Disruptive Innovation in Laboratory Medicine.

Over the last 5 decades, laboratory medicine has witnessed a remarkable wave of innovations that transformed the field from a peripheral to a central player in healthcare delivery. These advances enabled the introduction and performance of new tests on a large scale, some in a decentralized setting, in an accurate and a precise manner, thus leading to better diagnosis, more accurate prediction of disease prognosis, and improved patient management. This evolution was the result of both sustaining and disruptive innovation, the latter being a new concept, technology, product, or process that is at first inferior to an existing one but with time it improves, becomes superior to it, and eventually replaces it. Some examples of disruptive innovation in laboratory medicine include continuous flow analysis, dry reagents on dipsticks, pregnancy home testing, PCR, point-of-care testing, and use of MALDI-TOF mass spectrometry for pathogen identification. Although sustaining innovation steadily drives progress, paradigm shifts usually occur only with disruptive thinking. With the escalating cost of healthcare and the prediction that it will soon reach 20% of the annual GDP in the US, bold measures and disruptive approaches in delivering effective and economical clinical laboratory testing are more needed than ever. In this Q&A, a group of inventors, entrepreneurs, and cutting-edge scientists share their views on sustaining and disruptive innovation in laboratory medicine.