White Paper by Dr Dale Charlton - Applications Director of Applied Scientific Technologies

Pick up the news today, and we are surrounded by new technological innovations for everything from measuring our heart beat in real-time from a watch while we ‘Work, Rest and Play’, what’s in our fridge and that it can tells us when food is out-of-date or can instantly automate the purchase of new products via the Internet of Things (IoT) and up to and including Industry 4.0 and the next industrial revolution.

Actually, do I need a fridge to tell me the milk is out-of-date? And should I be worried if my heart rate goes up to 160bps when I climb stairs, is it dangerously high, should I not climb the stairs and take the lift instead? What do I do faced with all this new data? What does it give me, except maybe high blood pressure - eating too many dairy products and not exercising enough (pun intended)! On a more serious point, there is no doubt that there are for many people and under many circumstances when this connectivity and data could be useful even of critical importance. This IoT connectivity could relate to diabetes products or other critical drugs stored in the fridge or have dietary importance for recovering patients or children with dietary disorders etc. We are truly entering into another realm limited only by our imagination and at the beginning of another industrial revolution.

The laboratory is no different. Pick up any scientific magazine or read any online resource and we are inundated with stories about the Lab-of-the-Future, connected laboratories and inventory management systems, Laboratory 4.0 and the digital revolution on-going in many laboratories which will change our lives (for the better) forever!

I am old enough to remember the introduction of many new technologies during my lifetime. The classic text-book ‘beta-max v’s VHS story’ springs to mind and if I take a look at the evolution of mobile phones from the coffee-machine size units of the 1980’s to the iPhones and smart phones of Today. If technology takes off, there can be rapid development and diversity of products. I am looking at purchasing a new mobile phone as we speak and do I buy one with 5G or without (I don’t have 5G services near me yet with no real timetable of delivery). Do I get a phone with an S-Pen to make notes or with 6.7inch screen, do I need 108Mb pictures & 8K video formats etc.? It’s not so easy to predict the future or even what I might useful or is just a nicer-to-have? So, if the lab digital revolution is upon us, how do we back a winning strategy and when do we jump-in or buy-in to the concept much as the same conundrum I have with the purchaser a new, expensive mobile phone?

And yet, my own personal experience, after having worked in laboratories at the bench then moved into commercial management of laboratory products and/or their manufacture for over a quarter-century, I still come across many laboratories today that have not yet joined this digital revolution or indeed feel left behind, or are unsure of a winning strategy and/or simply do not know when to join-in on this revolution in a productive and affordable way – they are too busy working in the lab managing their day-to-day workloads, especially with the dramatic impact COVID-19 is having on occupancy of workers and social distancing in the lab. Sounds familiar?

When laboratory instruments first started producing digital files, they were simply stored on a local computer disk. Indeed, that is how I started collecting digital data, e.g. from an old Packard 1600A Scintillation Counter via a 3.5inch floppy disk and then transferred this data into an early Excel-style spreadsheet to manipulate the data on a 386 desktop PC.

After removable storage came networking abilities and Windows for Workgroups. Files could be collected and collated into a basic folder-based archive or ‘Data silo’ to give it its more modern name. Fast-forward to 2021, “does anyone know any lab that would function properly without a USB storage stick for file transfers”? While some laboratories might see the above comments as outdated, the truth is that most labs still do rely on local file storage, USBs, for simplicity and cost effectiveness, viewing more modern and automated systems as too complex and costly. And as soon as we start moving into local area on-site networks, we run the risk that IT departments may take over and it slips away from the lab bench scientist for whom the system is meant to facilitate.

*Picture 03. A Packard 1600A Scintillation Counter circa 1994 with 3.5inch floppy disc*

Another interesting feature of digital solutions & IT projects, we are told, if one just simply Google’s a search on the subject, that many IT projects & digital projects often encounter difficulties in some way. According to “Improving IT Project Outcomes by Systematically Managing and Hedging Risk,” a 2009 IDC report by Dana Wiklund and Joseph C. Pucciarelli, 25 percent of IT projects fail outright. Meanwhile, 20 to 25 percent don’t provide ROI and up to 50 percent require material rework. https://www.forbes.com/sites/bernardmarr/2016/09/13/are-these-the-real-reasons-why-tech-projects-fail/ https://ibmsystemsmag.com/Power-Systems/2/2012/7-reasons-it-projects-fail There is still, arguably, similar issues with implementing larger IT projects today as we move into 2021 even.

We also see that for many of these ‘failed’ projects, it was more often not the technology that was at fault but other factors including project management and a perhaps misguided premise about what benefits digitalisation would bring?

