I haven’t worked in industry but from the previous jobs that I’ve had there are many enterprise environmental factors and organizational process assets.
In terms of the culinary field, an example of an enterprise environmental factors include the pos system used for retail where orders are made and when workers can sign in and out. Another exa…[Read more]

The budget is an integral component of a project. Without financial support, the project will not be able to continue and resources cannot be procured. Budget cuts are very detrimental because during the cost estimation for a project, the best option within the available budget is chosen and because of the budget cut, changes must be made which…[Read more]

I think that there should always be quality testing throughout the project and not just at the end. Each component must be tested and inspected before they are assembled. This is important so that problems within the design can be easily identified and the problem can be pin-pointed without the dismantling the whole design. If there is something…[Read more]

I agree with everyone’s answers. However, I disagree that specific members are necessary to have a successful team. I think it’s more important to have specific qualities within team members.
Overall, I believe that people should have:
Management – members should be able to properly allocate resources such as time and money. Money would be lost…[Read more]

What about sports shoes? For running shoes, its intended use is for strenuous physical activities such as running. There are also basketball shoes which are intended for people who play basketball in order to promote better performance but also for ankle protection during playing. Since these physical activities are considered as exercise.…[Read more]

In any project, I believe that there are 5 stages that are necessary in starting the development of a project.
1. Finding the “market gap”: This is the first stage and this is when the idea is evaluated on whether it is valid to even begin the project. This stage is used to determine the required components of the project in order for it to bec…[Read more]

I agree with Roberto’s point. Every product has its own respective life cycle. However, durations of each phase will vary depending on the product. From your prompt, you mentioned sutures. Although the general concept of sutures have not changed, the method at which it is administered has greatly varied. Back then, they used ants as a way to s…[Read more]

Starting a project is the most difficult part of the project. There are numerous directions that can be taken when starting a project and there are a lot of times, for those lacking experience, that you don’t know where to start. There are so many variables that have to be factored in when starting the project. The inventor must keep in mind the r…[Read more]

I personally believe that there is very little difference between a clinical project manager and a project manager. A clinical project manager is a type of a project manager which seems to be more focused on the clinical trial aspect of a product. Both project managers must follow schedules, protocols, and must set up quality control models in…[Read more]

This is a good question where it brings up the issue where the definition for significant risk is relative. There may be varying perspectives in the proper definition of the term and this can cause an argument on the possible drawbacks of the device. However, despite the relativity in reality, the true perspective definition that controls the flow…[Read more]

The thalidomide disaster established a standard of how much testing must be performed before a product must be released. It builds integrity within the safety of the product, making sure that people are not negatively affected by the medicine. The Thalidomide disaster may have changed the course of the medical device regulation, however, there are…[Read more]

In my opinion, Design Validation (DV) refers to the assurance that a device falls within the requirements that are set forth in the beginning of the project. I believe that DV makes sure that the design of the product fulfills its intended purpose.
Before I comment on whether a product requires clinical trials, I want to first elaborate what…[Read more]

I believe that leadership skills are necessary to become a successful project manager.
Part of being a good leader is to be organized. His organization skills will ensure the smooth operation of the project and will account for the numerous different aspects that involve any project. Furthermore, it is important to note that project managers…[Read more]

Project managers, in my opinion, ensure the completion of a project or a product. They are the ones who are in charge of organizing the schedule and the logistics of a given project. Although, he/she may not be directly working on the project, he/she must be able to contribute to its development.
With that, I believe that to be a successful…[Read more]