Medical Device Link.

INDUSTRY OUTLOOK

As a packager, you are probably always thinking about product protection. Our recent survey of subscribers shows that maintaining product integrity is the top objective of pharmaceutical and medical device packaging professionals. (See the figures on pages 14 and 16.)

But you’ve probably also found yourself wrapped up in a lot of other work this past year. FDA’s bar coding rule for most drugs used in hospitals became law. Its Counterfeit Drug Task Force urged radio-frequency identification (RFID) implementation. And the agency began requiring labeling information to be submitted in Structured Product Language as well as revamped package inserts, both in the name of promoting patient safety. With FDA emphasizing its role in patient safety to celebrate its 100th anniversary this year, it is looking to the package as a means of providing track and trace capabilities as well as to encourage patient education and compliance.

But even as packagers are being asked to tackle these additional projects, these professionals are being asked to help control costs, both their own as well as those in the healthcare industry. “One of the greatest challenges present in healthcare today is how to provide the highest quality of care using the latest technological innovations, while at the same time driving cost out of the system as a whole,” explains Brent Binkowski, operations engineering manager, new product and packaging for American Medical Systems (Minnetonka, MN).

Renard Jackson, executive vice president of Cardinal Health’s packaging services, agrees. He adds that “Improving efficiency (i.e., lowering costs) without reducing quality of care provided (i.e., outcomes) continues to be the lead challenge for the industry. As reimbursements continue to decline, doctors, hospitals, and pharmacies need to become even more efficient to keep their margins intact.”

Binkowski sees a role for the package. “Packaging and labeling can help address this challenge by eliminating waste throughout the supply chain. Packaging professionals can have a significant impact in reducing costs throughout the distribution channel by designing packaging that uses less material, occupies less shelf space, is clearly labeled to prevent misuse, deploys the product easily, and finally reduces the amount of packaging material discarded.”

Jackson says that packaging could help by improving patient health. “Compliance packaging helps patients take the right medications at the right time. This improves on-time refills, which could lead to improved outcomes and lower long-term costs for patients and providers.”

However, “The biggest challenge is educating the patients,” says Deanne Marie Gonsalves of Alcan Global Pharmaceutical Packaging. “An educated patient is a compliant patient. When a patient understands his disease, he recognizes the importance of the medication prescribed. Packaging and labeling enable the medication to educate a patient once at home.”

Packaging is beginning to play an important role in streamlining processes for pharmacy fulfillment, says Tim Groff, director of marketing for Automated Packaging Systems (Streetsboro, OH). Solutions include “unit-dose packaging, kitting, and other personalized packaging applications.”

But packaging can’t be too fancy. “Packaging and labeling can help by meeting and exceeding packaging requirements but not [by] being too extravagant,” explains one implant packager. “The packaging and labeling should be functionally capable for its intended application but not be any more than is really needed. Retail packaging is one thing, where it is intended to catch the consumer’s eye, but for product going to a hospital, I believe the packaging can be more conservative and cost-effective.”

Could packaging cure some of the ills suffered by the healthcare industry as a whole?

BAR CODING

Respondents to our survey included “adding bar coding” as one of the challenges faced by healthcare product packagers. “Overall knowledge of the bar coding requirements” is particularly challenging, writes one.

According to FDA rules, reiterated in April’s new guidance, “Bar Code Label Requirements, Questions and Answers,” drugs manufactured on or after April 26, 2006, for hospital use must bear a bar code. FDA is not recalling any drugs packaged and labeled without bar codes before April 26, 2006, that are distributed and sold after April 26, 2006.

All packages, even small ones, must comply. “We declined to exempt small vials or containers (including suppositories, prefilled syringes, and other small products) and stated that firms may, alternatively, modify the drug’s immediate container to accommodate a label bearing a bar code,” the agency writes. Also, every cavity of a unit-dose blister needs a bar code, if that cavity has a label. Packagers must take steps to ensure that the bar codes are not printed over perforation lines.

While linear bar codes encoded with the National Drug Code (NDC) must be present on most prescription drug products and certain OTC drug products, other technologies to encode lot and expiry-date codes may be used, too. Rule revisions may involve new automatic identification technologies, FDA says.

