I agree that risk avoidance is the most ideal path to manage risk, followed by mitigation. If you make a device so it can’t cause harm, then your are eve protected from improper use.    [quote data-userid=”22596″ data-postid=”18764″] How is…   Read more»

  There are definitely some pro’s and con’s…   Read more»

[quote data-userid=”55586″ data-postid=”24606″] It is common for the manufacturers of medical devices to upgrade their products after they are already developed and released. Each alteration, however, can create new dangers, as well as add to the costs of development and…   Read more»

Labelling should absolutely be taken seriously for medical devices. As much as they inform what is inside the packaging, they can also indicate notable hazards, who should/shouldn’t use the product, and other information that increases the likelihood of successful usage…   Read more»

[quote data-userid=”55511″ data-postid=”24587″] During capstone this semester, we had to create user needs as well for our project. One issue and feedback that we got was making our user needs measurable. We would put needs like “easy to operate by…   Read more»

[quote data-userid=”1481″ data-postid=”434″] In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex,…   Read more»

[quote data-userid=”17937″ data-postid=”13282″] In lecture, it was mentioned that the two terms are different from each other. Validation is when we are comparing our products to the customers’ needs while verification is comparing the physical properties of the product to…   Read more»

As mentioned in prior comments, meeting minutes direct functional importance can be minimized by meeting summaries, gannt charts/schedules, and other deliverables that can render many aspects of the meeting minutes redundant. Additionally, the taking and reviewing of detailed minutes can…   Read more»

As mentioned in prior comments, meeting minutes direct functional importance can be minimized by meeting summaries, gannt charts/schedules, and other deliverables that can render many aspects of the meeting minutes redundant. Additionally, the taking and reviewing of detailed minutes can…   Read more»

Placebo effects certainly can have an impact on clinical data, and is why clinical studies should be intentionally designed to minimize its impact where possible. As discussed in class, this can often be remedied using placebo-controlled, randomized, and/or blinded prospective…   Read more»

I think that there is a line of how a patient should be compensated for a clinical trial. From one perspective, patients are exposing themselves to increased risk, potentially incurring additional medical expenses and time commitments, missed work and wages,…   Read more»

I do not think AI should be used as a replacement for Clinical Trials, nor any virtual medium. While AI and technology is growing in capability, anything it could produce would just be a model that does not represent, but…   Read more»

I would argue that effective sales persuasion crosses the line into manipulation once the strategy stops considering they best interests of the customer. Of course the salesperson always has the goal of closing as many deals as possible. However, since…   Read more»

I think that physicians should be able…   Read more»

The way a company sells, brands,…   Read more»

Personally, I believe that privately owned companies (with the exception of those acquired by private-equity) are the most likely to stay aligned with their initial vision and goal for the company. While a goal for every for-profit business is to…   Read more»

…   Read more»

I agree there are many tradeoffs made when deciding whether to outsource aspects of a business or complete them in house. These decisions are situation specific, so it is difficult to say one way is better than the other. Some…   Read more»

[quote data-userid=”24139″ data-postid=”22176″] Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Control executes the rules, measures results, and…   Read more»