June 15, 2017

Designs, Delays and Failures, Oh My

We are big on removing barriers and delays. If you’re in the medical device industry, you know that medical device needs packaging. And you probably also know that the packaging problem comes with a bunch of  barriers, like risk management, sealer validations, FDA expectationsunderstanding the fundamentals of ISO11607,  and reducing lead times, to name a few.  But barriers start even earlier, in the packaging design concept phase. By partnering with a medical-dedicated packaging engineering firm early, you can save untold headaches and delays later, with confidence in the feasibility of your packaging design concept.

Startups are a great example of teams lacking the capability to manufacture products and packaging internally. They rely on contract packagers to provide that service.  Don’t get us started on the difficulty that many of our startup clients deal with – simply getting quotes and then onboarded into contract services can take months. It doesn’t have to be this way. The Packaging Compliance Labs new Feasibility/Proof of Design Concept MicroProgram is a great option during the design phase to eliminate many of these insane delays, while getting top quality, validated packaging out of the way.

Other clients with established production capabilities may still find it difficult to shut down a production line to build validation samples, or to expand the clean room to accommodate new equipment.  Often engineering bandwidth is constrained, so even finding someone to manage and supervise a validation build is challenging. In all of these scenarios, packaging timelines see delays. PCL is seeing brisk demand our Sealer Validation MicroProgram to solve a number of expensive problems, while saving weeks (or months!) of time for the client wishing to handle the sealing tasks with in-house equipment. Our team extends the scope of work by retaining the sealer, developing robust packaging instructions, and training our expert team to actually build DV samples here at the lab. Both transit and aging, as well as other builds that may be needed (feasibility testing, marketing / sales samples, even sterilization validation).  We quarterback the sterilization of samples at your preferred sterilizer (or we can recommend one we work closely with), and then bring samples back to the lab for transit / aging testing.

Furthermore, in the unfortunate event of a transit or aging failure – by having the sealer, packaging materials, and sample devices at the lab, it is much easier for our team to troubleshoot, course correct, and rebuild, thus getting your schedule back on track immediately.  By the way, we ALWAYS recommend performing a preliminary transit study well in advance of DV to get a handle on how the system is performing and gain confidence in the design.

Please contact us today to learn how we can accelerate your timelines and help you speed to market with confidence.