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 especially true for medical devices, which include various components/subsystems that, when under the right…   Read more»

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 to the hazard. When risk assessment is conducted, there is an order of precedence…   Read more»

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 a variety of equipment with varying levels of risk. One…   Read more»

@shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding living documents, progress traceability & structure. I want to add my thoughts on using these methods. When…   Read more»

Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct difference between them enables specialized processes that cater to the target audience(s). Putting it together would unlikely be effective….   Read more»

Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve their market share. This is especially true when considering all…   Read more»

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, but at the same time, they cannot expect us to produce certain extraneous features that…   Read more»

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 in the lecture. To turn a qualitative design goal into a quantitative result, you need to…   Read more»

Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. This gives professionals the ability to keep tabs on a project’s progress through crucial milestones and data, especially during…   Read more»

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 expectations relating to the response to the given drug sample. It yields more accurate data…   Read more»

Patients participating in a study should generally be compensated in some form, including financially. This is dependent on several factors, namely the phase of the study and the severity of the preexisting condition(s) they have been selected for.   For…   Read more»

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 how a product should be developed based on market needs, statistical trends, and limitations. Thus, I’d likely…   Read more»

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 pertinent information in a shorter period of time than it would take with…   Read more»

Patients should definitely have a say in the design of their products for companies. As they are the end users for the products intended to solve or at least mitigate their ailment(s), they can discuss what they enjoy most about…   Read more»