Finding the Upside to Downgauging
Do medical device packaging professionals really downgauge their materials? I hear the term downgauge frequently, but I also know there is a lot involved in switching from one material to another. So just how often does it happen? Could the benefits of thinner, stronger, or cheaper materials convince medical device professionals to make a packaging change? Or to add a new material to their existing roundup?
I asked a small group of medical device packagers during this issue’s roundtable discussion. Sure, we would switch materials, the group seemed to be saying, but only if there is a good reason. And that reason isn’t always cost.
Jordan Montgomery, senior packaging engineer for Medtronic Cardiac Rhythm Management, says that stronger pouches would be attractive. Randy Troutman, project manager for global packaging development at Smith and Nephew Orthopedics, says that he, too, is interested in strength, calling his ideal the “bulletproof” pouch. “The challenge is identifying a film pouch structure that can withstand the rigors of sterilization and distribution over the product’s shelf life,” Troutman says in our roundtable, which begins on page 68.
But even when a great replacement is available, a change may be too difficult to effect. Says Troutman: “Sometimes the amount of work that goes into rolling out a downgauging project quickly offsets any cost savings or process efficiency.” For instance, Montgomery says the paperwork required to change packaging for the Japanese market may not be worth it.
Industry veteran John Spitzley, who just retired from Medtronic this year, says that he “doesn’t know that downgauging happens all that often.” Now an industry consultant, Spitzley is cochair of the medical device packaging committee of the Institute of Packaging Professionals.
“There is a considerable amount of data required for such a switch,” adds Curt Larsen, the committee’s other cochair. (He also serves as a packaging consultant for DuPont.) In addition, Larsen says that manufacturers “don’t want to have to [rotate] from one material to another on packaging lines, because they would continually be changing sealing parameters and other settings.”
Yong Cho is giving downgauging a shot. As staff packaging engineer for Edwards Lifesciences, Cho is in the middle of such a project. “We are considering coextruded nylon-based bottom webs for form-fill-seal,” he says.
Roundtable participants all agree that to make a material switch, they need more data from material providers. And those data include testing results on how the material handles typical medical device processes, such as sterilization and distribution. Such data may help packaging engineers demonstrate the worth of a complex downgauging project. Says Troutman: “The biggest challenge is that it is hard to say, ‘We want to change what we have been doing for many years because we can reduce cost or lead time.’ I need more relevant test information when I present the project. So if converters have new ideas, I need a little bit more help in justifying making those changes internally.”
So keep coming up with innovative materials, say Troutman and his peers to medical packaging converters. Just provide more relevant data. Such efforts will make downgauging less of an uphill battle.