Laboratory data management will be at the core in revolutionizing our lives. The convergence effect will involve two key areas: technology and regulatory. Scalable, low-cost infrastructure technology will enable laboratories to efficiently identify, understand, manipulate, improve and control the global supply chain as it relates to research, manufacturing and living organisms. Building upon this architecture is a rich mobile and micro-technology boom, enabling realtime, in-depth monitoring of processes. Meanwhile, globalization and international regulatory and safety standards will continue to profoundly affect corporations as public safety concerns over supplier and final product quality climbs. Economics will serve as a tertiary driver, pushing more efficient computing due to energy price spikes, along with the potential to move the millions of corporations off of manual, labor-intensive and costly paper-driven data management systems.
The overall effects are exciting to consider, and may include significant improvements in both quality of life and life span, augmented product safety, an acceleration of globalization, collaboration, redistribution of wealth, shifts in power, and positive environmental impacts. What's hiding under all that lab data will no doubt be astounding!
Technology: Powerful, Reliable, Cheap
Sick of the word "cloud" yet? Even the funny pages have noticed the overuse of that word, showing high-paid consultants who can only mutter two words: "cloud" and "platform" (Adams, 2010). This too shall pass, so don't go out and name your kid, "Cloud," (sorry, Dot Com McGee!) but one cannot deny that the cloud is the very foundation of the laboratory data informatics revolution.
If cloud technology is the conduit, then purely from a spend perspective, the changes are already astonishing. In 2009, cloud spend was a whopping $16.5 billion (IDC, June 2010) a mere three years after it was established, and is expected to exceed $55 billion by 2014. Some observers claim that cloud computing is a revolution in itself. For the purposes of this article, the cloud represents the idea that if many people join together they can share in the benefits and the expense of a large data center, and that if many computers join together - powered by virtualization, open standards and grid configuration - the overall cost/benefit ratio can be lowered by extreme proportions. The result is massive, energy efficient, low-cost computing power, unrivaled in redundancy and security and affordable to all.
Prior to the cloud, millions of companies did not have the critical mass to support an internal information technology department or hardware center. Therefore, the cloud really just represents a leveling of the playing field. To be precise, it gives small companies an edge over large enterprise, in that organizations that are agile enough - typically smaller businesses without legacy systems to decommission or defend - are able to move to the cloud and enjoy far more secure* and redundant computing power than, say, the Dow Industrial 30. How? Binding together the masses, however small the individual components may be, creates a network far superior to that of any single large enterprise. Small companies, millions of which still run their operations on paper, can, for the first time, confidently make a switch to electronic data management. These companies can now enjoy redundant networking, exceptionally fast response, and massive storage that would make even Oracle's Larry Ellison jealous.
A conversation on the power of the cloud would not be complete without mentioning open standards. Open standards, in a manner similar to the cloud, rely on a massive network of independent developers to advance and maintain a particular software's functionality. This has resulted in license-free, powerful and highly stable software, which is largely powering the cloud revolution with heavily supported open standards like Linux, MySQL, Java, PHP, LAMPand many, many more. Even proprietary giants like Microsoft - Microsoft, Google and Amazon comprise the big"cloud three" - have embraced the power of the cloud by offering solutions through creative licensing, and are placing tremendous resources behind the engineering of novel cloud-based technology.
Working within this environment, a few companies have leveraged the power of the cloud to create environments that surpass the functionality provided by the tech titans. The result has enabled small business to use the type of tools reserved for those with large IT budgets. Salesforce, Skype and Mozy, for example, have eaten the lunch of traditional customer management, communication and storage companies by successfully providing their own take on cheap computing for all. This phenomenon has allowed businesses to focus on their core business while benefiting from advanced data management, thereby accelerating the coming revolution.
Technology: Mobile and Micro
The rise of serious, mobile computational power has exploded in the last year-plus, as seen in smartphone and tablet hardware, as well as diagnostic technology. This change in favor of smaller screens will continue to benefit laboratory end users in two ways. First, it has finally compelled software vendors to re-think the user interface. In a mobile environment, utmost care must be given to user interaction and choice architecture (Nudge, 2009). If done well, a user may actually prefer the mobile version to the full desktop interaction, because they can access "the important stuff" more quickly and easily without searching through deeply nested menus or wading through a database dump to the screen.
The second advantage of mobility is having data management capabilities in the field, at the experiment or the instrument where it is needed most. Too many systems try to eliminate data transcription through cumbersome integrations that enable the data to move directly into the LIMS. High-volume operations benefit here, but when flexibility is required, keeping it simple by entering data at the source is a great option never before available.
