About this event
When Platforms Evolve – Managing Device Change in a Platformed World
Platform approaches have become a well-established strategy in drug delivery, valued for the efficiency, consistency, and scalability they can provide throughout the lifecycle of drug-device combination products. Today, pharmaceutical companies are increasingly seeking to leverage a single device platform across multiple products and biosimilars to accelerate development while reducing risk. But, as market needs change, what happens when the platform needs to evolve?
In this webinar, Dr. Nina Fetz of SHL Medical and Katy Rommel, PhD, of Kymanox will explore the practical realities of evolving device platforms while maintaining the benefits of standardization and platform-based development. The discussion will focus on assessing the regulatory and user impact of device changes, particularly those affecting Essential Drug Delivery Outputs (EDDOs) and user interfaces, while outlining strategies for bridging studies and governance controls that help safeguard sponsors, platforms, and products over time.
- Understand the opportunities and challenges associated with leveraging platform device strategies across multiple products and biosimilars.
- Learn how to evaluate the regulatory and user impact of post-commercialization device changes, particularly those affecting Essential Drug Delivery Outputs (EDDOs) and user interfaces.
- Explore practical approaches for bridging studies, governance controls, and risk management to help maintain platform consistency while supporting long-term product and portfolio success.
SHL Medical
Enable patients' independenceAs a pioneer in innovative self-injection solutions, SHL Medical enables patients’ independence through partnerships with leading pharma and biotech companies. We design, develop, and manufacture high-quality solutions, leveraging our vertically integrated capabilities and regulatory expertise.
