GxP Lifeline
Masters Summit 2022 Recap: 3 Takeaways for Medical Device Manufacturers
Gathering all together in person for the first time in three years, Masters Summit 2022 attendees were treated to an array of learning and networking experiences, plus noteworthy addresses by presenters as diverse as former U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and comedian Tom Papa. This year’s event, held October 24-28 at the Hyatt Regency Hotel in Salt Lake City, Utah, offered new and exciting opportunities for manufacturing and quality professionals to “Forge the Future” of their organizations and industries.
The speakers, training sessions, and demonstrations at Masters Summit 2022 were all geared toward providing valuable insights into the future of manufacturing and quality and helping companies in life sciences industries become more effective and efficient. Three themes that repeatedly surfaced throughout the event will have a profound impact on professionals and companies in the medical device manufacturing industry. Here are the highlights:
Modernization Is the Key to Staying Competitive in Medical Device Manufacturing
- Real-time access to operational data.
- Predictive and preventive quality.
- Deployment of digital twin simulations.
- Intelligent process automation.
- Automated decision support.
Regulators Now Expect Digital Transformation in Medical Device Manufacturing
Medical Device Manufacturing Industry Leaders Stay Ahead by Finding Innovative Ways to Connect Systems, Processes, and Data
Findings from the recently released “MasterControl 2022 Digital Manufacturing Maturity Study” were discussed in several Masters Summit sessions, and they uncovered some startling conclusions about the digital inequity in manufacturing.
For instance, the research found that only 57% of manufacturers in the life sciences have a digital manufacturing execution system (MES). Of those, only 9% have fully implemented their MES. This may not come as a surprise to those who are all too familiar with the inflexibility, costliness, burdensome implementation, and other inherent issues with traditional MES offerings that have been well covered in this blog. However, medical device manufacturing organizations that choose not to implement an MES are still bogged down with paper-based processes and the inefficiencies accompanying them – issues their more digitally mature competitors have conquered.
The key to overcoming rampant digital inequity is a more adaptable “light” manufacturing solution, according to MasterControl SVP of Go To Market Martin Smyth. Modern MES solutions are designed with flexibility in mind and are much easier to install, configure, scale quickly, and deploy broadly than traditional MES tools. Smyth highlighted the top five benefits a medical device manufacturing company can achieve by enhancing its digital maturity with a modern, lighter MES.
The digitally mature organizations whose successes were touted at Masters Summit made it clear that manufacturers can’t afford to delay modernization initiatives.
“The biggest risk right now is inaction,” said Kyle Jackson, manufacturing director at Dendreon, who has overseen the successful implementation of a modern light MES solution that has dramatically streamlined the biotech company’s manufacturing processes. “If you think your paper or legacy systems are going to be sustainable, they’re not. It’s better to embark on this journey when you want to rather than when you have to. The earlier you can start digitizing and harmonizing your software solutions, the better.”
LNS Research President Matthew Littlefield echoed the sentiment that advanced digitization can’t wait, urging Masters Summit attendees to invest in a “converged self-learning system that builds knowledge and automates actions.”
“If companies stop investing now – if they stop applying these next-generation technologies to quality and manufacturing processes – many companies may never catch up,” Littlefield said.
If you subscribe to Moore’s Law, the phenomenon suggesting that computation progress grows significantly faster, smaller, and more efficient over time, you understand the criticality of digital transformation in the medical device manufacturing industry. In today’s era of continual digital disruption, digitally connected data and processes aren’t just business accelerators – they’ve become the norm that regulatory bodies like the FDA have come to expect.
Most life sciences companies are coming to terms with the current regulatory expectations. As proof, 69% of those surveyed by Axendia reported they are undergoing some type of digital transformation. However, too many medical device and other manufacturers are woefully underprepared to meet those expectations.
“The one thing you never want to be is behind your regulator when it comes to technology,” said Axendia President and Founder Dan Matlis. “FDA is moving everything they can to the cloud. They’re streamlining their software, and they’re cleaning up their data. …If the FDA is modernizing, you need to as well.”
He shared a good rule of thumb that summarizes everything a medical device manufacturer should know about the relationship between compliance and digitization: “If you are not modernizing, you’re probably out of compliance.”
The primary barrier to digital transformation in the medical device manufacturing industry is culture, Matlis said. And the reason he cites for the lag between regulatory expectation and reality is that manufacturers are conditioned to focus too much on regulatory compliance and not enough on improving innovation and quality.
The first step to modernizing in preparation for meeting regulators’ expectations is “getting your digital house in order,” Matlis said.
“If you have a bad process and you automate it, you’re going to get more bad stuff out more quickly,” he said. “First streamline the process, then digitally transform, and then apply the right technology.”
If a medical device manufacturer’s core systems are disconnected, it creates information islands and data silos. Representatives from manufacturing innovators like Carestream Health Biovectra, and Pfizer were on hand at Masters Summit 2022 to share their secrets to breaking down these barriers and keeping data harmonized.
Two vital components of success are connectivity enhancements and standardization, according to Pfizer BTxPS Manufacturing Systems Business Lead David Eisenberg.
“By implementing templated workflows with tools such as MasterControl, we allow our data to be captured in structured systems that will enable our success in the future,” Eisenberg said. “Not only do those systems bring data together, but they also pave the way for us to integrate systems together and create the digital environment we want to see.”
Eisenberg recommended that manufacturers evaluate their existing enterprise systems to determine the impact that enhanced digital capabilities could have on three primary areas of importance: compliance, precision, and productivity.
“Look at the current system and its capability in its current state, and work to develop key opportunities to develop and enhance digital capability,” he said. “By looking at the system as a whole, you can create solutions that span across systems, pilot new technologies, and really become experts in technology implementation and change management.”
The biggest factor in Pfizer’s success, Eisenberg said, has been the partnerships his group has forged, both internally with other Pfizer departments and externally with vendors of purpose-built software solutions that offer integration capabilities.
Masters Summit 2022 also featured vendors with deep integrations expertise, such as LabOps technology pioneers Elemental Machines, who shared real-life applications of beneficial integrations and showed how innovative internet-of-things (IoT) sensors and other advanced tools automate the transfer of data between critical systems.
Stay on the Cutting Edge of Medical Device Manufacturing Trends
There’s no better way to stay informed about the latest trends shaping the medical device manufacturing industry than learning about the successes your peers have achieved by applying modern approaches and technologies. Make plans now to learn from industry leaders and network with like-minded colleagues at the annual Masters Summit, which will return to the Hyatt Regency in Salt Lake City in 2023.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
