A project manager’s motivation level will of course affect the team he/she manages. Lazy project managers beget lazy project teams, aggressive/motivated project managers beget aggressive/motivated project teams. Of course, individual personality has a great deal of influence beyond just the project manager, but their influence is felt…[Read more]

As had been mentioned above, an engineering change order (ECO) will be required since the device design controls portion of the process has already been completed. Since the device now requires a recall, the design review process will likely need to be reopened in the monitoring and controlling phase, but it could go all the way back to the…[Read more]

Another example of a combination product is a drug-eluting stent. This product can fall under CDER or CDRH guidelines. But a request for designation by the FDA would likely place this under CDRH jurisdiction since its primary mode of action is to act as a stent, which is a medical device. The secondary action of the device is to elute drug(s)…[Read more]

At the company I work for, we are constantly developing prototypes and special products for customers based on existing devices that we have filed for. In order for us to determine the approval pathway, the regulatory department uses a flowchart/decision tree provided by the FDA in order to determine which classification the device will fall…[Read more]

Engineering change orders are a critical aspect of design and process improvements. The description of the ECO has been echoed by many of the previous posts. ECOs are often critical controlled documents that enable changes to designs or processes to be appropriately documented. In my personal experience, ECOs are often initiated as the result…[Read more]

At my current job, logging and lack thereof, has proven to be far more critical than anticipated. As I work primarily in R&D and am responsible for much of the new product development, logging my work in a registered laboratory notebook is critical. The project I am currently working on is already on its 16th formulation, and tracking each…[Read more]

One interesting aspect of a project manager’s responsibility is meeting customer expectations. I bring this up because this is something that I see my project manager deal with on a regular basis. Customer’s will often come to my manager with parameters for a custom product. He will then take this information and consult with the R&D and any…[Read more]

As has been mentioned above, communication is the key when handling the majority of issues when it comes to team members and personnel. Transparency and communication when it comes to leaves of absence and vacation is immensely helpful. By knowing when people will be unavailable and what deadlines overlap with these leaves allows for…[Read more]

As has been mentioned above, the general selection of a vendor for a given supply is probably considered in the planning phases of a project, but not finalized until the execution phase. However, no matter who the vendor is, they do need to be qualified according to the quality system. This is something I am currently experiencing first hand at…[Read more]

This course has echoes many of the things I experience on a daily basis at the company I work for. As a small medical device company, each team member has expanded roles and responsibilities. Although I primarily work in R&D and quality, I am very often involved in regulatory meetings. Having an understanding of FDA regulations has helped me…[Read more]

One of the largest considerations when taking a company global is meeting various international regulations. As an employee of a medical device company that has reach in Europe and Asia, much of our regulatory teams responsibility is deciphering and meeting standards set forth by the EU and individual countries. Our project manager is…[Read more]

During project planning, consulting with the members of the various teams would help to develop more accurate project timing forecasts. This is something that I experience at my company rather frequently. As projects move into the planning phase, critical members of each of the teams (regulatory, quality, manufacturing/processing, R&D) come…[Read more]

As previously said, budget cuts will be detrimental to project cost estimation. I believe that the timing of the cut can determine its ultimate damage to the project. Essentially everything downstream of the cut will have to be conducted in a much tighter window. The pressure to succeed and execute will be even higher since there is less wiggle…[Read more]

Working for a small company results in an environment in which failure to plan or forecast budget demands can become catastrophic. Unexpected costs can result in project cancellation midway, resulting in wasted resources and no return.

I have been fortunate to not have any of the projects that I have been directly involved with cancelled.…[Read more]

The company that I currently work for is notorious for unexpected issues that move “extraneous tasks” onto the critical path. One recent example was in the production of a prototype gel pad. The prototype was commissioned as a special request (outside our current product offering) for a customer’s clinical trials. Upon completion and approval…[Read more]

A particular product I swear by is the Sleep Cycle app. It is an alarm clock that uses the accelerometers and microphone in your phone to monitor your sleep (by function of breathing patterns and movement). It tracks activity to determine how an individual is progressing through the stages of sleep. By monitoring the sleep patterns, it provides…[Read more]

I tend to agree with sentiments shared above. And I do especially agree with Myton and Hiren’s responses.

I believe that there should be a hierarchy of sorts.
Starting with a knowledgeable and communicative manager. Someone who understands the strengths and weaknesses of their team members. And is capable of positioning their team member…[Read more]

I tend to agree with Agnieszka’s assessment of product life cycles. While the need does not decline, the product that fulfills it will eventually go through all the phases of its life cycle, including decline. While it can be argued that even such basic staples of everyday life may not seem to go into decline, careful analysis does show that…[Read more]

Regulation tends to be a very tricky topic. The stances on what should be regulated and how much it should regulated seems to vascillate with each individual. As such, I believe that a flexible policy on regulation, when it comes to the FDA, may prove of benefit to specific populations. The above mentioned group of terminally ill patients may…[Read more]

As other individuals have mentioned, my first experience with design control came from my Capstone Senior Design class at NJIT. Our course instructors and team advisors performed the role of external agencies (customers, FDA, consultants, project manager). Using their input and suggestions combined with research performed by individual team…[Read more]