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A Publication for the Practicing Medical Specialist, Industry Executive & Investor

INDUSTRY EXPERT ARTICLES

Medical Device News Magazine features byline articles from medical device and biotechnology industry experts (KOLs). Our experts share their views including what the future holds for the medical device industry, how devices can improve patient outcomes, functionality and more.

Usability Testing and HFE/UE

Engineering Better Healthcare: The Vital Role of Usability Testing and HFE/UE in Medical Device Development | By Oliver Eikenberg

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.

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Success in Medical Device Manufacturing

Scaling with Demand: Requirements for Success in Medical Device Manufacturing | By Laura Beckwith, Director of Product Management, Configit

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.

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Coronary Arteries

Plaque Quantification In Coronary Arteries Is a ‘Game-changer’ | By Campbell Rogers, M.D., F.A.C.C., Executive Vice President & Chief Medical Officer, HeartFlow

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.

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