The specifications should always have bounds, and if there is a bound for the coefficient of friction, then it is because that is what is desirable for the specific function. For example, sometimes you wouldn’t want there to be that little amount of friction in a product. However some bounds you can theoretically say would just make the product…[Read more]

This year my capstone project suffered from scope creep because we did not have a defined end product. We essentially would complete the main project task, and if we had time then we would start discussing other tasks that could be done. However since our expectations were mainly for the one project, we did not plan in any time to attempt the…[Read more]

As stated above, a poorly structured WBS can have multiple undesirable consequences. Such an example would be many delays because sometimes you do not expect a problem to occur until you are actually doing the task and run into the problem itself. Then each problem must be resolved, and some times this simple issue may need many meetings and…[Read more]

Our capstone team also created a gant chart, and in the beginning it was a lot of guessing on how much time we thought each task would take. We tried to be as accurate as possible by asking the person who would complete the task how much time they thought it would take them. However since the gant chart does not take vacations, spring break, and…[Read more]

This year my senior capstone project focuses on the attachment between a polyethylene component and tibial implant used in total ankle replacements. There is currently two piece total ankle replacements on the market, so our device would be classified as class 2. However this is still a lot of testing for our team to complete in capstone to show…[Read more]

As Dr. Simon said in his lecture, “Metrics are calculations that let you measure things,” during the monitoring and controlling phase. Metrics are needed in order to show variances (difference between the baseline and what you have) in order to keep the project under control, measure success, and evaluate the project.

I agree with krp67 that communication and status meetings are a great start to design transfers. I also believe that organization of all files if very important, making it as easy as possible for the new team to find individual files, etc. All documents must be updated and organized in a fashion that is easy to follow to save the new team as much…[Read more]

This semester during my capstone project we had not anticipated a few delays, and learned a couple lessons. As a team we added additional tests to validate our design, but did not sit down and discuss all possible risks. During testing, one of our 3D pieces that we printed as an attachment to a force sensor kept breaking under the required load to…[Read more]

Sometimes the planning phase consists of a lot of guessing, as stated above. I have experienced this at my internship over the summer and one of the engineers had overlapping tasks and projects within the main project. This was a large amount of responsibility and he had to plan his days weekly according to importance and project priority. During…[Read more]

In my company the design reviews were pretty standard as discussed numerous times above. However the only point I would like to add that hasn’t been discussed is that I believe typing all of the changes during these meetings is the most efficient way. Some companies, or in capstone we are reviewing all of the documents before class and the scribe…[Read more]

One medical device of my particular interest would be total knee replacements. One specific risk of knee replacements is loosening due to wear and tear over the years. Worst case scenario the implant would have to be removed, and a secondary replacement system will have to be implanted after resecting even more bone. Companies manage this risk by…[Read more]

In industry there are many times where an extraneous task suddenly turns into the critical path for a project. I had experienced this while working at Stryker on surgical cut guides that were 3D printed out of grade 5 Titanium. It was not observed until after the design freeze during a cadaver lab that the cut guides created a lot of debris while…[Read more]

Preventative maintenance is very important in projects, which is why there is a huge emphasis on risk analysis. I see your point that task scheduling can create risk as well since each task can ultimately severely delay the project. Some project planning softwares include features that incorporate employee’s 8 hour work days, vacations, and other…[Read more]

I agree with the two posts above about Gant Charts, as they are very useful in the Medical Device Industry. However there are some downfalls included, such as the time estimates being inaccurate due to the guessing nature of the chart. The chart also does not account for personal obligations by the team, as there may be delays due to schedules,…[Read more]

I agree and like all of the above examples of verification and validation for different projects. Over the summer I worked on patient specific cut guides used for total ankle replacements. Just by the name, you can tell that verification itself would not be sufficient, and there would be a substantial amount of validation. One aspect of…[Read more]

I worked for Stryker last summer as an R&D intern on the Foot & Ankle team, and it is a matrix organization. My team consisted of two engineers leading the design of the project, and we worked closely with many other departments, such as quality, testing, advanced operations, additive engineering, marketing, etc. Our project had at least one…[Read more]

The verification and validation process can be very lengthy, especially because of all of the detail that is required. I wouldn’t necessarily say that there are risks within the V&V process itself, but potentially because of the amount of time it takes. For example, if a test failed, or if the engineers cannot figure out how to perform the…[Read more]