Commercial off-the-shelf solutions
The unpredictable costs and risks associated with customising a traditional generic Laboratory Information Management System (LIMS) make companies think long and hard before changing or upgrading their software. In the search for new sales, LIMS suppliers have been working hard to increase the flexibility and configurability of their software to make them more attractive to resistant companies and sectors.
LIMS companies have now taken to describing some of their recent releases as commercial off-the-shelf (COTS) software solutions, which suggests that they are in the same category as operating systems, word processors and similar programs. Is this a measure of their success in transforming the software, or just sales talk? Certainly the term COTS, which originated in government (defence) departments, has been abused as a marketing tool in the past. Some of the talk of COTS is designed to appeal to customers, says Keith Huxford of LIMS specialist Autoscribe. But the latest generation of LIMS are more configurable than ever before, he insists, which is exactly what these customers want.
Frost & Sullivan sector analyst Charanya Ramachandran agrees that things are changing. 'The LIMS market is likely to progress naturally from customisation to configurability with customers showing increasing demand for configurable off-the-shelf solutions that address their specific application need,' she says in a market survey of the European LIMS market. And she thinks that some of the more resistant customers are the main target. The trend towards configurability gives LIMS companies an excellent opportunity to achieve strong product differentiation, which can help them win over their more demanding customers – such as the pharmaceutical industry, which is subject to a strict regulatory climate, she says.
However, intensifying competition and the strict regulatory climate in the pharmaceuticals industry pose a strong challenge, Ramachandran warns. Companies that are most likely to succeed are those that are able to meet the changing laboratory experimental requirements and can sufficiently differentiate their products. As well as cutting down on the amount of customisation needed to implement their products LIMS firms have been aiming at more open standards, to make it easier for customers to appreciate the technicalities of their packages. They have also aimed to make products simpler at user-level to reduce training costs. Another way that software companies are attempting to deal with the business needs of customers is by making as much use of the internet as possible to deploy web-based frameworks at no additional cost.
All of these trends and more are evident in the recent software releases from two very different LIMS suppliers – Autoscribe and Thermo Electron. Both products – Gemini Matrix and Darwin LIMS respectively – are described as COTS LIMS.
Privately-owned specialist LIMS supplier Autoscribe has made a substantial investment in making its new Matrix Gemini LIMS a pure Microsoft .NET product and not a mixture of other technologies. The Matrix software family dates back more than 16 years, but there is no legacy code in its most recent release. In a development programme that took three years, Gemini has been completely rewritten in C# (pronounced Cee-Sharp), says Huxford. Microsoft's .NET environment and the C# programming language are growing in popularity, especially in corporate environments. The latest figures from Dutch consulting firm, TIOBE Software (www.tiobe.com), which rates the popularity of programming languages and the availability of software engineers, show that C# is not yet as popular as rival object-oriented language Java, but is gradually catching up.
Using .NET for Gemini takes greater advantage of close integration between the Windows operating system and web technology. But the hidden value and true benefit of Matrix LIMS lies in the power of its configuration tools, says Huxford. These tools do not need custom programming or esoteric, proprietary scripting languages. Instead they use software 'wizards' to configure every part of the program. The 'wizard' style interface is used with a LIMS configuration knowledgebase, which helps the vendor during set up, and later the system administrator, create and/or modify end user screens. This is an important part of a successful LIMS, says Huxford. Companies and their businesses change and the configuration tools allow the LIMS to change throughout the lifetime of the system.
Matrix Gemini is not designed specifically for the pharmaceutical sector, but it includes many features to assist with the requirements of the highly-regulated laboratory, including audit trails, time and date stamping of all actions, version control of all reference data and features to help with 21CFR Part 11 compliance.
