By Julio G. Martinez-Clark, CEO, bioaccess
Planned and ongoing medical device clinical trials rose 14% in Q1 2022 globally compared to the last four quarters' average, according to GlobalData’s medical devices clinical trials database.1 According to a Grand View Research report, the global medical device contract research organization (CRO) market size is expected to reach $12.1 billion by 2028, registering a CAGR of 8.6% from 2021 to 2028. The main drivers of the CRO medical device market include time savings, cost efficiency, and expertise in the area, accelerating the process of devices reaching the market.2 There are over 6,500 medtech companies in the U.S., primarily small and midsize enterprises.3 More than 80% of these companies have fewer than 50 employees. Typically, the ones with fewer than 20 employees have limited financial resources and minimal to no sales revenue.4,5 Waiting for long-drawn-out ethics and regulatory approval on an early feasibility study (EFS) or a first-in-human (FIH) study could tie up investment dollars and quickly lead a startup company to starvation.
This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.
The Need To Go Outside The U.S. (OUS) For Medtech Trials
The FDA doesn’t require U.S. medtech startups to disclose their OUS EFSs or FIH studies on ClinicalTrials.gov.6 This makes it challenging to keep track of the number of OUS EFSs or FIHs that U.S. medtech startups are conducting in a specific country. According to the author’s experience and feedback from industry colleagues, the countries that most U.S. medtech companies traditionally choose for their OUS EFS or FIH studies are in Eastern Europe (i.e., Poland, the Czech Republic, Georgia), Australia, New Zealand, and Latin America (Colombia, Paraguay, Panama, Chile).
According to the FDA, an EFS is a limited clinical investigation of a medical device early in development. It typically enrolls a few subjects (fewer than 15), is used to evaluate the device design concept concerning initial clinical safety and device functionality, and may guide device modifications.7 An EFS gains early insights into an innovative medical technology during the development process before starting a larger clinical trial. An EFS is a critical step in device innovation and facilitates direct and interactive collaboration between FDA, sponsors, and innovators in the earliest product life cycle stages. Capturing EFS data supports subsequent U.S. clinical studies (e.g., pivotal, post-market). Historically, EFSs have often been conducted OUS due to actual or perceived resource constraints and requirements (costs and time) associated with U.S. study conduct.8
According to the FDA, an FIH study is a limited clinical investigation where the manufacturer evaluates its medical device for the first time in human subjects for a specific indication. An FIH can be an EFS, but not all FIH studies would be considered EFSs.9
According to the Medical Device Innovation Consortium, it takes about six and a half years and $37 million for a company to bring a device from bench testing to completion of an EFS or an FIH in the U.S. Therefore, many medical innovations never make it to market. These companies will not survive the time and financial burden if the device development times (including the clinical phase) are extensive.5 Time is critical for prospective participants and study teams. By some estimates, a delayed development program costs clinical trial sponsors $37,000 in operational costs each day.10
The unpredictable, inefficient, and expensive regulatory process to conduct an EFS or an FIH in the U.S. forces medtech startups to conduct OUS research, where trial regulatory hurdles are more favorable than in the U.S., and it is easier and faster to recruit subjects at a lower cost. According to a recent survey, most medtech company responders said that they have conducted or plan to conduct their EFS or FIH overseas to avoid the stringent trial ecosystem in the U.S. For example, GlySure, a U.S. company that conducted a trial in India, reported that the outcomes of its OUS trial far exceeded its expectations, with direct trial costs savings of 50% to 70%, compared to U.S. or EU costs and, more importantly, savings of nine to 12 months in development time due to faster regulatory approval processes.11 Over the past two decades, medtech companies have transferred a significant part of their initial clinical research activities overseas; this is in response to a more stringent legal, regulatory, and financial environment in the U.S.5
