Contract Pharma, November 2016
While the implementation of a digital platform can optimize workflows in many ways — centralizing data, real-time sharing of experimental results, ability to track various facets of productions — many pharmaceutical companies and contract development and manufacturing organizations (CDMOs) select overly ambitious software suites packed with too many features.
As a result, they often confuse employees and lead to expensive digital platforms being used as high-powered data loggers — if at all. When planning a digital transformation, CDMOs and pharmaceutical companies should begin by asking the fundamental questions: “What do we do?” and “How do we do it?” Although this may sound obvious, many companies neglect this important step and install a platform that is not suited to their company’s needs.
The goal of this article is to give an overview of what a digital transformation means both practically and philosophically for a pharmaceutical company or CDMO and to offer the first steps an organization should take in order to achieve a successful digital transformation.
What is a Digital Transformation?
The complexities of the drug discovery pipeline cause many pharmaceutical companies and CDMOs to work from decentralized data systems, in which different departments have unique methods for collecting, storing and sharing data. Transnational companies often experience an even more fractured system due to the fact that each department in each individual branch may use different methods. To counteract these inherent fissures, many organizations implement a standardized and sometimes automated software platform for logging data. While this is the logical step in streamlining the sharing of experimental results, these platforms are the tip of the iceberg in terms of what a digital transformation can mean for a company.
By definition, a digital transformation should transform a company by cultivating new ways to achieve goals, first by unbridling employees from “translational” tasks—the transfer of data from one system into another — and secondly by creating an environment that fosters new creativity for process optimization. Although research has shown that a successful digital transformation happens from the top down1 it is not recommended that a company approach the task with, “This is how we do things now,” but rather, “These are the tools we have at our disposal, how would you use them?” In the fullest sense a digital transformation should mean using new technology to enable new types of innovation and creativity in a particular domain, rather than simply enhance and support the traditional methods.2
A good analogy for this approach comes from urban planning and architecture in the form of “desire paths.” When designing communal spaces architects and urban planners have been known to not immediately pave the walkways between different structures but instead allow for the formation of desire paths — well-trodden areas where pedestrians traverse the space — that are then paved over.
Know Your Company — SIMER & Shadow
Before starting a digital transformation ask the seemingly obvious questions: What do we make here? How do we make it? One of the biggest problems with implementing a software suite is that the functionality is endless but does not always lead to a better end. Nice Insight recommends the following approach to beginning a digital transformation: Shadow, Implement, Monitor, Evaluate, Refine (SIMER).
The team in charge of implementing the digital transformation should begin by shadowing the laboratory staff to learn how and why they do what they do. What templates for calculations are they using to set up experiments? What are they writing down in their lab notebooks? Lab notebooks, for example, are a beloved companion and tool of many scientists, and so it will be a long time before they are done away with completely. But ultimately this is the crux of a digital transformation.
A seasoned scientists’ lab notebook will reveal more on how to proceed with the digital platform than ten seminars on the subject. More than a place to write down data and set up experiments, lab notebooks are in many ways an extension of the scientist, just as smartphones today have slowly become an extension of ourselves3 because they methodically chip away at the way we think. Meeting with technicians tasked with carrying out day-to-day experiments and observing what they write down, what software (Excel and others) they rely on, will begin to illuminate how a company should proceed with their digital transformation.
During the shadowing phase, existing workflow methods should be made clear to the digital transformation specialist so that any analog processes can be “translated” into digital templates. The transformation of analog to digital should be used as a probe at how the company functions overall, since a digital transformation should reinvent an organization through the use of technology to improve performance and better serve its constituents.1
The main thing to consider during the creation of the templates is that the new platform conforms to old standard operating procedures as well as to the unique ways in which that staff completes everyday tasks. Constructing a new template to collect the data should mimic the old system so as not to estrange the staff that are accustomed with the old reports and views, yet there should be additional functionality and efficiency that ultimately comes from the centralization of data.
It may seem obvious, but great care should be taken not to add additional complexities and steps to the existing system, for example, something as minor as adding more mouse clicks to a specific pathway used to complete a certain task. What may seem like a great improvement for a digital transformation specialist may in fact add an additional step for a laboratory employee, resulting in improper use of the system and data that is not centralized. “In our old system . . .” are words that should not be uttered after a platform has been installed.
What a company produces, and how it functions, will inform which software suite best fits the company’s needs. For pharmaceutical companies and CDMOs there are several different types of suites such as drug discovery, drug manufacturing, employee management and production schedules, among others. For example, a drug manufacturer might use a product lifecycle management (PLM) software suite that is capable of managing the entire lifecycle of drug production from inception all the way to packaging and distribution.
When a company undergoes a digital transformation it is very important that all the various pieces of information and data are linked and connected into one database and can be accessed through one system all under one roof. This is generally deemed the toughest part of the digital transformation process, as well as the one with the highest risk.2
A software suite with full data integration is something that is hugely important for a multi-facility drug discovery company. Ideally each experiment would be set up digitally to eliminate information being stored in lab notebooks; the outcome would then be logged automatically into the digital system. This seamless data integration ensures that scientists working at different facilities are not repeating the same experiment.
But other, less integrated options also exist for smaller companies. For example, a company might only have a material safety data safety sheet (MSDS) that will allow an employee to search all experiments that have been run using a certain compound.2 At the very minimum in terms of data integration the database might give the date and name of the person who ran an experiment using that compound, and then the person who is interested in running another experiment with that compound will contact that employee via email or phone to get details. This is not ideal in terms of data integration but might make the most sense economically for a smaller company.
Monitor, Evaluate, Refine
After software suites are implemented, it is recommended to monitor and evaluate which facets are working and which are not, and then refine accordingly. However, before wasting money on expensive platforms it may be important to understand whether or not a company is ready for a digital transformation. Although digital transformation failure rates range from 66% to 84%, a “failure” isn’t necessarily all-negative. A failed digital transformation can still mean that a company made several important digital upgrades that increase efficiency in one realm or another.4
A pharmaceutical company or CDMO should use the impetus of a digital transformation to probe at the efficacy of laboratory or manufacturing processes, and then, after a period of evaluation and reflection, should judiciously select a lean or extensive digital platform, whichever best fits the needs of a company. Minimal digital upgrades will increase efficiency and profitability, whereas a successful digital transformation has the potential to reinvent a company and foster creative ways to bring the organization into a new era of productivity.
1. “What is digital transformation?” TechTarget. 30 Oct. 2015. Web.
2. Jansen, Daniela, Reichwagen, Jens (2016, Sep 22). How digital transformation drives change and collaboration in the laboratory [Webinar]. European Pharmaceutical Review series Sponsored by Biovia. Retrieved from https://goto.webcasts.com/viewer/event.jsp?ei=1113322
3. Lynch, Michael. “Leave my iPhone alone: why our smartphones are extensions of ourselves.” The Guardian. 19 Feb 2016. Web.
4. Libert, Barry, Beck, Megan, Wind, Yoram (Jerry). “7 Questions to Ask Before Your Next Digital Transformation.” Harvard Business Review. 14 Jul 2016. Web.