To build off what you said, the venture supervisor can be a surprising huge motivator. To know that someone believes in what you can do so much to put forth a lump sum to create a product greatly validates your…   Read more»

What motivates me is the fact that one day I know the work I put it in will have a meaningful impact on someone else. I may never meet that person, know that person, or perhaps even like that person,…   Read more»

For my project, the smart-cast, integration was the toughest challenge to overcome! Simply put, our project had several components from both a hardware and software perspective. It’s very easy to get one sensor working to give an output signal on…   Read more»

In order to see if a vendor will meet our requirements, we actually did significant research on the vendor itself and looked to see if they actually made products to ISO standards, ASTM standards, so on and so forth. We…   Read more»

During the initial design phase of our capstone project, we laid out what we wanted to accomplish in the limited amount of time we had. Our scope at the beginning was actually too large so we cut it down before…   Read more»

A combination device is a device with multiple components that serve different purposes. Typically for a combination device, it is reviewed by the department in the FDA based on its primary mode of action. Sometimes the primary mode of action…   Read more»

The FDA is a regulatory institution and therefore can do some serious damage to your company/employees if the audit uncovers irregularities that weren’t accounted for. I don’t have any examples personally, but the story the person above me sounds exactly…   Read more»

For our capstone project, we have to write code for sensor components in the design. It was my responsibility as well as another team member to take care of the code. At first, we would constantly talk to each other…   Read more»

I can relate to this quite a bit. Project estimations are very difficult when third-party vendors are involved. During my capstone project, we purchased a strain gauge that ended up being too small for our application. We didn’t know until…   Read more»

1. Be prepared for issues regarding third party components: Suppliers have the potential to ship late, ship faulty components, or even not ship the components to you at all. You have to be prepared for all scenarios 2. Time management:…   Read more»

Missing milestones is not so bad if you either have the foresight to anticipate issues or if you have well-developed contingency plans. Missing milestones become an issue when something unexpected happens that you weren’t prepared for. For example, say you’re…   Read more»

The biggest thing from this course that I’ve learned is knowledge about the regulations and the bureaucracy involved with creating a medical device. During my undergraduate coursework, I never really went into detail about such regulations and what it actually…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   Read more»