Is Compliance a Part of Quality?

"You could be fully compliant and still unsafe. You could be fully safe and not compliant, and so compliance obviously matters," he says. "We like to say that there's a base level of talent in the organizations...that you just have to have", Bellachek adds. 'If you don't have antie, without that talent, there are other places for you to pursue excellence'

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How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space.

Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market.

Some of the highlights of this episode include:

Dan describes quality through culture as a way to move beyond compliance to get true buy-in and engagement throughout your organization.
Quality through culture is like a three-legged stool consisting of people, business, and quality. The three legs must work together and learn from mistakes.
Dan’s definition of quality depends on industry. In the medical device space, quality aligns with risk and safety. A risk-based approach is needed to understand the harm that will ultimately happen to someone using your device.
Compliance obviously matters, as much as safety. A medical device could be fully compliant and still unsafe, or it could be fully safe and not compliant.
Team Effort: A high-performing organization needs a dedicated leader and excellent talent. If you’re teachable, there’s always hope. Also, even if you can’t hire perfectly, you can fire perfectly.
The culture of quality management can be considered a partnership or the police. Create a process, not a problem for people to conduct reviews.
Instill quality and get people to say ‘yes’ by creating and crafting a culture-forward company for people to be ready for anything at any time.
Dan wrote the book, 28 Days to Save the World, which details how Velentium partnered with a small medical device company and large vehicle manufacturer to increase emergency ventilator production.

Memorable quotes from Dan Purvis:

“In our space, quality really, really aligns itself well with risk and safety.”

“Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.”

“You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.”

“The only rules in this company should be rules that are inspiring.”