The factors that you listed are definitely considerable when assigning risk index numbers. Much of risk management involves estimation, so often using your best objective judgment is helpful for deter...

Post-market surveillance seems to be a great way at determining how well a product is received, further determining user needs and inputs. The process may even contribute towards design validation eve...

From what I've learned from the Human Factors team at my job, not many customers tend to read the instructions for use (IFU) and may even discard them which can lead to potentially dangerous situation...

Depending on how many device inputs there are, a team will need to draft and propose test methods for each of these inputs. Designing test methods may require looking at previous test methods for othe...

In this week's lecture, Dr. Simon discussed the various processes that go into design controls. For design verification, inputs must equal your outputs, and for design validation, inputs must equal th...

A Gantt chart is used quite often in project management to establish a trackable timeline over the course of a project. I've heard it mentioned in a couple ME courses, in this course, and most recentl...

Even if changes did not need to be made on the device after verification, it does not necessarily mean that users will particularly like using the device. It's always safe to run a human factors study...

Meeting minutes are great to help keep track of team members tasks. I remember working on a design project with three other students for one of my courses, and I often logged what was discussed to pre...

During my internship, I recently worked with a couple engineers in reevaluating test methods for a device they're currently developing. It's a mechanical-based device, so some of the tests are done vi...

In a single-blind study, the investigator knows what they are administering while the patient does not whereas in a double-blind study, both the investigator and the patient are unaware if a drug or a...

A great incentive to attract patients for clinical trials is often money. The informed consent form attached to this week's agenda has an excerpt discussing payment for each completed visit towards th...

I think it is important to tackle that question early on in clinical trials as opposed to after the vaccine rollout. We can't really know how the vaccine affects other certain individuals if they're n...

Emotional intelligence (EI) is one's ability to pick up on another's emotional state and adapt their own emotions in order to effectively communicate and "produce beneficial outcomes". EI, like any in...

The product is quite specific to dentistry, so I'd sooner reach out to specialized physicians as opposed to hospitals and retailers. Dentists will be the ones mostly using these tools, so it makes mor...

In this day and age of streaming sites instead of cable television, it can be quite difficult to have a consumer sit through a commercial. However, some streaming sites like Hulu or YouTube will still...