Meet a GURU: Jesseca Lyons
Jesseca Lyons, a Senior Medical Device Guru at Greenlight Guru with a mechanical engineering background from Rose-Hulman and experience at Beckman Coulter, discusses the critical role of design controls and risk management in medical device development. She explains how she transformed her view of risk management from a tedious burden into an engaging process by using relatable analogies like ice cream and Sharknados to explain probability and hazardous situations. Lyons emphasizes the importance of documenting design decisions early to avoid costly remediation and shares her passion for helping customers navigate audits and regulatory hurdles to improve patient quality of life.