KENTWOOD — As medical device manufacturers work to maintain compliance with ever-tightening federal regulations, one West Michigan consulting firm aims to make at least one part of the process easier.
Kentwood-based Packaging Compliance Labs works with medical device manufactures to ensure the packaging equipment and the sterile packaging used for their producs meet criteria established by the U.S. Food and Drug Administration (FDA).
“A lot of companies aren’t as well versed in the complexities of packaging,” President Matt Lapham said. “They’ll spend years on the development of the device to get that process right, but as you put it in the package, it’s, ‘OK, what do we do next?’ The process of getting that packaging designed in a cost-effective way and demonstrating what the FDA requires is just not expertise these small to medium companies will have in-house.”
Packaging Compliance Labs’ toolbox of services came in handy when Keystone Solutions Group, a Kalamazoo-based contract manufacturer of medical devices, needed help finding a new piece of packaging machinery.
Ryan Erickson, vice president of Packaging Compliance Labs, traveled to Germany to inspect a new form-filling packaging machine Keystone was intending to purchase. After the inspection, Erickson came back to Keystone to oversee its setup and testing and ensure its compliance with federal regulations.
“Let’s say Keystone quadruples in size in the next few years: We’d still use Packaging Compliance for a few reasons,” said Jim Medsker, president of Keystone. “The equipment they have is very specialized and expensive and the knowledge they have is very specialized. I don’t foresee us really folding that type of work in-house. Let the experts be experts.”
Like Keystone, many medical device manufacturers are increasingly relying on outside laboratories to meet the ever-tightening federal regulations for sterile packaging, as well as to avoid making substantial investments in their own testing equipment, Lapham said.
Packaging Compliance Labs is banking on the trend toward outsourced package testing to accelerate its growth well into the future, he added.
In addition to working with manufacturers to set up their packaging equipment, Packaging Compliance Labs also performs environmental, aging and other tests to ensure packaging meets federal standards for sterility.
The company uses its array of expensive testing equipment to put sterile medical device packaging through numerous rigorous tests, including accelerated aging, tensile strength and “the worst of the worst of UPS and Post Office transportation,” Lapham said.
“We’re essentially the packaging department,” he said. “They say, ‘Hey this is what we need,’ and they’ll work hand-in-hand with the team to develop a solution.”
GROWING A MEDICAL DEVICE HUB
Lapham and Erickson launched Packaging Compliance Labs in 2014 to address what they saw as an underserved market for sterile packaging testing equipment in West Michigan. Prior to that, Keystone Solutions Group and other manufacturers relied on laboratories across the U.S., which were often backed up with other tests.
For Lapham, having a laboratory for packaging testing is essential to growing Michigan’s reputation as a hub for medical device manufacturing, which he envisions growing to the scale of what’s present in Chicago or Minneapolis.
“Access to packaging testing services has previously been non-existent,” Lapham said. “To promote the medical device industry, we wanted to bring greater access to that locally.”
The domestic medical device manufacturing industry is projected to reach $155 billion by 2017, according to data from the U.S. Department of Commerce.
Packaging Compliance’s services also have caught on with customers far beyond West Michigan. In the two years the company has been operational, it has worked with clients from states across the U.S. and internationally in Mexico, Puerto Rico, Switzerland and other countries.
The lab recently invested approximately $1 million into a 5,000-square-foot expansion project that will double its available space to accommodate a growing customer base. The company also plans to purchase additional environmental chambers for testing, as well as hire new employees.
Packaging Compliance Labs currently generates between $1 million and $5 million in annual sales and employs seven people.
Starting in February 2016, the company expanded its marketing strategy from focusing on referrals to other tactics, including publishing an e-book on packaging and other information on the industry. Putting out the publication helps the company generate leads from potential customers who call asking questions, executives said.
Alongside its marketing push, executives at Packaging Compliance Labs predict that a large amount of its business will be driven by increasing scrutiny from the FDA on the medical device industry.
“Packaging regulations have been there for some time, but the FDA is starting to take a closer look and scrutinize packaging efforts,” Lapham said.
Made in Michigan: Since opening its doors in 2014, Kentwood-based Packaging Compliance Labs LLC has seen its business grow rapidly as medical device manufacturers outsource packaging consulting and testing services to external labs. The company currently generates between $1 million and $5 million in annual sales. It is investing $1 million in an expansion that will double its facility to 10,000 square feet.