Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry. Risk is a critical factor to consider throughout the life cycle of a medical device because it can mean the difference between life and death for patients.

Industry resources like ISO 14971 exist to help medical device professionals define and clarify risk management best practices. According to the internationally recognized standard for medical device risk management, risk is defined as “the combination of the probability of occurrence of harm and the severity of harm.”

There are varying levels of risk factors medical device companies must consider in practicing effective risk management. By following the established processes outlined in ISO 14971 and leveraging the best quality management tools, medical device companies can improve their overall risk management system.

In recent months, the widespread lockdowns of Covid-19 have exposed global supply chains to unprecedented shifts and volatility in consumer behavior, impacting innumerable organizations, industries, and consumer goods. While much of the supply-chain overhaul conversation has focused on drops in demand and disruptions in business across various consumer categories, delivering on sharply rising demands for medical equipment has been particularly challenging for companies in the healthcare manufacturing space.

Up against a supply chain landscape paralyzed by lockdowns and factory closures, personal protective equipment (PPE) necessary for combating the virus and protecting the lives and livelihoods of essential workers may be at critical risk for quality erosion as companies race to speed up production, according to inspection data from QIMA, a leading provider of supply chain compliance solutions. And with Covid-19 deepening supply-chain diversification activity—which was already happening prior to the pandemic thanks to the ongoing U.S.-China trade war—it is expected that global brands will face quality risks for some time to come across all consumer product categories.

The Covid-19 pandemic has revealed glaring deficiencies in the U.S. manufacturing sector’s ability to provide necessary products—especially amidst a crisis. It’s been five months since the nation declared a national emergency, yet shortages of test kit components, pharmaceuticals, personal protective equipment, and other critical medical supplies persist.

Globalization is at the heart of the problem. With heavy reliance on global supply chains and foreign producers, the pandemic has interrupted shipping of parts and materials to nearly 75 percent of U.S. companies.

The reality for small and medium-sized manufacturers (SMMs) is that they are going to have to be good at training their workforce or they won’t make as much money. That’s a blunt assessment, but the need for proficiency in training will only increase, whether it’s retraining current employees for new products, processes, and equipment or getting new employees up to speed more quickly. Effective training should be able to drive down the time for training.