by Charlie A. Webb CPP, CMC
Clearly there are many compelling reasons to use contract packagers, they serve an important role for medical device manufacturers. First and foremost, startups are often ill prepared for the incredible regulatory density that comes along with the sterile device packaging function. After suffering through what I call “regulatory fatigue” brought on by the 510-K process, most medical device startups are unable to get their second wind in order to push once again against the strong tides of sterile device packaging validation and the regulatory process they’re in.
I’ve noticed over the last few years however that there has been a trend from small-to-mid size medical device companies to repatriate the medical device packaging function back into their facility where they can keep it close at hand and create a central point of production and packaging.
As a certified management consultant I would agree there are many compelling reasons to bring this process in house. First and foremost, it greatly helps the strength, and indeed value, of a company when intellectual resources for the technology they create, and use, and ultimately package are captive to the company. If we farm out every function of our company – and many companies do – are we a manufacturer or are we simply a distributor or facilitator? If we choose to create greater depth in the value of our companies, that depth should come from not just capital equipment in house, but also, I would argue, the more important, intellectual human resource, as this creates a holistic company where a spirit of innovation for additional products can take place.
We also have to remember there is often a great deal of time spent managing our outsource contract packagers. Many of our customers told us they were surprised to find when they brought their packaging line in-house, although it was certainly challenging it was very doable. I can tell you having first-hand knowledge as an operation manager at a micro-surgical company, it was very satisfying to see functions from raw material to shipping being engendered under a single roof.
As a certified packaging engineer, I also see this process through the lens of a regulatory specialist. We are, as a company, ultimately responsible for both the good and bad news surrounding compliance. If our company has a packaging recall, ultimately it’s going to be up to us to clean up the mess. And if you’re anything like me, if you’re going to be responsible for process, then you should control the very thing you’re responsible for. And that alone, is probably the most compelling reason to bring your process in-house. Every day your eyes are on the process, you’re creating the system, and therefore when the FDA or any other regulatory agency comes knocking on your door, you’re not blindsided by issues surrounding your packaging process.
Again, I truly believe there are times when contract packaging absolutely makes sense, particularly in the early days when your focus is on your technology and all of the regulatory issues surrounding your 510-K approval, it takes a collaborative team to see your product to market. The helping hand of a knowledgeable third party like a contract packager can truly be an important step in order to begin the siphoning process of your device into the market. But as your company develops through the maturation process, it may be time for you to think about how to create a more whole company with heighten captive capabilities.
When you bring your packaging process in house you create opportunities to save your company money, as the cost recovery tables for the packaging equipment can be quite impressive. And during this era of the lean manufacturing revolution, it is a perfect time to invoke a cost and regulatory control system that will indeed create a stronger more valuable firm.