Healthcare
Many countries face the reality of demographic aging: Fertility is plummeting and people are living longer. This raises critical challenges for the labor market, healthcare, and long-term care markets, as well as retirement systems and financial planning. A Wharton symposium on the implications…
Health systems across the country are unknowingly paying multiple times for the same medical equipment—once to own it, and again to rent it. The issue isn’t always an increase in clinical demand; it’s often availability and visibility to medical device inventory. The cost of these unnecessary…
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and…
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
…
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled…
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.…
