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

I tend to agree with the above post. I believe that the responsibilities of a project manager are largely similar across most industries. BB254 listed the primary ones: identifying requirements, creating objective, balancing time demands, cost and quality. Also mentioned…   Read more»

The organization I work for is primarily organized in a functional setup. The company is primarily separated into 4 functional teams: quality, process, operations, manufacturing. Employees of each functional area work together quite a bit to accomplish specific tasks. This…   Read more»