Patient-centricity is a buzzword in life sciences, part of a push for innovation made difficult by complex regulations and long-standing corporate cultures that favor the status quo.

Compare this to the tech industry, which is constantly developing new, high-quality products that surprise and delight customers. Companies like Apple, Google and Amazon, all of whom have pushed the limit and redefined what it means to be a thought leader.

What can medical device manufacturers learn from these tech giants? Let’s look at 4 of the most important lessons companies can use to improve quality and move confidently into the next era of innovation.

A major misconception about Quality 4.0 is that it is meant to completely replace your current quality management practices.

When I was a kid, I loved reading Highlights magazine. It always had really solid knock-knock jokes there, as well as informative articles and fun craft projects.

The number of warning letters handed out by the U.S. Food and Drug Administration (FDA) has been on a steady rise over the past several years. In fact, the agency handed out more than 100 warning letters in 2016 alone, often after missed opportunities to correct mistakes pointed out in Form 483 observation reports.

Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.

At the same time, data is also a key enabler of operational excellence, helping businesses make sense of the vast quantities of information generated in today’s manufacturing environments. All told, a full 85% of companies aim to be data-driven, yet little more than a third of them are successful.

Today, we’re looking at four ways companies can better leverage data for operational excellence, looking at elements like predictive capabilities, supplier quality management and measuring effectiveness.

The Resource Conservation and Recovery Act (RCRA) is the main U.S. law governing hazardous and non-hazardous solid waste management. The U.S. Environmental Protection Agency (EPA) is responsible for enforcing the law, handing out $200 billion in criminal fines in 2016 over RCRA and other violations.

The problem for manufacturers is that, despite many companies’ hopes of a more relaxed regulatory environment, the potential EPA penalties are more costly than ever. In this post, we’re looking at some of the most common RCRA pitfalls, including how to avoid errors in waste determinations, labeling and storage.

Nearly 3 in 4 Environmental, Health and Safety (EHS) professionals say their department is understaffed. Whether due to underfunding of EHS priorities or the current skills shortage, it’s a problem that many safety professionals must grapple with.

At the same time, adoption of EHS Software is growing, presenting new opportunities for improving efficiency of EHS processes.

With these facts in mind, let’s take a look at 7 ways you could be using your EHS Software more effectively to get better results.

Gartner recently released a report as guidance for organizations to build more efficient manufacturing process while keeping up with initiatives like Industry 4.0.

The five-stage maturity model for manufacturing excellence will help manufacturers assess current capabilities, make a plan for change and support the development of future manufacturing operations with the supply chain.

Previously, we discussed a basic overview of the five maturity stages that Gartner outlined. Now, we’ll be looking at the dimensions used to define those stages.

The five dimensions of maturity are a good to mature and transform manufacturing processes, with the end goal of developing smart manufacturing as per Industry 4.0.

Here’s a little bit more about each one:

Where do you start if you need to create a comprehensive employee safety program from scratch? What can you do if your company is struggling with high rates of injuries and illnesses?

These and other questions can be difficult to answer, particularly for companies in high-risk industries or without much in-house Environmental, Health and Safety (EHS) expertise.

What many organizations don’t realize is that the U.S. Occupational Safety and Health Administration (OHSA) offers a broad array of completely free resources to help improve safety. Today we’re looking at nine of them, from basic best practices to personalized guidance to resources designed specifically for small businesses.

The clock is ticking: in less than a year—February 28, 2019—previous ISO 13485:2003 certificates will no longer be valid. And if you plan to participate in the Medical Device Single Audit Program (MDSAP), that deadline is even earlier, as you’ll need to make the switch by the first of the year.

If you feel like you’re behind schedule, taking concrete action can help eliminate some of the stress. Let’s look at 5 practical steps you can focus on right now to make sure you’re ready ahead of the deadline.