Like so many entrepreneurs, Mike Hoftman worked tirelessly to expand his medical device business. But he soon learned that hard work alone would not lead to success. Smart, long-term decisions about capital equipment purchases would be crucial, and for a growing business like Mike’s, a misstep in identifying the right equipment solution now could cause production problems well into the future.
Northridge, CA-based Advanced Medical Innovations, Inc., was indeed growing. For two years, business was steady but the pouch sealers they were using to package their devices were approaching their practical limits. Then two unpredictable things happened almost simultaneously: Advanced Medical had a routine, scheduled visit from the FDA and in the same week a new customer placed an order that exceededcurrent manufacturing capacity by about 50%. The FDA informed Mike that the pouch sealers that were currently in use – though providing adequate seals – were not designed for seal validation, and they would require replacement. Advanced Medical Innovations was at a turning point; they needed a validatable sealer, plus productiondemand had increased significantly. It was time to search for a new validatable pouch sealer.
Focused research for a replacement machine was required, and, as luck would have it,the annual Medical Device & Manufacturing symposium in Anaheim, California was just days away. I visited the MDM convention in Anaheim with the goal of finding a cost-effective, validatable packaging machine to meet our new requirements”, notes Mike Hoftman. We walked the MDM show for 2 days, looking at all the various possibilities. Almost all the companies that manufacture validatable medical packaging equipment were at MDM, so I was able to save time on research and conduct a thorough, hands-on analysis. I found the Packaging Aids 552 Med Band Sealer from PAC Machinery to be the most cost-effective – plus it required minimal training and it had a good reputation for reliability. It looked to us like the Cadillac” of this category of machines”, said Hoftman.
Advanced Medical worked closely with the product specialists at PAC Machinery to configure a validatable continuous band sealer to the exact specifications required. The machine was built according to the agreed time-line and arrived in Northridge right on schedule – luckily, as the new, large customer order was nearing time to enter production. The timing could not have been better,” explains Hoftman, We were up and running in two days, thanks to the skilled service guys at PAC. The transaction from beginning to end was very smooth, professional and seamless – even though our production staff was not terribly tech savvy, we were moving full speed ahead in no time”.
Advanced Medical Innovations, Inc. accomplished two important things as a result of their purchase of the 552 Med. They were able to achieve FDA compliance with a validatable medical sealer, and they were able to boost production significantly. Rather than a capital equipment misstep”, the people at Advanced Medical made a smart choice and purchased a machine that will pay dividends now, and continue to do so well into the future.