An approach to quality that improves company culture and fuels innovation

October 28, 2021

For a global company dedicated to delivering innovative and life-changing medical solutions, upholding the highest quality standards is essential.

We spoke with Roz Burke, senior vice president of Global Quality and Regulatory for Boston Scientific, to learn more about the global quality team she leads and how a collaborative and preventive approach to quality can increase efficiency, improve outcomes and fuel innovation.

Q: What is the role of the quality team at Boston Scientific?

The Global Quality team oversees every process and product within the company – from the moment materials arrive at the warehouse door to when our products are in the hands of our customers. It’s our job to make sure that we meet all regulatory requirements and that the highest standards of quality are upheld throughout the entire lifecycle of each of the company’s 17,000 products.

Our work requires a lot of cross-functional collaboration. We are embedded in every division, manufacturing site and region, and we work closely with the supply chain and distribution teams. Our deep engagement throughout the organization enables strong coordination throughout the product development process.

Q: What’s something that may surprise people about the quality team or the work it does?

Many people think the quality function is focused solely on compliance, but our approach goes well beyond that. In fact, our strategy includes four pillars – compliance, yes, as well as culture, agility and performance. These four focus areas provide a framework to deliver great results for our team, our patients and our customers.

Earlier this year, McKinsey released a report, Smart quality: Reimagining the way quality works, which covered a lot of what we are already doing. The findings emphasize the importance of a preventive quality culture and agile quality systems to reduce bureaucracy or administrative inefficiencies. It was very gratifying to see our approach reflected in what is considered the future of smart quality strategies.

Q: How does the quality strategy drive innovation?

Agility is our focus on reducing complexity, removing obstacles and quickly adapting to changing business needs, which helps drive innovation.

For example, throughout the R&D process, we build in phases – or checkpoints – to confirm that development is on track with quality standards. Our quality assurance teams work side-by-side with the R&D teams to make sure these checkpoints occur efficiently. We are also constantly reviewing our processes to ensure they are accessible and understandable and aren’t an obstacle for the R&D and manufacturing teams.

We also take all product performance data received from the end-user and feed it into the development cycle. As teams are working on new iterations, this feedback loop informs the design teams if our customers’ needs have evolved or if there is an opportunity to address areas for improvement.  

Q: You mentioned that culture is an important part of the quality strategy at Boston Scientific. How do you move beyond structures and standards to build a true quality culture?

Every employee must feel personally connected to the patient experience and understand their role in helping transform lives for the 30 million patients our products help treat each year. One of the ways we do this is through our annual Everyone Makes and Impact (EMAI) onsite and virtual events. At EMAI, we welcome patients and caregivers to share how Boston Scientific devices improved – or saved – their lives. It’s an emotional and powerful reminder that all employees make a difference, regardless of where we work or what we do for the company.

Our leadership team is also dedicated to upholding the highest quality standards. It’s not just something that’s talked about, we also invest in our employees – from training on our processes to recruiting and retaining top talent.

Structures and policies will always guide our quality system, but when employees are engaged in the process and feel personally invested in the impact we have on transforming patient lives, a culture of quality can thrive. 

Hear stories from patients like Charles, Pamela and Kevin, whose lives have been changed by Boston Scientific innovations.

The transcript of this conversation has been condensed for clarity.