Health Product vs. Drug: Fundamental Differences in Clinical Studies

The healthcare sector is undergoing profound transformations, driven by technological advances and the rapid expansion of the global medical device market. In this context, understanding the differences between clinical studies involving health products and pharmaceutical drugs is essential for professionals, companies, and researchers.

During a recent thematic panel at CRMeeting 2025, Dr. Camille Rodrigues — a pulmonologist, master in health sciences at Unifesp, with extensive experience in the pharmaceutical industry and clinical research — presented a clear and objective analysis of this topic, which we summarize below.

Growth of the Medical Device Market

The global medical device market is expanding rapidly and has already established itself as one of the most dynamic segments of the healthcare industry. With estimated revenues of US$ 640 billion in 2024 and projections reaching US$ 1 trillion by 2034, the sector is expected to represent, in just over a decade, nearly half of the global pharmaceutical market.

This growth is driven by technological advances — such as artificial intelligence applications, new biomaterials, and digital solutions — which demand not only engineering innovation but also new methodological approaches to clinical research.

In Latin America, participation remains small — only 4% of the global market — but with strong growth potential, especially with the rise of innovative startups emerging alongside major international players.

Conceptual Differences: Drugs vs. Medical Devices

Although both require scientific evidence for approval and undergo clinical and nonclinical evaluations, they differ structurally:

• Drugs: Biological mechanisms of action, grounded in pharmacology. Clinical studies focus on efficacy, safety, and quality.

• Medical devices: Physical mechanisms of action, often rooted in mechanical or electrical engineering or biomaterials. Clinical studies prioritize quality, safety, and performance.

  
  

Additionally, device life cycles are significantly shorter — on average, 18 months — due to the fast pace of incremental innovation. In contrast, drugs may remain on the market for decades.

Regulatory Framework

In Brazil, Anvisa classifies medical devices into four risk categories, with increasingly strict requirements for scientific evidence and regulatory approval:

• Class I (low risk): e.g., simple dressings, tongue depressors

• Class II (moderate risk): e.g., rapid diagnostic kits, syringes, catheters

• Class III (high risk): e.g., intraocular lenses, heart valves, orthopedic implants

• Class IV (maximum risk): e.g., cardiac valves of animal origin, absorbable implants with collagen or hyaluronic acid

  
  

For Class I and II devices, ethical approval alone is usually sufficient for clinical studies. Class III and IV devices, however, require a robust clinical dossier, prior regulatory submission, and formal authorization from Anvisa.

Clinical Development Specificities

The clinical development of devices includes technical aspects that do not apply directly to drug development:

• Mechanical reliability: resistance of prostheses and implants to physical stress

• Durability: expected lifespan of valves, pacemakers, and prostheses

• Electrical safety: for equipment using external energy, often requiring Inmetro certification

• Usability: assessment of the learning curve of clinicians, healthcare professionals, and even patients for proper device use

  
  

From a methodological perspective, device clinical trials do not follow the traditional phase model (I–IV) used for drugs. They often rely on adaptive designs, performance studies, and comparative evaluations with established products.

Limitations and Challenges

Common challenges in device-related clinical research include:

• Scarcity of high-quality publications, limiting robust meta-analyses

• Heterogeneity of clinical outcomes, with no standardized measures in several areas

• Smaller sample sizes compared to drug trials

• Limited follow-up, due to shorter innovation cycles

• Learning curve associated with device-related procedures, which can directly affect outcomes

• Regulatory complexity in combination products (e.g., insulin pumps integrating drugs and devices)

Clinical Outcomes: Beyond the Gold Standard

Dr. Rodrigues highlighted the importance of selecting appropriate clinical outcomes. In medical devices, traditional metrics (such as physiological parameters) are not enough. It is necessary to consider:

• Quality of life and patient perception

• Functional outcomes related to daily life impact

• Economic and cost-effectiveness assessments, which are essential for technology adoption decisions in healthcare systems

Final Considerations

Clinical research involving medical devices is rapidly evolving and presents unique methodological and regulatory challenges. The exponential growth of this sector creates opportunities for researchers, clinical centers, and companies, but demands scientific rigor, regulatory understanding, and a focus on meaningful clinical outcomes.

More than demonstrating safety and technical performance, device studies must reflect real benefits for patients and sustainable value for healthcare systems.

👉 This article is based on the lecture by Dr. Camille Rodrigues, a specialist in clinical research and Medical Affairs, presented at an industry event on health innovation.