Behind the scenes at hospitals, health centres and private facilities all over the world, hundreds of thousands of medical laboratory scientists and technicians are quietly working to provide the millions of test results that keep global healthcare running each year.
But despite the central role played by diagnostic labs in the wider healthcare sector, it’s a system rife with inefficiencies and capacity issues. On top of the technical limitations of laboratory equipment, which can cause bottlenecks and delays, there is an ongoing shortage of qualified laboratory staff that is compounding the issue.
In the US, for example, the Department of Labor and Statistics predicts a future shortfall of more than 150,000 clinical laboratory scientists, exacerbated by a wave of retirements that will see a host of qualified personnel leave the workforce in the coming years. Around 5,000 American lab professionals are entering the labour pool each year, less than half of the approximately 12,000 workers a year that are necessary to meet rising demand for their services.
Advances in lab technology, incorporating extensive automation, is one way of addressing the issue. Roche’s cobas pro integrated lab system, recently launched in CE Mark countries, is the industry’s latest attempt to bring tech to bear against understaffed labs and bottlenecks. The system, developed by the company’s Serum Work Area (SWA), is designed to automate many basic maintenance tasks, giving human scientists more time to interpret results and work on other complex tasks. With a throughput of up to 2,200 tests an hour and three synchronised modules creating a relatively small footprint, the cobas pro is intended to simplify and streamline processes for lab workers.
Here, Roche vice president and international business leader of SWA systems Dr Benjamin Lilienfeld discusses the design of cobas pro, and the benefits and challenges of the automated lab.
Chris Lo: What initially inspired Roche to develop the cobas pro integrated lab system?
Benjamin Lilienfeld: There are a number of problems that we knew we wanted to address. To summarise, it’s all the non-value added tasks. We wanted to reduce maintenance as much as possible because it doesn’t bring you anything as a customer – it doesn’t help you analyse samples, it doesn’t help you create business if you’re a private lab.
Then we also saw that there is room for improvement in terms of calibration, especially on the clinical chemistry side. We’ve now introduced automated calibration, where you can simply download calibration information. Of course, anything that would slow down the operation, like if you have to go to standby before you can reload new reagents or auxiliaries or consumables – all of these steps we wanted to improve.
CL: What role does automation play in the cobas pro system?
BL: I think overall, automation is part of being efficient. Being fast, being efficient, means you automate processes, and usually it’s processes that are repetitive – anything that a machine can do better than a human. But it’s also simplifying processes overall. With automation you simplify processes and avoid mistakes that users can make.
Especially if you’re looking at mature markets like the US, Europe and elsewhere, you see that there are not enough qualified personnel anymore. It’s very difficult to recruit those staff, and it’s very hard to retain them. So we wanted to look for a way of reducing all non-value added steps so that these qualified staff that you don’t have enough of can really concentrate on the more complex stuff.
CL: What are the benefits you have observed in terms of reducing the time between receiving samples and providing accurate results for diagnosis?
BL: First of all, a faster start-up. Relatively quickly in the morning you can start producing results because you don’t need to do daily maintenance, so start-up is much faster.
A very nice innovation on cobas pro is cobas SonicWash, an ultrasonic wash station that washes the clinical chemistry probe on the cobas c 503. This ultrasonic wash station cleans the probe so thoroughly that virtually nothing is left. We’re not talking about parts per million anymore; we’re talking about parts per billion. It’s a whole different level of cleanliness, which means that now we can route any sample, even if there are several requests on clinical chemistry as well as immunochemistry for the same sample, to either of the analytical units first, whereas before we always needed to route it to immunochemistry first, which is obviously the more sensitive method than clinical chemistry.
CL: Cobas pro is now available in all CE mark countries; what are Roche’s plans for expanding cobas pro’s availability outside Europe?
BL: Usually CE markets are the first to be launched; now we have a lot of markets in Asia especially, but also in Latin America, that base their regulatory process on the CE Mark. So we will see, in the next six to nine months, launches in Singapore, Brazil, Argentina, the Middle East – these kinds of markets. And then in 2020, the US FDA approval is foreseen, and in 2021 the China approval is foreseen as well.
CL: Is Roche planning to expand the platform’s capabilities in the next few years?
BL: Absolutely. As I mentioned, cobas pro is really a platform for the future for us. At the moment we have it available as a platform that is able to hold an immunochemistry module, the e 801, and the clinical chemistry module, the c 503. In the future, we will be able to hold up to four of these analytical units, and we will also develop a new high-speed clinical chemistry unit that will be able to fit into cobas pro as well.
Cobas pro will also be the host for our integrated mass spec [mass spectrometry] analytical unit in the future. Although it’s several years out, I think it’s an important step where we, for the first time, will be able to integrate mass spec into the Serum Work Area core lab of today.
CL: How do you think these kinds of advanced lab technologies will evolve in years to come?
BL: When we look at the pure throughput of each and every analytical unit, we’re probably very close to the highest-throughput module that is physically possible. At some point you just cannot be faster. One of our other focuses is to speed up and increase efficiency by integrating the whole lab automation, as well as the analytics, into one big piece.
Because you look at labs today – you have pre-analytics, analytics and post-analytics – they are linked together but they’re not really designed together as one. They happen to be together and we connect them physically and via IT, but usually they aren’t designed as one. In the future, we’re looking at having a fully integrated core lab where everything is designed as one, so you have the smoothest interaction between lab automation and analytics.