Prior to this lecture, I don’t believe I really put any thought into this topic. To say I’m an engineer, it makes sense that I was unfamiliar with just about all of the corporation types, and what exactly each one…   Read more»

In short, there really is not a correct answer to this question. Although of course an influence, the type of corporation chosen will not determine if a business is going to be successful or not. Many more factors, other than…   Read more»

It is true that the initial cost of investment with a partnership will be split between the partners; however, I would not consider this a lower risk for a few different reasons. First, just as you are splitting the cost…   Read more»

As I am still new in industry, I have yet to meet someone who believes Quality is a burden; but from the perspective of a Supplier Quality Engineering Intern, if I ever do meet someone who believes this, I would…   Read more»

A Form 483 is given by the FDA when a company fails to comply with the practices set in place by their own Quality Management System (QMS) or the FDA’s standard regulations. I believe the analogy of receiving a speeding…   Read more»

I do agree there is a game being played between physicians and drug companies- you go to the doctor, tell them what’s wrong, they prescribe you some pills and you hopefully feel better soon. Well, if that weren’t the case,…   Read more»

Accuracy is defined as how well a value agrees with the a standard measurement of comparison. In regard to medical devices, accuracy can mean a few things. First, the accuracy that the product proves to be effective in its intended…   Read more»

There are many challenges that go into the creation of a medical device, whether that it be novel or a predicate device. During the pre-market lifecycle of the product, the physician must go about defining exactly what kind of medical…   Read more»

During this MDD course is the first I was made aware of what the FDA’s mission statement is. I actually giggled out loud at the second portion which claims they are “advancing the public health by helping to speed innovations…   Read more»

I would like to respond to this question by respectfully challenging the initial hypothesis of academic research creating results for future generations, and industry for now. In a sense, I believe this to be true. Although there is the perspective…   Read more»

To answer the first question posed regarding if projects in industry are successful- well, yes. In fact, many times in industry, a company’s success is based off the success of their projects. Projects are obviously focused on the objective at…   Read more»

I unfortunately do not believe there is a current alternative that can produce results as reliable and meaningful than on living animal subjects when testing for safety and efficacy of a product on living human subjects. Recent technological advancements have…   Read more»

I also do not have much experience within the industry and am only speaking from an academia perspective in terms of project management, however, I believe there are a few commonly overlooked attributes in identifying a good project manager. The…   Read more»

I have not had the opportunity to work on a project where there were multiple project managers, although depending on the size of the project, I do think this method could be more efficient in some cases. Having multiple project…   Read more»

While working on my Capstone Design Project with a team of six, it was very difficult to find time outside of class for everyone to meet. The focus of our project was to prototype a functional near-infrared spectroscopy (f-NIRS) cap…   Read more»

Good topic- I feel like this is a common struggle, especially coming out of undergrad. I believe a BS is the minimum requirement to obtain any sort of industry or academia job in BME. An MS/ME provides benefits of a…   Read more»

BME is definitely a broad degree and depending on where the education is from, can be taught in many different ways- such as theory vs practical. One of the main reasons I decided to pursue my Masters in Biomedical Engineering…   Read more»

I am also new in my career as a Biomedical Engineer and find myself struggling over the decision to pursue a career in academia vs industry. I resonated with the conclusion stated by kak33 to become a Research Engineer because…   Read more»