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 building 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. Some of the highlights of the show 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.