The medical device industry is a highly competitive, high-profit industry. The global medical device market size was valued at USD 488.98 billion in 2021 and is projected to grow to more than USD 7 billion by 2029, according to Fortune Business Insights. Companies introduce new products to the market every day, which means that start-up medical device manufacturers must overcome significant market entry barriers to be competitive.
Our team at PCL recognized that high-volume requirements for contract packaging restrict many start-ups, so we’ve launched Packaging Compliance Medical (PCM), an ISO 13485-certified medical device contract packaging facility located in PCL’s Kentwood location that specializes in low to medium volumes.
With PCL and PCM operating under the same roof, we added a cleanroom to accommodate multiple lines and additional sealing technologies. PCM services include:
- Light Assembly
- Kitting
- Sealing (pouch and tray)
- Device Cleaning (IPA Wipe, Ultrasonic Parts Washing)
- and Labeling
PCM’s contract packaging clients can launch devices faster if they use our sterile pre-validated packaging system, CompliancePack™ (CPack). CPack comes in both pouch and tray options, which means a product can launch in 16 weeks rather than the usual 68 weeks for custom packaging solutions.
CPack pre-validated sterile packaging is ISO 11607 compliant and includes the following validations:
- Sealing Process (DOE and Operation Qualification)
- 5-Year Accelerated Aging (AA) for GAMMA and EO
This expansion of services means that PCL and PCM are the industry’s turnkey solutions for medical device launches with low to medium volumes. Our engineering team, validation lab, and contract packaging facility are under one roof.
“Startup medical device manufacturers tend to have issues with meeting minimum volume requirements of contract packagers and packaging manufacturers which means their speed to market is a major hurdle,” says Matthew Lapham, PCL President. “They may not have a skilled in-house packaging team, and many contract manufacturers/contract packagers are set up for larger volumes. PCM with the addition of our CPack is the optimal solution to help these medical device companies launch quicker.”
“PCM’s experienced professionals tailor clients’ needs for the right-sized solution. We’re excited to fill this industry void.”
Takeaways:
- PCM has no minimum volume requirements which help startups launch their device.
- Clients who choose PCM for their contract packager + CPack for their packaging can launch their device months sooner than by traditional launch methods.
- PCM is under the same roof as PCL so you have a turnkey solution for your packaging needs.