To me, risk/benefit ratio for a company mainly comes down to money. For any company that wants to create a high quality product, cutting corners should be kept to a minimum. However, there are certain specifications that can be made that will have the benefit of keeping costs down. One example would be designing a device that is only meant to…[Read more]

I would say that even if the product itself is okay, something such as missing information on a label can still force a recall. If, for example, a drug label is missing an ingredient and a patient taking that drug has is allergic to said ingredient, this poses a series health issue. The example of the label falling off is much less extreme…[Read more]

The company should absolutely go for the project and here’s why: Grants are not solely limited to academic institutions and non-profit companies. A for-profit company also has the ability to apply for grants. Large, well established companies may not need to take this route of funding a project but this is perfect for small start-up companies.…[Read more]

One of the biggest disadvantages to a project team is that the people within the team can cause a poor culture to form within the group. More importantly, as stated in the notes, projects run well after the team adjusts. The better everyone within the group gets along, the quicker progress can be made on the project. This can be due to a…[Read more]

On top of evaluating market appeal for a certain product, I believe one of the most important parts of the project proposal is the implications it can have on regulations. Obviously the more complex the design, the more time and money that are required to go into the project. But having an idea of what classification the device will receive is…[Read more]

Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar products, the difference in material really makes these two separate products. The different materials will react differently with whatever the…[Read more]

I believe that the FDA should regulate electroacupuncture. I think traditional acupuncture would be hard to regulate but with this new advancement I would argue that addition of electrodes can qualify this as a medical device. Comparing this to something like ultrasound therapy, the FDA is not involved with ensuring the qualification of the…[Read more]

I think the definition for a project and the experiences you have listed actually complement one another. What I mean by this is that in the beginning a project created with the criteria listed as having a defined beginning and end along with other related goals. Having a project placed on hold does not interfere with this definition. What was…[Read more]

I think we can all agree that all those responsible for a project, ranging from the upper management all the way down to “lowest level” employee needs to be on the same page requiring transparency and harmonization as previously mentioned. But this point does not actually address whether or not the hierarchy mentioned is in the correct order. In…[Read more]