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 provide more useful information since it allows engineers to measure how well a device…   Read more»

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. Even though the pump does meet the technical…   Read more»

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 device would meet its design requirements, perform…   Read more»

@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 requirements. It is important to understand that human error…   Read more»

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 anatomy, age, or medical conditions that can directly impact how…   Read more»

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. Adding to your perspective, in cases where a product…   Read more»

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 clinical research. If a patient is…   Read more»

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 is also essential. For instance, if a clinical…   Read more»

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 overall excellent to an AI simulation,…   Read more»

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 trained on one…   Read more»

@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 will always influence how they will view the medical device,…   Read more»

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 other priorities, such as costs, reimbursement, training requirements, compatibility with equipment, and…   Read more»

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 course of action is to look beyond the…   Read more»

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 early phase of a product, a company may just focus on…   Read more»

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 manufacturing processes, testing methods, or supplier specifications….   Read more»

One of the challenges with developing a unified quality system is not only deciding what the system will look like in its final stage but also deciding how the company will transition to the system. If there are two medical…   Read more»

Many companies focus more on quality control because it can create a familiar reactive dynamic where problems are fixed after they appear. If a company relied on inspection for a long time and has been able to catch most defects…   Read more»

In this case, the final decision should heavily depend on the level of risk involved instead of just choosing an AI system. If the AI flags a quality issue and a QA professional disagrees, then the disagreement is actually a…   Read more»

Choosing the product claim is important when viewing it with the means to the future of a product and company. A company’s launch claims can influence more than just the FDA submission. The decision can affect how a device is…   Read more»

@ahmed-elmonier The FDA should definitely consider the specific kinds of risks a potential new device can pose when deciding a new pathway. Certain risks can be easily detected and controlled compared to other risks. For instance, if there is a…   Read more»