I was in Memphis on business a few weeks ago and took time to revisit my favorite shrine in American music: Sun Recording Studios, the serendipitous ground zero of the world of Rock & Roll. This odd and unassuming little building (and still functioning recording studio) is where Howlin’ Wolf, Elvis Presley, Johnny Cash, Jerry Lee Lewis, Carl Perkins and Roy Orbison all began their music careers. Where would the music world be today without their influence, ideas and talent, or that of Sam Phillips, the then-owner and operator of Sun Records who captured their genius and introduced these inventors to an unsuspecting but eager audience? They came along at just the right time and their impact has been profound.
Inventions can be like that; so far ahead of their time they cannot possibly predict how they will transform the future. The seeds of great ideas often lay dormant, waiting around for technology and consumer interest to make the connection between discovery and practical application in hopes that they might one day flower.
Take, for example, the steam engine, first described in 31 A.D. by the Greek engineer Hero of Alexandria. He detailed more than 70 steam-powered, workable inventions — including one he built to automatically open doors. His ideas simmered for nearly 2,000 years before the rest of the world caught up to them, ushering in the industrial revolution.
And then there is the humble and elegant Post-It Note, a colossal marketing failure when first introduced in 1977. The now-ubiquitous attention-grabber was the result of an experimental adhesive developed in 1968 by chemist Spencer Silver at 3M. Strong enough to stick to most surfaces, the tacky substance would not dissolve, melt or dry, left no residue after removal and once applied, it could be repositioned. It was interesting, it was unique, and at the time, it was considered totally useless. Seeing no practical application for such a glue, Mr. Silver and 3M shelved the idea. Several years later a work colleague named Arthur Fry approached Mr. Silver for a solution to a problem: he was in search of a method for retaining a bookmark in his church hymnal — something that would keep it from falling out during services but not damage the pages of his choir book. Mr. Silver handed Mr. Fry a sample of the nearly forgotten, unusable adhesive. He swiped a strip of the goo along the edge of a piece of paper and viola; his church hymnal problem was solved and the rest, as they say, is history.
Such inventions have also touched the world of insulated packaging (although arguably less dramatic). Two years ago, I chronicled a couple of techniques in thermal packaging that were the inspirational forerunners to evaporation technology; namely the Crosley Icy-Ball of the 1920’s and Mohammad Bah Abba’s 1995 invention, the Zeer. (May 2010, Advanced Degrees: Refrigeration without Electricity: Archaic technologies get a 21st century makeover).
This issue I’d like to talk about another niche technology introduced to the pharma industry well over a decade ago but which never really found its place — until now.
In the late 1990’s, while I was a packaging engineer at Abbott Laboratories, the founders and inventors of a start-up company in Texas called Kodiak Technologies asked me to evaluate their prototype insulated packaging system. I was encouraged to “put it through its paces,” and give them my feedback — no matter how ugly.
The unique and proprietary technology immediately caught my attention, for it was neither active nor passive. The walls of the durable container were made of a bland, grey, blow-molded polyethylene filled with first generation vacuum panel insulation. The hinged lid was detachable and contained what the inventor described as “the engine of the package,” a rechargeable refrigerant that operated by means of a non-electric / non-battery-powered thermostat which regulated the amount of heat absorption based on the internal temperature of the package. To charge the lid, all that was necessary was to remove it from the base of the container and place it in a -20° C freezer for a minimum of 24 hours. Internal cooling resulted by placing the fully charged lid back onto the base, which kept the contents of the 36-liter payload area below between a temperature range that was more or less 2-8°C. The package also contained an integrated temperature data logger with an external LCD screen. (Considered very high-tech at the time).
I had no intention of adopting this system when our passive, disposable EPS and PUR systems were meeting our needs, but I was intensely curious about how this novel technology performed, so I agreed to their request. The package became buried in the corner of the lab where it remained along with other low-priority requests until I made time a few months later to subject it to our thermal and distribution testing protocols.
The results were less than stellar, but still impressive. In terms of thermal performance, the system lacked continuity of temperature throughout the payload area regardless of package orientation, as evidenced by the placement of multiple thermocouples during the operational qualification. Internal temperature stratification could only be reduced by relying on the mass of the product load. Duration was also a concern. Response of their patented mechanical thermostatic control was slow and inefficient, creating a pendulum effect, broadening the internal temperature range and wasting precious (and limited) thermal energy. The data logger proved to be inaccurate and thus, unreliable.
From a distribution perspective the container was heavy and cumbersome. It had too many raised and unprotected external features: hinges, handles, corner guards and the data logger, all targets for damage in the small parcel or LTL distribution environment. The tare weight of container was high, exceeding the dimensional weight calculations used by integrators, thus making shipping expensive. On a follow-up visit by the company’s senior management I gave them the width and breadth of my assessment. They were disappointed but not deterred; barring a few glaring performance issues, design, ergonomic and logistics hurdles, this technology showed promise, I thought. I recall telling the executives of this fledgling company that from a user’s perspective, the biggest drawback of their system was the fact that it wasn’t disposable. No one at the time was using using a closed-loop returnable packaging system for temperature-sensitive healthcare product shipments. (ULD active systems were only in their infancy in our industry at this time, unproven and feared unreliable). Why would anyone invest the time and Resources in a returnable and sustainable system when disposable packaging was less costly, readily available and much more convenient?
My, my, how the times have changed and good ideas as we have seen, are often about timing. Kodiak Technologies subsequently went through a series of management, ownership, and name changes (now Intelligent Thermal Solutions; ITS for short), but they never lost site of listening to the market and improving on their product. They borrowed from the design of rugged and nearly indestructible ATA-style cases used for sensitive electronic equipment for the external shell of the container. They replaced the problematic first generation vacuum-insulated panels with a newer and remarkably efficient lightweight variety. The detachable lid concept was replaced with a completely self-contained, drop-in thermal regulating unit (TRU) which houses the mechanical thermostat and the improved phase change materials serving as the refrigerant. The TRU contains a clever lighted go/no-go button indicating when it is fully charged and ready to be loaded into the container. Dramatically improved thermostatic response and uniformity is now aided by the inclusion of a patented metal thermal barrier embedded into the interior walls, transferring cooling by means of conduction to all six sides of the container — virtually eliminating internal temperature stratification and increasing duration. Its quick and simple loading protocol radically minimizes temperature deviations that commonly result from packing error.
The collective design and evolutionary changes in conjunction with its performance improvements are impressive — and so is the payload-to-packaging ratio, which is at a noteworthy 19%. ITS continues to enhance its product line with additional sizes, features, and temperature ranges beyond 2-8°C, all with the same basic design logic and performance characteristics.
But for all the technological improvements, where the container really gains traction in today’s packaging, logistics and distribution market of temperature-sensitive healthcare products is in its reusability. The overall cost per shipment of these containers to safely transport temperature-sensitive drugs around the world has been tremendously reduced and now rivals that of consumable packaging.
As the economic paradigm shift of the market begins to gain momentum favorably away from disposable, unsustainable packaging to that of total cost of acquisition of high performance reusable solutions, ITS can stand proudly on the shoulders of their innovative founders and look back to realize that they have had a Sam Phillips moment: a great idea that is helping to transform an industry and bring benefit to people the world over — and in the immortal words recorded by Elvis Presley at Sun Studios on July 5, 1954, “That’s alright Mama, any way you choose.”
Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.clutchcargo.us He can be reached at firstname.lastname@example.org.