Sounds easier said than done. Bar coding pharmaceutical packages on the packaging line—perhaps the most efficient and practical means of adding bar codes to the unit dose—remains a challenge for some firms.

FDA’s rule for hospital products aside, many pharmaceutical companies are interested in using bar codes as a backup to RFID. “Technical issues still remain with RFID, as it has not been proven to be 100% reliable yet in the healthcare environment,” explains Rich Hollander, senior director of packaging services for Pfizer. “Until it is, we need backup systems to be in place when something goes wrong. For Pfizer’s RFID pilot with Viagra, we utilize bar codes as a redundant data carrier should the electronic product code (EPC) not be readable from the RFID tag. For small containers, we put a two-dimensional bar code on our bottle labels. On our larger containers, such as the shipping container or pallet, we use a linear bar code because we have the real estate there. On those packages, we also print a human-readable number.”

Packaging and labeling space may dictate a course of action. “More generally speaking, data carriers, be it linear bar codes, two-dimensional bar codes, or RFID, will largely be a function of many factors ranging from whether or not the application requires line-of-site to what real estate restrictions there may be on the package,” says Hollander. “One also needs to consider the package type, physical package characteristics (size and shape, containing liquids, metals, etc.), available technologies to encode on-line at high speed with high quality, and, of course, how it will be utilized by the users.”

There is also discussion about the widespread use of bar codes for medical devices. One medical device packager says that “Bar coding and RFID [could help address challenges with] cost, paperwork, confusion, and errors.”

At the GS1 Healthcare User Group’s (HUG) June meeting at Medtronic (Minneapolis), Tom Werthwine of Johnson & Johnson and Jackie Rae Elkin of Medtronic, both leading GS1 HUG’s regulatory and standards implementation team efforts, recounted their meeting with FDA and AdvaMed in April. “There is value to medical device serialization,” said Werthwine. Industry can “track devices being recalled, deter counterfeiting, prevent transmissibility of disease and infection, and conduct postmarket safety analysis.” There are some challenges, however. “Healthcare users do not always document device use in patients, devices lack unique identification, and manufacturers continually make modified versions of their devices,” said Werthwine.

Volker Zeinar of B. Braun Medical explained a pilot in Paris involving the tracking of single reusable instruments using an etched Data Matrix code. Zeinar leads GS1 HUG’s Instruments & Implants team. He noted problems related to code quality, position, and durability as well as with reading distance and speed. “Not all instruments can be directly marked,” he said. But the advantages were clear: coding can help staff keep “instruments from crossing trays.” This was an important finding for the pilot, which took place at the Hospital European Georges Pompidou in Paris, because France hopes to destroy all reusable devices used on patients with Creutzfeldt-Jakob disease. “France requires that hospitals must identify the last five patients a device was used on,” he explained.

The use of auto-ID technologies like bar codes and RFID brings up the issue of standardization, especially for those pharmaceutical and medical companies supplying products worldwide. GS1 HUG is working to standardize such systems around the world for both pharmaceutical and medical device industries. “Our mission is to lead the healthcare industry to the effective utilization and development of global standards with a primary focus on auto-ID to improve patient safety,” explained Hollander at the group’s June meeting. Hollander serves as the group’s cochair. “Our vision is to become the single source for regulatory agencies and trade organizations to seek input and direction for global standards.”

ANTICOUNTERFEITING

When it comes to automatic identification technologies, RFID has been the headline maker in 2006. In fact, RFID may have stolen bar coding’s thunder. “The growth in personalized bar code scanning data on packages will soon be outpaced by RFID techniques,” says Groff of Automated Packaging Systems. “In both cases, the real cost-benefits are linked to back-end data tracking and supply-chain management as the package plays a growing role in transporting data from the point of manufacturing, through distribution, to the point of delivery.”

FDA has driven interest with its belief that RFID can be used to fight counterfeiting and diversion through electronic pedigrees. In addition, Cardinal Health’s Jackson says that “anticounterfeiting and RFID gained a lot of coverage as pedigree legislation is making its way through multiple state governments. Also, the Dateline NBC story on counterfeit pharmaceuticals raised the profile of this issue.”

