Christopher Delporte10.20.06
Tackling the Quality Equation
Third MPO Summit Examines the Many Factors
Critical to Product Quality
Christopher Delporte
Group Editor
Maintaining quality. It’s a broad subject, particularly when you examine it in the context of manufacturing. The focus gets a little sharper when you zoom in on outsourcing in medical device manufacturing, but it’s still a pretty big picture. And as outsourcing companies respond to the speed of innovation within the medical device sector (both the device and outsourcing industries are expecting 10%-12% growth over the next 10 years), keeping quality initiatives on track becomes an increasingly daunting prospect.
The goal of the third MPO Summit, held Sept. 25-26 at the Hilton Hasbrouck Heights in New Jersey, was to examine the many different methods OEMs and their outsourcing partners employ to ensure top-notch quality throughout the product development and production processes. Speakers examined the quality question with presentations including outsourcing success stories, global supply chain issues, liability risk management and outsourcing in China.
The MPO Summit provided ample time for networking—not to mention time for attendees to discuss what they learned during the conference sessions |
“Outsourcing should be a true partnership, and it is everyone’s responsibility on the quality side,” he said.
Tom Black, vice president of OEM Sales & Marketing for B. Braun’s OEM division echoed Blank’s comments. While a “womb to tomb” approach—finding an outsourcing partner who can provide full-service product lifecycle support to an OEM—is a growing trend, he said, “sometimes quality is about finding that one supplier who has expertise in a certain area and does that well.”
Michael Kagan, vice president of operations at Immunicon, based in Huntingdon Valley, PA, discussed how his company realized the value of outsourcing early in the development of its cellular diagnostic product line. The company was able to deliver a quality product in less time and at a reduced cost because outsourcing partners allowed Immunicon to focus on its core competencies—the software and reagents behind its diagnostic technology.
“Quality often is about knowing where your strengths are. We’re not about the nuts and bolts,” Kagan explained. “Non-core distracts us from making ourselves different. We knew someone out there could do the manufacturing better than we could.”
David Malpiedi, vice president of global business process for Becton, Dickinson and Company, described how his company’s overall quality initiative is driven by a guiding corporate coalition including its supply chain, manufacturing, information technology, quality, regulatory and financial departments. He described how the $5.4 billion manufacturer of syringes and diagnostics began a “change in its corporate culture” to reduce inefficiencies, improve process management and get different departments and management levels to “buy into and understand” how the larger pieces of the manufacturing process fit together, ultimately to deliver a quality product.
Don Young, senior vice president for Quality Assurance at Fort Worth, TX-based Avail, agreed with Malpiedi’s company culture-as-a-driver argument. “You must establish a culture that supports a quality system and communicate it deep into the organization,” he said. “The people in the organization really bring the quality systems to life. You can have a great process on paper, but if you can’t bring it to life, it doesn’t mean much.”
If quality systems within an organization—particularly for contract manufacturers that often have many different clients with myriad requirements, specifications and product types—aren’t changing and evolving constantly, they’re not effective, Young explained.
To help keep costs low, more companies are evaluating the risks and rewards of overseas manufacturing. And no discussion would be complete without mentioning Asia. Ames Gross, president and founder of Bethesda, MD-based Pacific Bridge Medical, a medical consulting firm focused on the Asian marketplace, discussed the opportunities and challenges of medical outsourcing in China.
Gross said Chinese manufacturing is becoming more sophisticated and product quality has increased dramatically, but US companies still must be cautious about the kinds of products they choose to manufacture in China, focusing on less technical, higher-volume products.
Intellectual property protection lacks enforcement and is “one of the most difficult challenges in doing business in China,” he added. For companies that decide to make the Pacific leap, Gross advised taking the time to learn the culture and build relationships.
Considerations other than supply chain and process management also factor into the quality equation. How well a company prepares for quality can affect its legal footing, according to Kevin Quinley, senior vice president of the Medmarc Insurance Group in Chantilly, VA.
“Companies get into trouble when they place budget, financial and scheduling considerations over quality,” he said. Quinley urged attendees to have a “rigorous” quality assurance program in place because of the “formidable tort and litigation climate” that currently exists in the medical technology sector.