The implementation of the EU Medical Device Directive (MDR) in 2021, with its new rigorous requirements for substantial clinical data to back MDR regulatory submissions, will be the main driver of medtech companies seeking higher-performing countries in which to conduct clinical trials outside the EU region. In the EU countries, the competent authorities and the ethics committees (EC) in each country can take many months to review the documentation required to seek approval for a clinical program. In some countries, it can take more than a year to negotiate successfully with the authorities to gain approval for a new clinical trial. Also, after CE marking approval, medtech companies will be looking at finding new regions to conduct good quality post-market clinical follow-up (PMCF) programs since many research sites in the EU do not have the research staff and support to conduct the PMCF programs that the MDR now requires. This is making the EU a less desirable location for medical device clinical trials, and it may be increasing companies’ interest in emerging markets like Latin America.12
Latin America Is Emerging As A Desirable Medtech Clinical Trial Destination
The Organization for Economic Cooperation and Development (OECD) – an intergovernmental economic organization with 38 member countries, founded in 1961 to stimulate economic progress and world trade – has never been closer to Latin America than it is today: Chile, Costa Rica, Colombia, and Mexico are OECD member countries, and on Jan. 25, 2022, the OECD Council decided to open accession discussions with Argentina, Brazil, and Peru.13
Increasingly complex and inconsistent clinical trial regulations are causing delays and rising costs and may lead to a decline in the number of international trials. To boost medical research and help regulators overcome this problem, the OECD calls on its member governments to harmonize their clinical trial approval processes to promote medical research and save lives. The aim is to encourage international collaboration in clinical research and streamline procedures for conducting clinical trials. The OECD has encouraged its member countries to update their clinical trial regulations to align them with OECD recommended best practices and encourage foreign investment in international clinical research.14
Due to its ethnically diverse population, its high rate of urbanization, and solid doctor-patient relations, Latin America has become one of the most attractive locations for international clinical trials.15 According to Clinicaltrials.gov, in 2020, there were 67 medical device trials in Latin America – an explosive 67.5% increase from 40 in 2017!16
Latin America’s history of medtech clinical trials can be traced back to 2008. The University of Miami (UM) Miller School of Medicine and the UM International Medicine Institute (IMI) and Angiografia de Occidente (AO) – a network of cardiovascular catheterization labs in Cali, Colombia – have been working together since 2008 under an education, research, and training affiliation agreement. Since then, the IMI has bolstered AO as one of the centers for excellence for cardiovascular disease in Latin America. Under this affiliation, AO has emerged as a premier leader in structural heart disease therapy in Latin America.17
In 2008, Eduardo De Marchena, M.D., was a professor of medicine and surgery, director of the interventional cardiology program, and associate dean of the UM Miller School of Medicine and the IMI. For several years, Dr. De Marchena has co-directed and participated in the Structural Heart Latin American Symposium at AO in Cali. The AO annual symposium is considered one of the most important in South America and attracts heart experts from the Miller School and throughout Latin America and Europe. De Marchena has co-directed the symposium with his longtime collaborator Antonio Dager, M.D. – who heads AO and trained from 1985 to 1988 as an interventional cardiologist at the University of Miami Miller School of Medicine.17
The educational research affiliation between the University of Miami Miller School of Medicine and AO allowed both parties to collaborate on developing research projects with innovative cardiovascular devices in Colombia. Colombia stands out in Latin America for its solid institutions and commitment to the private sector, making it one of the most economically and politically stable countries in Latin America. The country also stands out as a destination for medtech EFS and FIH clinical trials. The educational research affiliation between UM and AO led them to use the symposium as an initiative to train doctors in Colombia and the rest of Latin America. This affiliation sparked a wave of EFS and FIH research in Cali, Colombia, including several sponsored clinical trials. U.S. medtech companies such as DirectFlow, Synecor, Mitralign, MitraSpan, InterValve, Avinger, Medtronic, Amaranth Medical, and others did their EFS or FIH studies at AO with Dager as their principal investigator (PI).
