Improving quality assurance processes in the medical device industry is essential to preventing failures like the DePuy ASR hip implant recall. One of the most critical strategies is strengthening pre...

In my opinion, it is important to find a balance between time spent on communication and working on projects. Communication is key to the success of any team working on a project and should not be ign...

Determining when the planning phase is complete without knowing exactly how a project will unfold is a challenge that project managers face. One way to address this is by using progressive elaboration...

To ensure that a verification protocol is rigorous and detailed enough, project teams must focus on clarity, thoroughness, and traceability throughout the process. One key strategy is developing clear...

Project managers can efficiently manage their inboxes by implementing strategies to prioritize and organize emails effectively. One common approach is using email filtering and rules, which automatica...

In biomedical engineering project management, the planning and execution phases are critical to ensuring the success of a project. Effective planning begins with defining clear objectives and project ...

In my experience, the most present risk in nearly every project is usually schedule risk. Deadlines are often affected by unexpected delays, resource constraints, and dependencies between tasks. This ...

Cost estimation is a major challenge, especially in highly regulated industries like medical devices where unexpected compliance hurdles or clinical trial delays can increase costs. One of the best wa...

I would agree that many teams struggle with identifying which tasks are truly critical versus those with flexibility, leading to wasted resources and unnecessary delays. One of the biggest issues I’ve...

Balancing design controls with flexibility needed for innovation is essential in regulated industries like medical devices. To achieve this, companies can adopt approaches that integrate structured pr...

Hi everyone, my name is Megan and I am currently pursuing my MS in BME at NJIT. Connect with me below: linkedin.com/in/megan-crawford-180324294

A work breakdown structure (WBS) facilitates better project planning by providing a clear definition of the project’s scope and breaking it down into manageable tasks, ensuring that all necessary work...

In order to create a robust final product, it is important to understand the worst-case scenario outcomes. If a product undergoes rigorous testing of worst-case scenarios, it will be assumed to last u...

I completely agree with your perspective that the Design History File (DHF) should be treated as an active part of the product development process rather than an afterthought. Maintaining a well-organ...

The verification failure shows the importance of integrating a strong risk management framework and focusing on continuous improvement in medical device projects. Conducting a FMEA early in the design...