@archishak brings up very good points, but I would also add that which option is chosen for cost estimation should also depend on the state of your organization at the time of pitching the project. Companies go through fluctuations in…   Read more»

There is also the matter of long term effect of choosing one vs multiple vendors. If there is a need to change the DSD anyways and alter the project timeline, then the drawbacks (design changes, time) of adding another vendor…   Read more»

Another strategy can be in holding stand-up meetings to keep track of every team member’s task. This will ensure that critical tasks are being completed in a timely manner and that nothing is off-track. This will also help keep team…   Read more»

A good tool for ensuring that all knowledge areas are synced and properly coordinated is the Work Breakdown Structure (WBS). This tool allows the project manager to keep track of all the workstreams, from an integration management perspective, scope management,…   Read more»

The scope is largely defined by the budget and target product release timeline. For example, the original scope for the project in the initial planning phases may require a 6 year launch timeline, however through discussion with stakeholders, you find…   Read more»

Most significantly, a WBS shows 100% of the project, as in it shows every aspect, from the overall project top-level objectives, to the breakdown of tasks, to the team member responsible, to the budget allocated for each task. This allows…   Read more»

Most larger medical device companies have developed an ‘Approval Matrix’ that details out every potential type of change and document category (ex. change to material spec, process spec, risk document, etc) and based on this matrix you can see which…   Read more»

An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity levels, and mitigation plans. Throughout the project, these risks may come to be…   Read more»

There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as described in the replies above. One important thing to consider is how to mitigate conflicts like this from…   Read more»

Validation is not required when the customer need is self evident. For example, if the customer need is for a sterile device, no validation test is required since the sterilization is documented as part of the manufacturing process and verified…   Read more»

As @shahil mentioned, setting up rules in your email to sort is a great tool for keeping your email organized. There are a few ways to do this:creating a folder for every team member so that you can reference emails…   Read more»

@torikul Agree with all the above but especially wanted to highlight your point about running pilot studies. As a working engineer, I have seen projects dismiss holding a pilot for the sake of ‘saving time’ only to discover several issues…   Read more»

Hi everyone!
My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson.
Looking forward to connecting: https://www.linkedin.com/in/nora-moustafa?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app

A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initial step is gathering customer needs since they are a main stakeholder in the device. 

Think of it this way – design controls are what you have to do to develop a medical device, project management is how you get it done. Design controls involve key milestones and documentation that needs to be done and…   Read more»

The two go hand in hand to form the final business case that allows the project to be chartered. Marketing will do market research to see what the gaps are in the market, gather data on the target customer and…   Read more»