094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).

Rumi walks through:

• Connected Devices and Combination Products
• How Regulators approach regulating new technologies
• Traceability Technologies and what they mean for manufacturing and use
• Comparability Protocols and Pre-Determined Change Controls for Drugs and Devices

Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.