In that Dateline NBC special, which aired in June, correspondent Chris Hansen went undercover to cultivate a relationship with a Chinese counterfeiter, Cherry Wong, to obtain counterfeit Viagra. During one of their several meetings, Wong claimed that she could pass her counterfeits off as the legitimate Viagra. “If Pfizer changes the packaging, do you know, so you can change as well?” Hansen asked.

Figure 1. Importance of objectives to pharmaceutical packaging, with 5 representing a very important objective and 1 a not-at-all-important objective. Source: PMP News 2006 Healthcare Packaging Trends Survey.

Wong replied, implying she could: “Our lab in America. They always give us the newest information.”

Dateline NBC isn’t the only one broadcasting the potential threats. In its June 2006 report, FDA’s Counterfeit Drug Task Force wrote that even though “we believe that counterfeiting is quite rare within the U.S. drug distribution system . . . we have witnessed an increase in counterfeiting activities and a more sophisticated ability to introduce finished dosage form counterfeits into legitimate drug distribution channels over the years.”

Purdue Pharma’s use of ultrahigh-frequency (UHF) RFID tags for Oxycontin bottles and Pfizer’s use of high-frequency (HF) tags for Viagra are meaningful attempts to stem counterfeiters while pushing RFID advancement.

“The real success of those applications has really been groundbreaking,” says Robert Ryckman, CCL’s vice president of sales and marketing. “One of the biggest packaging stories for Pharma this year has been the actual use of RFID to solve some of these problems, although it has been talked about a lot in the last few years by companies like Pfizer and Purdue publicly sharing some of the applications data.”

But rather than implementing RFID now, many pharmaceutical companies are still just evaluating solutions in pilot programs. Others are still just waiting. “RFID implementation is the most difficult due to lack of standards in the industry coupled with high initial cost,” writes one respondent to our survey. “We don’t want to choose the wrong technology and have to start over and absorb the initial cost again.”

Paul Glintenkamp, director of pharmaceutical packaging for Packaging Insights & Carton Service Inc. (Norris, TN), has seen many companies express this very concern. “RFID initiatives continue to be a focus for many companies; however, we’ve found many were willing to wait until a true leadership position was taken within the industry or FDA mandated a date and/or method of application,” he observes. “Many customers were uncomfortable with committing to a certain technology, fearing it might be incompatible, unaccepted, or made obsolete by wholesalers or end-users.”

Respondents to our packaging trends survey revealed that RFID implementation was the least important objective of those asked about.

Glintenkamp says that “implementing RFID will only be effective if all links within the supply chain are ready to receive product and verify its authenticity. Packagers, suppliers, wholesalers, pharmacies, and hospitals must all be prepared and aligned. The continued development of global standards will go a long way to RFID success.”

Such is Cardinal Health’s goal. According to Jackson, Cardinal Health is running the first end-to-end RFID pilot. The company is applying RFID-enabled labels, encoding RFID tags during the packaging process, and reading the tags throughout the distribution channel. “Our end-to-end RFID pilot has gotten a lot of attention because we are the first company that can conduct a pilot from labeling to packaging to distribution, but also because we are attempting to use UHF tags at all three levels (pallet, case, and unit). Most pilots use UHF tags for the pallet and case, but use HF tags for the unit level. We wanted to try UHF at all levels to decrease the costs and complexities of the infrastructure needed for two different frequencies of tags.”

Other packaging suppliers understand the challenge. “As an industry, we need to develop a standard that all companies can use to track the product from manufacturing, to packaging, to distribution, to the patient,” says Howard Thau, president of Sonic Packaging Industries (Westwood, NJ). “Several companies are testing RFID systems to track the product from start to finish, yet we cannot afford to not have a universal system that everyone can efficiently utilize.”

Adds Ryckman: “At CCL, the last 18 months have really been quite exciting with our security products group. Being selected by some of the leading pharmaceutical companies to innovate and deliver their security needs is quite an honor and one we take very seriously.” The firm has also announced several partnerships with technology firms—including JDSU (Flex Products) for color-shifting ink, Verify Brand for its unique track-and-trace code solutions, and the Kodak (formerly Creo) product line.

