Prime Time: the Fine Line Between Innovation and Regulation

We live in an age of wonders. New technologies with new and usually improved capabilities are springing up far faster than we can keep up with them. And those new technologies occasionally revolutionize not only the field they spring up in, but other, sometimes unrelated fields. A good example of this is how tandem mass spectrometry revolutionized newborn screening (NBS). An instrument and test system once considered essentially a research tool has led the way to improving and standardizing NBS across the United States. Because this is true we must always be ready and willing to learn about the newest technology. However, sometimes it’s difficult to walk that fine line between leaping ahead too fast and not moving ahead at all.

In the laboratory field, and the medical field in general, a LOT of checks and balances are in place, many of them in the form of the regulations and controls we love to hate so much. If you are going to be possibly putting a person’s health, well-being or even life on the line, the level of checks and balances becomes totally understandable and even necessary. However, we must be careful not to refuse to see new technology because it doesn’t fit the mold of our current regulatory environment. Sometimes in order to move forward, we must reinvent the regulations as well as the technology. A good example of this was learning to deal with and regulate electronic quality control when instruments like the I-STAT were introduced to the field.

There can be an incredibly fine line between stifling innovation and having necessary and appropriate controls in place. It takes an astute eye, keen insight, and understanding of not only the new technology, but also the purpose and design of the regulations. It’s not enough to blindly follow the letter of the regulation. We must ask ourselves: What was the intent of the crafters? Why is this important? Is there a way to make sure the new technology meets the regulation? Can the regulation be reinvented to make sure the new tech does follow the intent of having that regulation in place? Next generation sequencing has been struggling to perform this balancing act since its inception. We do not wish to sacrifice neither our ability to create and innovate, nor our need for safety and “do no harm.” When an innovation enters the laboratory, we need to make sure both it and the regulations which monitor its performance are “ready for prime time.”

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

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