I could not agree more. I had started interning in industry before taking any of Dr. Simon’s classes. I entered not knowing anything about the FDA, GDP or the design control process. Through my experience I learned what I could from the limited facet that I had interacted with. In taking Dr. Simon’s Medical Device Development course I was much…[Read more]

In my senior design course we created a Gantt chart early on and estimated all of the required steps in the critical path. One of which was the procurement of the prototype components. This was a major milestone as it would allow the construction of the prototype. However, due to ordering small quantities of components, components were often…[Read more]

You make a good point tn58. This will certainly affect the overall project and may require reallocation of time in the preliminary steps of the project schedule. Not only R&D, but other phases such as testing and verification will need to be altered. This could create a significant delay, but the reconsideration of what criteria the device has to…[Read more]

More often than not, certain tasks will take longer than estimated and push the project back. This is sometimes unavoidable as there may be many possible bottle necks and obstacles. These can include external suppliers and internal processes or approvals. This can be combated by building in extra time to the project schedule in these cases. And if…[Read more]

A budget cut certainly has an effect on cost estimation. I believe generally most projects hope to come under budget or plan ahead to have some wiggle room as more often than not, projects are more costly than expected. A budget cut is an additional hurdle that may have grave consequences on the project. This could mean as much as its shut down.…[Read more]

Shachi, you bring up a good point. However, though it may delay other processes it is essential to, at the very least, carry on project development with verification in mind. Even though the official verification step comes later during the execution phase, unofficial verification tests should be carried out i order to ensure the appropriate…[Read more]

I am also working on a capstone project where seemingly minor details have manifested into critical issues that impede the progress of the overall project. This is certainly something that has to be accounted for. One of these issues is contacting suppliers. We received the wrong part for one of our pinch valves and could not finish our…[Read more]

The validation and verification steps are extremely important and encompass the overall design control process. Verification ensures that the design outputs adhere to the requirements given in the design input and is constantly conducted until they do. Validation comes at the end of the process when the device or prototype is produced to ensure…[Read more]

You make a great point Shachi. A team with cross filed knowledge would definitely be advantageous. Often times ideas come from those with different perspectives. In companies where there is little variety, projects may not come to effective solutions. Temporary solutions are often arrived at, but constantly need adjustment. A diverse team can…[Read more]

Though there is usually more face to face communication in industry, a great deal gets done via email, phone calls or web chats. This is an essential part as projects can include individuals at other sites or suppliers. Not to mention international projects as some of our classmates have mentioned. Research is conducted similarly as in the…[Read more]