RFID solutions for the pharmaceutical industry are evolving. O-I has integrated RFID chip technology into a bottle, giving drug manufacturers an alternative to label technology. According to Mike Paparone, prescription products general manager, the RFID-enabled bottle provides “higher reliability at the manufacturer and throughout the supply chain, with no chip alignment issues and lower filling line investment since the chip is already in the package.” The chip can be written or read before bottle filling any HF or UHF chip can be used. Finally, “the package is more difficult to counterfeit, since it is in the package and cannot be removed without destroying the bottle.”

While it seems as though RFID has become synonymous with anticounterfeiting, other technologies are just as viable, say some industry folk.

Alcan offers a family of solutions under its N’Crypt brand name, reports Nina Goodrich, director, innovation, Alcan Global Pharmaceutical Packaging.

“Anticounterfeiting technologies are evolving rapidly to protect consumers and brand owners. They have to move quickly to stay ahead of well-funded counterfeiters,” she advises. “Solutions fall into three main categories. Overt technologies are visible on the package, hard to copy, and raise awareness that these products are being watched closely. Covert technologies are hidden by design and need special detection equipment and unique identification technologies in order to establish an individual identity for each package. Overt technologies can include holograms, special artwork, color shifting inks, and special features. Covert technology options are often layered with overt options for added protection.”

Figure 2. Importance of objectives to medical packaging, with 5 representing a very important objective and 1 a not-at-all-important objective. Source: PMP News 2006 Healthcare Packaging Trends Survey.

Cardinal Health offers “a multipronged approach with many different layers of security in our packaging, including both overt and covert security technologies, such as security paper and inks, holograms, microtext, and RFID solutions,” says Jackson. “We give customers a wide range of choices to help improve the security of the pharmaceutical supply chain.”

Counterfeiting is not just a pharmaceutical issue. Jordan Montgomery, a packaging engineer for Medtronic, expects “medical device packaging to become much more sophisticated in the next five years. Technologies such as RFID and overt/covert security designs will become commonplace in the near future.”

Says another medical packaging professional whose firm makes implants: expect “more use of track and trace and product verification devices to reduce counterfeiting and speed up the efficiency of product recalls.” Technologies that this professional is interested in are “more packaging and labeling monitoring devices such as RFID and electronic labels, various smart labels, and self-healing or smart packaging to visibly indicate package integrity and/or content status.” 

Packaging technology suppliers do have the medical device industry in their sights. In July, Karen Polkinghorne, a packaging consultant for DuPont Medical Packaging, shared her firm’s solutions for brand security and anticounterfeiting at Abbott Vascular (Temecula, CA) for the Institute of Packaging Professionals’ Southern California chapter.

And using RFID to track counterfeits may also be a bridge to streamlining the supply chain, thereby containing costs. “By reducing counterfeit products and efficiently managing the supply chain, pharmaceutical companies will be able to consistently deliver a premier product at a cost the insurance companies and patients can afford,” says Thau.

ENCOURAGING COMPLIANCE

The average family contends with a variety of health issues, often turning to prescription drugs. Chronic conditions such as high blood pressure and high cholesterol plague millions of patients, as do diseases like diabetes, asthma, and cancer. According to a 2003 report by the Medical Expenditure Panel Survey (MEPS; cosponsored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics NCHS), noninstitutionalized patients purchased an average of 10 prescriptions each. And that was in 2003.

Many of today’s widely taken drugs are used to manage chronic conditions. “The single-largest therapeutic subcategory in dollar sales continues to be the hypolipidemia class, selling $29.09 billion with a growth of 6.9% in the 12 months to April 2006,” writes IMS Health (Fairfield, CT). “The second-biggest group is the antiulcerants class, at $22.74 billion with a 2.9% growth.” The top-selling drug for the period was Lipitor, worth more than $11.43 billion, reports IMS, followed by Nexium, Plavix, Zocor, and Seretide (sold as Advair Diskus in the United States).

“Patients are consuming more and more drugs,” observes Narendra Srivatsa, business development manager for New Jersey Packaging (Fairfield, NJ). “We need tools to keep track. There is a lot to be gained from packaging.”

