Often I am asked, “How do you adapt to all the changes in the marketplace?”—in our case, the laboratories. We can look at that question from two perspectives: one from the equipment user and one from the equipment supplier. The lack of economic growth in the United States is often blamed on the lack of productivity gains. At least that’s what some economic analysts bring forward. From a customer perspective, however, in the last four to five years, major U.S.-based industries have held off on replacing aging production equipment with newer, innovative ones and with that have given up some significant productivity gains.
Some businesses, such as contract research organizations (CROs), are holding off with investments into new facilities and technologies until they can see where the next technological breakthroughs will take them. The same is true for research labs in the pharma/biotech sector. As long as turnaround time allows, it seems less risky to reach higher productivity by moving routine sample analysis offshore for operational cost savings.
For equipment companies, the very best way to adapt is by inducing change rather than reacting to it. It has to be by technological innovation that we bring about economic advantages, safety or convenience. There have been a few examples during my time at LEAP where we made it to market and have developed and introduced so-called enabling technologies. One specific example is complete automation of the sample workflow for hydrogen-deuterium exchange (HDX) by LC-MS. The technique is part of the drug discovery process in pharma/biotech R&D.
Other techniques have proven slow and more cumbersome. HDX is a challenging way of generating information of the tertiary molecular structures of peptides, because the series of experiments with the same sample requires precise timing of the workflow and also precise temperature-controlled hardware. One experiment can take one minute or one hour. The robotic liquid handler tightly controls, for example, 10 experiments—each with different incubation times—while the rest of the process is kept cool at a stable temperature. It requires a multiplexing, computerized management scheme. A robotic sample handler is better suited to perform this workflow 24/7 than a group of skilled lab technicians. Overnight and over-weekend runs can be maintained totally hands-off.
New technology becomes game-changer
The very nature of centralized sample processing (process-centric) has started to show some weaknesses in terms of productivity. In the past two decades, capital-intensive analytical equipment with automation required a critical mass of samples to come in on a daily basis to justify the investments. During that time, CROs for the same reason were growing and also consolidating. In addition to the return-on-investment demands in a CRO, pressure came from hospitals and doctors’ offices for analytical results of their samples to be available in minutes, not hours or days.
A recent personal experience in a European doctor’s office impressed upon me that a big change is already underway. As a patient, I was diagnosed for a hidden infection with a few in-house, but compact and sophisticated, analyzers—point-of-care chip-based instruments. A small volume of blood was retrieved as a drop by pricking my fingertip. That was fast, painless and simply very convenient. The treatment was equally efficient by dispensing the therapeutic drug at the doctor’s office. That expedience in decision-making and patient care, plus convenience and cost reduction, can be achieved by a drastic change in workflow of care (sample/patient-centric). This workflow resulted in a surprisingly low bill to me, the patient.
New compact low-cost, approved chip-based instruments will become a game changer in healthcare. Centralized sample analysis, which was for 30 years an important sales basis for rather sophisticated robotic sample handlers, will largely change in that sector.
A strictly defined workflow is the main prerequisite for any successful automation project. Customers often need help with additional justification for the price tag of new equipment. As long as the process can be repeated flawlessly many times, multiple benefits of automation will result. This means not only the obvious labor cost savings but also higher quality and performance. Higher throughput and fewer random errors are the most obvious results. Operations should expand to 24/7 hands-off.
Automation has also affected sample volumes, solvents and other liquid volumes. Higher reproducibility in dispensing and transferring liquids made reductions in volume down to microliters or even fractions of microliters standard. Manually performed liquid handling requires tools and containers that fit the limitations of a steady hand and perfect eyesight. Fatigue compromises the precision of any manual steps. Existing decade-old (or more) automation hardware might prove obsolete and needs to be replaced with the new generation every three to five years.
This poses the challenge that the equipment has to be fully amortized in a shorter period of time. In many labs, old automation equipment (over 10 years) has been kept alive, which led in many cases to giving up improvements in productivity. I have been associated with equipment from CTC Analytics that is well known for its ruggedness and flexibility. Only recently it has been replaced by the manufacturer by a new generation after 15 years.
However, the speed of change in analytical chemistry has grown much higher. With that in mind, my four axioms of automation—faster, smaller, more precise and simple to use—can’t be met over such long periods of time. Research in biotech and pharma is driven by the economics of speed to market for new drugs and compounds. Samples of synthesized biologicals are extremely valuable and are available only in small amounts. Therefore, analyses of such sample-limited compounds have become the newest projects with special challenges.
Equipment service/repair has to be eliminated
Lab equipment should never need service. Or if it’s needed, it should be fixable with spare modules or equipment that can be exchanged by the user. Downtime is just not acceptable for automation equipment.
When we look at today’s automobiles and their service, it’s pretty much planned for the car’s useful life in periodic 5,000-mile or 15,000-mile intervals. Periodic performance management that includes inspection of wear-and-tear should be all that’s needed for lab equipment. The person that comes with a toolbox to the customer site should soon be something of the past.
Lessons that we have learned are in two categories. One is in modular and simpler designs for hardware and software. The other is self-diagnostics. Support and service in itself can be automated to provide accurate information and trigger a module or part to get on its way to the end-user location right away. Cross-trained sales/support personnel with a complete know-how is a real topic again. This model takes advantage of fewer people that are traveling.
Detector technologies represent a clear driving force in the analytical chemistry world. Miniaturization of detector systems has accelerated and is getting more digital. It will induce dramatic changes as to how we collect information to diagnose events in fields such as healthcare, forensic, environmental and food safety. Chip technology will unite liquid handling and detectors in many application areas. Complete paradigm shifts are to be expected in the next decade and the sample handling needs will change with them.
We can’t wait and adapt to new detector technologies. If possible, we should enable changes to be more efficient and aid rapid detector technologies. Those that hide behind old traditions, old regulations and guidelines will ultimately be forced to change under the rapidly increasing pressure for higher productivity and convenience. I choose to induce change rather than react to it.
Werner Martin is senior business development engineer at Trajan’s LEAP Automation Group. He was a founder and owner of LEAP Technologies (acquired in 2016 by Trajan Scientific and Medical) since 1989 and also a founder of Tecan US in 1981. Both companies have offered and continue to offer lab automation to clinical and analytical chemistry applications. Werner was essential in developing both Tecan’s and CTC Analytics’ acceptance in the U.S. market.