Early start (ES) and early finish (EF) can be helpful in scheduling flexibility and resource planning. In terms of scheduling flexibility, ES helps the team know the earliest date the task can start and helps prepare for the task that…   Read more»

We can determine the risks which are worth taking by evaluating the residual risk evaluation. Ask yourself on a high level whether the product’s overall residual risk should be considered acceptable. This is really a question of whether your product…   Read more»

Gantt charts can be a useful tool in all stages of designing a medical device. Pros of using Gantt charts is that they identify which tasks have slack and which tasks are on the critical path. Tasks that have slack…   Read more»

One thing to consider with medical devices is that they don’t all carry the same level of risks, hence the classification. Implementing different risk-adaptive techniques for different classifications can speed up the process for Class I medical devices, as they…   Read more»

Some responses already mention ways to increase innovation during a project by using software to communicate throughout the project team effectively or having a change in project structure. Another important factor that can affect the project is the psychological state…   Read more»

Hello everyone! My name is Bryan Xavier, and I’m an undergraduate at NJIT pursuing a BS and MS at NJIT. I can’t wait to connect with everyone! Connect with me here:http://www.linkedin.com/in/bryan-xavier-a680b429a

Yes Organizational culture and resources have a deep impact on project execution. A strong culture shapes an organization’s decision patterns, guides actions, and drives individual behavior of all members. Project leaders who lack cultural awareness can become restricted and handicapped…   Read more»

A structured, continuous approach to risk assessment, as outlined in ISO 14971, is key to preventing overlooked hazards. Narrowing the planning process into specific steps allows teams to focus on each task and identify potential pitfalls early, rather than waiting…   Read more»

Project managers often factor in potential delays, and missing a milestone sometimes yields benefits—like uncovering technical flaws that improve the final product. However, if the delay results from poor planning or communication, it can harm the company’s reputation. Ultimately, it’s…   Read more»

Balancing rigorous design controls with innovation is a crucial element in medical device development, ensuring compliance and the continuous evolution of technologies. Implementing robust documentation systems helps organizations systematically capture key decisions and track risk mitigation efforts without stifling creativity….   Read more»

To balance between rigorous design controls and innovation, companies can leverage robust documentation systems that can help to manage critical decisions and get a leeway for development by risk management. The engineers need to prioritize areas for innovation but in…   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:
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 is identified, and no critical tasks are overlooked. This allows…   Read more»

Generally, when planning, project teams have a broad picture of the goal or process in aim but typically forget the sudden risks found during the development. The planning process should be narrowed down into more specific details about each step…   Read more»

A Work Breakdown Structure (WBS) simplifies project planning by breaking a large, complex project into smaller, more manageable parts. This allows teams to clearly see each task, who is responsible for it, and how it connects to the overall project….   Read more»

The initiation phase in medical device projects is crucial because it lays the foundation for everything that follows. Key inputs like feasibility studies and regulatory assessments help determine whether the project is worth pursuing. For example, if initial testing shows…   Read more»

Strict design controls are essential for ensuring safety and regulatory compliance, but they don’t have to stifle innovation. Companies can maintain flexibility by integrating early prototyping and parallel testing within the design control framework. For example, instead of waiting until…   Read more»

An organization’s culture and resources directly impact project execution by shaping how teams collaborate and make decisions. A company with a hierarchical structure may struggle with slow approvals, causing delays in project initiation, whereas a more flexible organization can adapt…   Read more»