Noncompliance with drug regimens is an issue throughout the healthcare system. “Research conducted shows widespread noncompliance with prescription regimens resulting in billions of dollars in unnecessary healthcare costs,” explains Matt Dawes, an account executive with Anderson Packaging (Rockford, IL). “Despite an increasing trend for compliance packaging in the industry since these studies, the issue of noncompliance continues to loom large in the pharmaceutical and healthcare industry.”

Adds Thau of Sonic Packaging: “The biggest challenge to the pharmaceutical industry is to develop a system that will ensure the patient receives the correct dosage each and every time.”

Retail pharmacies are reportedly investigating the role unit-dose packaging can play in compliance. Daryl Madeira, product manager for MeadWestvaco Healthcare Packaging, says that the retailers he speaks with are considering “adopting compliance packaging as a means to get closer to patients and to provide more value through its pharmacies.” He points to a 2006 pilot studying retail pharmacy dispensing of King Pharmaceuticals’ Altace 10-mg solid-oral-dose antihypertensive drug. It is packaged in MeadWestvaco’s Dosepak by McKesson RxPak using equipment from Uhlmann Packaging Systems. The package was recognized as second runner-up in the Healthcare Compliance Packaging Council’s (HCPC) annual Compliance Package of the Year program.“Early data from this study has led us to replicate the same type of study with other pharmaceutical manufacturers,” says Madeira. “Another retailer with a pharmaceutical partner will be studying our Shellpak compliance package for the retail prescription market.”

Adds Larry Blake, director of marketing for MeadWestvaco: “We are trying to leverage the initial compliance packaging study by Ohio State University with Cardinal Health and Merck’s Prinivil (lisinopril).” [This study showed that more patients using unit-dose packaging saw their blood pressure improve than those patients using bottles.]

More studies are needed. “This is just the initial success of tying better persistence and positive health outcomes to compliance packaging. “We are now asking, ‘What can we do to replicate the success with other drugs?’” explains Blake. “When the industry sees multiple positive points of data emerging, they will recognize that the utility of packaging is not a singular spike but a statistically significant trend that can have real impact on their brands. So, hopefully the discussion will move from ‘Why are you using compliance packaging,’ to ‘Why aren’t you using compliance packaging?’”

Some pharmaceutical companies are making the effort to design helpful packaging. “We regularly are asked to help with package designs that will make the customer’s product easier to administer while also providing information for the physician and healthcare provider,” says Glintenkamp.  

Jackson says Cardinal Health’s Pill Calendar “has been proven to improve compliance, which led to greater patient outcomes.”

Simplifying dosing regimens may also help. “Thin-film strips are gaining popularity as a dosage form for pharmaceuticals,” says Cardinal Health’s Jackson, who points to his firm’s child-resistant unit-dose packaging of oral thin-film strips. “Other unit-dose packaging solutions from Cardinal Health include single-dose pouches for creams and ointments, which also include a built-in applicator sponge.”

Unit-of-use packaging can also do more than encourage compliance. “Prefilled syringes and unit-dose packages would help eliminate errors,” says one medical device professional.

Blake predicts that insurance companies may even change their reimbursement procedures in favor of packaging technologies that encourage better health outcomes. “If the data is there that proves that compliance packaging leads to better health outcomes and can impact the total cost of health, insurance companies and other payers will follow the data.”

“In establishing mechanisms to improve medication adherence, The Centers for Medicare and Medicaid Services (CMS) has risen to a leadership position by implementing a progressive Medication Therapy Management Services (MTMS) component to its Medicare Part D provision.” says Madeira. “The MTMS program is defined broadly, and CMS is looking for creative solutions and will measure results. We feel that packaging can be part of an MTMS program and look forward to the day when CMS stipulates that drugs be packaged in a way that encourages compliance.”

Figure 3. Current operations for packaging pharmaceuticals, reported by percentage of respondents. Base: 108 respondents whose companies package pharmaceuticals. Source: PMP News 2006 Healthcare Packaging Trends Survey.

