This semester I am in part 2 of my capstone project. We have all of our protocols written to begin construction and testing but we are missing one key component of the device. The materials got delivered about a month ago. Purchasing, the company, and the professor told us the order was there. In the meantime we could not start testing until our…[Read more]

I think one of the main issues lies in increased customer demands. When the design team first hands off the project to the manufacturing team, a certain plan is made based on the expected demand. Once the product becomes more popular and there is increased demand, rather than manufacturing just scaling up I think it may be important to include the…[Read more]

I agree with everything that is said above. In addition, I think there should be a re-evaluation step which happens once the project has started to make sure that the way everything was planned is working out and that nothing needs to be changed. For example, during re-evaluation it may bring to attention that there was too much work put on the…[Read more]

If a problem in the planning is identified mid-scope it should be reassessed with the entire team present, taking into account resources and timing. Pushing forward with flaws in the scope can cause bigger issues down the line. Using a Gantt chart or a similar planning mechanism, the critical path can be identified and certain tasks can be chosen…[Read more]

While I think all of the above are important, I think it is important to assess the situation. While a team member that is not good at communicating and keeping other team members up to date can certainly make a project more difficult, they may bring a unique skill or talent to the team that is not easily replaceable. In addition, if more than one…[Read more]

I am currently working on a capstone project. We won a $3000 URI grant to design and fabricate our device. This grant must be used only for this project. As a result, we based our entire budget around this $3000, not considering if we could potentially do it for less or if we need more since those were not options. As a result, we unfortunately…[Read more]

In my experience, at design review meetings, everyone attending the meeting reads the document beforehand. The meeting starts by everyone saying their initials one by one and how long it took them to review the document. The people who wrote the document attend the review but cannot make commentary unless asked by the group. A reader reads line by…[Read more]

I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a project is planned out, sometimes obstacles and setbacks are unforeseeable. However, when going back to the planning phase, it is still important to stay as on schedule as possible and to hit…[Read more]

While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthroughs and great medical products that can advance the company. If everything is over prioritized and analyzed, the company will be playing it too safe and limit creativity. Risk is needed to make new…[Read more]

In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and could result in people having issues with the company’s products. Not only is this against the company’s mission but it could also cost the company…[Read more]

I think an important thing to add to this discussion is how to adjust things when out of scope – whether it be due to budget or time. An example is in capstone, whenever something takes more time than our schedule planned for, putting us in the negative, we have to make a contingency plan on how we are going to fix it. How my team fixes this is by…[Read more]

I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with their devices to get it approved by the FDA, this most certainly is even harder in smaller companies. When a really good idea is brainstormed, even…[Read more]

Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceuticals go through more testing than medical devices. Does anyone have an opinion on this statement from their experience? Also, if you do believe this to be a true statement, why do you think that…[Read more]

From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked.

For example, Lenzer makes a point, “So the FDA has a database where doctors and hospitals can report deaths and serious adverse events, but they don’t…[Read more]

Through getting my bachelors degree at NJIT, I felt that my interpersonal skills have improved tremendously. Different experiences that improved my interpersonal skills included getting involved with clubs and organizations, being an the executive board of clubs and organizations, learning to work in teams in labs and engineering projects,…[Read more]

Of course emotional intelligence combined with technical knowledge are important qualities in a project manager, as well as all of the qualities people mentioned above.

To me, one of the greatest skills in a project manager are the ability to get to know and gauge all team members and how to best work with them and assign them projects to…[Read more]

Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it is not adequately planned, not only will the schedule have to be extended but the overall cost of doing validation and verification will increase.

A lot of this can be avoided by well thought out r…[Read more]

I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and time to re-test this device is not the responsibility of the company. I think a good example is that older knee implants were not intended for the life spans that people are living. As a result, some…[Read more]

In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it does monitor such as heart beat. On the other hand, there are a lot of different wearable devices being worked on currently such as a wearable blood pressure monitoring watch. Any of these…[Read more]

In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinical testing, even if a device is proven to be entirely safe, it still needs continuous monitoring. For example, a device may have only been tested for…[Read more]