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Articles from 2016 In January


Consider potential cybersecurity risks when developing smart devices, says MD&M West speaker

Consider potential cybersecurity risks when developing smart devices, says MD&M West speaker
Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM

Have you considered cybersecurity risk? FDA has just released the new draft guidance, “Postmarket Management of Cybersecurity in Medical Devices.” 

“A growing number of medical devices are designed to be networked to facilitate patient care,” the agency writes in the draft. “Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats.” 

Should cybersecurity be considered during the development of smart drug-delivery devices? We asked Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, Henry Ford Health, this question and more. He intends to cover traditional medical devices as well as smart drug-delivery devices on Wednesday, February 10 at the upcoming MD&M West 2016 conference in Anaheim, CA.

PMP: Medical device cybersecurity has been identified as a potential concern by FDA. When it comes to developing smart drug-delivery devices (such as devices that may interact with a digital device for tracking dosing or other patient activities), what cybersecurity risks are there, and how can drug and device companies minimize those risks to protect patients?

Youssef: When it comes to developing medical devices, it’s critical for manufacturers to focus on the entire system, taking into account the network environment of a clinic or hospital as well as the clinical efficacy of the device. There are risks associated with the device itself, as well as how the device interacts with the network and the rest of the hospital or clinic ecosystem.  Some of the key areas that are of concern are: 

1) End-users leveraging default, or shared passwords on the device or the network that the device is relying on.

a. Device manufacturers can create workflows to ensure that the passwords in use are sophisticated and difficult to decipher using dictionary attacks.

b. Discourage the use of Pre-shared keys, WEP, or TKIP and rather promote AES encryption and authentication.

2) Patient Data compromised, or intercepted.

a. Ensure that data is encrypted in transit as well as while at rest or being stored on the device.

3) Medical device being susceptible to attack from within or outside the network.

a. Manufacturers can take measures to ensure that only secure protocols are used to access the device configuration.

b. Work with the hospitals and clinics to implement role-based access controls to ensure that a given device can only access what it requires on the hospital or clinic network.

c. Work with the hospital to ensure that a defense in depth strategy is in place to protect medical devices and the data they transmit.

4) Underlying OS vulnerabilities.

a. Manufacturers should move away from using backend Operating Systems that are no longer supported such as Windows XP.

b. Promote regular security patch management.

c. Promote routine security audits.

5) Promoting redundancy.

a. Manufacturers can build a layer of redundancy in the device to ensure that if a given communication medium is disrupted, the device can continue to safely and effectively function.

It is difficult for medical device manufacturers to mimic a hospital network, so every measure should be taken to test the devices on test beds that are configured as closely as possible to a hospital network, or on the hospital network itself.

PMP: Does the concern about cybersecurity only apply to smart medical devices and drug-delivery devices used in hospitals, or would it also be a concern for smart devices that patients use at home (or on the go) that communicate with phone apps? 

Youssef: It’s a concern in both arenas. The challenges are similar from a device security perspective regardless of where it is being used.  When we introduce apps into the equation that adds another layer of complexity and a multitude of additional potential vulnerabilities.

If anything, in a hospital setting, there are usually security measures in place with traffic segmentation onto dedicated VLANs and robust firewalls.  The typical home network environment typically lacks this level of security.

PMP: What can potential attendees expect to learn from your session?

Youssef: This session is intended for medical device manufacturers as well as hospital staff. I will cover typical medical device cybersecurity concerns with a focus on:

1) How device manufacturers can help alleviate some of these, and

2) How healthcare workers can take proactive measures to identify cybersecurity issues.

PMP: What actions do you hope attendees will take after attending your session?

Youssef: My hope is that medical device manufacturers will make an effort towards establishing test beds that are more IT network focused. The other side of this is to ensure that health systems implement robust test processes and device onboarding processes to try and proactively isolate potential security issues.

Here are details on Youssef’s presentation as well as those from a few other speakers at MD&M West (Feb. 9-11; Anaheim, CA):

Wednesday, February 10

1:25 pm -1:50 pm 
Assessing Medical Device Cyber Risk in Your Connected Device

  • Recognizing various security threats to integrated medical devices
  • Listing controls relevant to a medical device IT security assessment
  • Exploring ways to manage risk when there is a cyber-security issue

Ali Youssef, Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM

1:50 pm - 2:30 pm
 Panel: Managing Risk to Keep Data Secure and Patients Safe

  • Overcoming the 3 main risk areas: patient safety, malicious activity, and data security
  • Factors to consider during product design with an eye toward cyber security
  • Recognizing cultural challenges such as availability vs. confidentiality of data and how to effectively deal with these in your organization

Moderator: Andrew Herger, Director of Engineering-IoT, DEDICATED COMPUTING

Michelle Longmire, MD, Founder, MEDABLE


Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM


Melissa Masters, RAC, Manager, Electrical, Software and Systems Engineering; Director, BATTELLE DEVICE SECURE SERVICES, BATTELLE 

Also, FDA had held a public workshop on cybersecurity on January 20-21, 2016, entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” It was held in collaboration with the National Health Information Sharing Analysis Center, the Department of Health and Human Services, and the Department of Homeland Security.

