08/14/2026 | Saúde Digital News

https://saudedigitalnews.com.br/14/08/2026/inteligencia-artificial-acelera-o-desenvolvimento-de-dispositivos-medicos-e-ja-integra-a-rotina-de-78-dos-medicos-brasileiros/ 

Technology is also reshaping research and development processes

While much of the debate regarding artificial intelligence in healthcare focuses on patient care, an equally significant transformation is taking place behind the scenes of innovation. Today, algorithms play a role in medical device development from the initial research stages, helping researchers design, simulate, test, and refine technologies even before the first prototypes are built. They can also anticipate risks, reduce development steps, and accelerate processes that previously relied exclusively on laboratory or clinical testing.

This transformation is already engaging regulatory bodies. In 2025, the U.S. Food and Drug Administration (FDA) published a draft guideline titled *Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations*. This was the first comprehensive guideline addressing the full development lifecycle of AI-enabled medical devices.

The publication outlines recommendations for the development, documentation, validation, and monitoring of these technologies throughout their entire lifecycle—from model conception to post-market surveillance—reflecting a new approach to evaluating devices capable of continuous evolution.

In Brazil, the Federal Council of Medicine published Resolution No. 2,454 in February 2026. This resolution regulates the use of artificial intelligence in medicine and establishes standards for AI-supported medical practices, aiming to foster technological development and the efficiency of medical services in a safe, transparent, and ethical manner. Advances in research are proceeding in parallel with the growing adoption of AI by healthcare professionals. This is according to the study "Overview of AI Use in Healthcare: Physician and Patient Perspectives," conducted by the Afya Research & Innovation Center in partnership with the Conexa Research Center, which surveyed 551 physicians and 511 patients.

78% of Brazilian physicians already use artificial intelligence in clinical practice, primarily for drug research, clinical decision support, and staying up to date with scientific developments.

From research to patient: AI accelerates innovation even before the first prototype

Long before the final product is reached, artificial intelligence is already part of engineering and applied research. Computational models analyze vast amounts of data, simulate thousands of scenarios in just a few hours, and allow for the virtual testing of different configurations prior to manufacturing the first prototypes. This expands teams' analytical capabilities, reduces development stages, and steers experimental studies toward the most promising alternatives.

According to Prof. Dr. Luciana Almeida-Lopes—a researcher, president of the Nupen Foundation, and consultant for the DMC Group—this shift significantly expands research teams' capabilities. "Artificial intelligence does not replace scientific research or clinical studies. It accelerates extremely complex stages of development, allowing researchers to explore a far greater number of possibilities before the first prototype is even built."

From behind the scenes to clinical practice

The advances achieved during development are already beginning to be felt in clinical practice. In some cases, AI can assist in defining therapeutic parameters, reducing variability in equipment settings, and supporting clinical decision-making—always backed by scientific validation and professional oversight.

"Artificial intelligence can organize a massive volume of information and transform it into support for clinical practice." "The benefit lies in making complex processes more consistent and predictable, while preserving the professional's central role in determining the course of action," highlights Luciana.

Smart devices require a new regulatory logic

The incorporation of artificial intelligence also changes the logic behind medical device development. Unlike conventional technologies, AI-based systems can evolve over time, incorporating new evidence and improvements whenever technical validation and regulatory backing are in place.

This characteristic requires a shift in perspective for the industry and regulatory bodies, which must now monitor not only the device's initial approval but also its performance throughout its entire lifecycle. "The challenge isn't getting the algorithm to learn more. It’s ensuring that every evolution of the technology remains backed by scientific evidence and maintains the same safety standards expected of any medical device," the expert explains.

This shift helps explain the publication of the new FDA guideline, which expands the regulatory focus to cover the entire device lifecycle and reinforces aspects such as data quality, traceability, documentation, and continuous monitoring.

The future depends as much on solid evidence as it does on robust algorithms.

As artificial intelligence advances, the quality of the data used to develop these technologies becomes increasingly important. Representative and scientifically validated clinical datasets are crucial for reducing bias, enhancing algorithm reliability, and ensuring consistent device performance across diverse patient profiles.

This evolution mirrors a broader shift in the relationship between healthcare professionals and artificial intelligence. Trust in the technology grows when it serves as a support tool, while clinical judgment and decision-making responsibility remain in human hands. This is also the likely path for the next generation of medical devices, as Dr. Luciana points out.

"In medicine, every innovation must answer the same question: does it improve patient care? Artificial intelligence accelerates the journey to that answer, but it is ultimately science—underpinned by clinical evidence and regulatory validation—that determines which technologies are truly safe and effective," she concludes.