Medtech companies may be eyeing the cloud for capturing and analyzing manufacturing and quality data, but the transition from manual-entry spreadsheets or even paper records may seem daunting. At MD&M East 2019, MasterControl launched one potential solution, the MasterControl Manufacturing Excellence software tool, for helping manufacturers eliminate paper production records and manual data entry processes.
“When manufacturers have a paper or hybrid process, data becomes trapped in the paper, making it much harder to see the trends,” Matt Lowe, executive vice president for MasterControl, told MD+DI. “You can certainly capture data in any environment, even in spreadsheets, but unless you have a system that allows you to organize it, query it, track it, trend it, and predict on it, it’s of minimal use in preventing the problem.”
Lowe said that “ideally, medical device manufacturers should be collecting all manufacturing data, but some of the inefficiencies that exist today prevent that from being a reality. At the very least, manufacturers should be looking at all key attributes of the product and tolerance limits over time. This would allow companies to see the variances and when they are approaching control limits and catch issues before they become a problem.”
While MasterControl has been helping medical device manufacturers manage data for 25 years, Lowe reported, its latest cloud-based tool gives them additional capabilities. “If you think about traditional QA quality data—things like deviations, out-of-specifications, variance—those attributes are well defined quality channels for documenting things that went wrong,” Lowe said. “Today, MasterControl offers a product platform to manage quality throughout the product life cycle and ultimately connect systems that help catch things before they go wrong. When our clients can be preventive in their quality and manufacturing environments, they can significantly reduce deviations and variances and things of that nature.”
For instance, “siloed data, paper records, and disparate systems are low-hanging fruit for these companies to make the move to digitization, which ties processes together and improves both quality and manufacturing excellence,” he explained.
Collecting manufacturing quality data in the cloud offers a number of benefits, Lowe said. The “cloud equals speed in getting to a digital environment,” he said. “On-premise system installation and configuration takes a lot of time and IT manpower to get going—in the cloud we can get the process going much faster.”
Application security in the cloud may also be enhanced. For SaaS providers, “100 percent of our time, or any provider’s for that matter, is spent on securing our application in a network environment,” Lowe said. “Most internal IT departments do not have that same level of resource availability, nor do they understand the intricacies of each individual application they must support."
Accessibility could be the most significant gain. “Not only is data secure in the cloud, it is easily accessible across regions, people, and departments in real-time,” he said. “This leads to the biggest benefit—leveraging big data, where all the data is there and connected. In this environment, companies can see trends, make predictions and understand how to stop quality events, and create huge time efficiencies.”
The platform also provides manufacturers with the VxT tool, a risk-based validation tool that uses algorthims to evaluate changes in manufacturing processes and evaluate potential risks. “Our VxT tool allows us to take a risk-based approach for validation, because we are in the cloud,” Lowe said. “When companies are managing their quality data in a single environment and we deliver feature improvements in small, incremental changes, it is easier to validate. It’s large, monolithic changes that introduce more risk to your business.”
He added that while “many life sciences organizations have been laggards to digitization due to the validation process,” they could “benefit from the cloud deployment model.
“VxT allows them to accurately assess the different risks in the software changes as it pertains to their business and rely on all of the testing that we do as a vendor, as opposed to having to replicate all that work for their individual instance,” he said. “VxT takes the validation burden down from weeks and months to hours and days.”
There can be challenges when moving to a cloud-based system, but a few steps could make the process more efficient, Lowe explained. “A good place to start is with a systems audit to give a clear picture of needs and gaps and bring those processes together. If making the transition seems overwhelming, implementing in small, quick projects can be more palatable,” he said. “Additionally, users will start to see successes with the small implementations and get excited by the change instead of resisting change. The final piece to a successful digital or cloud transition is building a culture of open-mindedness around the project and investing in the right training tools so users can be successful.”
Data migration for existing users can be streamlined in a hosted or on-premise environment to make the move to the cloud, Lowe said. “We can pick up their data and populate it in a replicated cloud system. For new customers who may be digital, paper, or hybrid, the process has a few more steps to map the data migration into a similar configuration and get it ported over to the MasterControl system in the cloud. But at the end of the day, companies should not be intimidated by the process, as there are validation practices in place to make sure data is migrated properly and risk is mitigated.
“If you are comfortable banking in the cloud, you should be comfortable having your quality data in the cloud,” he added.
Manufacturers that have not yet used a cloud-based application may experience “organizational resistance or a senior leader that is ultra-paranoid about putting data ‘out there,’ ” Lowe acknowledged. “While these emotions might have been warranted 10 years ago, security protocols have advanced so much in cloud applications and with service providers, this thinking is outdated. Why rely on your internal IT team to secure an application they know little about? MasterControl, and almost any SaaS provider, know how to secure data in their system, configure it properly, and make sure that ingress/egress situations from applications are properly secured. This is especially true if a company has integrations to third parties—we know the best way to do that in a secure fashion.
“There also might be concerns about loss of control or job redundancy with IT departments,” he continued. “In reality, hosting in the cloud helps companies, and many times overburdened IT departments, become more efficient and free up time to work on other projects. Projects like this are often administered by the business leadership instead of IT experts, and that can cause some angst because it’s a change. But truly this puts the responsibility and ownership of the software configuration on the people who will actually use it and mitigates the time burden for the IT department.”