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January 17, 2019

Christopher Kim, MD, Talks Managing Risk in Medical Device Development

On Wednesday, January 30th, at 1 p.m. ET (10 a.m. PT), Christopher Kim, MD, User Research Manager, Medical, joined Cary Bryzek, Principal Solutions Analyst at JAMA Software to present a Virtual Lunch & Learn called “Accelerate Medical Device Development While Reducing Risk.”

With a majority of FDA recalls attributed to human factors or use error, managing risk through traceability is vital to the success of medical device development. Mitigating design-related problems that contribute to unsafe or ineffective use is critical to overall risk management and speed to market. 

Christopher Kim’s 
perspective on the importance of medical device-related user research is enriched by his medical background — he spent nearly nine years as the University of Pennsylvania’s Penn Medicine’s sleep medicine research and development director. He shared best practices and case studies from Bresslergroup’s design and user research team to show how to help uncover risk and improve product performance by integrating usability research throughout the product development process. Cary Bryzek demonstrated how JAMA Software helps medical device developers manage requirements, risk, testing and project volatility to ease the path to compliance.

Attendees learned how to build a robust usability engineering plan based on regulatory guidance and medical device industry best practices, and more. 

About Jama Software
Jama Software brings innovative analytics, solutions and insights to companies creating complex products and mission-critical software systems. With expanded product and service capabilities, the Jama Product Development Platform empowers large enterprises to accelerate development time, mitigate risk, slash complexity and verify regulatory compliance.

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