Both of these agreements can be enforced with valid evidence to back it up in case of any allegations held. However the main difference between these types of agreements is the chance of an individual not sticking to their word in a verbal agreement. Verbal agreements can be just as valid as a written argument, as long as there is evidence to…[Read more]

Like many of my classmates have said, this course has provided me with a lot of useful information that goes beyond the BME curriculum, and teaches practical skills that is needed in the workforce.

The lectures provided very useful information regarding the role of each department in a company. The forums allowed us to take the information we…[Read more]

Just a few days ago, Medtronic Spine is facing anti-kickback allegations for promoting a bone growth promoting device, Infuse (limited for use in the lower back) to physicians with methods not approved by the FDA. This device is used in the spine to promote bone growth, solely for application to the lower back. However, Medtronic had been urging…[Read more]

The key to a successful project is a successful team. I believe the best working teams succeed when there is no prior relationships between any of the team members. When it comes to choosing people for a specific role, from what I have seen with companies like Stryker, personality traits plays a major role in determining the kind of position one…[Read more]

I also agree with what has been said about the success of organizational structure. I believe it can be applied to any type of project and works great for medical device development. The culture this type of structure brings is an environment that is welcoming and encourages everyone’s success. The chances of success are very high since there is…[Read more]

When learning of the upper management role and the middle-man role, I initially thought I would be capable of taking on the upper management role. After doing some research on these two roles, along with the link kak33 mentioned, I see myself well suited as a Middle Manager. I find myself to be very detail oriented, and like to do the technical…[Read more]

Nowadays, people are willing to sue over anything and anyone. Therefore, companies must take all measures in avoiding, mitigating, transferring, and accepting risks without having any legal issues arise. However, there is a limit for how far a company can go to prevent risk, depending on the product and audience it targets. A company should only…[Read more]

I think that it is fair. I do not think there is anything more a company can do to prevent an overdose for example after all the risks have en avoided or mitigated. On many pain killer bottles, there are multiple warnings on the amount that can be ingested before it can become hazardous to one’s health. Once it is on the market, the consumer has…[Read more]

A good way to run a risk management meeting is to plan ahead of time and leave the meeting with enough information to write a risk management plan. As part of the quality department, it is imperative to ensure that there are no risks taken when developing a new device to avoid any legal issues. Prior to the first risk management meeting, a solid…[Read more]

Like many of you have said, verification is key to a successful device that will benefit the end users. However, carrying through with this process is imperative to the success and potential risks a company is taking when producing a device. Like Dr. Simon had mentioned, if verification is not done properly, it could lead to issues with the FDA.…[Read more]

When working in research, there is no standard design document when conducting an experiment as experiments are always subject to change. Let’s take coming up with a new formulation for a hydrogel for example. Once we come up with an idea on what ingredients would be needed, we test out the formula. While conducting this experiment, it is…[Read more]