When it comes to meeting minutes, they are extremely important in the process of everything when it comes to the development of everything especially medical devices. The reason why they are important is because it the most vital time when…   Read more»

A contract manufacturer (CM) plays a vital role in process in which validation and the responsibilities with the executing of the validation plan. With the validating multiple pieces of equipment and establishing a preventative maintenance plan for it as well….   Read more»

I do believe that the four columns of input, specification, verification, and validation are always enough for a complete Design Matrix. I do feel how ever though that it would necessary to add a column to it of the way…   Read more»

Some of the consequences that may arise from the from faulty design controls is that the product can be more likely to fail and there is no fail safe options when it come to the fixing the broke product or…   Read more»

When it comes to the design controls be in place, I find that it will in fact lead to better results and help with innovation of the products as it places rules in place to limit the amount of risk…   Read more»

When it comes to looking at companies who that neglect necessary steps to for the design process and other QA and QC process, I don’t know of many that do cut the corners to get their products to get them…   Read more»

I think biomedical engineers play a much more active role in clinical research today than ever before. As technology and data analytics become essential to clinical trials, engineers are helping to bridge the gap between the technical and clinical sides….   Read more»

The placebo effect can present a significant challenges in accurately interpreting clinical trial data. When patients receiving a placebo demonstrate outcomes similar to those taking the drug in question, it becomes difficult to distinguish between true pharmacological efficacy and psychological…   Read more»

At first, I thought a single-blind study would be enough since the patient’s response is what really matters. But I realized that if the researcher knows who’s getting the actual drug, as it can unintentionally influence how they treat the…   Read more»

When it comes to the colors that should be used in branding to catch someones eyes, it should have a good mix of blue, red, white, and a tad bit of black to outline it. The reason for this is…   Read more»

A sole proprietorship is tied directly to one person aka the owner. So when that person wants to pass the business to someone else, it can’t just be simply handed over. The business would technically end when the owner steps…   Read more»

I would say that having general business class that engineers need to take can be very vital as everyone at one point will have to deal with some sort of topic in business throughout their career. By having this better…   Read more»

When it comes to getting a MBA, you don’t necessarily need one to start a company. A lot of the skills to run and start a business can be learned at any point and all the rules and regulations needed…   Read more»

When talking about the FDA, they have certain rules in place to reduce the amount poorly designed product to enter the market. Some of these devices can help to support life or keep someone alive, so since this is the…   Read more»

When it come to recalls after a device that has been placed on to the market, I think that most of the fault comes from the company itself as they could have changed as the product was placed onto the…   Read more»

Combination Product: Transdermal Patches with Nicotine, Nicotine patches.  This product creates for a release of nicotine through the skin barrier. This allows for the patient to get a delivery of nicotine straight through the skin for relief without of a…   Read more»

When is come to determining when too much detail in a projects plan, it come down to how much of the risk needs or wants to get mitigated and how much extra steps does the project actually need. If there…   Read more»

When talking about the most important skill that a project manager must have, has to be communication. The reason for this is that with communication is not only allows for the needs of the higher up for continuation of the…   Read more»

When talking about the most important people with a project, I would say that all of the people are equally important to a project to it self. As I saw it was mentioned above it is like a machine in…   Read more»

For the comparison of academia to industry, there are a lot of pros and cons to both of them as a whole. For academia so of the pros to it are that the hours are a little more flexible and…   Read more»