MEDTRONIC INC. CORPORATE STRATEGY | OPERATIONS PACKAGING GROUP HAS MEDTRON THE MEDICAL DEVICE GIANT'S SPINAL AND BIOLOGICS DIVISION HAS A GROUP THAT BRINGS SPECIAL FOCUS TO PACKAGING CHALLENGES. f you have a back prob- lem, it’s Medtronie’s job to fortify your spine And it's the job of Medtronic’s packaging group to fortify product develop- iment and manufacturing Medtronic Inc, the third- ranked medical-device company on Food & Drug Packaging’s Top Duar ree eer Packagers list, has a Spinal and Biologics division that’s devoted mostly to producing screws, plates, connectors and other components for spinal surgery and implants. (The division is currently best known as Sofamor Danek, after its founding compa nies, but that name is being phased out in favor of Spinal and Biologics.) The division produces every- thing from single screws to instru- ments to surgical kits, inchuding some cutting-edge treatments like recombinant protein applications for bone regeneration. ts plant in Warsaw, Ind., churns out up to 20,000 pieces a day (see “Plant is the backbone of spinal implant business” on page 46). Medtronic claims to be the global leader in spinal implants, The Spinal and Biologics division has 1,500 employees at its head- ‘quarters in Memphis, Tenn, and 2,500 worldwide. In 2000, about a ‘ear after acquiring Sofamor Danek, Medtronic established the division's packaging group. “The company was growing at such a pace that marketing and product development couldn't handle the packaging themselves like they did when there were fewer product options,” says Robin Turner, senior manager for packaging development. “They ‘were basically sending out prod- uct to an outsice source and say- ing, ‘Hey, Ineed a carton. Ineed a package for this’ So whatever that supplier offered is what they got. What came out of these individual requirements was inconsistency. There wos no Medtronic brand.” Sterile or not The packaging group, now mum- bering 11 at the Memphis head- quarters, is charged with bring- ing about the needed consistency to the Spinal and Biologic divi- sion’s daunting array of prod: uucts—more than 25 keepirOPERATIONS corroeu? S¢srcov basically can be divided into two classes: non-sterile and sterile. Non-sterile items are shipped from the manufacturing facility to the distribution facility in clear poly bags. Kits are built for each surgical procedure and then shipped to hospitals in instru- ment and implant trays that are sterilized once they reach the sales reps and hospitals. Sterile products are more chal- lenging to package. These are packaged, at Warsaw or at other Spinal and Biologics facilities in Puerto Rico and Germany, in the form in which they will arrive in ‘Tho old packaging fr Medtronic: Infuse Bone rat surgcal Kit (et) worked wll ‘but ha alot of uaneceseary spece.A Fecent resign (right) makes more offclent use of space, it into the sterile field. And we try to incorporate suggestions we get from the users into our designs.” Spinal and Biologics solicits these suggestions in various ways, inclucling surveys at trade shows for surgical nurses and other med- ical professionals, Medtronic national sales meetings and focus ‘groups at Memphis. Another ‘important source of ideas is wit- “If you can look outside of the medical arena to consumer products, you can get a lot of great packaging ideas.” Robin Turner, senior manager for packaging development the hands of medical profession- als, (Sterilization, usually by gamma radiation, occurs off- site.) Determining how those meclical professionals prefer to receive them is a major part of packaging design. “Before we design any of our sterile packaging, we always go out and collect customer feed- back,” Tamer says. “We want to know what makes their lives eas- jer as far as using our product, such as opening it and presenting 40 FoopepRug pacKncies / may 2007 nessing medical procedures, either ‘mock surgeries on cadavers or zeal ones on live patients, A double barrier package, now used across the industry, gots consistently positive feedback from users. “Double barrier packaging is preferred to allow proper presen- tation into the sterile field,” says Chris Bagozzi, manager for ster- ile packaging and labeling. “They like to open the outer tray and let the nurse within the sterile field remove it, or they simply allow the inner tray to fall from the outer onto the sterile field table” New package infusion One of Spinal and Biologics’ most intriguing packaging innovations is for one of the division's most dynamic products: Infuse Bone Graft, a recombinant human bone ‘morphogenetic protein (rhBMP-2) that can regenerate bone growth in a targeted area. It’s used in cases of degenerative disc disease, severe fractures and—under a recent approval by the Food and Drug Administration—dental reconstructions. Infuse has been used in spinal surgery since 2002, but Spinal and Biologics decided last year to revamp the packag- ing, Compactness was the major concern. Because thBMP- 2 must be held in a temperature range of 2° to 30° C., the Infuse kit has to be shipped with refrigerated gel packs. Only three of the old kits could fit into the refrigerated shipper. The new packaging, of course, had to contain the same kit ele- ments as the old: vials of pow- dered rhBMP-2, vials of sterile water for reconstituting the powder