Laboratory informatics is a critical piece of the puzzle for clinical diagnostic lab startups. Without some serious thought about how they’ll manage their instruments, software, and data management tools, labs can find themselves travelling along a well-worn but meandering path—even though there’s a more direct route to managing operations and optimizing their processes for efficiency.
Frequently, startup labs get their start as a result of a piece of novel research. Based on that research, they receive seed funding from an investor, they perform research and development (R&D), and from there, they go into production. It’s when they reach production that they may suddenly realize they need a robust lab informatics system. We think that’s leaving it too late. Devising a strategy now will save you pain later.
Three stages on the startup journey
We commonly see labs go through three distinct stages as their business matures. At each stage, we recommend choosing a system that provides just the capabilities truly necessary. But we also recommend labs be prepared to make adjustments as their needs change.
Performing R&D with funding to develop your first product
Whether your lab is seeking to develop a diagnostic product or a laboratory developed test (LDT), during this stage of the startup journey, the business generally needs the flexibility of a lightweight, unstructured system like an Electronic Lab Notebook (ELN).
It’s difficult to know exactly what information you’ll need to track while you’re doing research and experimentation. For instance, if you simply need to record data, then any tool that stores test results is a good solution. However, if you also need to correlate and compare results, you might need a solution with more structure, including searching and reporting capabilities, like a Laboratory Information Management System (LIMS).
Your main goal at this stage of operations should be to build a proof of concept with the least amount of effort. That means using the tools you’re most familiar with and that have a low barrier to adoption so you can get to your desired outcome as quickly as possible. Instead of buying a customizable off-the-shelf LIMS and learning how to use it or even customize it—a distraction you don’t need—we recommend focusing your funding and time on the research itself.
The best approach initially is to try a more user-friendly solution and see if it’s adequate. The act of trying something, whatever it is, will help you identify what you need and where any gaps are, and it’ll help your lab develop business and institutional maturity while gathering a complete set of system requirements.
A solution that quickly provides 70–80% of what you need is better than a complex system that gets you to 99% but requires more than two years of your staff’s valuable time and attention. Furthermore, if you have tried one or more applications and then choose to work with a consultant, they’ll be able to guide you more effectively based on these experiences.
Moving to production with your first lab informatics solution
At this stage of new product development, you’ll have a better sense of the information you need to track. For instance, you might now also need to record turnaround time and consumable use. Although you won’t know everything you need to track, based on your previous work, you’ll have some idea of the pain points you need to resolve.
Your lab will likely need a more structured system than what you were using during the R&D stage. Hence, this is the point at which many labs seek out a LIMS. Make sure the system collects the data you need and supports your lab’s legal requirements (CAP, HIPAA compliance, etc.). Once you’re sure of that, it’s time to begin to track and trend your key performance indicators (KPIs) via operational reports and dashboards.
One common mistake we’ve seen labs make when they’re heading into production is using a system that’s too restrictive. Even if you’re moving just a single product into production right now, this is the time to consider if the informatics system has the flexibility to support change. Change management is a critical pain point in most every lab informatics solution, whether it comes in the form of new requirements with your first use case, or future assays or products which require different capabilities.
Iterative R&D for future products
At this stage, labs have already moved through production with a product and understand the complexities of new product development with different requirements while maintaining regulatory compliance. The business will be more mature now, so you’ll have to re-evaluate the systems you have in place to meet these new needs. It’s important that your system is flexible enough to accommodate changes easily.
Common strategies you can use to prepare your lab for production
Once you’ve considered your lab’s new product development stage and understood the different requirements of each, we suggest you use the following strategies:
- Define your business goals. Knowing where you’re headed makes it easier to choose a solution that meets your needs, and that will lead to your desired outcomes.
- Balance flexibility and constraint. Choose a LIMS that is generic enough to meet all your requirements but supports your scientific domain well.
- Keep an eye on the future. The business will change over time, so make sure the system works for your current product but can also support the new products you’ll develop in the future.
- Realize that there will be difficulties and unexpected challenges. Your lab informatics platform is a foundational component of your business and will need to grow and evolve with time. Keep in mind that:
- Building a software stack of mission-critical applications might involve multiple vendors, timelines, and budgets. All of these need to be managed carefully.
- Integrating an ELN or LIMS with other applications requires planning. The end-to-end solution needs to be built incrementally. Individual components must be validated first before the entire platform can be validated.
- Working in a production environment might require some applications you didn’t need during R&D. For instance, in production, the lab is likely to need bar-code label printing and well-integrated freezer management.
- Shifting business goals is common practice. As your lab matures, you’ll need to re-evaluate and revalidate your systems to ensure they still meet your needs. For example, while new products are often processed by a single lab, that can quickly change, and you could find yourself needing to track samples from multiple facilities with different service level agreements and accounting needs.
As your lab moves through the various stages of the startup journey, you’ll need an increasingly complex system. The following table provides a quick overview of the types of software tools you might want to consider at each stage.
|Informatics System Type||Best Suited For||Pros||Cons|
|Word processors and spreadsheets||Startups in R&D stage||
|Enterprise resource planning (ERP) software||Generally not suitable for startups||
|Customizable off-the-shelf LIMS or ELN modules integrated into a single end-to-end system||Startups moving into production||
|Fully custom LIMS||Startups moving into production that also have a permanent software development team to implement and maintain it||
|A comprehensive off-the-shelf software suite||Scaling enterprise labs with large panels of testing||
Our main recommendation to startups is to remember that your informatics requirements are very different compared to those of an enterprise lab, though you probably aim to evolve to the enterprise scale. Keep things simple as long as it makes sense to do so, but know that over time you’ll need to re-evaluate your system so that it meets your evolving needs.
If you need help selecting the right laboratory informatics software for your current business stage or forming a strategy that will help you optimize your lab business in the long term, contact us today.