Introduction: What Are Human Factors Human Factors (HF), also known as ergonomics, is the scientific discipline concerned with understanding interactions among humans and other elements of a system. In healthcare, this translates to how patients, caregivers, and clinicians interact with medical devices, digital tools, and combination products. The goal is to design systems that…
Origins and Overview of the V-Diagram The V-diagram emerged as a response to the complexities inherent in developing large-scale, high-reliability systems. Originally adopted in industries such as aerospace, defense, and automotive engineering, the model has since found applications in various domains where system safety, reliability, and performance are paramount. At its core, the V-diagram is…
Released in June 2024, the FDA’s draft guidance on Essential Drug Delivery Outputs (EDDO) provides critical recommendations for industry stakeholders involved in the development, production, and marketing of drug delivery devices and combination products. This guidance aims to ensure that medical devices intended for drug delivery perform as expected, guaranteeing patient safety and product efficacy….
In the intricate space where drugs, devices, and biologics intersect, the resulting products are known as combination products. This segment of the medical device and pharmaceutical industry is thriving. However, the path to developing, manufacturing, and marketing these products is fraught with complex regulatory requirements and operational challenges that demand meticulous attention to detail. For…
Upon completion of the risk assessment, a comprehensive benefit-risk analysis is carried out. This vital step establishes the acceptability of product risk, carefully weighing the potential benefits against the identified risks. All of these critical measures culminate in the creation of a detailed risk management report, effectively summarizing the full range of risk management activities…
After determining the scope of the product risk management activities and documenting them in the Risk Management Plan, now the actual risk assessment can begin. In this article, we look at the various elements of what goes into a risk assessment for a product and how to determine the overall acceptability of the risks for…
When performing risk management activities for a medical device, those activities shall be planned according to the ISO 14971 risk management standard. The risk management process, if conforming to the standard, should include provisions for creating a Risk Management Plan to guide and govern the various steps involved in assessing the risk of the product….
by Charles Ventura, President Design Controls, do we really have to follow them? Design Control is a topic that medical device professionals seem to either love or hate. Many Engineers call Design Controls, “the paperwork” or “just the documentation”, and rarely seem to value them. The thought of having to create the Design Control documentation…
