INDUSTRY EXPERT ARTICLES

Both HFE and UE are based on the international usability standards IEC 62366-1 and IEC 62366-2 with consideration of risk management (ISO 14971). By planning and integrating usability testing for human interaction with medical device technology throughout the device lifecycle and risk management processes, HFE/UE ensures that medical devices meet the complex needs of healthcare professionals and patients, and that user-related and use-related risks are eliminated or mitigated.

Our expert writes: Historically, medical device companies have provided value by producing equipment for diagnosing and treating patients worldwide. However, contemporary challenges such as heightened pricing pressures, regulatory compliance, supply chain volatility and operational inefficiencies have significantly changed the landscape for these companies.

The integration of AI in biopharma workflows is not just a technological advancement, but a paradigm shift that promises to completely revolutionize how we research, understand, and treat diseases. Read what this expert has to say.

Artificial intelligence provides a simpler and faster alternative and could be a potential game-changer for their heart patients. For example, HeartFlow’s AI-enabled Plaque Analysis tool leverages an automated, deep learning-based, non-invasive method for identifying, characterizing, and segmenting plaque throughout the coronary arteries. By offering a more comprehensive view, plaque analysis tools can improve diagnostic accuracy, enhance treatment planning, and help stratify risk.

Explore how the intersection of medical device design and disruptive technologies is reshaping the healthcare industry. Discover how new players armed with AI-driven devices and advanced manufacturing tools are pushing boundaries and revolutionizing the future of medical innovation. Steve Levine, Senior Director at Dassault Systèmes, shares insights on the next plateau of medical device design.

In brain health, traditional inpatient monitoring systems present a myriad of barriers. They often require travel to a specialized health center, are cumbersome and restrictive for patients, and technical requirements and limitations impede providers’ ability to even provide such services. Today, advancements are disrupting this model to fuel the growth of person-enabled health and the ongoing treatment of chronic neurological disorders and conditions