By Eric Carlson | Senior Packaging Consultant | Chainalytics |
I have been attending HealthPack for more than 12 years and once again content of the premier medical device packaging conference is the main reason to attend; and then there are all the terrific people who are the heart and soul of the industry. These people are genuinely engaged and passionate about their packaging responsibilities as a part of safe, quality healthcare delivery. The main themes this year revolved around design & innovation, standards, and human factors. When you consider the functions a package needs to perform, whether in the healthcare sector or not, these themes would be appropriate for almost any industry.
Packaging Design Considerations: Dimensional Weight still an opportunity area
Those in medical device packaging design often have limited flexibility to use innovative design and materials because many devices are line extensions or physically similar. These devices are often launched under the FDA rules of a 510(k) submission. Per the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” The ‘equivalence’ claim refers to both the device and the packaging where the packaging includes both the sterile barrier system and the distribution packaging. Thus, if the device maker can show ‘substantial equivalence’, then former packaging qualification test results can be leveraged to reduce overall product launch costs.
The option to use 510(k) submissions has led many packaging professionals to lean on past qualification success which also leads to the impression that there is a dearth of innovation in medical device packaging. Although there may be some truth to this impression within a group of products, the diversity of devices continues to grow in number and diversity, so there are a lot of packaging challenges that cannot be solved by just scaling up/down anything in the existing design arsenal.
The packaging professionals at HealthPack both described and showcased the use of innovative design. Although many medical device packaging professionals regularly look at the effect their designs on the supply chain, this was the primary focus of a talk by Jeffrey Barnell of Medtronic who proclaimed to the engineers in attendance that “dimwt (dimensional weight) is the most powerful cost savings tool you have.” Dimensional weight is how nearly all the parcel carriers charge for low density products; if the product is less than a target density, the carrier charges for the size of the product. This was a very strong message to an industry in which the two main foci are patient safety and risk reduction.
“Standards are Fun!”: Updating ISO 11607
My packaging healthcare career began before the harmonized standard ISO-11607 replaced the international country by country splintered regulation landscape. I would like to take a moment to publicly thank all those involved in the hard work by those that volunteer their time and expertise in the writing and maintaining standards through organizations such as ISO, AAMI and ASTM. Nick Fotis of Cardinal Health is one of those yeoman actively involved with colleagues from around the globe in crafting an update to ISO-11607. At this conference he introduced the phrase “Standards are Fun!” as well as providing a very timely, engaging and much anticipated glimpse of the updates to the one standard virtually all medical device packaging professionals use daily.
Nurses Panel provides Voice of Customer & insights on Human Factors
The Nurses Panel is the most anticipated annual program at HealthPack in which three local nurses are asked to evaluate packages to get a public ‘voice of the customer’ (VOC). Typically, these packages are submitted for evaluation prior to their introduction into the marketplace. The Nurses Panel package evaluation and the follow on Q&A lasts an entire afternoon. The nurses’ opinions are frank, and occasionally humorous.
There were two programs specifically focused on ‘human factors’ which in this case, studies how humans interact with packaging and labeling. Dr. Laura Bix, of Michigan State University has been a leader in the ‘human factors’ subject with and through her graduate students for many years. Dr. Bix’s presentations are always interesting and welcome by this audience because of her skill in blending relevant technical expertise and a disarming delivery style. The topic this year was an evaluation of labels; content, layout, cognition and the lack of standards. Considering the amount of regulation in this industry, it may surprise you that there is no standard for layout, font, point, etc. One of the most interesting points is that symbology alone was less effective than text alone; symbology education may be the gap.
For those employed by the healthcare industry in the packaging engineering field, the HealthPack Conference is a worthwhile annual event to network with your colleagues around the world and to keep apace on industry standards, packaging design insights and trends.
A lifetime IoPP (Institute of Packaging Professionals) certified packaging professional, Chainalytics’ Senior Packaging Consultant Eric Carlson helps clients manage packaging challenges with a high degree of complexity that stems from their unique combination of scale, variability and geography.
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