Imaging Technologies, LLC
Dr. Uzbelger Feldman's mission is 'Smiles for All'. He is the first Hispanic dentist to adopt Teledentistry and the first dentist implementing it in Ohio, Pennsylvania, Minnesota, and South Dakota since July 2018 as well as in Latin America. Due to his exceptional front-line services during the first month of the pandemic, Daniel received ‘The Teledentist of the Month’ award in March 2020. He received his IBM Blockchain Certificate in February 2018 and is currently innovating in blockchain for healthcare. Daniel has been granted several awards for his patented cinematic radiography and low radiation dose pioneering NeoImaging breakthrough. This research has been presented at the Massachusetts Institute of Technology as well as at prestigious dental meetings. In 2014, his low-dose x-ray imaging concept received the Medical Device & Diagnostic Industry Dare-to-Design Reader's Choice Award at the Medtech Design Challenge.
Since 2003 Dr. Uzbelger Feldman has been teaching in the Department of Endodontology at Temple University Kornberg School of Dentistry where he earned his DMD certificate in 2006. With 25 years of experience, he practiced dentistry for seven years in Philadelphia, PA, nine years in Cleveland, OH, and was serving patients in Ballantyne/Indian Land, NC/SC suburbs before Covid-19. He is currently introducing and expanding pioneering Teledentistry and dental aligners services.
Kameel Farag, Principal at KDF Ventures LLC
Kameel is the Principal of KDF Ventures LLC, venture capital and private equity firm. He is a leader in global finance with over 20 years of experience in established and emerging markets within the biopharmaceutical industry.
Prior to KDF Ventures, Kameel was the Senior Vice President of Finance at Ionis Pharmaceuticals, Inc the world leader in developing RNA-based human therapies. He also worked at Amgen, one of the world’s leading biotechnology companies, for 16 years. While at Amgen, Kameel held multiple leadership positions in International operations and regional CFO roles of Latin America/Canada/Australia, the Middle East, and Africa.
Jhonatan Bringas Dimitriades, Chief Medical Officer & Chief Communications Officer at Finnish MedTech NUKUTE
Jhonatan Bringas Dimitriades, MD is a Medical Doctor and executive who works with technologists, developers, medical professionals, and patients to deliver the right digital and technical solutions to enhance the diagnosis, treatment, recovery, and quality of life of patients around the globe.
Dr. Bringas believes in the democratization and digitalization of medicine. He Bringas has worked in the implementation of medical technologies in some of the top medical centers worldwide, such as the Mayo Clinic, the Cleveland Clinic, the Panama Clinic, the Hong Kong University Hospital, the AMC UMC Amsterdam, and many others. His work is related to the medical implementation of technologies, digital health, and innovation in the medical devices area.
Jhonatan is a certified Occupational Physician, with postgraduate education in Public Health, Business Strategy, and Digital Healthcare solutions. Jhonatan holds a Medical Degree, recertified in 3 continents and has held the positions of Medical Director, Chief Medical Officer, and is currently the Chief Communications Officer of Finnish MedTech NUKUTE, a respiratory / sleep medicine wearable company with a deep development in diagnostics and digital health tools.