During my capstone project for the smart-cast, we’ve missed a couple milestones due to external factors. We also just a gantt chart to record our progress, and when we missed a milestone it would set us back considerably. Things like the 3d printer not working or components not shipping on time would contribute to missed milestones. However, I…[Read more]

I’m also currently working on my capstone project, and we also broke down the project into categories. We split up the project into hardware and software. The project is developing a smart-cast, a cast that can measure the degree of inflammation around the affected area and give a more accurate representation of the healing process. We further…[Read more]

Certain factors may include any of the following: Time, Budget, Contingency Plans, and any inspection dates.

For time, the PM needs to readjust the gantt chart in order to make up for lost time because of missing a milestone. He has to consider the importance of certain characteristics during development and allocate time to focus on those…[Read more]

You can begin the integration of six sigma with project planning with the development of a project life cycle. By doing this, you can add statistical knowledge of the problem, reduce the chance of an incorrect assessment of the issue and reduce the bias that influences perceptions about a particular problem.

Six sigma can also be used for…[Read more]

You can begin the integration of six sigma with project planning with the development of a project life cycle. By doing this, you can add statistical knowledge of the problem, reduce the chance of an incorrect assessment of the issue and reduce the bias that influences perceptions about a particular problem.

Six sigma can also be used for…[Read more]

Currently I’m working on my capstone project, and one of the tasks I thought to simple ended up becoming a part of the critical path. What I’m talking about is making components stay in place. For context, I’m designing a cast that will measure temperature and swelling in an affected area to help monitor how an individual is healing. One of the…[Read more]

A budget cut is something a pm and a whole project team should always be prepared for. It does affect the overall cost estimation of the project, but more than that, a budget cut can result from several issues outside of the project team’s control. It can be difficult to adapt, but a pm should react by taking the resources he/she has and start…[Read more]

I share your concerns with the idea of Trump removing efficacy as a critical step in the approval process. It was because of the need for better efficacy that we avoided the Thalidomide disaster in the United States. The potential for side-effects could be greater, but more importantly, overlooked if efficacy testing loses its place.

The…[Read more]

I agree that this should not be classified by the FDA because it does not pose significant risk to the user. The fitbit is an extracorporeal device that is non-invasive and it a general wellness product, like the individual above me has already said. I’d like to expand by also saying that there are other general wellness wearable smart devices…[Read more]

I’m actually using this biomedical device for my capstone project. It’s called the comfortprene wrist and thumb-wrap. It’s a general wellness product that would fall into the second category of the FDA’s definition of said general wellness products. The reason being is that this brace is ideal for dealing and aiding ailments such as wrist…[Read more]

The design controls that could potentially be visited do include DID, DDP, DSD, verification/validation protocols, risk analysis, and risk management. However, since this is a homeopathic product, the FDA has less oversight on it than say a injectable vaccine. A homeopathic product doesn’t get scrutinized in the same way by the FDA as other…[Read more]

From my experience, the initiation process can be divided into 4 phases for project management:

Objectives: The first phase involves creating an objective(s). This is where you determine what information you need about from the project so that they can justify the project. Objectives are essentially the outcomes businesses wish to obtain from…[Read more]

From my experience, the initiation process can be divided into 4 phases for project management:

Objectives: The first phase involves creating an objective(s). This is where you determine what information you need about from the project so that they can justify the project. Objectives are essentially the outcomes businesses wish to obtain from…[Read more]

I have an example I can share based on the definition you give. Take a smartphone for example, focusing mainly on the touch-screen interface. Validation processes would involve making sure that the pressure exerted on the display would translate from physical data as pressure to a change in some value (say, resistance) and the phone would be able…[Read more]

I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM:

-Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
-Serves as…[Read more]

I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM:

-Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
-Serves as…[Read more]

Going of la82’s post, I think the way the FDA defines the line between a device of significant and non-significant risk is blurry. I think this guideline especially raises a few concerns:

• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject”

It’s a blanket statement and quite vague in what con…[Read more]

I have not worked in industry before, nor do I have experience in any type of the organizations listed. If I were to go into industry, I would feel more gravitated towards a project-based organization. The structure of working in a group is really appealing to me because with so many different ideas will lead to curation, and curation will lead to…[Read more]