The modern clinical laboratory and the primary industries it serves — healthcare and all its segments: biotech, pharma, medical devices, patient care, R&D, etc. — sometimes presents a conundrum. Groundbreaking work is often being done using outdated systems, solutions, and workflows. 

Consider laboratory monitoring solutions and services. In many cases, labs working on products and programs that could eventually be worth billions are using off-the-rack, siloed sensors to ensure the efficacy and security of their equipment, environment, and facilities. Or they’re using a homegrown solution, one implemented piecemeal over multiple years and invariably fragmented as a result. Or, worst of all, they’re not using anything.

If you’re overseeing a clinical lab — and serious about the security of your facility, projects, and intellectual property, the operational efficiency and preventative maintenance of your equipment, the safety of your staff, and the purity of your environment — it’s time to implement a completely connected, always-on and always up-to-date laboratory monitoring solution.

Here are some of the major questions and issues for managers and stakeholders to start with when researching a new monitoring system:

• Should a lab monitoring solution be wireless or wired?

• How, and by whom, should lab monitoring tools and platforms be implemented?

• What are the systems and integration requirements?

• What are the implementation milestones?

• What’s the total-cost-of-ownership of a lab monitoring system?

And while these questions are a great place to start, they are truly only a start. For a deeper dive, contact an experienced clinical laboratory monitoring professional.

1. Should a lab monitoring solution be wireless or wired?

Most people already think they know the answer to this question. “Wireless, of course!” Because most everything is wireless now. It’s easier, “cleaner,” etc., but as we outlined in a recent article, wireless is not the best choice for the modern laboratory.

The primary reasons are uptime and security. In other industries, a little bit of “network downtime'' is never really the end of the world. You’re offline for a few minutes, and then you get back on, and can just pick up where you left off. But in a clinical lab, too much downtime can ruin years’ worth of R&D, result in the loss of patient tissue samples, and be simply catastrophic.

While wireless solutions devices like Bluetooth are an ideal way to connect your phone to your car or your speakers to your Spotify, they can have security gaps that make it risky to use in a clinical lab where IP is being developed. Additionally, as every Bluetooth user has experienced, there are often connectivity issues, which may be minor when enjoying a playlist but absolutely disastrous in the lab.

2. How, and by whom, should lab monitoring tools and platforms be implemented?

As mentioned, some labs consider monitoring to be a DIY (do it yourself) undertaking, nothing the IT or facilities department can’t handle. And while your average IT staffer is fully capable of attaching a simple sensor to a laboratory door, that’s basically where the simplicity ends.

Because even a simple sensor must be specifically placed, the wiring tension must be set with precision, and — ideally — the data each sensor collects must be centralized on a network or business application for alerting and reporting purposes. Additionally, there are often regulatory and compliance standards (especially in healthcare) attached to any and all data collected, such as being 21 CFR Part 11 compliant.

The best-case scenario is training your lab and facilities staff on the lab monitoring platform (for reporting and responding to alarms), but having the actual installation and system management done by lab monitoring professionals, people who have the experience to ensure all sensors, probes, and equipment, work in harmony and without system downtime.

3. What are the systems and integration requirements?

Although properly attaching sensors and other monitoring devices to laboratory equipment, cleanroom doors, etc. can be a complicated undertaking, it’s barely half of the equation. A professional laboratory monitoring service provider will focus as much on integration as they do on installation.

Many life sciences begin their search for a monitoring solution by focusing on monitoring for temperature changes. This is to be expected since temperature often has the largest influence on samples, experiments, etc., but is far from the only parameter that needs to be monitored in the modern clinical lab. A monitoring platform that aggregates data from any type of sensor, lab equipment, or facility system is the best option to ensure a long-term, scalable solution.

Because while some monitoring solutions are “pull” solutions (e.g., individual sensors collecting data that then will need to be pulled from each sensor), leading clinical labs require “push” solutions, a platform that not only collects data but pushes it to back-end systems for analysis and reporting.

In some cases, the tools to integrate with may already be in place (such as a LIMS platform or ELN), while in other cases it may need to be created and delivered alongside a monitoring solution. But in ALL cases, staff will likely need training on how to manage the devices, as well as the data they deliver. It’s much like the thought experiment, “If a tree falls in a forest…” If a sensor collects data and no one knows how to analyze or act on it, does it even matter?

4. What are your implementation milestones?

Once you have “the what” addressed, it’s time to move to “the how,” which means teams, tools, and especially milestones. Mapping out your lab monitoring solution is a fairly templated approach.

Preliminary documentation: kick-off calls and planning, creating/reviewing SOWs (assuming you’re using an implementation partner), platform design review (hardware, software), and identifying potential issues.

Implementation planning: role assignment, testing/shipping hardware, review of back-end IT requirements and training, configuration of alerting/reporting protocols, and design confirmation.

Installation and configuration: placement/wiring of sensors and hardware, systems testing, and user training.

Final documentation: final testing/confirmation, dashboard creation, documentation delivery, sensor calibrations, and final SOW review/project sign-off.

5. What’s the total-cost-of ownership of a lab monitoring system?

TOC is driven by a multitude of factors: hardware costs, software costs, staffing costs, and the cost of doing nothing and possibly losing everything.

Monitoring hardware is often a large, up-front cost with the inherent challenge built into every piece of hardware: it can rapidly get outdated. In many cases, it may make more sense to lease or have a service provider deliver, install, and maintain your sensors and hardware, ensuring it’s always up-to-date.

Additionally, your monitoring platform: in the cloud or on-premise? The cloud has recurring costs, but also additional safety measures (back-ups, co-locations) that tend to offset the costs of hosting yourself. Also hosting on-premise means additional stress on your own back-end systems and IT department.

Calculating ROI is often a challenge when risk-mitigation is the business driver, which it absolutely is in lab monitoring. With risk-mitigation being central, it always makes sense to ensure your monitoring solution is built on the most reliable equipment, the most proven software, and overseen by experienced professionals, which is why many labs are choosing “lab monitoring as a service.”

Leaning on the experience and expertise of a dedicated service provider ensures you’re taking the most complete measures available to ensure optimal conditions in your clinical lab, and also means your costs are predictable, which is impossible in a DIY scenario.

With lab monitoring as a service, you’re putting the security of your facility and IP, the operational efficiency of your equipment, the safety of your staff, and the purity of your environment into the best hands possible.