More than $4.3 trillion was spent in 2021 for healthcare in the U.S., and 17% of that was spent on drug costs alone, declared Chris Peters, senior offering manager, batch automation, Honeywell Process Solutions. “That’s pretty significant. There are opportunities for us as a business,” he said.
Those opportunities lie largely in data that is shifting from a physical, paper-based record to a digital form, enabling aggregation and analysis on a larger scale, as well as treatments that are more personalized and biological than their mass-produced chemical rivals.
“Traditional chemical-based therapies have shifted into the biological space,” explained Peters, who spoke about the digital transformation of the industry at the 2023 Honeywell Users Group meeting in Orlando, Fla. “There’s been a shift into precision and personalized medicine. You can be born with a genetic deficiency, such as being blind your whole life, and now they can inject you, and you can see.”
Based on genetics, patients might have multiple choices for treatments, noted Peters. “We’re having more options as therapies. Batch sizes are going down because one size doesn’t fit all. All the while, the FDA is putting together more restrictive regulations.” This makes data capture and analysis more important than it’s been in the past. “How do I ensure data hasn’t been altered from its source?” he asked.
Beyond paper records
The need to connect data and systems, combined with increasingly complex operating environments and the pressure to improve business outcomes, is driving life sciences in new directions. New regulations and a growing interdependency of the supply chain have upped the need to connect data and systems. The transition away from manual, paper-based processes will enable connectivity within a single manufacturing site and across sites, bringing together people, processes and policies. And a modular integrated approach to data will help operators and businesses to make better decisions on all levels. “Get it working, make it better, and make it flexible,” stressed Peters. “Then optimize it.”
In response to these larger trends, most industries, and specifically life sciences, are addressing challenges with the implementation of flexible manufacturing, single-use systems and digital transformation, said Peters. “If I’m building a facility, the core goal is to get it working and make revenue. Once it’s built, we can make it better,” he noted.
“I need to have my infrastructure set up to be flexible,” explained Peters. “Once you have the latest data and have it connected, you can address your quality issues. You can leverage that data. Disparate systems and data sources are one of the key challenges in addressing top manufacturing objectives.”
Only 16% of electronic quality management systems are connected to the manufacturing floor, warned Peters. “We have data. We just don’t have it connected,” he said, noting that 70% of shop-floor data goes unused and listing five advantages to connecting data and systems:
• Elimination of manual and paper-based processes;
• Connected solutions that are scalable across sites;
• System standardization to drive collaboration, quality and operational excellence;
• Real-time, predictive analytics and artificial intelligence for insights and continuous improvement; and
• Optimization with digital simulation for sustainable, autonomous operations.
“The integration of quality into the manufacturing process enables team collaboration, resulting in improvements in process efficiency, quality, compliance and data integrity,” explained Peters.
“When you have this need for data and data integrity, a large amount of data that’s collected is unused,” reiterated Shawn Opatka, vice president general manager, life sciences, at Honeywell Process Solutions. “Gartner says you have systems of record. Then you have systems that make you different. And then you have systems of innovation. What’s interesting is you can start to look at your validated production data in a facility. We’re suggesting these could be a single integrated system with the ability to connect different systems and integrate them. At Honeywell, that’s the journey we’re on.”
Honeywell’s approach is to provide a Manufacturing Excellence Platform (MXP), which includes a manufacturing execution system (MES), along with visualization functionality and historian using Experion, for integration with apps. “There’s no more reason to look at Level 2 or Level 3 systems,” said Opatka. “By collapsing this into a single integrated solution, you have all of your data in one place.”
Providing a single-user interface gives the tools to migrate and make it easy with fewer people, noted Opatka. “In an app-based approach, if we get the platform right and build apps on it, you can start plugging apps in and not have to worry about the aging technology,” he said. “With some of the new technologies becoming available, I’m seeing a shift in the industry and the willingness to adopt sooner. Technology has taken a step change.”