prior to surgery, a ster- ile sponge that the suzgeon uses to apply the rhBMP-2 and syringes. The old package com- www-fdp.comprised two polystyrene trays— one for the sponge in a sterilized package, one for the other ele- ments—in a paperboard box with two big foldout flaps. “When you take look at this [old package], you've got wasted space and extra packaging that can be redesigned.” says packaging, development engineer James Inabinett, “The package worked ‘well, but it needed to be redesigned to eliminate packaging waste and redluce size for better shipping and storage.” Inabinett and the rest of the packaging team designed a new package that eliminated the polystyrene trays. The sponge package, instead of dominating the ‘outer carton, is tucked into a pocket ina foldout flap. ‘This change drove a 40% down- sizing of the overall package, allowing four of them to fit into a shipper that held only three of the old ones, It also frees up hospital storage space, makes the contents more immediately visible and allows for an outer sleeve that car- ries strong branding graphics. “The inspiration for the new Infuse Bone Graft kit was, believe it or not, the carton that Pods come in. That's not the frst time a Medtronic pack- age has drawn from consumer products. Most ofthe trays that hold sterilized single components now ‘come in a paperboard carton with a www-fdp.com Paklech We are the Handle People ..and we make exceptional Application Equipment PakTech Delivers Cee ee UE en Peletele nee ial Ins A Cease aa bed Pig ele oN uh Cees a a Oa Rs a ana Paolo ure) cea Nelacae ke asee CnC e Peeieuckec eluate Look no further for your sustainable packaging handle solutions- We can Handle it! (541) 461-5000 www.paktech-opi.com on (MAY 2007 / FOODZDRUG PACKAGING 41| OPERATIONS Other departments will “run [the past us. We'll either entertain those ideas or come up with something on our own, or COMPFOMISE.” cris Bagoz, manager stele packaging and lbsing ‘Tumer was with Smith & Nephew Orthopaedics from 1996 to 2000.) Getting the angle Of course, medical device packag- ing is under certain unique con- straints. More than two-thirds of Spinal and Biologics’ products are sterilized by gamma radiation, which pretty much dictates poly- ethylene terephthalate gly (PETG) as the tray material. And the nature of thermoforming means that there are limits to how precise the tray’s indentations can be—so Iedtroni's Spinal and Biologics packaging includes both parts that anv at the hospital storlized (tp) an kts for string parts on the hospital grounds. 42 FOODSDRUG PACKAGING / MAY 2007 MEDTRONIC INC. CORPORATE STRATEGY leas not all components can be held as tightly as one might like For instance, when the packaging, for a recent product line was devel- oped, the marketing department asked for a “stabrand-grab” capa- bility, meaning that the surgical instrument should be able to grasp the implant and screws right out of the package for insertion into the patient's spine. Ideally, the tray would be able to hold all the com- ponents perfectly stil, but in this ase, a campromise was needed. “With the thermoforming process, you need to have a draft angle on the tray,” Bagozzi says. “Whereas we would have liked to have a straight angle that ‘would enable [the instrument] to grab this part a litte better, we had to compensate and allow the part to have slight movement within the cavity, because we have a seven-degree draft angle that we have to work with.” Nevertheless, marketing got stab-and-grab as desired. It was an example of the give-and-take that the Spinal and Biologics group engages in with other departments whenever a new package must be designed. “Product development and mar- keting comes to us with the prod- ‘uct and tells us basically how it ‘works and how they plan to insert it,” Bagozzi says. “They'll already usually have some ideas as to how they would like it presented, and they'll run those ideas past us. ‘We'll either entertain those ideas orcome up with something on our own, or compromise.” Uniformity ‘One of the packaging depart- ments long-term goals is to make this collaboration more systematic, not just with ‘Medtronic’s USS. divisions but worldwide. Currently, Spinal and Biologics products pro- duced in Germany and else- where have different designs, graphics and cartons; the pack- aging group is going for a uniform look. Uniformity brings the advan- tages of savings through volume, stronger branding and fewer regulatory hurdles, “If you form consistent packaging for all facil- ities, you're more likely to be able to use existing testing vali- dations,” Tumer says. The Spinal and Biologics packaging group also provides an important service for Medtronic as a whole: package testing. A lab at Memphis does ASTM-telated tests on shipping packaging, including vibration, drop and compression tests. It complements the shelf-life test- ing, both accelerated and real- time, that the packaging group performs on primary packaging. (Currently the global packag- ing design hub for Spinal and Biologics, the packaging group’s challenge is to implement con- sistent packaging with the man- ‘facturing facilities in Puerto Rico and Deggendorf, Germany. “We're going, to become the central packaging design hub to satisfy al of the Spinal and Biologics packaging needs,” Bagozzi says. FOP www fdp.com