The Early Years: The Advent of a Total Quality System

Originally Published MDDI August 2004

Reflections



Medical manufacturing benefited from the critical methods developed for military and aerospace, leading to sophisticated devices such as pacemakers and biological sensors.

Allen M. Hans

I was speaking one day with a neighbor who had just returned from a conference in San Francisco. The conference featured medical devices. At that time, I was working in the medical device field in the San Fernando Valley of Los Angeles. My neighbor was Clay Camburn, one of the founders of Canon Communications and the publisher of MD&DI magazine. Clay asked me if I was interested in writing an article for the inaugural edition. The article was titled “A Total Quality-System Approach to Devices” and appeared in June 1979.

Now that 25 years have passed, it is amazing to me how far the industry has developed in that span of time. The U.S. Congress passed Public Law 94-295, which amended the Food, Drug, and Cosmetic Act to address medical devices. The amendment became effective on May 28, 1976. Two years later, FDA implemented the good manufacturing practices (GMPs) regulation under 21 CFR Section 820. The GMPs identified the essential elements required by FDA for a manufacturer's quality assurance program.

Advances in Manufacturing

The nature of medical device products and the methods developed during the 1970s and 1980s were, in part, a result of the needs of the aerospace and military electronic industry during the 1950s and 1960s.

Prior to the 1950s, design, development, and manufacturing of electronic products were based on the technology of vacuum tubes and discrete components. The products were large and cumbersome. Electronics were powered mostly by standard electrical-generation power systems. In those days, commercial manufacturing was using the hopper method of manufacturing. The hopper concept consisted of putting large quantities of components and products in a hopper at the beginning of the manufacturing process and discarding rejects throughout the process until the few good ones reached the end of the line, where they were packaged and shipped. The need for change in the manufacturing process was driven by the demand for military products of good quality, large quantities, and predictable performance. Rigorous requirements were imposed on manufacturers of communication and navigational electronic equipment that had to be reliable and interchangeable in the field.

During the 1950s, military rocket and aerospace programs demanded a higher level of performance, quality, and reliability to accomplish the goals established for these expensive and mission-critical applications. These exacting requirements led to the development and availability of highly reliable, small, rugged, and durable components and materials for use in medical devices.

Emerging Medical Technologies

We in the medical device field were the beneficiaries of these innovations and of the criticality of the requirements. The development of analytical methods and scientific techniques had made it possible to address areas of emerging technology that were not possible previously.

One such example was the development of a high-reliability cardiac pacemaker by The Johns Hopkins University Applied Physics Labora-
tory (APL) in 1969. This innovative device used concepts that had originally been developed for aerospace satellites. The entrepreneurial expertise of Alfred E. Mann, in concert with APL, resulted in the development of a new concept in pacemakers—the long-term rechargeable pacemaker with a life span of 30 years.

This development occurred during a time when the typical pacemaker battery life was 9–12 months, and the patient, therefore, required implantation of another device when the battery failed. The company, Pacesetter Systems Inc. (now St. Jude Medical), manufactured this aerospace innovation. Similarly, many of the materials used in implantable devices today are a result of the transfer of aerospace technology.

The development of sophisticated and complex medical devices (e.g., CT scanners, MRIs, cardiac and other pacemakers, cardiac defibrillators, patient monitors, ultrasonic devices, biological sensors, in vitro diagnostics, etc.) have been the result of the so-called high-rel methods developed during the 1950s and 1960s. These methods relied on analytical tools such as fault-tree analysis, failure modes and effects analysis, reliability assessment, risk analysis, and human engineering for user-friendly applications to ensure that we developed and implemented “a total quality-system approach to devices.”

The Next 25 Years

It is exciting and rewarding to be involved in the evolution of technology. The past 25 years of innovation, expansion of concepts, development of new technology, and entrepreneurial endeavor have taken our industry from its infancy into its adolescence. The next 25 years will advance medical devices to unimaginable heights as the industry develops into adulthood. MD&DI will surely be there for the industry's next 25 years. 

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