Having worked in Quality, risk is very important when it comes to projects and product development. It is what runs companies and allows them to continue developing products. From my experience working in the quality department, I have worked alongside…   Read more»

The team I work on currently is a functional organization type. My department is very efficient when it comes to completing projects needed from our department. Communication is excellent across all individuals in our department. At times, individuals from the…   Read more»

When I was scrolling through the prior posts, I agreed that certain projects should not be cancelled and that they may be given lower priority if another project can maximize the company’s profit. However, after reading @sindhupriyapulagam’s response, I agree…   Read more»

Each type of organization has their pros and cons, and largely depends on the company and its goals. For a company that provides products/solutions for specific clientele, a project-based or matrix organization would suit the company more than a functional…   Read more»

Posted by: @as934 My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels from our simulation were peeling…   Read more»

From my experience working in a professional environment, and from my senior design course, one skill that I believe is essential for a project manager in order to succeed is organization. With organization, comes everything else, such as allocation of…   Read more»

If faced with such a crisis where my company’s manufacturing sites can not meet the demands of what the company requires, manufacturing of products would definitely see a decrease. From a supply and demand perspective, prices of raw materials or…   Read more»

Like many of my classmates have mentioned, no company should have to consider “embellishing a new device” in order to complete a 510(k) rather than a full-on PMA, it can be representative of how serious or not that company may…   Read more»

@jafar I agree with the key points you mentioned regarding how to identify your target market when proposing a project you wish to launch. From my experience in working in a medical device company, we focus on exactly those three…   Read more»

Working in a corporate environment, I feel that having the face-to-face interaction is definitely helpful, but not necessary. We have been able to navigate through the pandemic without the need to see each other every day. This can be attributed…   Read more»

Considering the fact, that success is broken down to 70% interpersonal skills, I believe that there should be a stressed importance on developing interpersonal skills in educational degrees, regardless the degree. In my professional career, I have noticed the importance…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»