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13 October 2026 6:00PM EDT
Abstract: Same test. Different molecule. Repeat. If your combination product development feels like Groundhog Day—waking up to prove the same device performance again, living through the same review meetings, having the same leverage conversations that never quite stick—you’re not alone. As portfolios scale, the program-by-program approach becomes a trap. Each new molecule triggers redundant work, inconsistent rationale, and no coherent baseline to build from. The challenge isn’t efficiency—it’s the absence of a systematic way to determine what can be leveraged and what genuinely requires novel development. Without deliberate architecture, February 3rd never comes.
This session explores a platform library strategy for keeping design assets molecule-agnostic wherever technically justified. The presenter will share early experiences building platform asset libraries that span design inputs and selected outputs, establishing defined design spaces that allow programs to configure rather than recreate.
Central to this approach is a decision framework—a way to finally answer “can we leverage this?” with criteria rather than gut feel. But here’s the twist Phil Connors would recognize: the technical architecture is the easy part. The harder work is changing mental models, governance processes, and organizational habits.
This session addresses strategies for combating “this is how we’ve always done it” resistance, gaining alignment in committee-driven organizations, and evolving governance from “review everything” to “focus on what’s truly different.” This work is still maturing, and the session invites dialogue. Attendees will leave with questions to challenge their own Groundhog Day—and a vision for what February 3rd could look like.
Bio: Joe Rayes is a Senior Principal Systems Engineer and Systems Portfolio Architect at Eli Lilly and Company, where he leads platform systems engineering across Lilly’s device platforms within Device Delivery and Connected Systems. With more than 25 years of experience, Joe has guided platform, System of Systems (SoS), and systems engineering programs from innovation through regulatory submission and product launch, and has built cross-organizational technical collaboration across siloed teams and external partners.
His work centers on platform-based design control for drug-device combination products, including requirements engineering, verification and validation strategy, and risk management. He also champions practical AI enablement for engineering teams. A Charter Member of the INCOSE Crossroads of America Chapter, Joe has served as Secretary and Board member and is the chapter’s 2026 President. He has also served on the INCOSE National Events Committee and is Technical Program Chair for the INCOSE Healthcare Working Group’s HWGSEC 2027 conference.
Outside of work, Joe enjoys spending time with his family, serves as an adult leader with Scouting America, and performs live music on cajon, acoustic guitar, and vocals.
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