MTQS Guest Header_SparkBiomedical

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.

 

Links:

Spark Biomedical

FDA - Medical Devices

483 Observation

ISO 14971

Greenlight Guru

 

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

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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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