Monica Burt
Monica Burt has spent 25 years in medical device quality. She led quality at Smith & Nephew, Medtronic and Wright Medical, then founded MB&A, a quality, regulatory and recruiting firm with more than 200 FDA and ISO audits behind it. Device makers and their investors bring MB&A in for remediations, due diligence and inspection readiness. In 2025, she founded Qualera, an AI audit platform built on a simple idea: an audit shouldn't be a guessing game about which records to pull. She also publishes The Quality Signal, a newsletter on medtech quality, and is based in Memphis.
Wednesday April 22, 2026
The Make vs. Buy Question: Factors for the Decision
What goes into the decision to make versus buy? Is the answer always black and white or clear-cut? What factors and considerations must be used in the evaluation? Is there a middle ground or hybrid approach that can be leveraged? This session will feature a panel discussion among industry representatives who have had to address this question. They will share the best practices they use and their own recommendations for an effective evaluation.
Moderated by Monica Burt