Michelle Lott is the Founder of Lean RA QA, an organization that provides organizations across the life sciences with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and grief counseling! As we all know, working with regulators is tough stuff. Michelle also serves on the FDA Device Good Manufacturing Practices Advisory Committee. During this episode, Michelle discusses her insights as it relates to Private Equity and Venture Capital in the Life Sciences. Some of the highlights we cover: -How the rapidly changing Regulatory environment is impacting investments in the Life Sciences -What type of Regulatory information you can gleam even before a detailed design or prototype -Factors to indicate whether a company will have a successful exit -Trends in the M&A space within the Life Sciences Michelle and Lean RA QA can be found at leanraqa.com