Within the medical device industry, there’s a right way and a wrong way to address quality and compliance.
Today, our guest is Daniel Powell, CEO of Spark Biomedical, a startup supporting the development of non-invasive neurostimulation systems. Daniel’s been working in the medical device industry for almost 20 years and shares stories that led him to shift his mindset and focus more on quality.
“Experience is what you get when you don’t get what you want. Unfortunately, you find yourself with the FDA coming in with lots of changes.” - Daniel Powell
“It was one of the worst things I ever went through, but also one of the most valuable things for my career to have a higher quality IQ on what can go wrong.” - Daniel Powell
“(FDA warning letter) It’s extremely disruptive when it happens because it stops everything.” - Daniel Powell
“We’ve put that patient at the center of the risk universe. Understand the patient perspective first, and use that as your guiding force.” - Jon Speer
ABOUT MEDTECH TRUE QUALITY STORIES PODCAST
MedTech True Quality Stories Podcast, powered byGreenlight Guru, takes listeners on a storytelling journey through personal narratives of MedTech executives who offer real-world, actionable advice to industry leaders for guidance towards future imagination, implementation, and innovation of True Quality medical devices.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...