Category:
INDUSTRY EXPERT ARTICLES
Medical Device News Magazine publishes feature articles from industry experts on medical device technology, regulation, reimbursement, and business strategy.
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.
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.
Optimizing Biopharma Workflows: Integrating AI to Enhance Research and Discovery | By Christian Olsen, Associate VP & Industry Principal for Biologics at Dotmatics
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.
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.
The Crossroads of a Revolution: Medical Device Design Meets Disruption | By Steve Levine, Senior Director, Virtual Human Modeling, Dassault Systèmes
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.
How Technology Is Driving Person-Enabled Brain Health, Fueling Better Outcomes and Options | By Mark Lehmkuhle, PhD, CEO, Founder of Epitel
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
Artificial Intelligence: Balancing Risks & Potential of a New Frontier in Health Care | By Brad Jobe, Chief Information Officer, TRIMEDX
Using artificial intelligence in clinical environments will change the cybersecurity landscape for health systems. Mr. Jobe explains how.
Enhancing Patient Safety with Hospital at Home Initiatives: Proactive Strategies for Fall Prevention | By Amy Hester, PhD, RN, BC, FAAN, chairwoman and CEO,...
Hester writes, "Patient safety is a fundamental priority in healthcare and fall prevention is a critical component in achieving this goal. Hospital at Home (HaH) initiatives, which bring hospital-level care to patients' homes, offer innovative solutions to improve patient safety, reduce costs and decrease unnecessary hospital stays."
The LM Scaffold System™ | An Evolution in Tracheobronchomalacia Treatment | By Richard Lazzaro, MD, Co-Founder of Lazzaro Medical and Southern Region Chief of...
Dr. Richard Lazzaro recognized that there was an opportunity to create a less invasive option to treat tracheobronchomalacia (TBM) and improve the quality of life for millions of patients; in 2013, he pioneered robotically assisted, minimally invasive tracheal repair (MITR™). He later co-founded Lazzaro Medical to develop the LM Scaffold System™ which is set to further improve the treatment of Tracheobronchomalacia (TBM) by offering a minimally invasive, robotically-assisted approach that also ensures precision, safety, and effectiveness. With the recent $2.4 million Direct to Phase II SBIR grant from the NIH, Lazzaro Medical is poised to evolve TBM treatment, providing patients with a solution that addresses the root cause of their symptoms and help improve patient outcomes.
