The Medical Industry’s Move Toward Quality, Part Four

Design control is the key to quality health care products.

Previous columns in this series discussed how the concepts of process management and risk-based initiatives are changing the FDA’s approach to medical device and pharmaceutical product reviews. We also examined the global movement toward process management and its subset, risk management, in medical device reviews and approvals, as reflected in the stated primary objective of ISO 13485:2003: “to facilitate harmonized medical device requirements for quality management systems.” In this column we’ll look at one of the most critical aspects of ISO 13485--design control.

Most high-tech industries, such as aerospace, telecommunications and medical devices, have advocated that quality must be designed into a product or process--not tested-in or built-in afterward. Indeed, most of the methodologies associated with design planning and control were introduced to the telecommunications industry before World War II and expanded and perfected in the aerospace and defense industries during the Cold War era. These include management tools such as documented procedures, documentation control and traceability as well as design techniques such as design planning, risk analysis, reliability predictions, and design review, verification, and validation. These management and technical methods complement each other. ISO 13485’s requirements and the tools of design for Six Sigma (DFSS), as applied to medical devices, are an excellent fit.

DFSS--by a variety of names--has been applied for decades in most high-technology industries, where product reliability and user safety are as important as advancing technology and leading-edge performance. The DFSS stages of define, measure, analyze, design and verify (and/or validate) describe the traditional steps applied to planning or improving any product or process. Moreover, the tools of DMADV include the essential methodologies of process control and risk management.

But in its changes to ISO 9001:2000, ISO 13485 gives some essential guidelines for the DMADV steps as they apply to medical device design. For example, under product realization planning, the standard specifies, “The organization shall establish documented requirements for risk management throughout product realization.” Later, ISO 13485 states that design-and-development planning must include design review, verification, validation and design transfer activities “as appropriate at each design and development stage.” The standard explains that design transfer activities ensure that outputs are “verified as suitable for manufacturing before becoming final production specifications.” Also, design-and-development inputs must include functional, performance and safety requirements as well as risk management outputs.

Under design-and-development review, ISO 13485 states, “Participants in such reviews shall include representatives of functions concerned with the design-and-development stage(s) being reviewed, as well as other specialist personnel.” Hence, design reviews can’t be restricted to the design team and its peers; they must also include manufacturing, quality, regulatory and customer service experts.

Under validation, there are two significant additions. First, validation must be completed prior to product delivery or implementation. Second, the organization must perform clinical evaluations and/or performance evaluation of the medical device in accordance with national or regional regulatory requirements.

From these types of additions, it’s clear that ISO 13485 is imposing far broader and more stringent design controls than the more generic ISO 9001 standard. But the tools to implement these controls have been around for a long time, grouped under a variety of names: concurrent engineering, quality function deployment, integrated design and DFSS/DMADV. But the labels aren’t as important as selecting the appropriate tools to ensure a product’s quality, commensurate with performance requirements and potential risks. Successful outcomes are always an optimized “fusion” of management models, continual improvement methods and performance assessment criteria.

If DFSS/DMADV provides the tools for medical device design and development, ISO 13485 offers a quality management model commensurate with the stringent needs of the medical device industry. In addition to mandating additional documents and records, ISO 13485 requires that for each medical device, the organization establish a file of documents that “define the complete manufacturing process and, if applicable, installation and servicing.” The design-and-development process requires risk management and design output records in addition to those already required by ISO 9001: records of design review, verification and validation, and all design-and-development changes--including the review, verification and validation of those changes.

Moreover, ISO 13485 requires that the supplier provide “any other documentation specified by national or regional regulations.” These documents and records must be retained for at least the “lifetime of the medical device as defined by the organization… or as specified by regulatory requirements.”

Process-oriented and risk-based initiatives are intended to speed up the review and approval of new medical devices while ensuring their effectiveness and safety. ISO 13485 provides a framework for this approach, ensuring the depth of documentation and records needed to support initiatives like the FDA’s Quality System Inspections Technique. Most important, ISO 13485 requires an orderly and logical design-and-development process, which can be met by applying the principles of DFSS/DMADV to the requirements of the medical device industry.

In short, ISO 13485 points the way toward globalization of the medical device industry and, by extension, the pharmaceutical industry. Some of the positive results from this will be shorter time-to-market and better, safer health care products. In subsequent articles, we’ll look more closely at the FDA’s initiatives in these areas as well as the obstacles to successfully implementing risk-based approaches.

About the author

Stanley A. Marash, Ph.D., is chairman and CEO of The SAM Group, which includes STAT-A-MATRIX Inc. and Oriel Inc. He is the author of the recently published Fusion Management (QSU Publishing Co., 2003). Fusion Management is a trademark of STAT-A-MATRIX Inc. ©2004 STAT-A-MATRIX Inc. All rights reserved.