Closing the Blind Spots: Designing Device for the Real World

Overview

Building defensible evidence for a medical device requires more than controlled testing. This panel session, featuring CEO Kelley Kendle alongside experts from 3Aware, Dassault Systèmes, and Canon Medical Informatics, examines how human factors, real-world evidence, in silico methods, and regulatory strategy can be applied early in the product lifecycle to reduce risk, improve adoption, and support regulatory success.

Key Topics Covered:

• Human Factors Integration (Kelley Kendle, ClariMed) — Why engaging usability engineering early prevents costly design lock issues and accelerates market entry

• Real-World Evidence Applications (Amelia Hufford, 3Aware) — How early RWE uncovers patterns invisible in controlled environments and strengthens regulatory submissions

• In Silico Modeling (Steven M. Levine, Dassault Systèmes) — Using virtual environments to test device performance before prototyping, reducing reliance on animal and human testing

• Regulatory Strategy (Jay Vaishnav, Canon Medical Informatics) — Balancing business needs with regulatory requirements through strategic data-driven decision making