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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Some of the Episode highlights include:
- From FDA warning letters to lots of changes, companies face challenges when trying to fix their quality management system (QMS).
- From such experiences, Daniel developed a higher quality IQ on what can go wrong and how critical thinking skills put a QMS back on the right track.
- Believe that it will happen someday. FDA does an inspection and gives you a warning letter, which is disruptive, stops everything, and takes years to resolve.
- You may get a 483 observation; you’re one-and-only chance to prevent a warning letter. Take it seriously, provide a response, and learn from it.
- There’s a difference between being compliance vs. true quality focused. Don’t use your own terminology and reduce engineers’ cognitive load.
- FDA submission, audit, complaint, and other items always come back to risk. Implement a risk management system that works.
- Trying to manage risk can get out of control. Embrace spirit and definition of 14971, and understand the patient perspective to use it as your guiding force.
- You have a responsibility to improve quality of life. Do the right thing as you design and develop. Also, learn from others and refresh your knowledge.
FDA - Medical Devices
Memorable Quotes from this episode:
“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 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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