The rise in mobile software and hardware is a precursor to micro- and even nano-technology that is forthcoming. The continuation of hardware advances for exponentially smaller, faster and cheaper semiconductors has fueled IT for the last few decades, and will continue as the transistor gate length shrinks to the sub 12-30 nanometer scale. This trend will increase the availability of low-cost computing and enable the development of ubiquitous embedded sensors and computational systems in products, appliances and environments that have never existed before. We may see clothes that measure vital systems, mobile "chips" that are added to biological processes or chemical synthesis that can interface directly with lab data management systems (LIMS) to fine-tune or accelerate new discoveries.
These mobile micro-tools will forever change food processing, chemical synthesis, drug discovery and disease monitoring by supplying a plethora of diagnostic information. This will take massive computing power and vast storage, but thanks to advances in affordable computing via the cloud, data crunching on a scale once reserved for MIT is now available to even small laboratory operations.
Regulatory: Tougher Guidance
Perhaps the most important benefit of this technology is the increased regulatory spotlight effect caused by raising the bar for well-organized and easily accessible lab and process data. This can effectively incentivize good research and manufacturing by more easily exposing fraud and rewarding those that pay close attention to operations. All good economists know that the way to effective management is through the use of proper incentives (Thaler and Cass 2009, 60).
Regulatory agencies are tightening their guidelines in response to increasing safety issues, perhaps due in part to the emerging global supply chain. Apart from pure safety, there has been a boom in chain-of-custody theft, adulterated raw and finished materials, and outright fraud. Regulatory agencies around the world are beginning to collaborate on expectations (EMA/299895/2009-2010) and lately there has been an emergence of volunteer organizations like Rx-360 to help establish auditing standards. In areas of food processing, new guidance concerning supplier compliance is being enforced, not just limiting the reviews to only the final finished good (FDA, 2011).
Let the Revolution Begin
The field-leveling benefits provided by the cloud - along with the staggering advancement in mobile computing power and platforms - is truly astonishing. While social media may have sparked the recent growth and development in the cloud and even acted as a driver for smarter mobile devices, lab data management will be at the core of revolutionizing our lives.
References
Adams, Scott. 2011. "Dilbert on Cloud Computing". Dilbert comic strip archive 2011-01-07 http://www.dilbert.com/strips/ comic/2011-01-07/ (Adams 2011)
EMA. 2010. The European Medicines Agency Road Map to 2015: The Agency's Contribution to Science, Medicines, Health. Draft for Public Consultation. (EMA/299895/2009-2010)
Federal Food and Drug Administration. March 2011. "Food Safety Legislation Key Facts" http://www.fda.gov/NewsEvents/ PublicHealthFocus/ucm237934.htm?sms_ss=email&at_xt=4d434354a4e5feaa%2C0 (FDA / 2011)
Federal Food and Drug Administration. December 2010. "Update from Center for Drug Evaluation and Research on initiatives and details 2011 public health priorities to biopharma
executives" at FDA/CMS Summit in Washington D.C. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm237934.htm?sms_ss=email&at_xt=4d434354a4e5feaa%2C0 (FDA / 2011)
Google. 2011. "Hot Topics" Top ten hot topic online search trends. http://www.google.com/trends (Google, 2011)
IDC, June 2010. "Worldwide Public IT Cloud Services* Spend by Offering Category" http://blogs.idc.com/ie/wp-content/ uploads/2010/06/ww_IT_cloud_services_forecast_Jun2010.jpg (IDC, June 2010)
Rx-360, 2011. "Consortium for the establishment of auditingstandards" http://www.rx-360.org/ (Rx-360, 2011)
Thaler, Richard H., and Cass R. Sunstein. 2009. "Nudge: Improving Decisions About Health, Wealth and Happiness." New York: Penguin. (Thaler and Cass 2009, Intro 12, 60)
*Cloud security and privacy can easily surpass typical enterprise security if the application, authentication, encryption and proper firewalls are in place or leveraged through vendors.
Mike Weaver is founder and chief executive officer of The Weaver Group, Inc., a Santa Monica, CA-based developer of cross-platform software for data management. He previously worked in regulatory, quality, process transfer, lab and business technology at Merck,
followed by two global laboratory information system deployments at Pfizer and a consulting role at Amgen. He can be reached at mw@theweavergroup.com