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 determining the severity and probability of failures. It also depends on…   Read more»

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 even after design controls cease. PMS is also a useful…   Read more»

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 situations. There’s only so much risk…   Read more»

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 to understand how one…   Read more»

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 prevent us from getting…   Read more»

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 via an Instron. For some of the tests, we…   Read more»

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 placebo is being used. Double-blind studies…   Read more»

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 not included in clinical trials to…   Read more»

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 intelligence, requires work and application in order to hone it…   Read more»

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 more sense to primarily sell to them….   Read more»

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 show ads or commercials if…   Read more»

Personally, I am not someone who is looking to start a big business, so I would most likely prefer a sole proprietorship if I’m thinking small-scale. However, if I was really looking to start one, I would definitely go into…   Read more»

Double taxation is definitely a huge disadvantage, but S-Corps can still be highly limited in terms of ownership. The more owners there are in a company means less risk to them, unless one of the owners is involved in fraudulent/shady…   Read more»

As I’ve said in a previous reply, Quality is a necessary delay. There needs to be a sort of “checks and balances” in a company during a project. While the engineers and researchers have the practical knowledge to act on…   Read more»

While I’m sure it is incredibly frustrating for R&D to be delayed by the Quality department’s need to follow and enforce compliance, it is a necessary delay. If a project moves forward at any point and the procedure(s) is not…   Read more»