In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a big focus, there are also other strategies like reducing risks and accepting them if necessary. One way…   Read more»

A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address device risks, HFE focuses on how users interact with devices to avoid mistakes that could harm…   Read more»

When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It involves doing a risk-benefit analysis, applying the ALARP principle (reducing risk as much as reasonably possible), and using…   Read more»

Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it down into clear sections that follow the product development process—like design inputs, outputs, verification,…   Read more»

Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issues and keep quality up. First, making sure the design, quality, and manufacturing teams communicate…   Read more»

Design Controls under FDA’s 21 CFR Part 820.30 are all about making sure medical devices are developed with safety, effectiveness, and compliance in mind. They help keep things organized and reduce the risk of errors, ensuring that the design meets…   Read more»

Great point! It makes sense that every design input should ideally have a corresponding output. Inputs set the foundation—they’re the requirements a device has to meet. In a perfect world, each input would lead to a specific output showing how…   Read more»

You bring up a great point about validation—it’s all about making sure processes can reliably produce a product that meets specific standards. Defining clear success criteria upfront is key; without it, goals can shift, which wastes time, resources, and can…   Read more»

You’ve nailed an important point about design controls—they’re all about making sure a medical device is safe and effective by following a structured process. By having these controls in place, manufacturers can catch potential issues early, which helps avoid expensive…   Read more»

One of the biggest challenges with multi-center clinical trials is keeping everyone on the same page. Since these trials are all about gathering a lot of data quickly, it’s super important to have clear expectations to ensure that all the…   Read more»

Interestingly, researchers have made it easier to find clinical trials nearby and figure out what to expect if you participate. Clinical trials are crucial in medical research because they help ensure that treatments are safe and effective before the FDA…   Read more»

Clinical trials are so important for ensuring we develop safe and effective treatments. One treatment that comes to mind is carotid artery stenting (CAS) for patients with narrowed arteries in their necks. This procedure helps reduce the risk of stroke…   Read more»

You’ve pointed out the connection between sales and marketing pretty well; they really do go hand in hand. Marketing does a solid job of drawing in customers through various channels like social media and email campaigns, which helps build brand…   Read more»

You bring up a great point about the need for long-term customer connections. One effective way businesses can boost customer retention is by creating personalized experiences. Customers who feel understood by a brand are much more likely to stick around….   Read more»

Absolutely! Closing a sale is just the start; the real challenge is keeping customers around for the long haul. Businesses can really up their game by providing personalized experiences, staying connected with custom messages, and creating loyalty programs that reward…   Read more»

You’ve got a good point about how corporate teams and research labs differ! In a corporate setting, having clear roles and hierarchies can really help with getting things done since everyone knows their responsibilities. But it can also stifle creativity…   Read more»

An extra business course could really help engineering students, especially those looking to get into project management, product development, or even starting their own businesses. While NJIT’s engineering management course covers the basics, having a deeper understanding of things like…   Read more»

Regulatory agencies like the FDA and EMA act more like government service organizations than typical businesses. Their main job is to make sure medical products are safe and effective, and they fund this work through a mix of government budgets…   Read more»

For Quality Assurance, two big things that come to mind are regulatory compliance and training. Sticking to regulations like ISO 13485 and FDA guidelines is a must in our industry. Using tools like document control software and compliance management systems…   Read more»

I don’t have much firsthand experience with root cause analysis (RCA), but I understand its importance in quality management, especially in the medical device industry where safety is a top priority. RCA is about analyzing to find the actual cause…   Read more»