Medtech clinical trial success cases in Latin America include:
- enVVeno (Nasdaq: NVNO) (formerly Hancock Jaffe Laboratories) has experience in Colombia. After consultation with the FDA and as a precursor to the U.S. pivotal trial, enVVeno conducted a small FIH study for the VenoValve, an FDA-designated Breakthrough Device – in Colombia, which included 11 subjects.18 enVVeno also conducted a FIH study in Paraguay with its CoreoGraft device. Adrian Ebner, MD, director of endovascular and cardiovascular surgery at the Italian Hospital in Asuncion, Paraguay, led the study as its PI.19
- Spine Stabilization Technologies, a medtech company with an FDA-designated Breakthrough Device, is conducting a post-marketing clinical follow-up (PMCF) study in six research centers in Colombia as required by the new EU MDR.
- Secretome Therapeutics, Inc. (formerly known as NeoProgen, Inc.), a U.S.-based pre-clinical stage company developing human neonatal heart-derived medicinal signaling cells (nMSCs) and an exosome-based product for tissue repair and regeneration for the treatment of heart failure and other inflammatory diseases, has informed the author of this article of its intention to conduct an FIH study in Colombia.
- Other U.S. medtech companies have successfully started OUS EFS and FIHs clinical trials in Colombia. These include PAVmed Inc. (Nasdaq: PAVM);20 ReGelTec, Inc., with an FDA-designated Breakthrough Device;21 Avantec Vascular, with two studies with two different devices;22 Cook Medical; SpectraWAVE, Inc.; Nectero Medical, Inc.; Amaranth Medical, Inc.; InnoVein, Inc.; and others. Other companies like 3ive Labs, LLC, Contraline, Inc., and Rapid Nexus, Inc. are currently evaluating research sites in Colombia.
- Vascudyne, Inc., a Minnesota company developing, manufacturing, and commercializing regenerative acellular in-vitro grown “allograft” tissue, announced in 2021 the successful first-in-human use of its TRUE vascular graft in end-stage renal disease patients requiring hemodialysis access. Dr. Adrian Ebner was the PI.23 Vascudyne recently informed the author of this article about its plans to start another EFS in Panama this year.
- NuVera Medical announced in 2020 the initiation of the company’s FIH clinical trial to evaluate the performance of its NuVision intracardiac echocardiography (ICE) catheter. Dr. Adrian Ebner was the PI.24
- Artio Medical announced in 2021 that it successfully completed the FIH use of its Amplifi vein dilation system in Paraguay. Dr. Adrian Ebner was the PI.25
- Urotronic, Inc. announced in 2022 that it successfully completed the FIH of its Optilume drug-coated balloon (DCB) in men with recurrent urethral strictures in Panama.26
The Hotspots For Medtech Clinical Trials In Latin America
The clinical trial industry in Colombia expects to reach close to $120 million in foreign clinical research funding inflow and to treat over 20,000 subjects.27 Experts agreed that Colombia could benefit from over 100 new clinical trials every year, with close to $500 million in economic gains per year.28 Several studies have found that Colombia's level of education, physician-patient relationships, adherence to trial protocols, and patients’ enrollment and interest in the research are all perceived as high.28 Colombia’s regulatory agency, INVIMA, recently announced to the research community in Colombia that it is working on updating the medical device clinical trial framework to make the approval process more efficient and to align it with its 10-year plan to become a knowledge-based society29 and OECD best practices recommendations for international clinical research.30
According to Clinicaltrials.gov, in 2020, Chile welcomed 62 clinical trials; this represents about about $19 million in pharmaceutical clinical research investments.31,32 Although Chile, with about 19 million people (84.4% in urban areas), appears to be an attractive country for medical device EFSs, it has a three- to four-month EC review and approval timeline (and a very complex list of requirements). Chile lacks a mandatory medical device regulation. Check out my recent article on the regulatory framework for medical devices in Chile. Chile's clinical trial regulations have not been updated since Law 20120 from 2006.33 Chile lacks a clear regulatory pathway for the approval of medical device clinical trials. Only a select list of hospitals in Chile have an accredited institutional EC, limiting the site selection process to only those hospitals. The hospitals with an accredited EC are primarily public and academic university hospitals, making setting up a clinical trial in Chile overly bureaucratic and complex, and not aligned with the speed and predictability that a medtech startup wants to see.
