As people have stated before, I think a good way of improving QC/QA is to have better communication among different departments. I think in most cases, the quality department only reviews the product at the very end, right before a potential release. This can sometimes run into problems because if issues are found, then the product might have to…[Read more]

I think most companies view the QA/QC departments as being a burden because of the amount of questions that need to be addressed before the release of a certain product. People may be on a time crunch to release certain lots of that product and so they get frustrated when confronted by QA/QC. However, the QA/QC departments are necessary in order…[Read more]

I think the reason the FDA is so harsh when it comes to rules, regulations, and the process to approve a device/treatment is because of liability issues. If a patient/customer is not satisfied with the device or shows any adverse effects, it becomes a huge issue. Not only would companies lose money, but patients can also become hurt or ill as a…[Read more]

In terms of medical devices, accuracy measures how closely certain data fall into the acceptable ranges of operation. If this does not hold true for the device, the device may not perform as intended. Precision requires the device to perform in a similar way consistently so that the same results are produced every time. The FDA requires medical…[Read more]

Recalls usually occur due to the product no longer adhering to the FDA laws. For instances where certain devices are recalled after 5-8 years, I would say it is usually because of long term adverse effects that are not detectable during the preliminary stages of development or even soon after the device is FDA approved. Certain side-effects are…[Read more]

While very unfortunate, animal testing is critical in developing medical devices for humans. If someone in a medical device-related field is completely against animal testing, they might be in the wrong business. The alternative would be to not have animal studies and go straight to human studies, which would be even more detrimental. However, if…[Read more]

If a company were to develop a new biomaterial, there would need to be a significant amount of tests done to ensure that the device has a strong biological performance. Toxicity tests (from the toxicity chart attached with this week’s course material), as well as material characteristic tests, such as tensile and compressive stress/strain among…[Read more]

Outsourcing, in general, gives you less control over the final results. You have no way of directly observing how the study is being conducted. Also, if the university really is 1000 miles away, it would be too far to monitor what is going on, even on, let’s say, a monthly basis. Even communication and/or transportation of materials can be delayed…[Read more]

Some other questions that would definitely need to be asked in the initiation phase of the project are:
1. Do I have the necessary resources to do this? If not, how feasible is it to obtain those resources.
While there may be a business need for your project, sometimes it is not financially feasible to get the resources you need to make it…[Read more]

Missing critical milestones such as deadlines can push back the deadlines of other critical milestones and delay the completion of the project. However, there can be ways to override this problem. Sometimes, you’re able to figure out a way to complete the project on time by somehow cutting down the time needed to complete other aspects of the…[Read more]

The biggest difference, in my opinion, between a project manager for a medical device versus a that of a construction project is the customer, which in most cases, is a patient seeking medical aid. Along with making sure the device is “audit-ready” using GMP/GDP, there is also a concern of ‘who’ that device is going to. Questions asked by a…[Read more]

Not necessarily! If we’re talking about an undergraduate student, they may or may not know what they want to focus on. However for a Master’s student, I would think that at point in their academic career, they have a better idea what they want to focus on. I think that if there are more options available for both academic or practical classes,…[Read more]

I definitely this MS program lacks in the amount of practical courses offered. As other people stated previously, working in the industry is a lot more involved and requires a lot of “hands-on” experience, paid or not. In my opinion, I think the ratio should be about 50:50. Academic classes are there to give you information and allow you to…[Read more]

While I agree that academia has more flexibility in terms of work hours/balanced work life you’re able to focus on the areas that you’re truly passionate about, I really think working in the industry gives you more opportunity to branch out into different positions. Industry allows you to see the business side of things along with the…[Read more]

I do definitely agree that BME is really broad degree that overlaps into a lot of different fields. In my opinion, when starting out, it’s definitely good to some a variety of skill sets, rather than just one. Companies want to see that you’re capable of adapting and learning new things. This can be hard if you’ve only focused on one skill and…[Read more]

I would definitely agree that networking is huge part of landing that first job. It also helps if you’ve had previous internships/co-ops while completing your undergraduate degree. However, sometimes this can be difficult because a lot of companies want to hire people with a lot of experience and making yourself stand out among other students…[Read more]