Kevin Sheehy

Additive manufacturing is widely used in medical device development, yet many organizations still struggle to determine where it delivers real value and how to implement it reliably in regulated production. Drawing on decades of experience supporting additive manufacturing in highly regulated industries, Stratasys Direct will share how additive manufacturing can be successfully applied across the medical device lifecycle — from development through production.

In this session, we will examine common medical applications, key technology considerations, and practical approaches to achieving repeatable, production-ready additive manufacturing within ISO 13485 quality systems. We’ll also share the validation fundamentals such as the role of IQ/OQ/PQ in establishing process stability and production readiness. Real-world lessons will highlight where additive delivers the greatest impact, how to avoid common implementation challenges, and what it takes to translate additive capability into dependable, production-grade medical manufacturing with the right validated manufacturing partner.

This session is ideal for teams that are evaluating where additive manufacturing fits in their product cycle, transitioning toward production, or seeking a validated manufacturing partner for regulated medical device programs.

Attendees will leave with:
 A clear understanding of where additive manufacturing delivers value across the medical device lifecycle
 Insight into selecting the right additive technologies and materials for medical applications
 Understanding of what enables repeatable, production-ready additive manufacturing in regulated environments
 A practical view of how ISO 13485 and validation — including IQ/OQ/PQ —support reliable medical manufacturing
 Awareness of common pitfalls when implementing additive manufacturing
 Clarity on how experienced, validated manufacturing partners help move programs from concept to dependable production