There are two kinds of problem solving in the medical device world:
1 – Solving for improvements in effectiveness and efficiency
2 – Solving for corrective action/preventive action (CAPA) compliance
The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products.
Ironically, many of these same wannabe medical device companies have a robust Lean and Six Sigma culture, where a large percentage of employees hold Green Belts.…» Read more