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.
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“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
MedTech True Quality Stories Podcast, powered by Greenlight 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.
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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...