The Early Years
The mechanical pipette (micropipette) was invented in the early 1960s and has historically become one of the most significant laboratory tools over the last 50 years. It was further developed into an adjustable micropipette in 1972. At this time, there were limited service options for pipette users, as pipette manufacturers initially guided customers toward replacement pipettes. While clinical laboratories were dominated by the MLA brand; Eppendorf, Gilson Pipetman® and Finnpipette® dominated the R&D laboratories, and new brands ensued. The pipette calibration market had yet to develop, as pipettes were mostly sent back to their manufacturers for repairs, which included lengthy turnarounds. Scientists then were at a disadvantage, as pipetting accuracy and repeatability remained largely unchecked, and laboratory procedure had to accommodate wide tolerances.
In the 1980s, as pipette manufacturers continued their pursuit of pipette sales revenues, they also offered calibration services, but again with lengthy turnaround times. This opened the door for independent traveling pipette service providers, who surfaced, offering the ultra-convenience of onsite measurement and maintenance services. Although unregulated, substandard and unchecked, these onsite providers changed the pipette service landscape. With these services, the lifecycle of a pipette were extended and these onsite service providers flourished. The pipette market continued to grow and these onsite service providers thrived. Recognizing this opportunity, manufacturers began to expand their calibration and repair services, even accepting other pipette brands for calibration and repairs.
With the increase of independent pipette service providers, replacement parts became a precious commodity, and service providers competed fiercely for pipette calibration and repair services. Rainin, Brand, Oxford Benchmate™ and Biohit were a few of the now prominent brands in the U.S market and the race was on. Pipette manufacturers even turned to limiting the availability of their pipette parts, as a way to control the competitive landscape of the pipette service market.
Introduction of Standards
As the 1990s rolled around, laboratory emphasis on metrology (the science of measurement) expanded and FDA (Food and Drug Administration) regulators began enforcing tighter controls over testing and calibration standards. Since FDA approval was the objective of most scientific laboratory organization, those regulated laboratories were accountable to manage, control, monitor and document the performance of their test equipment, including their pipettes. Pipette service providers were subsequently being required to meet the regulatory requirements of their regulate customers and demand for calibration accreditation to the competency standards, ISO 9000 or ANSI Z540 for manufacturing labs and ultimately ISO 17025, gained momentum in a race to market.
Many labs continued to operate below the regulations and remained unaccountable to the requirements and uninformed about quality benefits these standards were providing. Scientists and managers, who had grown accustomed to the onsite pipette services, became increasingly curious about the validity and integrity of these traveling providers, as these competency standards and published methodologies circulated the scientific community.
A market divergence was being created for laboratory managers, one which still remains today. While the quality, compliance and controls of a standards-based calibration was on the rise, the convenience and low price of a traveling onsite pipette service provider continued to draw the interest of basic research labs, who were not held to any compliance standards. With little perceived risk, lab managers were less interested in the shortcomings of onsite pipette services and the risk to their science. Instead, they continued to value the convenience and low pricing available from an onsite service provider, accepting lower and lower price bids.
By the end of the decade, many independent pipette calibration service providers, who were attracted to the regulated laboratory market, began seeking accreditation to the new ISO 17025 standard. This new standard was designed to provide testing and calibration laboratories an unbiased, verified compliance of service competency. Accredited pipette calibration labs became the provider of choice for regulated laboratories, to meet their growing quality assurance programs. Unaccredited pipette providers were no longer capable of meeting the needs of the regulated lab market.
Still, with few barriers, little overhead, no oversight and seemingly limitless revenue streams, traveling pipette service providers thrived. New outfits popped up regularly. From 1-man service units to small armies, they arrived at academic laboratory facilities, each with a suitcase and scale in tow, moving from move lab to lab and soliciting low priced service and ultrafast turnaround. Oversight was absent and access to these facilities was unimpeded.
On September 11, 2001, the world changed…