Panama updated its clinical trial regulations in 2019 (Law 84 of May 14, 2019) and received 16 clinical trials and about $3.9 million in pharmaceutical clinical research investments.32 Panama has about 4 million people (68% in urban areas).34 The country has a three- to four-month central EC review process and has 11 accredited ECs.35 However, Panama may be too small to ensure fast recruitment. It only has five private hospitals in Panama City,36 with little medical device clinical research experience since the country is mainly known for vaccine trials. Panama is mainly underdeveloped outside Panama City, limiting subject recruitment and the site selection process for a medical device EFS or FIH study to just the five hospitals in Panama City, with about 1.8 million people.
Paraguay is a South American country with about 7 million people – about 525,000 live in the capital, Asunción. Paraguay has the lowest urbanization rate in South America – 61.6% compared to an average of 84.6% for the countries in the region.37 The Paraguayan population suffers from endemic rheumatic heart disease likely correlated to the country’s high poverty rate. Within the last 15 years, Paraguay has become a popular medical device OUS EFS destination, especially for cardiovascular medical technologies. Adrian Ebner, an internationally renowned cardiovascular surgeon trained in France, stands out as the pioneer of medtech clinical research in Paraguay. Ebner has been involved in more than 70 first-in-human studies for products that have gone on to receive CE marks, FDA approvals, or that have been acquired by large medical device companies.19 According to local experts, the timeline for a study approved in Paraguay is three to four months, but the time can be shortened to as little as one week with the right government contacts. Since Resolution 614 of December 2016, the Ministry of Health in Paraguay has put in place a robust regulatory framework for the approval of clinical studies.38 Paraguay was once classified among the six most corrupt countries globally and the second most corrupt in the Western Hemisphere. Observers maintain that corruption in Paraguay remains a significant impediment to the emergence of more vital democratic institutions and sustainable economic development in the country.39 There are industry concerns about corruption in Paraguay's clinical trial regulatory approval process and light oversight of good clinical practices (GCPs). Medtech companies that want to have clinical studies above reproach have limited interest in conducting clinical trials in Paraguay.
Will The FDA Accept Foreign Clinical Trial Data?
The FDA accepts foreign clinical data from OUS studies if the following conditions are met: 1. The sponsor conducted the study following GCPs; and 2. The FDA can validate the data from the study through an on-site inspection.40
The medtech company sponsoring a study shall submit to the FDA a description of actions taken to ensure that the research conforms to GCP – defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that assures that the data and the reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. The supporting documentation must include:
- Qualifications of the investigator(s)
- Description of the research facilities
- Summary of the protocol, results of the study, and case records (in case FDA requests it)
- Description and details of the investigational medical devices used
- Information that shows that the study is adequate and well-controlled
- Name and address for the institutional research EC and a summary of the EC’s decisions
- A description of how the sponsor obtained informed consent from the subjects, what incentives, if any, the sponsor provided to the subjects in the study, how the sponsor monitored the study, and how the investigator(s) were trained to comply with GCP guidelines.40
How To Start Your OUS Journey In Latin America
Clinical trials require extensive planning. OUS medical device trials, particularly in emerging markets, add a new layer of complexity because of the unique challenges of distance, logistics, regulatory approval, and cultural differences. The success of an OUS medical device EFS hinges on choosing the right CRO, site, and PI to meet the study goals.
It is critical that a medical device trial sponsor works with its CRO to find a PI who is genuinely interested in the trial, provides feedback on the device's design, and has the right background and experience. It’s critical for a clinical trial sponsor to have people on the ground who live and breathe the local customs and can communicate effectively across geographical and cultural boundaries to resolve issues.
A U.S. medical device company should select a medtech-focused CRO with a local presence in Latin America and experience with development-stage medical technologies, not just pharmaceuticals, since the skills, the trial process, and requirements are vastly different. There’s a big difference between planning and conducting a trial where the investigational drug has been almost finalized compared with an EFS or FIH medtech trial with fewer patients and much greater risk. The CRO, the investigators, and the research site must be flexible to work with experimental early-stage medical devices.
