This is a very difficult topic because it is an opinionated debate between necessity versus ethics. And it appears from the majority of the feedback from our classmates, animal testing is bottom line unethical, but is necessary to an extent…   Read more»

Great topic!! I wish there were more responses because I am too (not to sound repetitive) very curious about this. I have been torn with the decision of MS versus PhD. I currently am working towards an MS and work…   Read more»

I have worked in the medical industry for about a year and a half and would recommend students to really take the time to find an internship/co-op opportunity and to find a semester project research opportunity to determine which path…   Read more»

I agree with previously made points. Design changes can affect several parts of the product and can create several moving parts that the project manager and team need to be aware of. First I would agree with merzkrashed is you…   Read more»

I haven’t personally worked with an ECO, but I have seen plenty of them in my current position. I have only noticed our company producing ECOs for product in the validation and post validation stages (once the design input and…   Read more»

I absolutely love and live by Gantt charts. In my undergraduate studies, we would use MS Project Gantt charts and Visio high-level schedules to organize and plan the steps it takes to develop new design concepts and prototypes. I currently…   Read more»

I agree. From what I have seen in the medical industry, when a design change is necessary the steps taken depends on the stage of the project. Currently, I am working on a project that hasn’t completed it’s clinical trials…   Read more»

I have also experienced this in the industry in one of the projects I have been a part of. There was a change in PM due to resource constraints. We had a kick off meeting to introduce the new project…   Read more»

I agree, Six Sigma is a very powerful tool for project management. The methodology of Six Sigma is DMAIC: define, measure, analyze, improve/implement, and control. Define the problem and relate it to the customer, setting the scope. Measure the impact…   Read more»

Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a medical product, ultimately increasing the product’s safety and efficiency. ECO can be used for components that need to be…   Read more»

I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidance made the packaging requirements more stringent for blood glucose meters. The label of the products need…   Read more»

Sorry technical difficulties! Posted this out of order! This was meant to be after Ashley’s post… This is a really good addition to the conversation Ashley. It seems like more innovation is with start up companies, yet while the bigger,…   Read more»

I agree with f-dot, I think there is a good purpose for this book to open people’s eyes to the medical industry. If a company fails a clinical trial, the results still become public which can hurt trust and confidence…   Read more»

I agree with ial4 and appreciate sharing the guidance for market approval/submission when there is a change in a medical device. Depending on the risk from the change being made and the classification of the device determines whether a interim…   Read more»

Responding to one of bnb6’s questions, I feel clinical trials (depending on the product and its intended market) are very expensive and can be very time consuming, but are critical in proving the quality of the product. I don’t believe…   Read more»

I agree with hc225 that most countries adapt the structure of their plans from the standards written in ISO13485:2016. Medical products need to be of highest quality to deliver confidence and reliability for the health care professionals and patients using…   Read more»

Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with their devices, then I believe the FDA would regulate the “therapy” or service differently than what is…   Read more»

FDA 510(k) submissions are for class II devices that have already been approved in the market since the FDA passed the Medical Device Amendments Act in May 28th, 1976. When submitting a 510(k), the device must be compared to other…   Read more»

Continuing from alexandrabuga’s response, a Request for Designation is a written to the Office of Combination Products (OCP) requesting regulatory classification to determine if it is a device, drug, and/or biologic product and which Agency will be assigned. The FDA…   Read more»

I agree with your ideal skills, having a team that varies in their experience and background, works well together, and has a passion and drive in their efforts as a valuable team member. Reliability, involvement, determination, and the ability to…   Read more»