In 2010, the medical device community faced a significant setback when DePuy Orthopaedics, a subsidiary of Johnson & Johnson, had to recall its ASR hip replacement system. The recall was prompted ...

In the context of business collaborations like the one between BoneFix and FactoSet, companies often choose to collaborate when they lack the necessary capabilities or resources to develop a product i...

Strategic and business management skills are increasingly vital for project managers in navigating complex project landscapes and aligning project goals with broader organizational strategies. These s...

Scope verification and design controls verification serve distinct purposes within project and product management, particularly in fields where precision and adherence to regulations are crucial, such...

Effective stakeholder management in projects such as the Injectable bone growth factor syringes between BoneFix and FactoSet hinges on proactive engagement and strategic foresight. One innovative appr...

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'...

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, ...

One of the biggest challenges in project planning is identifying the critical path—the sequence of tasks that determines the shortest possible project duration. If any task on this path is delayed, th...

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 miscomm...

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 exp...

One of the biggest challenges in project initiation is ensuring that the Project Proposal is clear, realistic, and aligned with business and regulatory requirements. A poorly defined proposal can lead...

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 fo...

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 whe...

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 pa...

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,...