The reality is, many smaller labs simply do not have the kind of IT infrastructures and project management resources necessary to implement big multi-discipline and resource-intensive efforts to bring, what the literature suggests, might be a failure or problem project which may or may not achieve real gains in the laboratory? I am not sure if laboratory digitisation projects have such failure rates as main-stream IT but clearly, this is obviously a concern to smaller laboratories and lab managers.

If I quickly move on, laboratory informatics systems, such as electronic lab notebooks (ELNs) and laboratory information management systems (LIMS), have furthered the proliferation of digital information generated by the laboratory. Arguably, and despite their obvious value and major successes in many laboratories, these disparate systems have also created multiple data silos, with data often only accessible through proprietary vendor software and with incompatible data formats, which to be fair as digital technology evolves, is currently rapidly changing as more effort is made to ensure data format compatibility, but nonetheless remains a limitation to an open integration platform of all lab management systems. So, although a digitalization has been achieved in many laboratories, the effective use of digital data for scientific and business purposes might not be there yet or is at least a ‘work-in-progress’.

So for many laboratories, the Lab-of-the-Future and laboratory digitalisation is a conundrum and a potential minefield to navigate? If digitalisation is going to work and offer the rewards in productivity gains and wealth creation through scientific business success, we need to involve everyone in the chain and this starts with connectivity of the actual day-to-day instruments in use at the bench by the average laboratory bench scientist, in the average laboratory and at a technical level & price point which is executable and affordable for the majority of laboratories.

We need standardisation alongside digitalisation. The wider use of industrial automation standards has taken a significant leap forward with the Internet of Laboratory Things (IIoT) initiative and Industry 4.0 from the likes of global players such as Siemens, who offer an extensive range of system automation and cloud technology products. We need these giants of industry to bring their expert knowledge and open architecture platforms to be on-board and help lead the way.

*Pic 04. Siemens SIMATIC distributed IO industrial automation solutions*

Attempts like SiLA 2 standards in laboratory automation and digitalisation and AniML file formats are also a commendable effort to put laboratory automation and digitalisation into the everyday hands of instrument manufacturers and users alike? There is a growing list of vendors and lab instruments with SiLA 2 open architecture drivers on the SiLA website https://sila-standard.com/product-store/ with more being added regularly through hackathons and workshops such as exemplified by Eventbright in London April 2020. https://www.eventbrite.co.uk/e/sila-lab-automation-hackathon-opentrons-meets-eva-tickets-96218954483?aff=ebdssbdestsearch

We already reply on and accept Bluetooth industry protocols, WiFi and cloud-based industrial standardisation for many non-laboratory based activities in the home, gym and at work, even in the car with automatic GPS and emergency contact call upon an impact with the car such as OpelCONNECT™.

So why not the same type of connectivity in the lab? So can we link laboratory instruments in an open, non-proprietary, user-friendly way to offer real buy-in at the level of the bench instrument and lab scientists. Arguably, there are other higher level digital systems already in play at the LIMS. LIS and ELN level that we should take advantage off, if we can collect all the digital data and get that data into these systems productively.

Third-party ware and product offerings like CSOLs ‘Links4LIMS’ software help bridge data input to and from classical analytical instruments into LIMS and higher lab management systems https://www.csols.com/wordpress/csols-links-for-lims/ . Perhaps as we generate data lakes, new AI and algorithms can start to make more effective use of the data and we can feed that back to the humble lab instrument and the real unsung heroes of the lab, the laboratory technicians in their everyday routines and practices.

I often hear the comment from lab instrument manufacturers, “yes, we have digital connectivity in our lab instruments”. There are ethernet, USB, RS232/485 communication ports, even Bluetooth™ and WiFi™ in some of their newest models but “few users seem to make great of it, yet!” So it seems, even when we can integrate lab instruments into a digital network, we often don’t do for a variety of different reasons?

Lab-of-the-Future Early Adopters

There are many fine examples of companies preparing for the Lab-of-the-Future concepts, Laboratory 4.0 and a digitalisation future. Many of the global players have been steadily expanding the functionality and connectivity of major laboratory software management systems especially in the area of LIMS, LIS and ELN, many of whom have extended integration to include more lab instruments and have cloud versions available. Indeed, it is clear there is a revolution on-going in digitalisation and the Lab-of-the-Future concepts.

As is so often the case, it is new, start-up style companies, disruptors, or simply experts coming from a different perspective that can often make the breakthroughs in thinking and innovation required to propel established industries into the digital age.

May I point the reader to several such companies and to help support any lab digitalisation project in a direction and that might have a greater chance of success based on all the pitfalls we have spoken about above.

