FMEAs are indeed a useful tool for evaluating the types of failures a system could experience if one (or several) of its components fail. This is espe...

I believe risk acceptance and its effect(s) are directly tied to the quality of the risk assessment itself, which also affects the form of a response ...

During my time as a co-op at GAF, I have witnessed a variety of hazards that had to be mitigated, mostly within the R&D labs. Each of the labs had...

@shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding livin...

Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct diffe...

Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to...

Design teams, from my experience, tend to prioritize the most realistic aspects of a design. The end goal is to meet the customer’s requirements, yes,...

Hi Jacob, you’ve provided a great definition of what makes an effective design input. There’s actually a mechanism that Dr. Simon discussed this week ...

Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. ...

Unlike a good portion of the responses here, I believe the placebo effect is a reliable way to keep patients and researchers from having implicit expe...

Patients participating in a study should generally be compensated in some form, including financially. This is dependent on several factors, namely th...

As I’ve worked closely with designers, manufacturers, and everyone in between during my short time in the industry, I’ve gained much understanding of ...

The ethical value of AI can be twofold. On one hand, it’s a powerful resource that will help researchers & even designers compile a large chunk of...

Patients should definitely have a say in the design of their products for companies. As they are the end users for the devices intended to solve or at...