Engineering should be involved when designing the DID. The engineers will be able to give a more educated feasibility rating. Also, even though details are not needed as much in the DID as other aspects of the project it is still important to be able to provide enough information that it could be understood. A customer and a marketer might have a…[Read more]

When planning and executing any project it is almost normal to fall of schedule I believe. Even when developing a gantt chart there is a critical path and supplementary paths that allow time for slow downs or hiccups. When running my own capstone project, we saw hiccups that are very hard to account for like shipping and manufacturing times.…[Read more]

I do believe the label is just as much a part of your product as any other aspect. If a label falls off and a product is used incorrectly a company could be liable for leaving the consumer unaware of proper use. If this failure of use causes death or injury your company could fall to blame for not clearly labeling. When a product is not working…[Read more]

This is a very interesting topic that you have brought up ap962. The knowledge that as934 shared is very knew to me and is a very interesting concept to rad up on. It is good to see that there are steps in place to allow these smaller market shared health concerns still receive the treatment they need. It is alarming that these products do go…[Read more]

Having previously worked in the medical device industry I have seen the testing they do on products that have already been tested and approved and I can say it is very intensive. To see that products from other companies are being produced without significant testing is very disappointing. It is not surprising entirely because the FDA can go years…[Read more]

The risks in a failure during the verification and validation is missing details that will later become a large issue for the engineer or other department that is running the project. Also, not thinking to test an aspect of the product during the V&V can lead to failures in the distribution part of the product life cycle. Failures after…[Read more]

Quality will eventually be one of the largest resources a company has is its ability to be confident that the product is able to perform after distribution. The quality testing will also come under high scrutiny from the FDA. After Research and development has been completed and clinical trials are finished the quality procedures is what will…[Read more]

I believe that biggest importance with handling a project proposal is to pay strong attention to the details when making the proposal. When details or omitted or forgotten they can become a way larger issue later in the projects development. For a proposal to be productive it must be easily understood by who is reading it. When developing a…[Read more]

I believe when deciding the primary mode of action, you should see what is the main function and what is the secondary function. The primary function of the digital pill is to deliver the mental illness medication and the sensor is a secondary and meant to assist the drug delivery. I believe this falls under the CDER department in the FDA. A…[Read more]

The idea of transplanting a artificial human organ into another human is clearly a Class III procedure. This would definitely require a tremendous amount of testing and would be strictly regulated by the FDA. This testing would not only take a long time to complete but also would cost an exuberant amount of money. I believe the “Murderless m…[Read more]

The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt to monitor the wearers heart rate. It provides data from the day/wee/work out about where your heart rate was. The device does seem to fit the…[Read more]

The most important thing for me in a group aspect is the ability of the team to communicate and work together. A team that is less talented but able to work together well will normally surpass the team that is individually talented but in capable of working together. This whole project management ideal is be efficient and effective and this is…[Read more]

I believe that it is the schools responsibility to teach the technical aspects of the field. I think it is on the student to learn the outside business and social skills needed to succeed in business. Personally, I believe the campus offers a multitude of venues to practice your interpersonal skills. I became a retreat counselor for Albert Dorman…[Read more]

My project management skills are from the corporate standpoint and more from the individual projects I have taken on through my personal life. I have handed school projects well and often taken the leadership role for the projects. In my fraternity, I was my own pledge class president. This means I led my pledge class to the best of my ability to…[Read more]

@Julienneviuya I understand that the spouse does have a good deal of leverage but I have heard that this ca lead to some very uncomfortable situations. As a medical device sales person it is hard to maintain a friendship with someone in the medical field. Treating a friend to dinner that is a physician can be seen as an infraction and lead to…[Read more]

I think I would definitely prefer the matrix organization in every position except for the project manager position. I believe that it is difficult to lead a project when the functional managers are constantly pulling on your employees to do other work . The project can be easier to figure out when the team is fully focused on the project at hand.…[Read more]

When it comes to building a project team it is definitely necessary to focus on skills and not personal relationship. I do not believe that it is healthy from work and personal life to overlap too much so to avoid better friends with you and your team or amongst team members should be avoided. I think that obviously personal relationship does have…[Read more]

I believe that personally I would be more fit for the upper management aspect of the procedures. I can better work with multiple groups and be able to reason out a fair schedule for groups to follow. The middle management is definitely a great skill to have but I do not believe I would be as strong at this aspect. Staying focused on one project…[Read more]

One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment but it is never going to be a 100% perfect situation. A product that is failing at a very low rate and is not damaging or hurting patients does not…[Read more]

I was not aware that you have to pay to view the regulations. I am sure that it does help in the upkeep of the companies that are writing the regulations but I do think this favors innovations from current companies rather than a start up. A startup company facing a charge of a couple thousand dollars for instance is going to be hurting much more…[Read more]