It is quite dangerous to mix cost/benefit analysis in with risk analysis and it is not advised to do so. Here's an example of why: Changing the design is often the best way to mitigate risk, but it is...

Though risk management is a continuous process and must be done throughout the entirety of a product's lifecycle, I think it is undoubtedly most important in the early stages. Evaluating risk during t...

I don't think that accepting risk has any effect on the probability of harm. Logically, the only way to affect the probability of harm is to avoid or mitigate the risk, decreasing the probability of h...

Design teams prioritize customer feedback by analyzing it against the product’s intended use, market needs, and regulatory requirements. In cases where feedback is ambiguous or conflicting, teams can ...

I agree that it is possible to conduct validation and verification simultaneously in some cases, but that should not be the norm or the goal. It's best to keep verification and validation separate to ...

To define success criteria, a team should start by thoroughly understanding the device's intended use, regulatory requirements, and user needs. The team must collaborate with stakeholders to outline c...

I think it is very possible for teams to log additional design inputs beyond the basic requirements, especially when trying to anticipate factors impacting long-term performance, regulatory shifts, or...

When creating test methods and protocols, key factors include ensuring that the tests accurately simulate the device's real-world use, assessing risk to patient safety, regulatory compliance, and repe...

Design controls are critical to mitigating potential risks in product development. They guide the design process to make sure a medical device meets safety and performance requirements. By establishin...

Blinding is a very useful method for researchers to minimize the placebo effect in clinical trials. In single blinding, participants do not know whether they are receiving the active treatment or a pl...

I think having a standardized process in place to prepare for unexpected outcomes is always better than not having anything predefined. Without this, adverse outcomes could lead to confusion, blaming,...

If I was involved in a clinical trial, I'd like to work as the clinical research associate. This position speaks to me because it is very hands-on and involved in all the stages of a clinical trial. T...

Product Development focuses on the research and creation of new products, involving innovation, prototyping, and testing based on market needs. It requires collaboration among engineering, design, and...

I've seen the fifth "P" in marketing on streaming services. Sometimes, instead of showing just any ad, the viewer is given an option between two ads. The viewer is meant to choose the ad that is more ...

Though I'd much prefer to work in product development than sales or marketing, I can see the allure of transitioning to a sales or marketing position after working as an engineer. Once you know the in...