In reality, the initial purchase price of a new bioanalytical platform is only a small part of the total cost associated with implementing that technology in the laboratory. Many factors can drive the real price of implementation higher, and a variety of barriers can make software validation more challenging than anticipated. Choosing a platform that presents more roadblocks than benefits could ultimately make the purchase not worth the time, money, and resources that are needed to ensure its appropriate implementation. As a contract research organization (CRO), our commitment to efficiency demands that we look beyond the price tag of an instrument and assess the additional investments needed to ensure its effective setup, deployment, and management. This perspective helps us ensure that the purchase is essential, strategic, and will bring a positive ROI for our organization as well as for our customers.
Investing in Technology Implementation
It is true that costs are rising for bioanalytical instrumentation; as technology is evolved and enhanced to meet increasingly complex assay demands, it also becomes increasingly costly. However, we have found that the time and expense that goes along with implementing the instrument—bringing it on site, training operators, incorporating it into the LIMS system, validating the software, developing SOPs, and providing ongoing maintenance—all adds up to far exceed the initial equipment cost. These costs need to be considered up front, well before the purchase decision is made. There must also be realistic expectations on how long it may take to actually start deriving value from the platform. Instrument and software setup might only take a month, but it could take over six months to complete the software validation and full integration with other laboratory systems. If you want to bring a new platform on board, you have to be ready to invest the appropriate time and resources in the implementation phase.
Changing Trends and the Impact on New Technologies
In addition to dealing with more complicated regulatory requirements, the whole setup of who makes technology decisions has changed significantly in the past 20 years. Compare where we are today to where we were in the late 90s and early 2000s; we have gone from an environment where most of the discovery work was done within pharmaceutical companies and only went to CROs in later stages of development, effectively mandating which platforms the CRO should use. Today, CROs are being asked to do more in the earlier stages of development, as well as carry the work through to later phases, and therefore need to think carefully about what they will be getting out of every platform they invest in. They have more freedom the select the technology they find optimal, but also more responsibility to ensure their platform suite can handle diverse assay needs, depending on what the study requires.
The Challenges of Software Validation
As I mentioned already, software validation is a consistent challenge in incorporating new bioanalytical technology and getting it up to regulatory-required standards. In our case, even if the platform vendor provides fully validated software out of the box, the validation still needs to be fully redone in the regulated environment in which we operate. This process is becoming more challenging because pharma, biotech, and CRO organizations are increasingly using platforms intended for research and discovery in the later stages of development. Those instruments were not originally built with the intent to be used in a regulated setting, and this evolution has to be taken into consideration during validation; if you have a vendor who is thinking along those same lines, it can be very helpful. And even though validation can be a challenge, it will be worth the investment if the platform can deliver the necessary sensitivity or robustness to move a promising drug forward.
The Importance of Return on Investment
There are new and exciting platforms coming out every day, and the scientist in us all wants to jump at the chance to acquire and play with each one. But, the desire for innovation must be balanced with the ROI the platform can provide. It does not have to be in a strictly financial sense; it can also be ROI in terms of how much effort had to be put in to effectively progress a study. As a CRO, we look at both of these elements very closely before making any purchasing decisions, and it has helped us to introduce some of our most innovative platforms at precisely the right time. You may ask, what is the right time? For us, it is when the platform is mature enough to bring with it a level of confidence about the quality of data it produces, and when there are enough clients out there who have later-stage work that would benefit from that platform’s capabilities.
Learn more about how BioAgilytix manages the challenges associated with implementing new technologies in the full-length Business of Bioanalysis panel discussion from WRIB 2018, featuring BioAgilytix’s Founder & Global CSO, Afshin Safavi, Ph.D.