I have participated in 1 unannounced FDA audit and 1 MDSAP mock audit in the medical industry before. Prior to each audit, there are a series of training sessions for audit preparation that is mandatory for those who will be participating either directly (in the audit room or command center) or indirectly (owners of processes like SOPs) must…[Read more]

Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and need for the study, developing the schedule, budget, and coordinating the team through each stage (planning, executing, controlling, and closing). As a team, each subject matter expert (SME) will…[Read more]

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 to continue the advancements in medical science. Testing on animals is cruel and essentially is the…[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 in the medical industry.

Personally, I think it is about the industry you are intending on getting into and the amount of…[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 forward you want to take your career. You learn a lot about FDA, EU, and HC regulations and the aspects in a…[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 need to evaluate the design change, if it is necessary or if there are other options. Then you’d need to consider what…[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 verification are completed). We implement ECOs for design/hardware changes and for packaging/labeling changes of our…[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 work in project management and each program has their own Gantt chart for their own element teams and each…[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 yet, meaning it completed the regulatory submission necessary to launch to product. A change in the design was necessary…[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 manager with the existing manager present. Within the following weeks, both managers were in the program meetings and were working together offline…[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 of the problem and validate measurement systems (i.e. time, expense, steps needed to be taken).…[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 fixed or even recalled, for parts that are reaching their end of life…[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 to prominently display the their accuracy of their blood glucose results. The updated FDA…[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, well established companies, whom have a larger medical product portfolio, have an assumed easier time getting…[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 in the company brand name. And if that failed product moves forward, the failed clinical trial can be used by competition to show…[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 notification, a new 510(k) submission, or premarket approval (PMA) will be necessary. Either way, the FDA…[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 that clinical trials should affect product innovation. Innovation provides the ability to advance the technology…[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 the product. Being said, the project quality plan and its trace matrix are essentially the…[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 currently being done. Depending on the 510(k) submission, how a company legally markets their…[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 legally marketed devices in the U.S.. 510(k) submission requirements are detailed in 21 CFR 807 Subpart E. IF the FDA…[Read more]