Bottles, however, are still the leading container choice. According to our survey, 36% of respondents select bottles for primary packaging, compared with 19% of those who chose blisters. (See Figure 3)

Compliance may also be encouraged through product labeling. FDA’s attempts over the years, almost starting with its Drug Facts’ panel for over-the-counter drugs and now with its new Highlights section for inserts, are definite attempts to make drug information clearer and more accessible.

“Pharmaceutical and medical device companies are challenged with providing creative methods for patient education and product differentiation,” says Anderson’s Dawes. “Packaging has the ability to play an important role by integrating the message with the product itself.”

Adds Glintenkamp: “Marketing information within the package for the patient and attractive graphics designed to differentiate the product are common now, as well as additional business reply cards and/or Medication Guides for providing feedback and safety information.”

And patient information needs to do more than just satisfy a drug company’s legal liability, says Srivatsa. “Information needs to be more palatable. It is time for Pharma to look at packaging as a serious form of connecting with the patient.”

Collaboration is necessary. “Suppliers, packagers, and manufacturers working in harmony to develop effective technologies that can be implemented on existing packaging lines are a key,” Glintenkamp continues. The challenge for both the manufacturer and the packager is “to develop better packaging designs to promote appearance, accuracy, and compliance.”

Electronic information, either via the Internet or through electronic media provided to patients with products, will play significant roles in healthcare. One implant packager says that his firm “is moving toward more eLabeling to place insert and certain label information on the Web so more information can be easily accessed and continually updated.”  

Regardless of the vehicle, in the next five years Julie Clifford of Alcon Labs expects to see “more information to be readily available to the consumer on a moment’s notice.”

HARMONIZING MEDICAL PACKAGING

After years of debate, ISO 11607 has finally been revised. And it is big news. “The most significant event in healthcare packaging this year is the publication of ISO 11607-1 and 11607-2,” says Medtronic’s Montgomery. “These documents will be the global gold standard for medical device packaging.”  

The revision is significant for a number of reasons. Because it harmonizes ISO 11607 with EN-868, Part 1, the CEN standard for sterile medical packaging, global medical device manufacturers will be able to follow one standard to meet U.S. and European laws. “Adherence to ISO 11607 will provide the basis for proof that the medical device company is creating their packaging in accordance with the Medical Device Directive and therefore rightly can print the CE mark on their packages,” says Nick Fotis, director, packaging technology center, for Cardinal Health (McGaw Park, IL).

Following one standard may also help those firms interested in standardizing their packaging to meet global needs. Glenda Eilo, global industry leader, medical specialty plastics marketing, Eastman Chemical Co., points out that many medical device manufacturers are seeking “standardization of packaging for global distribution and manufacturing of medical products.”

The revision also breaks up material issues and machinery issues into two parts, perhaps making it easier for users to follow.

Another significant change is that sterile packaging manufacturers will be held to the standard. According to Curt Larsen of DuPont Medical and Industrial Packaging, manufacturers of preformed sterile barrier systems, such as preformed header bags and pouches, are now responsible for validating their manufacturing processes. Medical device packagers are now responsible for collecting documentation of such validations from the component manufacturers. Larsen and John Spitzley, formerly of Medtronic and now an industry consultant with Spartan Design Group, say that these packaging component manufacturers first bristled at the idea, but ended up participating at certain points during the revision and now support the change.

A significant number of the survey respondents purchase preformed materials from these manufacturers. According to our survey, 27% purchase thermoformed trays and lidding and 20% purchase preformed/ preprinted bags or pouches and seal them in-house. At this point, however, it seems as though tray thermoformers as well as lid suppliers are not covered by ISO 11607; only suppliers that create a seal on their products are covered, such as providers of chevron-seal peel pouches and header bags.

But many firms are also handling their own in-house package “manufacturing.” Our survey shows that 19% purchase preprinted rollstock to form-fill-seal packages in-house, and 18% purchase blank rollstock to form-fill-seal and print packages in-house. Some packaging professionals point to a growth in flexible packaging as a response to cost pressures.

Packaging can help reduce costs if “lower-cost thermoforming and lidstock materials, smaller and more cost-effective packages, and lower-cost equipment with greater flexibility and greater throughput all work in concert to bring the total price of packaging down,” says Fotis.

