© 2022 MJH Life Sciences and Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved.
© 2022 MJH Life Sciences™ , Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved.
Purpose-built assisted reality solutions help streamline processes and maintain regulatory compliance from the laboratory to the factory floor.
The past 3 years have brought enormous change to life sciences companies as the COVID-19 pandemic thrust the industry into a race to manufacture increasingly complex drugs at faster speeds. Many companies expanded operations during this time and outperformed expectations, delivering life-saving drugs to millions of people worldwide, while others struggled to keep up with a new and quickly changing industry.
One of the areas most affected by this transformation has been pharmaceuticals, which is undergoing a shift from legacy modalities, such as small molecule drugs into advanced cell and gene therapies. The processes involved in manufacturing these 2 types of drugs are radically different, and many companies have realized that their legacy systems no longer suffice in the move toward more personalized medicine.
What’s become clear is that the integration of people and advanced technologies is required for companies to survive and thrive in this new competitive landscape. Some companies hoping to grow in an already innovative field have turned to assisted reality (aR) wearables as a part of their larger technology platforms.
Tools for a Highly Regulated Industry
aR is a part of the broader extended reality (XR) universe that includes augmented reality (AR), mixed reality (MR), and virtual reality (VR). In many industries, AR and VR are being hailed as the next big step in boosting worker productivity, but these XR technologies can be inappropriate or even unsafe for workers in many cases.
Pharmaceutical manufacturers are held to a higher set of regulatory standards and cybersecurity protocols by the FDA and other international regulatory bodies in the kinds of technology they can deploy, making it necessary for them to invest in tools that are purpose-built for the industry.
This brings us to aR wearables, which are human-centered tools that safely bring together the real and the digital worlds to create new kinds of interactivity and perception while allowing frontline workers to maintain full situational awareness. Wearables, also called head-mounted displays (HMDs), allow a user to view a screen within their immediate field of vision, hands-free, and access necessary information when they need it. Many users liken aR wearables to a car dashboard that provides critical information at a glance.
A wearable appropriate for the pharmaceutical industry is a clean-room-ready, industrial-strength aR device that connects frontline workers within labs and factories and throughout entire companies with the data and collaboration tools needed to successfully complete job tasks safely and efficiently. Intrinsically safe ATEX Zone 1 and CSA C1/D1 certified wearables allow users working in hazardous conditions to securely interact and capture data hands-free using vision, voice, and head gestures, which is a game-changer for those working in highly regulated environments in which limited tools are allowed.
Keeping an Eye on Cognitive Load
According to HP Labs,1 the term cognitive load refers to the amount of mental effort required to perform a task or learn something new. Information processing capacity is fixed, limited, and varies from person to person.
When a technician is performing complicated tasks where full attention is required, it is important to keep distractions to a minimum. This can keep the user’s cognitive load at optimal levels, which leads to better information retention, less exhaustion, and greater enjoyment of tasks.
Some companies in the industry have attempted to implement augmented reality solutions, which overlay a computer-generated image on top of a user's view of the real world; however, they have rarely panned out in the rigid setting of a life sciences laboratory due to the distracting nature of the technology. aR solutions, on the other hand, allow the operator to keep the focus on the work and access the information they need when they need it, all without a screen impeding their view.
Next, let’s look at how aR wearables are being used today at 2 different stops in the drug development process—the laboratory and the manufacturing facility.
Assisted Reality in Regulatory Compliant Laboratories
As drugs quickly increase in complexity, the industry’s efforts to strengthen the manufacturing process across the drug lifecycle have become more important than ever. And ensuring accurate execution and collection of the data are a vital part of creating new medications and therapies.
The increasing complexity of today’s drugs naturally means that operators are tasked with more complicated steps and instructions to make a drug, which inevitably requires more compliance and validation requirements. Providing accurate data for each new action requires more processes and documentation, and operators are often trying to gather those data while their hands are tied up in the work.
Let’s imagine an operator in the laboratory, head to toe in a gown and mask, with their hands inside a pair of gloves. They are mixing a set of toxic chemicals in a tiny compartment while a colleague stands behind them, reading aloud a set of steps and recording when each step has been completed.
Now imagine that same operator has access to a lab-approved assisted reality wearable. There’s no longer the need for an assistant, as they can verbally access the checklist on their own and record the entire process, automatically saving and uploading the data to the larger IoT system.
