First of all, let me say that it does not escape me that a medical device packaging machine provider telling their clients to upgrade their machinery is akin to a barber telling you that you need a haircut. But I assure you my motivations on this topic are more than self-serving. As the director of quality for our ISO-IEC 17025 accredited laboratory, I am always making the delicate dance between my laboratory budget and the latest, greatest laboratory devices du jour.
Like many engineers I love gadgets, and I am a hopeless early adopter. Although after being stung on multiple consumer electronics lately as an unwilling participant in a beta test, I am far less likely to early adopt these days. So how do you know when you should roll into an upgrade on industrial machinery? Obviously, sales groups will convince you that the latest features are essential for your process to be sound, and because we are always concerned as engineers that a process could be affected by outdated machinery we’re easy targets to these scare tactics.
The decision to upgrade into new medical device packaging machinery can be a delicate dance. On one hand, we do not want to disrupt a process if it’s working, we tend to favor the status quo. Obviously, none of us want to delve into a re-validation and unfortunately, it keeps us holding on perhaps far too long before upgrading to equipment that could better our process.
With my quality management system, in my laboratory, I basically have a philosophy that if newer improved equipment can reduce the “risk to my customers” (this, by the way, is the language and spirit of the new ISO/IEC 17025-17 mandate) then it must be considered given it meets budget. Also if there’s an economic benefit that can be gleaned it should also be weighed heavily, as cost management is an endless process in order to keep our laboratory cost competitive.
Most of us know that microprocessor controlled machinery that is as little as five years old could be deep in the dark ages as technologies fold faster and faster each year. Many of our customers have chosen to upgrade their systems when they see how the latest iteration firmware and components of our packaging machinery can benefit their process. Our MS-350 medical device sealer at one time only had the ability to verify or calibrate temperature, we now have the ability to calibrate time, temperature, and force, this is a huge paradigm shift.
I believe this is why many of our customers have opted into the latest iteration on this particular medical device packaging machine in our offerings. My advice is don’t get duped with the pointless bells and whistles that are really, at the end of the day, sales tools and in terms of creating a better medical device packaging have little or no value. Look for the bolder/meaningful upgrades that focus in on meeting heightened regulatory demands, as these are the features that will make your job much easier as a medical device packaging engineer.
Management needs to understand that trying to keep old technologies relevant, particularly when the equipment is of a critical nature (such as sterile packaging machinery), you are likely playing a winless, perhaps dangerous, game. Don’t fight aging machinery that in the end costs more to operate and puts your company at risk of a packaging recall.