Every country has its pros and cons for conducting clinical research, and all regions may not be perfect destinations for clinical trials. Thus, it becomes crucial to identify and evaluate the best country to match your trial needs. This evaluation process can be achieved essentially by performing efficient country-level feasibility. Here are the top seven key areas to explore to execute country-level clinical trial feasibility successfully:
- Subject recruitment potential
- Regulatory and ethical approval processes and timelines
- Sites’ capabilities, qualified staff, and resource availability
- Regulatory benefits and incentives
- Confirmation of data acceptance
- Overall project costs
- Details on clinical trial shipment and connectivity.41
Development-stage U.S. medtech startups struggle to find highly talented medical staff who will give them the focus and energy to gather quality and ethical clinical data at a competitive cost. The global distribution of clinical trials is shifting to emerging (low-income and middle-income) nations.42 With the help of local experts, U.S. medtech companies should do country-level clinical trial feasibility before deciding on an EFS or FIH location. These EFSs or FIHs usually include a limited number of subjects treated with a device, which may be in its early development stage before the design has been finalized. U.S. medtech startups cannot afford delays in the development of their innovations and should explore Latin America for ethical, quality, and lower-cost clinical research. Colombia is looking to attract more clinical research foreign investment and has an ambitious 10-year plan to become a knowledge economy based on science, technology, and innovation. Many U.S. medtech startups are considering Colombia for their EFSs or FIH studies. Colombia and Paraguay have become the hottest countries in Latin America for EFS and FIH studies. Several U.S. medtech companies with FDA Breakthrough Device designations are conducting their EFS or FIH studies in Colombia.
- Market Data. Medical Device Network. [Online] April 12, 2022. [Cited: April 26, 2022.] https://www.medicaldevice-network.com/marketdata/new-medical-device-clinical-trials-q1-2022/.
- Medical Device Contract Research Organization Market Size Worth $12.1 Billion By 2028: Grand View Research, Inc. PR Newswire. [Online] January 12, 2022. [Cited: April 26, 2022.] https://www.prnewswire.com/news-releases/medical-device-contract-research-organization-market-size-worth-12-1-billion-by-2028-grand-view-research-inc-301459237.html.
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- SelectUSA. Events. [Online] [Cited: April 29, 2022.] https://selectusa.github.io/events/industry-snapshots/medical-device-industry-united-states.html.
- Blueprint for Early Feasibility Study Success: A report of the Early Feasibility Study working group of the Medical Device Innovation Consortium (MDIC). Medical Device Innovation Consortium. [Online] September 2016. [Cited: April 29, 2022.] https://mdic.org/wp-content/uploads/2018/12/MDIC-EFS-Blueprint-for-EFS-Success-2016.pdf.
- FDAAA 801 and the Final Rule. ClinicalTrials.gov. [Online] January 2022. [Cited: May 1, 2022.] https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered.
- Early Feasibility Studies (EFS) Program. U.S. Food & Drug Administration (FDA). [Online] May 5, 2022. [Cited: May 10, 2022.] https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program#:~:text=An%20early%20feasibility%20study%20(EFS,may%20guide%20device%20modification
- Early Feasibility Studies. Medical Device Innovation Consortium. [Online] [Cited: April 28, 2022.] https://mdic.org/program/early-feasibility-studies-efs/.
- FDA Regulatory Process. U.S. Food & Drug Administration (FDA). [Online] [Cited: May 10, 2022.] https://www.fda.gov/media/90419/download.
- Antidote Technologies, Inc. 10 clinical trial recruitment strategies that work. Antidote Technologies, Inc. [Online] [Cited: May 7, 2022.] https://www.antidote.me/blog/10-clinical-trial-recruitment-strategies-that-work.
- Study Abroad: Tips for Successful Clinical Trials Outside of the United States. MD+DI. [Online] December 11, 2012. [Cited: April 29, 2022.] https://www.mddionline.com/news/study-abroad-tips-successful-clinical-trials-outside-united-states.
- Novotny, Mark. Chief Executive Officer, Spine Stabilization Technologies, Ltd. June 12, 2022.
