Digital Lab Strategy: Guide to Master Lab Digitalization and Influence Innovation

Companies in the life sciences often discuss Business Strategy and R&D Strategy, focusing primarily on creating value and gaining an edge over their competition.?

But we rarely discuss a newer type of strategy: Digital Lab Strategy,? which has become a foundational pillar for a successful organization. The number of software and instruments that deal with raw data analysis, collaboration, and accessibility is now massive and an immediate need of day-to-day laboratory operations.?

So, if developing a Digital Lab Strategy is at the bottom of your to-do list, you may be setting yourself up for failure.

Digital Lab Strategy has revolutionized the industry by allowing labs and research facilities (and most likely your competitors) to drive innovation and digitalization. In this blog, we will discuss why labs need a comprehensive Digital Lab Strategy and how you can implement it to accelerate performance and achieve better results.?

Digital Lab Strategy: A Multi-Faceted Solution for the Life Science Industry

Whether navigating the road to FDA approval, applying for grants, and/or publishing research papers, there is generally a rough strategy that will help you achieve your goal. This may include hiring the right people, choosing the suitable therapeutic modality or target, developing the proper internal team hierarchy, identifying partners from other organizations, outsourcing animal studies to skilled collaborators, and attracting investors or grants to give you the money to achieve all of the above.?

Previously, digital solutions were just some of the many tools used to achieve these goals.

Nowadays, however, they define the strategies, set the pace and timelines, and serve as a unique selling point for collaborators and investors.??

For example, an un-digitized biotech start-up may appear not to be keeping up with times or keen on moving forward by a potential investor, regardless of how revolutionary their IP might be.??

But, Digitalization is Difficult…

Countless barriers stand in the way of organizations developing and implementing a Digital Lab Strategy.

For Big Pharma companies, the problem is being “too digital.” One of the biggest problems is having decentralized data and using many digital tools. This leads to a loss of data and longer data analysis periods.

In Academia, the problem is a bit different. Labs and PIs are rushing to get grants and churning out publications in an environment with a rapid churn of personnel. This makes it difficult to formulate a sustainable digital foundation and leads to repeating old experiments, losing samples, and a slower research pace.

In Healthcare, the lack of digital lab strategy is primarily due to using ancient, in-house systems. For example, an older Laboratory Information Management System (LIMS) can be inconsistent, not very user-friendly, and experience issues with data updates. Taken together, this makes scientists apprehensive about using it. Decentralizing data in different digital tools and creating a sustainable ecosystem becomes a headache for scientists working in the industry.

Your Digital Lab Strategy Checklist

To prevent these issues and inconsistencies, having a Digital Lab Strategy is integral for all labs and research facilities. Digitalization is multi-faceted, and there are a lot of different parts of lab operations where it can be integrated. To help you prepare a comprehensive digital lab strategy, we have provided a checklist for further guidance:

General Sample Strategy

• Make a list of all the sample types that you are working with
• Develop a suitable naming convention, and determine if you will be able to scale using your current system
• Make a plan regarding storing, tracking, accessing, and analyzing samples
• Conduct temperature monitoring; check if you have reliable sensors for your incubators and freezers
• Label and secure your prepared samples. Check if your labeling needs can be easily digitalized into your current system

General Inventory Strategy

• Check the equipment you are currently using, and see if you are keeping track of their calibration/validation schedules
• Determine how you are tracking the equipment usage
• Analyze the supply and ordering management you are currently using. Make a note if there are any persistent issues or concerns due to backorder
• Barcode your inventory
• Ensure that you have an automated workflow

SOP Tracking and Development Strategy

• Control all your protocols and procedures?
• Develop clear ownership of protocols, and create proper collaboration tactics
• Check if there is an approval process involved in the audit trail
• Determine if your protocol development integrates and positively influences your sample and experimental design management

Data Reporting and Experimental Design Strategy

• Check if a digital project management strategy is in place, such as program coding, naming conventions, collaboration hierarchies, etc
• See what tools you use to manage your general projects/tasks, and specify your experiments and lab reports?
• Clearly define lab report lengths and the format in which they will be completed (e.g., how are results written for easy access and translation)
• Ensure that everything is standardized and that everyone is developing their own result structure
• Implement a proper handoff system in place between colleagues and departments
• Maintain proper correspondence about data transfer and management with the automation team

Automation Strategy

• Utilize instruments and software that can be integrated with other systems
• Optimize your walkaway time

Customization and Integration Strategy

• Check if the systems you are using are capable of integration using an open API
• Check if the system has a Developer Hub
• See if you have an easily accessible Software Developer Kit (SDK) to make your own customizations
• Assess if you can integrate the system with your robots and other instruments
• Check if you have all the desired software and if integrating with them is a possibility

General IT and Digital Security Compliance

• Decide if you want to outsource the IT services or hire an in-house team
• Ensure you have the expertise and training to manage the servers internally
• Check your internal security standards

Compliance with Different Regulatory Environments

• GxP
• HIPPA
• GDPR
• 21CFR Part11
• CLIA?

Data Science Strategy

• See if you will be using AI and ML solutions, and if so, what are your guidelines?
• Check which analytical techniques (e.g., multi-omics, image, flow cytometry, etc.) ? you will base your research strategy on?
• Decide if you have plans to scale the business?
• See if you have plans to participate in continuous data analysis or do you plan to shift direction?

Overall Digital Strategy

• Determine your 3-year plan. For example, how many robots you’d like to integrate, what other integrations you’d like to have, and with which systems
• Pay attention to your long-term strategy. Decide how you will mine and analyze all the data that you have gathered over 5 to 10 years
• Think about the hiring trajectory and whether you have resources to train your staff, promote a culture of innovation, and continuously grow in the current space?

Conclusion

In conclusion, Digital Lab Strategy is now “in the DNA” of all labs, and it trickles down to the research and business strategy rather than the other way around. The sooner an organization embraces digitalization, the quicker it can pivot in the right direction. It is anticipated that labs that uphold strict and standardized digital protocols and adopt AI and ML, will be leaps ahead of their competition. This pattern can already be observed with the current customers.?