Even Eastman Chemical, provider of Eastar PETG copolyester commonly used for thermoformed trays, is aware of cost pressures. “Increasing costs of product development and price pressure from hospitals are the biggest challenges facing the industry,” says Eilo. She adds that Eastman’s copolyester products can be used for both rigid and flexible packaging. “Our polymers enable device manufacturers to reduce inventory by providing products suitable for various sterilization methods.”

Another challenge for both medical device and pharmaceutical packagers is dealing with combination products, points out Montgomery. “Device and pharmaceutical companies have been learning how to comply with regulations for both devices and drugs on-the-fly in recent years in order to meet the requirements of CDER and CDRH. From a packaging perspective, a standardized approach for combination product packaging development would streamline the process of producing a compliant package.”

Adds Clifford of Alcon Labs: “Combining the drug and the device is a challenge. The pharmaceutical packaging business has been fairly plain. The challenge will be adding the marketing splash without sacrificing quality.” To pull it off, Clifford says that low-extractable packaging is in order.

MARKET CHANGES

Jackson from Cardinal Health calls Medicare Part D “one of the biggest [stories] of the year.” Packaging could play a role in the program’s MTMS provision, but no one knows for sure.

Also making global headlines were two major recalls. One involved several pacemakers and implantable defibrillators from Boston Scientific/ Guidant. The other was Bausch & Lomb’s ReNu with MoistureLoc contact lens cleaning solution. While it appears that packaging was not the source of the problems, packagers still took note. None of them want to be responsible for a product failure. “Quality issues and recalls [have] dominated the news this year,” says Binkowski of American Medical Systems. “Repercussions can be felt across the entire industry in that no device company wants to be in tomorrow’s headlines regarding a quality issue.”

Illustrative of the effort put into ensuring packaging quality is a comment made by a packaging validation engineer interviewed for this feature: “One of our biggest news stories this year was that we validated our leak test procedure.” This professional adds that “the packaging department or person can help by following a documented process for developing and validating packages. Companies can help by supporting outside activities, such as Michigan State University’s School of Packaging effort to determine hole size. This is very important as most integrity testing involves some kind of leak test.”

But maintaining quality doesn’t have to preclude change. Rick Merical, director, R&D, Alcan Packaging—Medical Flexibles, says that in the medical device packaging industry, “The challenge is balancing the medical device industry’s propensity to be extremely risk adverse toward evaluating new packaging options, materials, and designs against significant cost-savings opportunities, enhancements in end-use package functionality, and innovative new packaging solutions.”

In addition, the industry “generally has an expensive and lengthy process for evaluating and qualifying new materials,” he adds. “This can limit the industry’s ability to achieve important goals related to enhancing functionality, cost-effectiveness, and package performance for hospitals, doctors, pharmacists, and patients.”

Figure 4. Current operations for packaging medical devices, reported by percentage of respondents. Base: 127 respondents whose companies package medical devices. Source: PMP News 2006 Healthcare Packaging Trends Survey.

These roadblocks can be avoided. “Packaging technology innovation can occur in conjunction with medical device regulatory and quality assurance, provided that the industry leadership can recognize the value of packaging innovation to improve functionality, cost-effectiveness, and ultimately increase market share for device companies,” says Merical. “There must be a willingness to change the process and current model in order for the industry to break through these barriers and realize the significant benefits of packaging innovation that is occurring in the marketplace.” One example, includes packaging suppliers providing documentation demonstrating critical compliance data obtained during machine validation as well as ISO 11607 documentation demonstrating the effectiveness of innovative packaging solutions when presenting to end-users.

COST CONTROL

The rising cost of oil-based plastic materials has been troubling to purchasers. Cost pressures have been a big challenge for pharmaceutical and medical device packagers. “With the rise in petroleum prices and consequent rise in resin prices, the pressure on the margin has created an increased demand for reduced cost,” explains Fotis.

Fotis expects “to see new materials and packaging systems that significantly decrease manufacturing costs. These innovations will be driven by cooperative agreements between MDMs, converters, and raw material producers.”

One medical device packager, however, predicts that “we’ll probably start to see a shift to other-than-oil-based plastics and paper materials.”

