Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it takes to break the pattern.
Shawn and Nick get into the learned behavior behind the roadblock stereotype, why quality's timeline never gets extended, the memo-to-file versus special 510(k) trade-off, and the difference between a compliance gatekeeper and a strategic risk advisor.
A few of Shawn's key takeaways:
The quality roadblock and the R&D cowboy are learned behaviors, and each one justifies the other
A regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive response
If quality is afraid of FDA, R&D takes the cue. Don't ask the agency what to do, but you can share what you plan to do
Quality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the schedule
Quality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan instead
Trust is built outside the meeting, over time, and you can't assume it when you walk in the door
Don't blindly defend your own team. A leader who lets their group go down the wrong road to protect the quality seat loses trust fastest
About Shawn Fuller
Shawn Fuller spent more than 24 years at Surmodics, joining as a regulatory manager and rising to Vice President of Quality, Regulatory and Clinical Affairs. She built the quality and regulatory infrastructure supporting Class I, II, and III devices and served as program director for a Class III device from concept through commercialization. She previously held regulatory roles at Protein Design Labs and conducted transplant research at the University of Minnesota. She is now semi-retired.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
