This video covers our managing director Travis Smith and Arif Iftekhar, VP R&D, discussing the outcome of Square-1 Engineering's recent online poll covering a crucial product development question:
What is the best way to predict medical device product failures on the bench before entering clinical trials?
Other notable comments from this online poll included:
Glen Rabito - Director Engineering: "get real about your pre-DV testing, it's not a check the box exercise. Perform as much pilot clinical work as time and money allows prior to starting your trial."
Jason Safabash - VP R&D: "Ensure inputs accurately reflect device safety and efficacy requirements and test early/ fail fast and feedback into development to reduce the risk of failures during verification or validation testing."
Jahnavi Lokre - COO: "definition and understanding of clinical user needs is key to the success of a clinical trial. Couple with a robust risk management process and pre clinical testing will provide confidence on the safety and efficacy of your medical device."
For more poll insights go to: https://www.linkedin.com/feed/update/urn:li:activity:7036389649199636480
About the Author
Travis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.