Closing the Blind Spots: Designing Device for the Real World
Closing the Blind Spots: Designing Device for the Real World
Date:
Sep 18, 2025
Presenters:
Kelley Kendle
Hosted By:
MedTech Leading Voice and Project Medtech
Overview
This recording features CEO Kelley Kendle alongside three other industry experts in a panel discussion exploring how to build defensible evidence from early design through post-market deployment.
The session examines how human factors and usability engineering, real-world evidence (RWE), in silico methods, and regulatory strategy can be applied early in the medical device product life cycle 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
Overview
This recording features CEO Kelley Kendle alongside three other industry experts in a panel discussion exploring how to build defensible evidence from early design through post-market deployment.
The session examines how human factors and usability engineering, real-world evidence (RWE), in silico methods, and regulatory strategy can be applied early in the medical device product life cycle 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
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