Organizations can balance innovations and compliance by following a structured approach. They should focus on the high-risk areas. Focus on the most important safety and quality requirements to avoid unnecessary delays. Use step-by-step approval so that compliance and innovation move…   Read more»

I think project managers can handle conflicts by various strategies. 1) Setting up a hierarchy, so that teammates don’t get confused in their roles. Define roles, responsibilities, and project goals early on to reduce misunderstandings. 2 ) There should be…   Read more»

Yes, common practice can sometimes limit the creation and innovation of better medical products for several reasons: 1)Premarket Approval (PMA) must undergo rigorous clinical trials and regulatory reviews, which can take years and cost millions of dollars. This discourages companies…   Read more»

The most significant regulatory challenge in developing emerging medical technologies is balancing innovation with patient safety and user acceptance. FDA has evolved and has regulatory rules for  AI/ML-based software.1)As AI-based devices are constantly emerging, getting FDA approval every time for…   Read more»

The manager can have various problems due to delayed supplies, damage during transport, and other factors. The issues can be dealt with tactically. First, maintain a good rapport with delivery agencies. The manager should always rely on reliable agencies and…   Read more»

When new technologies emerge during a project, the manager must assess the impact and outcome carefully. The risks and benefits are weighed before proceeding with the technology. The manager should communicate with other project managers who have used the technology…   Read more»

If there is a failure the manager and team have to diagnose the problem whether it is the failed design verification test, the actual device failure, or both. A detailed analysis of failure should be done, to determine the problem…   Read more»