It’s definitely important to put aside emotions and relationships for the most part when deciding on a project team composition. It’s always better to pick someone who is good at their role in a project team rather than your relationship…   Read more»

My team is flying through the project. We started the first week by working on the DID and DDP so that the Gantt chart could be worked on in the second week, as well as the pre-clinical protocols, clinical protocol,…   Read more»

I believe on the bottle that the drugs come with there are instructions on how to take the drugs. If someone has an adverse effect with the drug, they would go to the hospital and get examined and through a…   Read more»

One instance I can see accepting risk being okay is with vaccines. Now I don’t align with anti-vax principles at all, but I am pretty sure there is a 1 in a million chance that there’s an adverse effect in…   Read more»

Risk management is a vital part of any company as it is the practice of protecting the company from anything that can damage its image or get it in legal trouble. In my life I have witnessed these practices in…   Read more»

As a MS student working in research right now, from my short experience, the IRB is in charge of reviewing all research protocols. Whatever test is being run in the lab, the IRB is the ruling factor in deciding if…   Read more»

The FDA does give some guides to how the test should be run but the general rule of thumb is to have a test for every claim that your product proposes will happen to the human using the medical device….   Read more»

Design controls were made so that companies have documentation for every step of their design process, and so that these documents can be reviewed to consistently find any design and technical errors. This saves companies from any flaws in their…   Read more»

Verification tells a company that the developed device meets the requirements for the product. This is done through tests and a lot of analysis, which are operations that cost companies money to perform. What makes it worth that money (besides…   Read more»

Design controls are required by the FDA pretty much to ensure the developed device is safe for public use. While the company has to spend resources to create design controls, it also structures the development process and gives the company…   Read more»

Design inputs can greatly affect the functionality of a device. Therefore, one of the greatest factors in design inputs are the device’s functions. The design inputs have to comply with the requirements of the device. For example, a computer mouse…   Read more»

It is very important to have consent from the patient. Today, not only in medicine but also in other fields, consent to use a users information is a must. When you sign up for Facebook, you’re consenting to Facebook using…   Read more»

PCTs are definitely ethical and necessary. The placebo effect is real so to ensure that it is not what is making the cause of a change in a person’s health due to a medical device or drug, it needs to…   Read more»

I think for the most part, everyone is in agreement that the Right to Try act is good thing; it gives people who are close to losing hope a chance to try something risky but potentially life saving, and as…   Read more»

A great advertisement that I saw was on Instagram for this phone game where you move a sphere through a track and you can only touch the color of the sphere, not any other color. 2 things about this ad…   Read more»

Marketing is just getting people to know about your product and the good things about it. For people in the market looking to buy a medical product, there are obviously ads that they will see through the internet or another…   Read more»

I don’t consider sales as manipulation. Salesmen try to be friendly to customers so that customers don’t dislike them. Why? Because if you were a customer, you wouldn’t want to buy anything from someone that you don’t like! Furthermore, you…   Read more»

My answer depends on what kind of company I would be starting, but I would generally lean towards an LLC like many other people would. If I wanted to quickly start making phone apps and selling them, I could make…   Read more»

LLPs die when one owner dies, so beyond the limited liability part, there aren’t so many benefits to an LLP. That’s why, as per mentioned above, LLP’s aren’t used very much. Furthermore, it’s less likely that a company fits the…   Read more»

I remember reading once that businesses that are partnerships perform better than sole-proprietorships because the partners push each other to do well. I think that when it comes down to it, a partnership is better but only if the two…   Read more»