Highland Laboratories (Mt. Angel, OR), a dietary supplement manufacturer, has started using bottles made from corn-based plastics, although not for cost reasons. The bottles are made from NatureWorks PLA, a corn-based dextrose from NatureWorks LLC. According to a press release on Highland Laboratories’ new bottles, these bottles use 68% less fossil fuel than petroleum-based plastics. It also states that Highland Laboratories is the first dietary supplement manufacturer to use NatureWorks PLA for vitamin bottles and plans to use them for all of its 250 supplements in the next two years.

Many suppliers are making strategic capital investments to provide cost-effective packaging materials. “In order to reduce the lead time on custom-printed materials, Sonic Packaging will be installing a printing press that will run in conjunction with our liquid blister lines,” explains Thau. “By marrying this new press with our large inventory of high-barrier blister materials, Sonic can deliver a cost-effective solution to meet our customers’ unit-dose requirements in half the current time frame.”

Taking on the testing workload may also save drug and device companies time and money. “Sonic has also just completed several stability and compatibility tests on our new flow-through-applicator delivery systems and will continue to develop new styles of applicators based on our customers’ specific requirements,” Thau adds.

Amcor Flexibles (Mundelein, IL) is also driving costs out of the system by investing in new manufacturing equipment, qualifying new raw materials, reducing waste, and focusing on lean manufacturing. Solutions include newer resin technologies that address needs for stronger, yet thinner coextruded films to reduce costs. In addition, flexible alternatives to rigid packaging may help lower packaging costs, such as replacing glass with clear barrier flexible materials, reports an Amcor representative.

In-line printing and in-line bar code scanning are two other ways to streamline operations and potentially contain costs. For instance, Automated Packaging has helped Cardinal Health and other pharmaceutical and medical device organizations print personalized data on individual packages. “For example, bar codes can be printed in real time on personalized polybag packages, which can then be scanned at the point of patient delivery, for highly optimized data management processes that track security, medication delivery, patient billing, restocking/reordering quantities, and other pertinent patient and pharmacy data.”

FUTURE OUTLOOK

As medicine is practiced outside the doctor’s office, at clinics, and at home, packaging and labeling needs to convey product use instructions boldly and clearly to ensure proper use. Jackson says that “self-administered medications, particularly injectables, can reduce the need for costly office visits. The absence of the healthcare provider, however, raises the bar for package performance. Now, safer, more-effective, and intuitive packaging of not only the pharmaceutical, but also all the ancillary items needed for administering the drug, is required.” Jackson’s Cardinal Health has been supporting “specialized therapeutics” by providing “custom packaging for injectables that provide the syringes, vials, and the ancillary items needed to administer the drug—all in one package.”

Madeira and Blake of MeadWestvaco, too, foresee the rise of “customized healthcare, requiring packaging for unique drug delivery,” says Madeira. “Specialized medicines need specialized distribution.” In particular, says Blake, MeadWestvaco is looking at the cold chain and other specialty distribution channels, working closely with retail partners to develop new packaging formats as well as with sister company NanoCool LLC, which won a Medical Design Excellence Award this year for its self-contained semiactive cooler.

Madeira adds that smart technology may also play a future role. For example, MeadWestvaco’s Cerapak, which records dosing time and date and captures patient feedback for later analysis, is being adopted by a major pharmaceutical manufacturer and by academia for two solid-oral products launching at the end of the year.

Nanotechnology may also find its way into packaging. Srivatsa of New Jersey Packaging says that built-in nanotechnology could help packaging better preserve products, communicate beyond print, and even improve the quality of print.

In the future, “as new formulations are being developed, the focus on new packaging materials and delivery systems will increase greatly,” predicts Thau. “Demand for a superior product in a convenient and easy-to-use package will present the greatest opportunity in the next five years.”

“Ease and consistency of opening as well as clarity and optics to ensure the right item [is used] at the right time” will drive demand, says Merical. “New resins, such as modified nylons, mLLDPEs, and COCs as well other polymers that will improve cost-effectiveness and performance from a puncture, clarity, and peelability” standpoint, will address these needs.