Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies have given me insight into the challenges of balancing time, cost, and scope. From what I’ve learned, scope is often the…   Read more»

When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting contracts, being super clear about what needs to be done and by when is key….   Read more»

Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should be handled—like managing deals and legal stuff—so the business keeps running smoothly. I’d…   Read more»

To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful approach. NDAs should be specific and focus on truly confidential details, avoiding overly broad terms that could get in the…   Read more»

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»