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

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…   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…   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…   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”….   Read more»

I believe project based is ideal for smaller companies because each team can focus without being distracted by details of other projects. however, larger companies or companies with multiple integrated projects would benefit from matrix structure. as some have mentioned…   Read more»

In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission statement, “The Food and Drug Administration is…   Read more»

to follow up on what was posted above, for software updates, which may seem trivial, device approval is based on if the update “could significantly affect the safety or effectiveness of the device”. an excerpt of this FDA guidance publication…   Read more»

considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed by an experienced practitioner, and electroacupuncture is a combination of the two practices, i don’t believe it should be banned….   Read more»

Often times with group projects information is delayed because everyone works on a different schedule. at my current job, our in person meetings are organized, however are not given a time limit to ensure all avenues of thinking/troubleshooting are exhausted….   Read more»

In my experience, NDAs have been sufficient in protecting ideas during development. patents, even provisional ones must include every detail of the device. if the device is still in development, you don’t necessarily want to patent a feature that will…   Read more»

In many CDAs or NDAs it will be stated that the information belongs to the disclosing party, therefore any version or permutation of the information is still covered by the agreement. I believe in this situation specifically, the disclosing party…   Read more»