The Work Breakdown Structure (WBS) provides a hierarchical breakdown of tasks, ensuring that every aspect of the project is accounted for and properly assigned. Without a well-defined WBS, project teams may struggle with unclear task ownership, missed deadlines, or untracked…   Read more»

Risk management is an important aspect of project planning, especially in highly regulated industries like medical device development. A well-structured plan helps teams anticipate potential failures, assess their impact, and decide on mitigation strategies before they become costly issues. One…   Read more»

Unlike general project phases that gradually transition into one another, design controls in regulated industries like medical devices follow strict phase gates, requiring formal review meetings before moving forward. Once a phase is complete, going back is costly – a…   Read more»

One of the critical aspects of project initiation is understanding Enterprise Environmental Factors (EEFs). These include an organization’s culture, project management tools, and the availability of skilled personnel, these are factors that can significantly influence project success. For instance, in…   Read more»

Verification failure highlights the importance of risk management and continuous improvement in medical device projects. A proactive approach would involve a Failure Modes and Effects Analysis (FMEA) early in the design phase, identifying potential risks before verification testing. By assigning…   Read more»

Scope management is critical when verification failures occur, as unexpected challenges can lead to scope creep if not managed effectively. The project’s objective is clear – ensuring labels adhere under water submersion conditions. However, if modifications are needed, careful stakeholder…   Read more»

Verification failures are a common challenge in project execution, requiring a structured approach to problem-solving. For instance, label adhesion failure during water submersion testing suggests potential issues with material compatibility, surface preparation, or application technique. A thorough root cause analysis…   Read more»

The Plan-Do-Check-Act (PDCA) cycle is a powerful framework in medical device project management, ensuring continuous improvement and regulatory compliance. This cycle is embedded within the Project Management Process Groups: Plan: Initiating & feasibility studies, creating project proposals, and defining scope…   Read more»

Choosing the right organizational structure significantly impacts how medical device projects are managed. Functional Organizations have clear departmental hierarchies, making resource allocation straightforward. However, this structure often leads to silos, where teams work in isolation, hampering collaboration. In contrast, Project-Based…   Rea…[Read more]

The most important aspect of medical device development is Design Controls. These regulations, introduced by the FDA in 1996, ensure that products are developed systematically, reducing risks and improving safety. The structured nature of Design Controls covering Planning, Input, Output,…   Read more»

History has shown that regulatory missteps can derail even the most promising medical devices. One example is the Dalkon Shield, an intrauterine device (IUD) that was introduced in the 1970s without sufficient safety testing. The device led to severe infections,…   Read more»

One of the biggest challenges in medical device project management is balancing regulatory compliance with innovation. The FDA’s mission is to ensure safety and efficacy, but sometimes, these requirements can slow down the development of groundbreaking technologies.  Consider a company…   Read more»

A strong regulatory strategy is important for project management in the medical device industry. Without it, companies risk costly delays, failed approvals, and even market withdrawal. One key aspect of regulatory project management is determining the right regulatory pathway -…   Read more»