On this episode of the Life Sphere podcast, host Kathleen Brunner talks with Marnie Smith, Senior Director of Quality at Network Partners, about her career journey from aspiring doctor to engineer and how it led her to work in the medical device industry. Kathleen and Marnie discuss the role of quality in improving patient outcomes and emphasize the importance of not overcomplicating it. They also delve into the impact of digital transformation on quality, including Quality 4.0, and highlight the need to bridge the gap between software engineers and quality engineers. They further discuss how the pervasiveness of computer applications and the shift to Software-as-a-Service (SaaS) is affecting validation requirements and requiring greater resources to maintain compliance. Finally, Kathleen and Marnie consider possible solutions, from partnership opportunities to a move towards forward-thinking, while maintaining GxP best practices and bringing safe products to patients. With over 15 years of medical device experience, including design, project management, supplier quality, and manufacturing impacts on quality, Marnie's extensive background provides support and leadership to Network Partners and their clients.