Regulatory compliant HMDs help by capturing live process and operational data while employees work, empowering them to focus on the process instead of the manual collection of information that may or may not be accurate. In this way, attention can shift from a tedious and error-filled method to one in which accurate and up-to-date data is shared, transferred, and made available to stakeholders worldwide.
One company leading the way in the complex life sciences area is Apprentice.io. The company’s manufacturing execution system natively incorporates aR capabilities into mobile and head-mounted devices, which helps companies execute increasingly intricate batch recipes by providing voice-navigated audio instructions and assisted reality overlays, keeping workers completely hands-free.
“Making cutting-edge medicine like cell and gene therapies widely available is dependent on making a complex production process repeatable at scale,” said Angelo Stracquatanio, CEO and co-founder of Apprentice.io. “To do that, you need technology that helps human operators follow batch procedure and document process data faster and more reliably, ultimately getting medicine to patients faster.”
Assisted Reality in Modern Pharmaceutical Factories
The idealized world of Pharma 4.0, in which everything has a sensor and every machine is sharing information in real time, is simply not a reality for most companies and factories—at least not yet. For now, many facilities are dealing with machines that are cutting edge and might even be one of a kind, but those machines are also often older and difficult to maintain and repair. For that reason, aR technology is proving its utility in several areas within pharma manufacturing facilities:
Inspection and auditing
Due to the highly regulated environment, manufacturing facility operators perform regular maintenance checks on each machine to ensure that the equipment is working within its tolerance limits. For example, an operator might regularly test a machine’s final product for quality control while also completing that machine’s specific checklist so it doesn’t malfunction and ruin a batch, which is expensive and time-consuming.
Operators have traditionally used pen and paper to complete these checklists, but some companies today are using aR wearables to bring that process into the future. Wearing an industrial-strength HMD, an employee can easily approach a machine, use voice access to open the machine’s digital log, scan a QR code to access the maintenance specifications, and use voice control to complete each individual checklist—all completely hands-free.
In some cases, companies have also configured the devices to photograph and timestamp each step of the process and automatically upload the data to their information or maintenance management systems, ensuring that all procedures are properly followed and logged.
When a machine malfunctions in a pharma manufacturing facility, it can be an urgent situation. If that machine has stopped working altogether, it can cost companies valuable hours or even days while they wait for a technician to identify and solve the issue.
A few innovative companies are trying to speed this process by using HMDs armed with thermal imaging cameras, which can give technicians immediate information about where the issue might be located based on the machine’s temperature in different areas.
When working with older, highly sophisticated machines, thermal imagery can help maintenance teams identify the problem area quickly. For example, if a technician examines a machine with 4 motors and 1 of the motors is glowing red-hot, the technician can go straight to the problem without having to rule out other potential causes first.
Operators and maintenance engineers often walk the length of a facility several times just going about their regular activities in a day. Some companies are finding that employees who walk those routes wearing an aR device notice issues and anomalies with machines earlier and often identify new issues altogether.
For example, an operator wearing a thermal camera-enabled HMD and walking to a routine maintenance check on one machine stops at another along the way because they picked up something slightly off. After the issue is discovered and corrected, the machine’s productivity rose to rates higher than those seen with just regular maintenance.
Looking even further ahead, some companies see a day when embedded artificial intelligence programs will be able to generate insights and determine these kinds of anomalies automatically.
The pharmaceutical world is changing, both in how new drugs are discovered and how they are manufactured. With highly targeted technology like assisted reality, the sky is the limit for what companies might be able to create, uncover, simplify, prevent, and repair in the future.
About the Author
Rama Oruganti is the chief product officer at RealWear, where he is responsible for the product portfolio that includes hardware, software, and services. Previously, Rama held product and general management roles at HP, Magellan, and Deere and technical roles at Intel. Rama has an MBA from the Tuck School of Business at Dartmouth and a MS in Computer Engineering from UT Austin.
1. HP Labs: Cognitive Load. HP Developers Portal. Accessed September 28, 2022. https://developers.hp.com/omnicept/blog/hp-labs-cognitive-load
Wearables Made for the Pharmaceutical Industry – Pharmacy Times
© 2022 MJH Life Sciences and Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved.