This is an amazing definition of the concept of project initiation. Keeping in mind all the objectives of project initiation, I’m curious about what complications can arise within the medical device industry. A business case typically includes a summary of…   Read more»

In my opinion, Microsoft Teams simplifies sending direct messages, group chats, and file sharing via one interface.  For day-to-day communication, Teams is what I would prefer because it is faster and more convenient for quick questions or team chat, and also it reduces the clutter in my email inbox by handling most informal communication….   [Read more]

Emails are a much more formal mode of communication. I typically use it when sendging out formal requests, meeting minutes, or need to contact multiple people. I also use it when I am contacting people for the first time as…   Read more»

I definitely agree. Having a good grasp on business and strategy can also allow project managers to know which areas to prioritize. For example, if they know a competitor medical device company will also be laucnhing a similar product, they…   Read more»

Hello everyone! My name is Olena and I am a BME Undergraduate student at NJIT. Here is my LinkedIn, looking forward to connecting with you all!
https://www.linkedin.com/in/olena-sen/

Before the actual development work begins, the initiation phase of a medical project is crucial for ensuring that there are objectives, regulation, and risk management strategies predefined. This will help to ensure that there is no scope, cost, or compliance…   Read more»

The complexity and need for innovation in medical device development, which is often strictly regulated, makes adaptive project planning very important. Adaptive planning gives teams the flexibility to incorporate necessary changes due to technical issues, new regulations, or changes in…   Read more»

Verification protocols matter deeply in a medical device’s journey to market because they ensure that the device meets all design, regulatory, and safety considerations in advance of validation. A well defined protocol can help teams to detect issues early which…   Read more»

Hello all,My name is Paul and I am a BME masters student at NJIT. Here is my LinkedIn: https://www.linkedin.com/in/paul-zukowski/
 

As mentioned before, a RACI can certainly help decrease the ambiguity associated with the development of a syringe that does not leak and clump. However, a RACI does not directly address the risks that can occur, especially when engaging in…   Read more»

Designing a risk assessment properly by taking into account all the details that can contribute to risk in a project can help strengthen a verification protocol considerably. Identifying errors or potential points of failure in terms of the compliance or…   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»

Getting a medical device project off the ground is never easy, especially with the many moving parts involved in the initiation phase. One of the biggest challenges is making sure different teams are aligned from the start. If there’s miscommunication…   Read more»

In biomedical engineering, project managers need to strike a delicate balance between efficient execution, innovation, and regulatory compliance. Previous responses have brought up planning tools such as pilot studies and risk assessments, but another strategy that can be used is…   Read more»

A strong verification protocol is absolutely essential for ensuring product reliability and regulatory compliance. One way to ensure a strong protocol is to implement a structured validation approach which includes acceptance criteria and traceability. There are many strategies that can…   Read more»

A well-designed verification protocol is essential for ensuring consistency, reliability, and ultimately the success of a project. One major issue with a poor protocol—especially in a lab setting—is the inability to replicate results consistently. If test methodologies aren’t clearly defined,…   Read more»

I definitely agree that emails can be overwhelming, especially when important messages get buried. Setting up filters and scheduling time to check emails helps, but even with that, email isn’t the best for quick exchanges or urgent updates. I haven’t…   Read more»