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-market testing and risk management. This can be achieved through more…   Read more»

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 ignored, but too many…   Read more»

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, where planning is done in phases and adjusted…   Read more»

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 and measurable test criteria. Every requirement should have a corresponding test…   Read more»

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 automatically sort messages based on sender, subject, or keywords, directing them into specific folders…   Read more»

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 scope, typically outlined in a work breakdown structure (WBS) to break down…   Read more»

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 is seen especially in industries like medical devices, where regulatory approvals…   Read more»

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 ways project managers can balance cost control with quality is by…   Read more»

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 seen in my personal experience is scope creep, where…   Read more»

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 processes with creative problem-solving techniques. Check ins at each phase gate allow for feedback…   Read more»

Hi everyone, my name is Megan and I am currently pursuing my MS in BME at NJIT. Connect with me below:
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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 is identified, and no critical tasks are overlooked. This allows…   Read more»

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 under less severe and more realistic conditions. In…   Read more»

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-organized DHF not only helps meet FDA regulatory requirements but…   Read more»

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 process is a way to predict and plan for risks before…   Read more»

Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project needs while maintaining regulatory compliance and innovation. A functional structure provides stability and technical expertise, making it good for R&D efforts. To…   Read more»

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 submitting an application for approval…   Read more»

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving regulatory experts early in the development process, and incorporating validations into the development process. Viewing validation and verification as their own separate…   Read more»

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 will take time away from the project…   Read more»

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 most important elements of regulatory project management is identifying…   Read more»