The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
Unified communication systems can improve staff efficiency, while enhancing patient outcomes and staff and patient safety.
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
As surgeries become increasingly complex and involve more sophisticated technology, the mental and physical demands on surgeons and their teams are expected to increase. As an industry, we need to thoughtfully consider how each piece of technology introduced into operating rooms will impact existing surgical workflow and workloads.
Imagine a patient undergoing therapy being relaxed and enjoying the treatment, or receiving rewards for taking medicine religiously and on time. Creating a game-like experience can change patient perception of medical devices from boring or scary to engaging and attractive. This article covers ways to integrate gaming features into your medical devices, why games are so enticing and how they impact human behavior.
The chronic, progressive presentation of COPD, symptom overlap, and nature of patient self-reporting make it hard to identify exacerbations. We need more specific guidelines around, as well as tools for, assessing a patient’s progression from day to day. AI-supported diagnostic systems represent a potential breakthrough technology that could help us overcome significant knowledge gaps.
By deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.
Under the leadership of Jeff Thompson, MD, Gundersen Health System reduced its greenhouse gases by 95% and was nationally recognized for higher quality care and lower costs. Here Dr. Thompson and Urvashi Bhatnagar, DPT, MBA, author of The Sustainability Scorecard: How Firms can Implement and Profit from Unexpected Solutions, share the strategies and organizational mindset needed to advance sustainability in health care.
