First-in-Human (FIH) medical device studies are initial clinical investigations in humans, crucial for evaluating safety and preliminary performance. They are required when non-clinical data supports potential safety and benefit, paving the way for further clinical development.
A First-in-Human (FIH) study, also known as an early feasibility study, is the initial clinical investigation of a novel medical device in human subjects. The primary objective of an FIH clinical trial is to evaluate the device's safety, identify potential risks, and gather preliminary data on its performance in a limited patient population. These studies are foundational for demonstrating the device's safety profile before progressing to larger pivotal trials.
FIH studies are typically small, carefully controlled, and conducted in specialized clinical centers with extensive experience in device implantation and patient management. The data collected from an FIH study directly informs subsequent clinical development stages, including future study designs and risk mitigation strategies.
An FIH study is required when a medical device is entirely novel, represents a significant modification to an existing device with new indications or a completely new patient population, or when non-clinical testing (bench and animal studies) indicates sufficient safety to warrant human investigation but further human data is needed before proceeding to larger trials. The decision to proceed with an FIH study is based on a comprehensive assessment of preclinical data, including robust engineering testing, biocompatibility evaluations, and animal studies, which collectively demonstrate a reasonable assurance of safety for initial human exposure.
Regulatory bodies like the FDA, INVIMA (Colombia), COFEPRIS (Mexico), and ANVISA (Brazil) require compelling preclinical evidence to support the initiation of an FIH study. This evidence must justify the potential benefits against the inherent risks of introducing a new device into humans.
Before initiating an FIH clinical trial, sponsors must meet stringent regulatory and scientific prerequisites to ensure patient safety and data integrity. These include:
ISO 14155 is the international standard governing good clinical practice (GCP) for medical device clinical investigations. Adherence to ISO 14155 ensures that studies are scientifically sound, ethically conducted, and that the rights, safety, and well-being of subjects are protected. Regulators worldwide, including the FDA, ICH, INVIMA, COFEPRIS, and ANVISA, recognize and often mandate compliance with ISO 14155 for medical device trials.
The FDA offers an Early Feasibility Study (EFS) pathway designed to facilitate the timely conduct of FIH studies for novel medical devices in the United States. The EFS program allows for early clinical investigation of devices that address unmet medical needs or offer significant technological advancements. This pathway often involves close collaboration with the FDA to optimize study design and accelerate regulatory review, potentially offering a faster route to market in the US for eligible devices.
Comprehensive non-clinical data is paramount for an FIH study submission. Key requirements include:
FIH studies typically involve a small sample size, often ranging from 5 to 15 subjects, though this can vary based on device complexity and risk. The primary goal is to gather sufficient safety data and preliminary performance indicators without exposing an unnecessarily large number of subjects to an unproven device. Statistical power is often not the main driver for sample size in FIH studies; rather, it is determining the number of subjects needed to adequately characterize safety risks and gather initial performance data.
Rigorous ethical review by an independent Ethics Committee (EC) or Institutional Review Board (IRB) is mandatory for all FIH studies. The EC/IRB scrutinizes the study protocol to ensure:
Latin America has emerged as a preferred region for conducting FIH medical device clinical trials due to several compelling advantages for sponsors. bioaccess® has successfully conducted studies for 50+ clients across 10 countries with 200+ PIs.
| Advantage | Latin America (e.g., Colombia, Mexico, Brazil) | US/EU |
|---|---|---|
| Study Start-up Time | 40% faster (e.g., 6-8 week FIH start) | Significantly longer (months to a year or more) |
| Per-Patient Cost | 30% lower | Higher |
| Patient Recruitment | Access to large, diverse, treatment-naïve populations | Increasingly challenging, higher competition |
| Regulatory Environment | Clear, harmonized, and efficient pathways (INVIMA, COFEPRUN, ANVISA) | Complex, varied across nations/states |
| Quality of Care | High-quality medical infrastructure, experienced PIs | High-quality, but higher operational costs |
Bioaccess® leverages its extensive network and deep understanding of regional regulations in countries like Colombia (INVIMA), Mexico (COFEPRIS), and Brazil (ANVISA) to expedite the entire clinical trial process. Our proven track record demonstrates a 40% faster study start-up time compared to US/EU trials, with specific FIH studies initiated in 6-8 weeks. Furthermore, sponsors benefit from a 30% lower per-patient cost without compromising data quality or patient safety. The region offers access to large, diverse, and often treatment-naïve patient populations, which can significantly accelerate recruitment for FIH studies. These efficiencies, combined with a robust medical infrastructure and experienced principal investigators (PIs), make Latin America an excellent strategic choice for the timely and cost-effective execution of FIH medical device studies.
A First-in-Human (FIH) medical device study is the initial clinical investigation of a novel medical device in human subjects. Its primary purpose is to assess the device's safety, identify potential risks, and gather preliminary performance data in a small, carefully selected patient population. These studies are critical for establishing a basic safety profile before the device can advance to larger clinical trials and ultimately, market approval. They are performed after extensive non-clinical testing has demonstrated a reasonable assurance of safety.
In Latin America, particularly with experienced CROs like bioaccess®, the typical start-up time for an FIH medical device study is significantly faster than in the US or EU. We consistently achieve a 40% faster start-up time, often initiating FIH studies within 6-8 weeks from contract signature to first patient in. This accelerated timeline is attributed to streamlined regulatory processes with agencies like INVIMA, COFEPRIS, and ANVISA, combined with efficient site selection and contract negotiation processes enabled by our extensive local network.
Latin America offers several compelling advantages for FIH medical device studies. Key reasons include a 40% faster study start-up time, often within 6-8 weeks, and a 30% lower per-patient cost compared to US/EU trials. The region provides access to large, diverse, and often treatment-naïve patient populations, which accelerates recruitment. Additionally, countries like Colombia, Mexico, and Brazil have robust regulatory frameworks (INVIMA, COFEPRIS, ANVISA) and high-quality medical infrastructure with experienced Principal Investigators (PIs), ensuring high-quality data and ethical conduct.
Yes, ISO 14155 is critically important for First-in-Human (FIH) medical device studies. This international standard provides the framework for Good Clinical Practice (GCP) for medical device clinical investigations, ensuring that studies are designed, conducted, recorded, and reported ethically and scientifically. Adherence to ISO 14155 is a mandatory requirement by regulatory bodies such as the FDA, INVIMA, COFEPRIS, and ANVISA, to protect the rights, safety, and well-being of human subjects and to ensure the credibility of the study data.
Before an FIH study, sponsors must present comprehensive non-clinical data. This includes demonstrating a quality management system compliant with ISO 13485, thorough biocompatibility testing (ISO 10993 series), and validated sterility and shelf-life data for sterile devices. Furthermore, extensive bench testing verifying the device's performance and safety, along with relevant animal study data for invasive devices, are essential to justify the device's safety for initial human exposure to regulatory authorities like INVIMA, COFEPRIS, and ANVISA.
The sample size for an FIH study is significantly smaller than for a pivotal trial. FIH studies typically involve a very limited number of subjects, often ranging from 5 to 15, depending on the device's complexity and risk profile. In contrast, pivotal trials, designed for statistical significance and market approval, can enroll hundreds or even thousands of patients. The smaller FIH sample size is sufficient to identify primary safety risks and gather preliminary performance data without exposing a large population to an unproven device, making it a crucial de-risking step.