Gemini looks exactly the same to users no matter how you access the software – rich client on a LAN, thin client on a WAN or via the web using a standard browser. Autoscribe's licensing scheme allows companies to mix and match network and web connections as they require them, changing from day to day if necessary. Once a screen has been built using the software's configuration wizard, it is immediately available on a customer's network or via the web. 'Unlike most current commercial LIMS, the web interface is not a "bolt on" to an old application. This new technology allows you to deploy exactly the same interface to all users, reducing your deployment, training and maintenance costs,' says Autoscribe's Keith Huxford. Once set up, the screens are easy to use as POS (point of sale) software used on supermarket tills.
There is a bonus for existing customers too, says Huxford. Users of the previous version 4 of Matrix who upgrade to Gemini, supplied under their support agreement, will have immediate access to all their existing client screens via their web browsers, with no additional work or costs. This offers substantial cost savings to current users.
Scientific instrument giant Thermo Electron is quite a different company from LIMS specialist Autoscribe, but it is also promoting its newest LIMS – Darwin – as a COTS system, and more specifically one aimed at the pharmaceutical industry alone. Like Autoscribe it started afresh by rewriting its LIMS code in C#. Thermo Electron's Colin Thurston says the company chose to use Microsoft's software because it is 'robust and good technology'. And a lot of the code is pre-built and tested, which speeds up software development. It has also allowed Thermo to buy in commercially available software libraries to perform certain tasks, such as charting, says Thurston.
At the same time as writing Darwin, Thermo's standard LIMS SampleManager was also rewritten as version 9.0. But in this case legacy code, or 'cherished code' as it is sometimes called, was included by encasing it in a software wrapper, says Thurston.
Why pharmaceuticals? 'Because, historically, the industry has been poorly served by LIMS,' says Thurston. It doesn't hurt that the sector 'is growing ahead of the overall LIMS market'. LIMS sales are growing at around eight per cent per annum, while the pharmaceutical segment is growing at 10-12 per cent, some 50 per cent faster, says Thurston.
Darwin LIMS has built-in functions that meet the sector's specific requirements, says Thurston. It will fit much of the work carried out in drug manufacturing and quality control. For example, it has a comprehensive test library that includes complex pharmaceutical testing methods and a stability module that simplifies the process of designing, implementing and managing stability studies. Darwin regulates compliance requirements based on the type of data being manipulated – enabling a more flexible approach for R&D as well as meeting the tighter requirements of a regulated environment. But the software is not specifically for drug discovery or for toxicology studies. Other Thermo LIMS, such as Nautilus and Galileo, are more appropriate for these areas and can be integrated with Darwin, says Thurston.
Much of the configuration can be done with software wizards, but in the cases where customisation is necessary, Darwin uses standard programming tools like Microsoft Visual Studio .NET, not proprietary programming or scripting languages. Training is another area where Darwin lives up to its COTS billing, says Thurston. The interface is modelled around Microsoft's Office and is geared to the needs of users. For example, for quality assurance/quality control users, it uses terms they are familiar with – making it straightforward to learn on the job.
So who will win out as competition between LIMS firms intensifies? Due to the huge amount of investment required to buy LIMS solutions, pharmaceutical companies tend to prefer vendors that have a proven history of efficient installations, says Frost & Sullivan's Ramachandran. 'Vendors possessing good brand recognition will be able to penetrate the pharma user base with greater ease than new niche market participants,' she says. Vendors that retain a strong customer focus in product development are also likely to find favour.
Autoscribe and Thermo score well on these counts, despite being very different firms. Darwin has been developed and tested with the help of some of the larger pharmaceutical firms, although Thurston can't say which, and is now in the deployment phase. Gemini too has been developed with the aid of existing Autoscribe customers including a large pharmaceutical firm.
Both are benefiting from the globalisation of business. Privately-owned Autoscribe is having one of its most successful spells in its 23 years of trading. The company has seen new LIMS orders double in North America and nearly treble in the UK for the first half of the 2005/06 financial year. And its business has expanded outside its historic core of Benelux/United States/Britain and Canada to Israel, Brazil, Spain and India. Meanwhile Thermo too has been expanding its Asian operations – opening new demonstration laboratory centres in Shanghai and Mumbai.