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...

Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project needs while maintaining regulatory compliance and inno...

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as class III or the other way around. The time from sub...

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving regulatory experts early in the development proce...

When considering using new technology in a project, the PM must take into consideration the impact to the overall cost and timeline of the project. If the new technology is extremely expensive and wil...

A strong regulatory strategy is essential for effective project management in the medical device industry, as it reduces risks such as costly delays, failed approvals, or market withdrawal. One of the...

The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to strict regulatory safety standards and finding fl...