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, but it gives me solace in the fact that I can make a difference with my own two hands and my one brain. The more I work and the more I learn, the…[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 a serial monitor, but taking that sensor data and displaying whilst datalogging it whilst checking to…[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 were lucky enough to get in contact from the vendor’s previous customers, and some of our team members were even previous…[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 we began development to only the essential customer needs. For example, our project was a smart cast that was designed to monitor the…[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 is unclear. In that scenario, you would file an RFD, request for designation, to the FDA. It would only be…[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 like something that could potentially happen during an fda audit. Everything must be logged…[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 to ask each other what the other did in the code. We would always need to understand what the other wrote because neither of us…[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 we tested it, and this was well into development of the project. Testing and validation protocols had to be…[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: Allocate time towards the most crucial aspects of design. This may seem obvious, but sometimes defining what is…[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 building a device that is supposed to interface with an ECG, and you procure parts for…[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 took to have a device on the market. Capstone taught me the design and prototype phase,…[Read more]