Many of the tools mentioned, like FMEA, RCA, and scenario-based simulations, are essential for safety-critical projects, especially regarding systems-level risk management. But what often gets overlooked, particularly for technical employees, is how the human side of performance and communication plays…   Read more»

The risks and trade-offs of duration compression in medical device projects are complex. Both crashing and fast tracking can offer time savings, but the potential impact on cost, quality, and compliance makes it something that must be handled carefully. Integrating more…   Read more»

Compressed schedules are often encountered in the development of medical devices, particularly when the team is working under a prominent market opportunity, is facing pressure from investors, or has an urgent clinical need. Although having reduced timelines may bring a…   Read more»

When it comes to delivering safe and compliant medical devices, optimizing quality management is crucial. A company with a robust focus on quality cultivates trust and enhances operational efficiency while also meeting regulatory standards such as FDA QSR, ISO 13485,…   Read more»

Estimating costs is one of the medical device project planning steps in the planning phase of a project. It enables teamwork in identifying resources needed, setting budgets, and making critical decisions. At times, there is a compromise between precision and…   Read more»

In my opinion, using procurement to influence supplier behavior can be ethical, but only under certain circumstances. It must be approached with intentionality and equity. When large corporations use their purchasing power to push for reform, the impact can be…   Read more»

The suggestions regarding FMEA and RCA are great for safety-critical projects. Organizational planning for these types of projects should also use tools that bridge the gap between system-level safety management and resource coordination. Some techniques that can be used include…   Read more»

I think using Failure Mode and Effects Analysis (FMEA) can be an effective approach to prevent errors, losses, or subsequent issues. It is a tool risk management would utilize to identify how the project may fail and assess the severity…   Read more»

While regulations are very important for baseline safety and efficacy, I think an overemphasis on regulatory compliance can limit the full potential of quality management. Regulations are designed to prevent failure, but in my opinion, don’t always push teams to…   Read more»

I think it’s true that focusing too much on just meeting regulatory requirements can limit the full potential of quality management. Regulations are important for safety and consistency, but they’re only the starting point. A good example is the Johnson…   Read more»

Deciding between speed and accuracy in cost estimating really comes down to project context and risk tolerance, especially in high-uncertainty environments like medical device development. In early stages, top-down estimating is often the most practical approach because it allows teams…   Read more»

Regulations are essential in maintaining baseline safety and efficacy, especially in industries like medical devices. An overemphasis on regulatory compliance can sometimes limit the innovative potential of quality management, though. When quality is viewed as only meeting regulatory requirements, organizations…   Read more»

Before deciding whether to crash or fast track a project, project managers can conduct a risk-benefit analysis that takes into account the project’s constraints, stakeholder expectations, resource availability, and potential impact on quality. Tools such as a cost benefit matrix,…   Read more»

I agree with what has been previously mentioned: all 9 knowledge areas are critical for effective projects. However, if I had to chose the three most important, I would pick integration management, scope management, and risk management. Integration management is…   Read more»

The Allergan BIOCELL breast implant recall underscores the critical need for proactive, comprehensive quality and risk management in medical device development. While regulatory approval is essential, it must not be the sole benchmark for safety. Companies should implement tools like…   Read more»

When deciding between speed and accuracy in cost estimating—especially in high-uncertainty projects like those in the medical device field—a hybrid approach truly offers the best of both worlds. Starting with analogous estimates allows for swift decision-making and early-stage planning, while…   Read more»

Project managers can make informed decisions about using crashing or fast tracking by conducting a thorough risk-benefit analysis, assessing cost implications, timeline constraints, and potential impacts on quality and compliance—especially crucial in high-stakes medical device projects. Collaborating with cross-functional teams,…   Read more»

@ms3548 I think the way to managing the transition from broad to bottom-up estimating is to treat it as a planned-hand off. For example, scheduling a formal review point once enough detail is available, like a completed WBS or when…   Read more»