The medical device industry is facing increased challenges such as cost constraints, decreased spending, and new regulations. Paul Arrendell advises that companies must promote a culture of quality by understanding regulations, validating processes, making quality decisions, and integrating quality throughout the business. He discusses seven strategies for building a quality culture, including design and reliability engineering, robust post-production monitoring, supplier management, quality metrics, incorporating quality into roles and incentives, and learning from other companies' mistakes. Arrendell was speaking at the marcus evans Medical Device Manufacturing and R&D Summits in June 2014.

1. “The medical device industry is changing quickly as a result of increased competition, globalization, cost constraints,
decreased customer spending, demands for efficiency, new and revised international regulations, supply chain complexity,
and product and process changes as part of cost control and continuous improvement,” says Paul A. Arrendell, Vice
President, Global Quality, Kinetic Concepts, Inc.
“In this changing environment, it is incumbent upon companies to enhance current practices that adapt. Knowing the
regulations and compliance requirements and following the standard operating procedures is not enough. To succeed,
companies must understand and be able to interpret international regulations, implement (a.k.a. validate) processes and
technologies, make sound decisions about quality, and drive business benefit. Quality is everyone’s job, from production
floor workers to senior executives. Companies must promote a Culture of Quality that permeates the organization,” he
advises.
A speaker at the marcus evans Medical Device Manufacturing Summit Spring 2014 and the Medical Device R&D
Summit Spring 2014, taking place in Las Vegas, Nevada, June 26-27, Arrendell discusses some areas where such a
culture may begin, portions of which are from the FDA’s “Understanding Barriers to Medical Device Quality” (October 31,
2011).
Design and reliability engineering. Conduct validation with production parts, utilize design-for-reliability and
manufacturability, and ensure testing robustness for software. Use tools like Robust Parameter Design (Taguchi Method) to
help with developing products and processes that perform as intended for a wide range of user’s conditions throughout the
product life cycle.
Robust post-production monitoring and feedback. Implement a strong Post Market Surveillance program that
incorporates both proactive and reactive methods to understand how products perform on the market. A sophisticated
program not only follows a company’s own products, but also reviews competitor products through international adverse
event reporting and registries.
Supplier management processes. With complex supply chains, knowing what suppliers and critical sub-contractors
provide and having insight and approval to process changes are key to product quality and to continued regulatory
compliance.
Quality metrics and measurement systems. Move beyond compliance measures and drive to continuous improvement.
While there are regulatory requirements to track product quality, it is important to include metrics that enable measurable
process improvements.
Quality organization. Integrate quality throughout the business. Get rid of the “gotcha” mentality; focus on both
improvement and compliance.
Performance management. Incorporate quality metrics for key roles associated with quality outcomes, like design
engineers, as part of yearly objectives and provide incentives around the company’s quality performance.
Quality culture. Be on the look-out for other companies’ challenges and learn from their mistakes. Trawl for information
where companies have experienced severe quality, regulatory, and compliance issues to make your own improvements.
7 Strategies for Building a Culture of
Quality in Manufacturing
Paul A. Arrendell, a speaker at the marcus evans Medical Device
Manufacturing Summit Spring 2014 and the Medical Device
R&D Summit Spring 2014, on building a Culture of Quality.
Interview with: Paul A. Arrendell, Vice President, Global
Quality, Kinetic Concepts, Inc.

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