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Monica Burt

Founder of MB&A

Monica Burt is the founder of MB&A and a pioneer in Audit Intelligence, a new category of AI-driven quality assurance that transforms compliance data into predictive business insight. With over 20 years of experience in the medical device sector, she has become a trusted partner to private equity firms, investors, and innovators, guiding them through the complex landscape of global regulatory strategy and operational excellence. Recognizing that traditional, manual auditing could no longer keep pace with the industry's rapid growth, Burt shifted her focus from simply managing quality systems to modernizing them. She now leads the development of AuditNova, the industry’s first Audit Intelligence platform designed to help manufacturers and suppliers move from reactive "snapshot" audits to continuous, data-driven risk monitoring. Prior to this, Burt built MB&A into a premier boutique consulting and recruiting firm, helping medtech companies worldwide navigate product commercialization, due diligence, and talent acquisition. Her work bridges the gap between quality and operations, helping leaders view compliance not as a cost center, but as a strategic asset for supply chain continuity and growth. To explore her work in Audit Intelligence and consulting, visit burtandassociates.com.

4:15-5:15 p.m.

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