I think the greatest value this class provided by familiarizing ourselves with details of the Medical Device process which will inevitably improve your learning curve when operating at a device company. Even If you already have experience at a device company, I believe a better understanding of other departments that you may work with will…[Read more]

many of my colleagues have expressed to me that they love their job mainly because of the people they work with and because of how exciting their work is. I will also stay at my company because of the supportive staff. In fact, I am surprised that “working with great people” is not number one as no matter what the topic of the work, your…[Read more]

my biggest motivation is taking care of my family. a few semesters ago I was working on a product design that I had to have the draft finished by the about the end of the semester as the project was to begin prototyping. that semester i had 12 credits including 2 classes with Dr.Roman. I stayed up just about every night during that semester to…[Read more]

I think WMS7’s experience working overtime to complete a project on time is likely a main reason people work overtime. while many people are motivated, the motivation is not necessarily to finish the project early but to finish the project in general. poor performance at work will eventually lead to being fired. That being said, overworked and…[Read more]

something mentioned in the lecture which seems like common sense but likely proves to be extremely tedious is to review all materials before submitting to manufacturing to ensure there are no mistakes. a document such as the project closure document ashley mentions should be a great help to this as it can act as a checklist.. but also reviewing…[Read more]

As a PM, one of my greatest concerns would be time to prototype and manufacturing timeline. Depending on the equipment available and existing projects at a manufacturing company, the production time for a required part may vary. If the company selected for the outsourced part takes longer than expected for prototyping or manufacturing, it may…[Read more]

design verification is ensuring that the product that you just spent an extended period of time does what you intended it to do. without design verification there is no way of proving the efficacy of the device. this ultimately can lead to FDA disapproval and/or get you in trouble with the FCC as the device may not provide the functions…[Read more]

Ial4’s suggestion to consult with Dr. Malekai is correct for avoiding timeline issues about the animal study, however in this simulation, the initial timeline submitted to management was out of your control. what we can learn from this simulation as a PM is to structure your team so that any decisions that depend on the approval of a team member…[Read more]

I think monique expressed how to communicate effectly as personal issues can often affect a persons ability to function. Therefore, speaking to the person and being understanding of their situation can often improve their ability to function,and make them feel appreciated as a valuable team member.

I think it is the responsibility of the device producer to ensure that adequate measures are taken to ensure proper validation and quality. while FDA regulations are expansive and precise, they are not perfect. therefore, every company’s main goal should be to produce a safe and efficacious product, making any product failures or recalls are on…[Read more]

I agree with the answer posted above that a recall would not be take place with faulty adhesive on labels as it does not have an affect on the safety of the contents inside the bottle. Mislabeling however would be grounds for a recall as the ingredients must be accurate. in the case of a poor adhesive causing customer complaints, the company…[Read more]

as some have mentioned previously, I believe the project manager should be a great problem solver. on any team, each member should be capable of completing tasks on their own. it is when there are conflicts of opinion or challenges that the team members have difficulty solving that the manager shines. while communication is important, the…[Read more]

While some research states that belief may be a contributing factor in the effectiveness of acupuncture, the NIH acknowledges that “Acupuncture may help ease types of pain that are often chronic such as low-back pain, neck pain, and osteoarthritis/knee pain”. therefore, while the efficacy of acupuncture has not been “proven”, the evidence…[Read more]