Dr Stephaun Wallace, who leads the global external relations strategies COVID-19 Prevention Network at the Fred Hutchinson Cancer Research Center, receives his second injection from Dr. Tia Babu during the Novavax Covid-19 vaccine phase 3 clinical trial a

Over the past two decades, clinical research has shifted from Western countries to emerging low-income and middle-income countries (LMICs) in Eastern Europe, Latin America, and Africa, with offshored R&D activities from the US, Europe, and Japan gaining attention. Studies challenge the traditional cost-related reasons for offshoring clinical trials, emphasizing the importance of recruiting human subjects in trials faster.

Latin America attracts clinical trials due to its faster and easier patient recruitment, diverse population, and strong doctor-patient relationships. In 2020, there were 67 medical device trials in Latin America, a 67.5% increase from 40 in 2017. Colombia, one of the countries attracting more Medtech clinical trials in the region, is updating the medical device clinical trial framework to make the approval process faster and more efficient.

The availability of many FDA-approved palliative therapeutic options in the US prompts patients to be cautious when participating in trials with unproven therapies, particularly in phase I or first-in-human studies. Moreover, life science startups need more fast access to investigators at hospital systems and universities for clinical trials and also complain about the uncertain regulatory pathway to approve a first-in-human study at the FDA.

The national government of Colombia has been making efforts with its 10-year plan to strengthen the processes of science, technology, and innovation in the country over the years, along with the case study contributed to the Organisation for Economic Co-operation and Development (OECD) TIP Knowledge Transfer and Policies project, aiming to organize and improve the organizations and processes involved in these activities. Colombia, one of the only four OECD members in Latin America and one of the only three countries in the region with a vision to become a knowledge society by 2032, has a National Science, Technology, and Innovation System that promotes inclusivity, accessibility and classifies research groups based on excellence. Social appropriation in science involves linking individuals to scientific processes, creating knowledge communication strategies, and developing pedagogical strategies. With these initiatives, Colombia seeks to attract more US Medtech startups to transfer advanced knowledge to local investigators and collaborate in clinical trials.

bioaccess™, founded in 2010, is the only US-based clinical research organization (CRO) focusing on Medtech that facilitates the execution of clinical research studies in research hospitals in Colombia and other countries in Latin America. The company understands that medical device development can be challenging without the right people and processes catering to the unique needs of Medtech companies. The company assists startups and established medical device manufacturers in executing clinical trials, offering exceptional support and guidance.

The genesis of bioaccess™ can be traced back to the University of Miami (UM) and the collaborative efforts of visionary minds like former UM professor Dr. Pedro Martinez-Clark, a Harvard-trained interventional cardiologist, former UM professor Dr. William O'Neill, one of the top interventional cardiologists in the world, and Julio Martinez-Clark, the president of the Colombian Association for the Advancement of Clinical Research (AVANZAR) and entrepreneur, who recognized the untapped potential of Latin America in the realm of medical device innovation. Fueled by their passion for bridging the gap between Medtech startups and the burgeoning clinical research opportunities in the region, bioaccess™ embarked on a mission to facilitate seamless, fast, and cost-efficient access to Latin America's diverse patient population and robust clinical research infrastructure.

Medtech startups' challenges in the medical device industry in the US are multifaceted, ranging from regulatory hurdles to limited financial resources and prolonged subject recruitment timelines. US Medtech companies face professionalism, language barriers, fragmentation of resources, and lack of CRO corporate structures in Latin America. This impedes Latin American hospitals from having seamless communication and collaboration with American clinical trial clients, particularly in the medical device first-in-human clinical trial industry. These factors underscore the urgent need for a solution-driven approach to bridge the gap between innovation and execution in Latin America.

Recognizing these obstacles as opportunities for innovation, bioaccess™ has adopted a solution-oriented approach, offering a comprehensive suite of CRO services tailored to meet the unique needs of Medtech companies navigating the complexities of clinical trials in Latin America.

From first-in-human to pivotal trials and post-market follow-up studies, the US-based CRO company leverages its extensive expertise and industry insights to guide Medtech startups through every stage of the clinical research journey. By facilitating site selection, regulatory compliance, patient recruitment, and study project management, bioaccess™ empowers medical device companies to navigate the intricate landscape of clinical trials confidently and efficiently in Latin America.

Julio Martinez-Clark, the visionary CEO of bioaccess™, embodies the company's commitment to driving positive change in the Medtech industry. His steadfast dedication to reducing the time and cost barriers associated with clinical trial execution underscores bioaccess'™ overarching mission to empower Medtech startups and accelerate medical innovation in Latin America.

Julio Martinez-Clark, CEO of bioaccess™

Julio said, "Our mission is to help our clients buy time. They need time, and if I can help them save a few months of product development, I am helping them save funds - almost millions of dollars." This unwavering dedication underscores bioaccess' pivotal role in accelerating Medtech innovation and driving tangible outcomes in the industry.

Looking ahead, the co-founders envision a future where Latin America becomes the premier destination for Medtech clinical research. By streamlining the regulatory approval process and fostering a conducive environment for innovation, bioaccess™ aims to attract an influx of Medtech clinical trials to the region, catalyzing economic growth and transforming healthcare delivery by giving patients early access to innovative medical technologies.

Julio explains, "The three metrics I live by are time, number of studies, and patient impact. I feel there is a need to increase the number of trials in Latin America, particularly in Colombia. Every time I wake up, I think about how to shorten the time to get a study approved. How many more studies can I bring into the region, and how many more patients can benefit from early access to innovative medical technologies in Latin America?" His vision extends beyond mere business objectives with a broader mission to elevate healthcare standards and foster knowledge societies across Latin America, just like the efforts made by the government. Through strategic partnerships and knowledge transfer initiatives, Julio, through bioaccess™ and AVANZAR, seeks to nurture a collaborative ecosystem that transcends geographical boundaries, propelling Medtech innovation to new heights in the region.