In this episode of The Platform Rules podcast, host Dario Ambrosini is joined by guests Nicolle Cannon (CEO and founder, Cannon Quality Group) and Chuck Serrin (VP of MedTech & Life Sciences Industry Marketing, Propel)
As medtech experiences a period of rapid evolution, quality processes are transforming as well. Nicolle and Chuck discuss the dynamic intersection of technology and healthcare, exploring recent innovations, the role of the FDA, and the transformative potential of digital quality management systems (QMS).
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1. Innovate processes by rethinking former paper-based models.
2. Embrace systems that integrate easily.
3. Foster simplicity in digital transformation.
On Embracing Integrative Systems:
NICOLLE: "You want a solution that is more accepting of other software, more integrative, allowing people outside your organization to interact and move your data forward. When it's in a closed room, that's not progress."
On FDA Evolution:
CHUCK: "The FDA has moved faster in several regards, embracing technology. Things like CSA—computer system assurance—allow companies to move a little faster. There's just a more progressive stance now. We're seeing more companies looking to launch in the US first, before the EU."
On Innovations Reshaping Workflows:
NICOLLE: "Solutions should make you uncomfortable because they're not basically mimicking what we already do. Organizations are starting to push us out of the way we did things because we only did them that way when processes were based in paper. We don't need to do those things, check those boxes, as much anymore or have that flow anymore. We can really crack it open."
On Choosing QMS Solutions:
CHUCK: "When picking a QMS, you want something that is modern, that has real-time dashboards, real-time feedback, but also that users want to use and adopt. We have a much younger workforce today that wants these tools."