As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either through public announcements or coordinating return…   Read more»

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instead of the pharmaceutical companies. The financial planning…   Read more»

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance pathway. For example, Canada and the US have a mutual agreement which essentially help approve new medical devices in both…   Read more»

Assuming that once a smaller companies has identified a suitable clinical trial management company to contract with, payment could become a key part in managing the contract between the two companies. With smaller companies, monetary resources may not be so…   Read more»

One factor which can make or break communication within a clinical trial and project is communication latency. The time from delivery to acknowledgement of a message can be critical when it comes to completing stages of a clinical trial and…   Read more»

One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical trials may be the quantity of patients a company may be able to find. For medical…   Read more»

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company called Inovio. They were developing a…   Read more»

WBS should be closely aligned with a company’s risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as well can make areas with more uncertainty more visible to…   Read more»

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate the trade-offs faced when pressed for time. A project manager can approach the stakeholders or executives…   Read more»

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects that have requirements…   Read more»

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the project lessons without working off of them could defeat the purpose of doing so in the…   Read more»

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeholders prior to the design review meetings. Stakeholders can provide valuable insights that may have been overlooked…   Read more»

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it comes to the study itself and record keeping of…   Read more»

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for example engineering and compliance, are able to express their uncertainties…   Read more»

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the goals of the current project objective. Revising…   Read more»

Cross-functional teams are essential to many projects, and omitting a sequence of activities can significantly impact their purpose. The purpose of these teams is to allocate project resource effectively and distribute project tasks efficiently. When a project’s schedule is being…   Read more»

One way to make sure that all project documents remain accurate and update is by maintaining and utilizing version control software, along with access control. As mentioned, suppliers and manufacturers can run into issues with their schedule, which can impact…   Read more»

An important factor to consider which is equally important as pre-market approval is post-market surveillance of medical devices. A rigorous and well-made pre-market portion of a medical device project is essential for the approval and success of the device. An…   Read more»

Hello all,My name is Paul and I am a BME masters student at NJIT. Here is my LinkedIn: https://www.linkedin.com/in/paul-zukowski/
 

As mentioned before, a RACI can certainly help decrease the ambiguity associated with the development of a syringe that does not leak and clump. However, a RACI does not directly address the risks that can occur, especially when engaging in…   Read more»