While all these risks are incredibly significant, one that is constantly present from the beginning of a project is financial risk. Questions on the presence of the finances needed for resources, work, and further development, are details that permeate every…   Read more»

The most common risk in a project really depends on the industry and scope, but schedule risk tends to show up the most. Delays can happen for all sorts of reasons—resource shortages, technical challenges, or scope creep—and when deadlines slip,…   Read more»

Scope management goes hand in hand with time and cost management to keep projects on track. A clear scope helps with scheduling by breaking work into manageable tasks using a Work Breakdown Structure (WBS), making it easier to stick to…   Read more»

A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 knowledge areas and coordinating all elements within the project, but when a project is on the…   Read more»

Balancing rigorous design controls with the flexibility that is needed for innovation is crucial in various regulated industries like medical devices. While strict design controls ensure safety, accountability, and regulatory compliance, as well as proper documentation and formal review processes,…   Read more»

Gantt charts are very helpful for visualizing timelines, dependencies and progress in medical device projects. They serve as a helpful tool for R&D and testing and even manufacturing while ensuring that cross-functional teams devise a cohesive plan ahead of time….   Read more»

If you were to start a project without a clear proposal and a feasibility study in can lead to scope creep, resource misallocation and unexpected challenges. A well-structured proposal will align stakeholders on objectives, timelines, and other expected outcomes, while…   Read more»

Risk management is particularly important for medical devices since regulatory, technical, and market risks can jeopardize timelines or even result in complete failure. If a team doesn’t assess risk early on, they might be compelled to undergo additional testing, experience…   Read more»

Slack is a very crucial element in project planning because it helps accommodate for the unexpected, like delays, vacations, holidays or various emergency closures. Including slack in your schedule also allows for increased flexibility which will prevent the project from…   Read more»

Setting the initiation phase of a medical device project can lay the groundwork for its success. Projects can face unclear objectives, unrealistic goals, increased costs, problems with regulations, and ultimately delays or failure if there is no appropriate proposal and…   Read more»

In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often overlooked by many as risk management may not be taken as seriously as it should….   Read more»

I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation or Verification phases. Although it’s initially costly, the time given is valuable…   Read more»

I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects are often higher in risk, an can result in the scenario described above, where they discovered a…   Read more»

Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examining Project or Design Inputs. A device may have required more feasibility data, and…   Read more»

Gantt charts are a great tool especially for sticking to the project timeline in a visual manner. However, sometimes these charts do not offer flexibility in terms of deadlines. There are many ways Gantt charts can be improved. For example,…   Read more»

Some other things to keep in mind are ensuring that you are up-to-date with all the regulations and standards/qualifications that must be met. The FDA is constantly updating so it is important to be informed of any changes that would…   Read more»

Hi everyone! My name is Priyanshi Luhar and I’m a student at NJIT in the BS/MS program studying biomedical engineering. Looking forward to connecting with everyone. I’ve included my linked in below:https://www.linkedin.com/in/priyanshiluhar/

A very useful tool for managing scheduling in project management and medical device development is the Gantt Chart. Gantt charts can be used to visualize the timeline of a project. They give valuable information about which tasks must be finished…   Read more»

As previously mentioned above, there are many negative consequences of having a poorly designed project proposal: misused resources, shareholder disappointment, projects delays, etc. I have never been apart of a project with this challenge, although I have some ideas of…   Read more»