Design Transfer Project Managers (DTPMs) and Research and Development (R&D) Project Managers operate under the umbrella of project management but cater to distinctly different phases of a product’s lifecycle, each requiring a specialized skill set. R&D Project Managers are deeply…   Read more»

I believe financial risk is one of the most present and impactful risks in a project. A project can have a great schedule, the right resources, and high-quality output, but if it runs out of funding, everything stops. Within financial…   Read more»

Breaking down work into structured sections helps teams stay organized and ensures each task is clearly defined. If tasks are too broad, important steps might be overlooked, causing delays and miscommunication. On the other hand, excessive detail can make the…   Read more»

Cost estimation in medical device projects is challenging because many factors can change unexpectedly. A major issue is estimating costs before fully defining tasks, which can lead to missing key expenses. For example, if a team assumes only one round…   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»

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform future design and risk management processes. When a failure occurs, such as a label detaching during water submersion,…   Read more»

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibility and better organization. The DID acts as a foundation, outlining what the product needs to achieve, such as a…   Read more»

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginning. When verification failures occur, it’s crucial to assess whether the issue can be resolved within the existing scope…   Read more»

One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the same level of clinical effectiveness as other Class III medical devices, there’s a risk that patients…   Read more»

Organizations can make PDCA an ongoing process by making small, frequent improvements instead of treating it as a one-time checklist. One way to do this is by incorporating PDCA into regular team meetings where issues are identified, solutions are tested,…   Read more»