One obstacle that can complicate timeline planning for large scale clinical trials is the variability added by conducting trials across multiple countries. Global trials come with more complexity that...

The first step should be to identify why the underperformance is happening, which can lead to visits to monitor process or talking to the team themselves to find the root cause. Then the necessary cha...

One strategy that can be used for keeping clinical research teams motivated is to create and celebrate short-term wins. It was mentioned in this week's slides that one motivator for people is team bas...

@ms3548 I think the way to managing the transition from broad to bottom-up estimating is to treat it as a planned-hand off. For example, scheduling a formal review point once enough detail is availabl...

In addition to balancing detail and simplicity for the WBS, I think it's also important the WBS structure has clear traceability between work and regulatory paperwork, like design inputs, outputs, ver...

I agree that regulatory approval shouldn't be the end all be all for safety. There are multiple strategies that companies can and should take before a product hits the market. One such method is a Fai...

In my experience, I've used weekly in person meetings in order to make actual progress in a project I'm working and discuss with coworkers. Then I use Slack and some of my free time in order to conduc...

To build confidence in testing outcomes, companies often create a standardized test kit that includes the product sample, and instructions for handling, storage, and testing. This kit could include th...

When facing a late-stage development issue, one method to consider is using the "5 Why's" Method, where you're keeping asking why the failure is happening up to 5 times to determine whether the root o...

In complex and highly regulated projects like medical device development, changes are bound to happen. Design updates, documentation revision, and process adjustments are required to ensure compliance...

As much as learning from mistakes is important for future projects, it should also be important to use the lessons learned in real-time for decision makings during the project, not just as something t...

You raise an interesting point, others have mentioned already that EV, PV, and AC only show the symptoms of a project failing and do not explain why. Another shortcoming of earned value management is ...

One common way to foster team and individual developments is through peer mentorship and knowledge-sharing sessions. Less experienced team members are usually paired with professionals, and shadow the...

Asynchronous communication offers an alternative for small weekly meetings where everyone meets up for a status update. Instead of having excessive meetings, projects teams use tools like Slack, Trell...

One way to improve QA for medical devices is implementing patient-reported outcome measures (PROMs), which provides a direct pipeline for patients to communicate their experience and outcomes. PROMs a...