An important aspect of translating subjective user needs into measurable requirements is to actually understand the difference between quantitative data and attribute data. Quantitative data can provi...

There can be situations where a medical device could pass verification but fail validation, like an infusion pump that delivers medication at the correct flow rate but has a challenging user interface...

Safety and reliability should always be a priority when it comes to adding new features to a medical device in general. Before moving forward with production, engineers would have to evaluate if the d...

@ahmed-elmonier In cases where a medical device passes verification but fails validation, then the first step should be determining if the issue is the design itself, the process, or the original requ...

Laboratory testing is useful in identifying technical failures to an extent, but a notable drawback is how much patient variability can affect the device's performance. There can be differences in ana...

Packaging should be treated with similar importance as the device itself when it comes to evaluating patient safety because even a well-designed medical device can be unsafe if the packaging fails. Ad...

The way researchers respond to a patient's personal experience when it does not match the data collected during a study is also an essential element to consider when it comes to bringing trust in clin...

Adding to the significant elements in the systematic process of clinical research, I would add that the way researchers interpret results when it comes to patients drawing from a medical device trial ...

When it comes to a medical device, it is imperative to discuss the performance of the product, which heavily depends on the physician or surgeon utilizing the equipment. Even if a medical device is ov...

The decision is less about which company has the best product or best marketing and more about how difficult it would be for a hospital to switch to a new device. A hospital may already have staff tra...

@ahmed-elmonier Disclosure of finances is important, but I don't think it's enough by itself. Even if the surgeon is completely honest about the financial relationship with a company, the relationship...

Medical device companies should be aware that targeting physicians or patient needs does not automatically mean that the product will succeed commercially. Many hospitals and healthcare systems have o...

This topic is one of the most interesting conflicts I've seen with medical device companies. There is a balance of financial sustainability and also to improve patient outcomes. I think the best cours...

A medical device company can face events where it can entirely change its business structure when it begins transitioning from research & development to direct commercial manufacturing. In an earl...

An important factor to consider when deciding to outsource is also how it can affect their ability to respond to problems or to improve long-term. In medical devices a design change can impact manufac...