If we accept that many ‘IT / digital projects’ fail to bring the benefits expected of them, then some discussion around how to begin and execute a laboratory digitalisation project should be a good place to start. The highly readable article by the company Biosystemika “The 10-step guide to digitalising your laboratory“ is very helpful in this regard. It ‘does what it says on the tin’ – namely an overview to how to go about digitalising your laboratory and the kinds-of pitfalls and management overview for a successful outcome. Biosystemika also have developed several digital products such as Genio for qPCR and NGS workflows as well as offering consultancy services for the budding digital gene laboratory. https://biosistemika.com/wp-content/uploads/2020/07/10-step-guide-to-digitalizing-your-laboratory.pdf

There are a number of instrument manufacturers who are actively striving to develop digital connected instruments to be used in a truly connected lab environment. Efforts from Integra Biosciences and their VIAFLO electronic pipettes with Bluetooth™ protocol connectivity are valiant attempts to encourage a digitalisation pathway and are easy to connect to and control via Bluetooth™ protocol. https://www.integra-biosciences.com/switzerland/en/electronic-pipettes/viaflo

*Pic 05. Integra Biosciences’ VIAFLO electronic Bluetooth connected pipettes*

One of the most innovative, yet down-to-earth product offerings newly available, concern the innovative digital and lab automation company, Applied Scientific Technologies (AST). Who with their Digital Enabled Formulation Toolkit (DEFT) have developed, with significant input from bluechip, industrial lab users, an open, non-proprietary platform to connect almost any legacy lab instrument with a comms port to a sophisticated wireless network with unrivalled scalability at a price point that would fit to many large households let-alone commercial industrial laboratories. https://www.appliedst.co.uk/deft

One of the other noticeable differences about the AST offerings are that AST come from a digitalisation background with expert IT and Project Management. Thus, the DEFT platform already takes into consideration the problems with starting a lab digitalisation program and doesn’t require much in the way of external support or infrastructure from the customer site and is both modular and infinitely scalable.

Applied Scientific Technologies know only too well the issues around how to start a lab digitalisation project so have developed an IT Guide document (for IT groups) and a Lab Digitalisation Starter-Package connecting a single lab-instrument to a digital network via Bluetooth and WiFi protocol to either an Android-enabled or iOS device with a intuitive Graphical User Interface (GUI) or to the Cloud via either the users own network or to an AST cloud-based server. This Starter-Pack can be expanded very quickly to include at least 3 other instruments as the project progresses. In this way, AST have already developed more than 30 different drivers to integrate a variety of lab instruments from IKA, Metrohm, Mettler-Toledo, Anton Paar, Integra Biosciences, Julabo, Ohaus, Wega, Radwag, Malvern, Brookfields to name but a few with an expanding list available on their website. https://www.appliedst.co.uk/blog/compatible-equipment-with-deft

The connected and integrated laboratory instruments are identified by an App running on the Android or iOS device which is used to connect to an existing LIMS or in stand-alone mode, the App is used for experimental design and managing the formulations and instrument methods decided upon by the user. The App works like many mobile phone or tablet Apps and is as intuitive as it is simple to use and a scientist can be up and running in quite literally a matter of minutes.

Data security is assured with almost military-level End-to-End encryption. Every digital lab network project is built at their factory with all instruments connected to show all the features running through a factory acceptance test (FAT), then taken on-site and installed, often in less than a day.

The DEFT is primarily aimed at the formulation and R&D laboratories to offer a scalable bench level integrated and connected lab environment with Lab Reactor and Biotech versions in development including CFR21part11 executions. Almost any lab instrument with a comms port can be integrated into the DEFT platform. Scale-up is simply a question of adding more instruments to the network and expandability is almost limitless with over 200 instruments / site possible on a single Site Data Manager network. The DEFT Gateway unit converts all connected instruments into the SiLA 2 standard and even employs UPS inside the DEFT Gateway for data security and redundancy.

*Picture 07. of the cartoon network structure*

Laboratory Asset Management and Cloud-based Services

The local area network versions can be enhanced with Cloud-based services at the flick of a switch which open up a range of additional services including remote diagnostics, over-the-air-updates and Laboratory Asset Management options with KPI dashboards monitoring every aspect of your digitalised network.

By looking around and perhaps in some unexpected places, we can find the kinds of tools and innovative companies that are enabling a new era of connectivity and bringing together multi-disciplinary teams of laboratory, digital and project management experts in new ways of thinking to support the digitalisation of the laboratory and build a true Lab-of-the-Future.

In the era of viruses and pandemic alerts, social distancing work practices which is causing many changes to R&D working and industrial labs around the world, it might be that we need to realise a paradigm shift in productivity gain in the laboratory and life science industry sooner rather than later or we may well be facing more than just a failed experiment!

Dr. Dale Charlton is an expert in laboratory & process automation applications for more than 35yrs and is today, the Applications Director of Applied Scientific Technologies Limited, UK. www.appliedst.co.uk

Laboratory Digitalisation – “a paradigm shift in productivity or just another failed experiment?”

White Paper by Dr Dale Charlton - Applications Director of Applied Scientific Technologies