For me personally, I think of a yoga mat. It is intended “for maintaining or encouraging a general state of health or a healthy activity”. It is intended for only general wellness and is low risk. A yoga matt would fall into category (1). It is not intended for a specific disease but can be used for lower back pain, mental therapy through…[Read more]

For me personally, I think of a yoga matt. It is intended “for maintaining or encouraging a general state of health or a healthy activity”. It is intended for only general wellness and is low risk. A yoga matt would fall into category (1). It is not intended for a specific disease but can be used for lower back pain, mental therapy through…[Read more]

As a project manager, I believe the ideal team would be comprised of someone who is a technical expert, an expert on the regulatory processes of the industry, and someone who is an expert on the jargon and contacts in the industry. As the project manager, I would bring everyone together but each one of these skills would be vital to the team.…[Read more]

As a project manager, I believe the ideal team would be comprised of someone who is a technical expert, an expert on the regulatory processes of the industry, and someone who is an expert on the jargon and contacts in the industry. As the project manager, I would bring everyone together but each one of these skills would be vital to the team.…[Read more]

While working at General Dynamics Electric Boat on submarines, I took part in most of the design controls outlined in lecture and my experience was fairly similar to what was outlined in class except my company could benefit from some design controls we don’t have (no DHF). For the most part, I think it is similar across industries and very nec…[Read more]

 
I think initiating a project is the hardest part because this is where you have to provide enough  justification about something for management to approve it without actually having lots of details. Usually when you justify something, its because you have lots of data to back it up and you know its feasible. This is where you have to pitch so…[Read more]

I believe it would be under the CBER because it would be tissue (I’m assuming an artificially grown organ would be nearly identical to our actual organs). Tissue and blood would be under CBER. I believe the process of approval would be IND, (Phase 1,2,3) or Pivotal Trials, BLA as outlined in lecture.

If the organ is under the CDRH, one might…[Read more]

I believe it would be under the CBER because it would be tissue (I’m assuming an artificially grown organ would be nearly identical to our actual organs). Tissue would be under CBER. I believe the process of approval would be IND, (Phase 1,2,3) or Pivotal Trials, BLA as outlined in lecture. One might even go as far to call it a combination product…[Read more]

In my opinion, design validation is the first quality control parameter of a product that ensures that a product not only satisfies all the previously outlined requirements, but also the regulations of the industry. For example, when designing a project you might come up with unique requirements that are outside of the realm of what is currently…[Read more]

In my opinion, design validation is the first quality control parameter of a product that ensures that a product not only satisfies all the previously outlined requirements, but also the regulations of the industry. For example, when designing a project you might come up with unique requirements that are outside of the realm of what is currently…[Read more]

If I apply this question to submarine technologies, I believe the answer changes from what is already outlined. In this situation, security is important at all stages and influences how you do all stages. At any of these stages, foreign nations can compromise or gain sensitive information which would be catastrophic. Security would make it a lot…[Read more]

My experience while working at General Dynamics Electric Boat was it was mostly project based. Most of what the company does is to develop new products or system for submarines. The company has to stay competitive and submarine technology around the world changes fast. Every task lead or project manager has to manage a budget, schedule,…[Read more]

I think that project management in any industry can be broken down into the PDCA cycle outlined in lecture. For different projects, you might need to emphasize or concentrate on one part of the cycle more than another but that basic outline can be followed to output a quality product. The main difference would of course be the background knowledge…[Read more]

For 4-5 years before starting my PhD, I worked at General Dynamics Electric Boat. The company designs and builds submarines. I have worked in the field on submarines overseeing work done by the navy as well as on the design side managing projects in the office setting. I took several project management classes at my company through Stevens…[Read more]