Thought Leadership

The role of digital technology in medical devices has received a lot of attention in recent years – and raised a lot of questions. Where do consumer products end and medical devices begin? What are the potential privacy implications? How will the regulations governing these products evolve? The Food and Drug Administration (FDA) recently made […]

Cumin spice. Sunflower seeds. Pathogen contamination. Undeclared allergens. Recalls that originate with suppliers can involve many different causes and virtually any ingredient. This creates a “multiplier effect.” Like dominoes, a single supplier issue can bring down dozens of companies and hundreds of brands. Food companies should approach this problem in two ways: Take steps to […]

When a recall occurs, the Consumer Product Safety Commission (CPSC) typically requires that social media notifications be included in corrective action plans, so it is crucial for companies to have a plan for communicating the recall in this manner. But companies should not focus solely on a post-recall social strategy. Too often, by the time […]

A medical device recall that affects only the provider and physician level sounds like it should be a simpler process than one that impacts the patient level. But these recalls can still involve serious pitfalls, especially when it comes to data – specifically, outdated data.   While a brick-and-mortar hospital doesn’t change sites often, smaller […]

Many pharmaceutical recalls are routine. As demonstrated by the most recent Recall Index, they rarely involve the most serious Class I designation. But even when they aren’t high risk, they may be highly sensitive. That’s because pharmaceuticals treat conditions that may not be life-threatening but are critically important – even emotional – to the patients […]