Question

The founders of a medical device company need to take a different direction after they did not receive FDA approval for their equipment. What would not be part of an after-action review of their original decision?

A) Identifying lessons learned
B) Evaluating the decision-making process
C) Allocating blame for the failure
D) Assessing the impact on stakeholders

Answer 1

The after-action review of a medical device company that failed to receive FDA approval should focus on identifying lessons learned, evaluating the decision-making process, and assessing the impact on stakeholders, rather than allocating blame.

Step-by-step explanation:

The subject in question is regarding the after-action review (AAR) of a medical device company's strategy following a setback with FDA approval. In an AAR, allocating blame for the failure would not be considered constructive. The purpose of an AAR is to identify what happened, why it happened, and how it can be improved upon in the future. The focus is typically on identifying lessons learned, evaluating the decision-making process, and assessing the impact on stakeholders. It is a reflective process intended to enhance organizational learning and future performance, rather than focusing on punitive measures. Decisions about liability, whether involving hospitals, manufacturers, or government, fall outside the scope of an AAR and pertain to legal and regulatory considerations. These decisions are essential discussions regarding how to ensure the safety and efficacy of medical equipment and protocols.