- Supporting LAC countries in their reform efforts . The Organisation for Economic Co-operation and Development (OECD). [Online] [Cited: June 10, 2022.] https://www.oecd.org/latin-america/countries/#:~:text=The%20OECD%20has%20never%20been,with%20Argentina%2C%20Brazil%20and%20Peru..
- OECD. OECD urges countries to harmonise clinical trial regulations to boost medical research and save lives. OECD. [Online] February 25, 2013. [Cited: May 7, 2022.] https://www.oecd.org/sti/oecdcountriestoharmoniseclinicaltrialregulationsboostmedicalresearchandsavelives.htm.
- Doubly disadvantaged: on the recruitment of diverse subjects for clinical trials in Latin America, Tapuya. Pinto, Manuela Fernández. 1, s.l. : Taylor & Francis Online, Latin American Science, Technology and Society, Vol. 2, pp. 391-407.
- ClinicalTrials.gov. [Online] [Cited: 6 17, 2022.] https://clinicaltrials.gov/ct2/results/map?cond=&term=device&sfpd_s=01%2F01%2F2018&sfpd_e=12%2F31%2F2018&cntry=&state=&city=&dist=&Search=Search&type=Intr&fund=2.
- UM Surgeons and Cardiologists Play Major Role in Colombian Symposium. University of Miami, Miller School of Medicine. [Online] June 12, 2017. [Cited: June 10, 2022.] https://physician-news.umiamihealth.org/um-surgeons-and-cardiologists-play-major-role-in-colombian-symposium/.
- enVVeno SEC Filings. enVVeno. [Online] March 3, 2022. [Cited: April 29, 2022.] https://envveno.com/sec-filings/.
- Hancock Jaffe Announces Plans for CoreoGraft First-in-Human Study. enVVeno. [Online] May 12, 2020. [Cited: June 11, 2022.] https://envveno.com/hancock-jaffe-announces-plans-for-coreograft-first-in-human-study/.
- PAVmed Announces Successful First-in-Human Implantations of its PortIO™ Intraosseous Infusion System. PAVmed. [Online] March 17, 2022. [Cited: April 29, 2022.] https://ir.pavmed.com/news-events/press-releases/detail/193/pavmed-announces-successful-first-in-human-implantations-of.
- ReGelTec Successfully Treats First Eleven Chronic Low Back Pain Patients with HYDRAFIL™. BusinessWire. [Online] October 14, 2020. [Cited: April 29, 2022.] https://www.businesswire.com/news/home/20201014005342/en/ReGelTec-Successfully-Treats-First-Eleven-Chronic-Low-Back-Pain-Patients-with-HYDRAFIL%E2%84%A2.
- News. bioaccess™. [Online] [Cited: April 30, 2022.] https://www.bioaccessla.com/news.
- Vascudyne Announces Successful First Human Use of TRUE Vascular Graft for Hemodialysis Access. NewsDirect. [Online] July 1, 2021. [Cited: June 11, 2022.] https://newsdirect.com/news/vascudyne-announces-successful-first-human-use-of-true-vascular-graft-for-hemodialysis-access-352264410.
- NuVera announces successful first-in-human use of NuVision ICE catheter. Cardiac Rythm News. [Online] July 6, 2020. [Cited: June 11, 2022.] https://cardiacrhythmnews.com/nuvera-announces-successful-first-in-human-use-of-nuvision-ice-catheter/.
- Artio Medical announces successful first human use of the Amplifi vein dilation system. VascularNews. [Online] January 28, 2021. [Cited: June 11, 2022.] https://vascularnews.com/artio-medical-announces-successful-first-human-use-of-the-amplifi-vein-dilation-system/.
- A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. Virasoro R, DeLong JM, Estrella RE, Pichardo M, Rodriguez Lay R, Espino G, Elliott SP. s.l. : Dovepress, 2022, Vol. 14, pp. 177—183.
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About The Author:
Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He serves as an advisory board member for Stetson University's Leading Disruptive Innovation program. He has a bachelor's degree in electronics engineering and a master's degree in business administration.