South Jordan, Utah
Software for document management, quality control, and manufacturing execution
Launched with document management and document control software for ISO certification, MasterControl gained traction in industries regulated by the Food and Drug Administration (FDA) in 1996 after the agency issued new guidance for medical and bioscience manufacturers.
"In the 1996, '97 time frame, the FDA released some guidance and regulation around utilizing electronic software systems for medical device, pharmaceutical, and biotech companies," says Lowe. "We realized at that time that the capabilities of our software were well-aligned with those new regulations, so we found ourselves gravitating more and more towards life sciences."
A quarter-century later, life sciences clients represent about 90 percent of MasterControl's customer base of about 1,000 organizations, with the balance of sales coming from manufacturers in food and beverage, nutraceuticals, cannabis and CBD, and other industries. Customers include WD-40, Cochlear, Thermo Fisher Scientific, and Wellington Foods.
MasterControl's complete quality management system now spans employee training control, quality event management, audit management, and risk management.
In 2018, the company "expanded into the manufacturing sector with our Manufacturing Excellence product," says Lowe. "We've seen tremendous growth in that area and really good uptake from the industry." Payback on the investment typically requires less than a year, he adds, as product releases accelerate by 50 percent and data errors drop by 90 percent.
"The areas that seem to have taken to the product most quickly are those that have a high degree of variability in their product mix," says Lowe." The product that we developed is meant to be adapted by the company utilizing it in a very simple fashion. Manufacturing execution systems have existed for many, many years -- they're not very adaptable, so they tend to get implemented on product lines that don't change and are high volume, whereas the product we developed is really suited for the 70, 80 percent of product lines that don't meet that criteria."
About 100 customers use the Manufacturing Excellence software now. Early adopters include "nutraceutical and superfood folks who still have a fairly high regulatory hurdle," says Lowe. "We also see a burgeoning market in medical marijuana. That's kind of an interesting space for us. Contract manufacturing, whether it's life sciences-related or not, tends to be an area that we see a lot of interest from."
Lowe says manufacturers working with CBD and THC are preparing now by developing cGMP-compliant framework in advance. "The companies that are professional and really serious about this business, they see the writing on the wall," he explains. "Regulators are going to get involved there. It is a drug, so regulations are expected to be very similar to parts 210 and 211 in the pharmaceutical space."
He adds, "While the kinds of things that we do are required for companies that are highly regulated, they are also extremely beneficial for anyone who manufactures. From cost to quality to efficiency to time to market, what we're really providing benefits to these organizations that will improve those outcomes for their businesses."
MasterControl's key selling points are agility and adaptability. "The biggest differentiators for us are speed and flexibility," says Lowe. Whereas many competing solutions involve multi-million-dollar implementations, he says, "MasterControl is much less than that -- in many cases, six-figure-type implementations."
And the system can be live in less than 30 days, he adds. "That's a big difference from 18, 24, 36 months -- what is typically seen with these types of systems."
The capability to review by exception is a big timesaver for users after the system is up and running. "Because it's all electronic, it's tied natively to our quality management system as well," says Lowe. "Now folks are able to look at just the exceptions in a particular batch and oftentimes take their batch review times down to hours or minutes, as opposed to weeks and days.
More than 500 employees are based at the headquarters in Utah, and the company also maintains offices in the United Kingdom, Melbourne, Singapore, and Tokyo.
Sales grew by about 30 percent in the last 12 months as of late November 2021, says Lowe, with manufacturing solutions up 400 percent. "We've seen that growth curve continue to accelerate," he says. "What we've provided to people is a way that quality can engage with the documentation of the production bloc in a remote fashion. Clearly you can't manufacture remotely, but a lot of the processes around the manufacturing itself, we automate and enable that to be done remotely. We've seen huge interest and uptake because of the pandemic."
Challenges: "It's keeping up with growth," says Lowe. "We want to be sure that we're providing our customers with the top-notch service that they've been accustomed to, and that becomes harder and harder with rapid growth. We've added 120 new clients or organizations utilizing the software this year, so that's 120 major implementations projects. It's just staying on top of that and making sure that the customers are realizing value in a timely manner."
Opportunities: Lowe says MasterControl has room to grow in manufacturing industries outside its core market of life sciences, including food and beverage, autonomous vehicles, and aerospace and defense. "Really, anyone who experiences a fairly rigorous regulatory environment is going to be well-suited to what our products can provide," says Lowe. "We think that this combination of the product quality and manufacturing data is a really big opportunity for us to provide value to clients that they aren't getting today. As we're able to pull these two data sets together, we've got advancements in AI and machine learning that are occurring at an ever-quickening pace, so we think we're going to be able to operate these technologies on top of that data set to really allow clients to deliver higher-quality products at a lower cost."
The increasing regulation of greenhouse gases is another opportunity, he adds. "I think what we're going to see increasing regulation there [on climate change], so people are going to have to have processes for documenting what their process is and the resulting emissions, carbon footprint, or whatever it may be."
He also points to the company's growing product catalog. New in fall 2021, MasterControl Insights "is data analytics product that provides persona-based dashboards to our customers that surface insights about their business that they otherwise wouldn't be able to get," says Lowe. "We've seen excellent uptake on that front as well."
Needs: "We're in a business where 90 percent of our costs is people," says Lowe. "The labor market for tech talent is extremely tight. We're always looking for good software engineers and data scientists. I expect that need will continue to be acute for as long as I'll be alive."