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Have you considered testing the medical manufacturing waters? Make sure you understand the quality 
issues involved before taking the plunge.

Cynthia Rancourt

February 10, 2011

5 Min Read
Learning to swim as a supplier in 
the QbD waters


With the regulatory push toward the concepts of Quality by Design (QbD), OEMs are expecting a lot more from their contract manufacturing organizations (CMOs) and their contract research organizations. Over the past four years my company, with its independent laboratory testing facility, has seen a significant increase in onsite audits by medical clients who now are required to prove their suppliers meet their quality/compliance requirements. At the same time, we have met the increased compliance requirements through ISO/IEC 17025 accreditation, GMP Gap analysis by an FDA expert, and companywide GMP training of lab personnel, including risk management and method validation (two large components of the QbD process).

For medical parts processors, quality must be in their DNA. Jeff Somple, president of Mack Molding Co. (Arlington, VT), says the first person he would hire when moving into the medical field is a quality manager. Medical accounted for only 1% of Mack’s revenue in 2000 but now it accounts for just over 30%, and the company expects it to be 50% in a few years.

For medical molding, he relates, “Quality must be first, second, and third.” When referring to the transition to the medical market, Somple states, “The water is fine, but it’s also 10 ft deep and there’s no lifeguard, so you’d better know how to swim.” Plastic molders and compounders need to understand the high expectations and requirements of the heavily regulated medical products markets.

Chief marketing officers and chief risk officers must raise the bar in their companies with their level of technical, scientific, and regulatory sophistication as OEMs are putting a greater emphasis on partnering with their suppliers earlier in a product’s life cycle. Adopting the QbD concepts found in the International Conference on Harmonisation (ICH) Q8, Q9, and Q10 is a good business strategy. The ICH brings together the regulatory authorities of Japan, Europe, and the United States to discuss the scientific and technical aspects of drug registration.

According to Wynn Bailey, partner in the life-science advisory practice at PricewaterhouseCoopers, “QbD presents a real opportunity for companies to achieve dramatic improvement on the front end of the product life cycle by reducing process development and scaleup time, and further down the road by reducing ongoing manufacturing costs.” A supplier must understand the critical requirements of the product it supplies and how its product is being used.

In the last five years, at medical device symposiums, workshops, and conferences, and in technical articles, leaders in the field repeatedly have spoken of the importance of building a close partnership with suppliers. Unfortunately, little is ever spoken about how this relationship actually happens. Branding initiatives, successful quality audits, and extensive marketing tactics are all valid components of a supplier’s strategy in building partnerships with OEMs, but they are not the heart of the matter. The bottom-line question remains, “What is the expertise a supplier must bring to the table for successful development of the client’s product through its entire life cycle?” Again, it’s your DNA—what you as a supplier are really made of—that matters most.

Suppliers must have an integrated quality system focused on continuous improvement. The supplier must possess technological expertise in the area of its product/service. And suppliers must continually learn more about the market areas that their products serve.

Making QbD come to life 
in your company
The supplier’s quality system must incorporate a good understanding of the U.S. Food & Drug Administration (FDA) QbD initiative that is now a reality in the medical market. “In essence, QbD is a systematic approach to attaining desirable quality through careful evaluation of all attributes that characterize product quality, from early development through the entire product life cycle,” explain Russ Soma and Andrew Signore of Somma Tech Consulting & Integrated Product Services.

During the design phase, understanding the product, including common cause variability and variation of the process, applying risk analysis in the process development, and the use of statistical tools for validation of processes, are key components that make QbD work for the OEM’s product development. 

Expertise is not simply a collection of information. Expertise must be knowledge and experience combined. Recently, during onsite compliance audits, clients have made it clear they are also auditing our capabilities and other potential areas of expertise. We always jump at the opportunity to establish partnerships with clients by sharing areas of expertise. A company culture can foster growth in expertise through internal presentations, mentorship, and bringing in outside experts.

Employees’ goals and objectives can include growth goals in product-related areas. Internal auditing and management reviews are some of the tools that can determine areas for growth in expertise. And strategic hiring of expertise can add knowledge and experience in areas targeted for growth.

Finally, a supplier must expand its knowledge base to include familiarity with the needs in the market areas for their product. Simply put, you are better at meeting the client’s need when you understand what the needs are—and the client is not always able to fully communicate its needs.

Know your market areas! Clariant Masterbatches recognized the need to provide increased support to the medical sector. Steve Duckworth, head of the consumer goods and medical market segments at the supplier, comments, “The medical sector’s need for a higher level of support than traditionally provided by compound and masterbatch producers led us to rethink our approach.” The company designated selected facilities to serve medical with its  color and performance masterbatches and compounds, helping its customers more easily comply with regulatory requirements.

So how does a supplier swim successfully in 10-ft-deep waters without a lifeguard? Be prepared to meet the increased expectations and quality requirements of the OEM. There is no doubt that applying the QbD concepts to product development in the medical sector requires investing in more expertise, quality, and market sector knowledge early in the product life cycle. The investment will result in long, profitable relationships between the OEM and supplier. Even more importantly, the partnership of the CMO and OEM during the design phase of the product can produce a higher-quality and safer product for the market.

Cynthia Rancourt is the director of business operations at independent testing firm Polymer Solutions Inc. (Blacksburg, VA). Edited by Matt Defosse.

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