According to FDA’s draft guidance, “Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.”

Please click here for more details on attending MD&M West 2016.

What’s happening in motion control technology?

What’s happening in motion control technology?
HMI-replacing Programmable Automation Control simplifies programming and saves money.

Packaging automation developments centering on motion control are the topic of this Q&A with an expert from products supplier Parker.

Marissa Tucker, product marketing manager, Parker, takes a look at the past, present and future of motion control hardware design for packaging machinery and line automation.

Where do you see the design and shape of motion control going?

Tucker: The first step toward seeing into the future is to look into history, which has been marked by continuing integration and steady reductions in system complexity.

The development of modern industrial controls was sparked by the introduction of computers to the factory floor. This allowed replacing the functions of hundreds—if not thousands—of relays, cam timers, and drum sequences with a singular programmable logic controller (PLC). By the 1990s, programmable logic controllers (PLCs) began to assume today’s familiar “bookcase” form factor, allowing plant engineers to modularize their applications, and purchase only the components they needed.

What can you mention about modularity?

Tucker: If a plant engineer needed a new axis of motion control, it was a simple process to add another module. Although this modularity added to the flexibility of the engineer’s application, it also added more hardware and increased the overall cost of ownership. As the machines being controlled grew in complexity, bookcase PLCs required significant cabinet space, and motor control modules had to be manually wired from the controller to the drive. In addition, for truly synchronized motion between axes, another motion controller had to be added to the system, increasing cost and complexity. The solution came from a new technology: Ethernet.

What impact has the growing availability of Ethernet had on motion control?

Tucker: Buses like EtherCAT have made complex, coordinated motion control possible over a bus, alleviating the need for any external motion controller in the system. Drives can now be connected directly and controlled by the PLC via a single cable. This integration has transformed PLCs into multi-functional PACs, Programmable Automation Controllers.

EtherCAT also contributes to the modularity, yet reduced complexity of an industrial controls system. Systems engineers have the flexibility of adding as many or as few drives or other EtherCAT supported devices as required for their application. EtherCAT can transfer a tremendous amount of information over distances allowing for remote drives or devices up to 100 m away. With traditional I/O control schemes, this would have been impossible and would have required separate controllers and independent systems. Now that this can be accomplished through a centralized controller, it reduces time and cost: only one controller needs to be programmed and less hardware is needed. This is why Parker chose EtherCAT as the default bus for its PAC controller.

What’s the next step in the evolution?

Tucker: Human-machine interfaces (HMIs) are often afterthoughts that mean additional hardware and development time. Parker Hannifin’s PAC has taken a cue from the integration of the PLC with motion control and has added the HMI. The PAC incorporates visualization, allowing users to program their interfaces directly on the same hardware. The display can be viewed on any browser or used with Parker’s low-cost PAC terminal. This solution allows plant engineers to save time by programming a single device, and save money by replacing a complicated HMI with a simple, affordable display.

What does this mean for packaging operations?

Tucker: Although increased integration of hardware allows for a lower cost of ownership and smaller machine builds, the biggest benefit, especially to packing operations is the use of a single software platform.

For instance, Parker Hannifin’s Parker Automation Manager (PAM, shown above) allows users to configure their drives, program their visualization software, and program the PAC in one single development environment. This means packaging machines can be programed significantly faster since engineers only have to be trained in a single programming environment and the automatic sharing of tags between devices drastically reduces development time. This seamless integration of software also provides better project management capabilities.

Many packaging operations are unique and require special modifications to meet every clients need, PAM allows users to develop a single project with multiple device configurations or deploy modular software including custom libraries or function blocks. This means that a single project can contain the various versions of a machine (including HMI, PAC, and drive configuration) all in a single platform. This is incredible version control that was not previously possible before, allowing packaging operations to provide better quality control, troubleshooting, and customer support in addition to the cost cutting and time-saving benefits.

For more information, visit Parker. The company’s Medical Devices Division will be exhibiting in Booth #2801 at UBM’s Anaheim (CA) Event in early February that includes WestPack 2016.

 

About

Marissa Tucker is the product marketing manager of Controls and HMI at Parker Hannifin's Electromechanical and Drives division. She has been in the motion and controls industry for five years with a strong technical background and currently focuses on new product development and messaging. Marissa has a B.S. in Mechanical Engineering from Davis, CA, and lives in the Bay Area.

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Want to see packaging automation technologies in action? Then attend WestPack 2016, Feb. 9-11, in Anaheim, CA.

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Does this often-overlooked sustainable packaging metric deserve more attention?

Does this often-overlooked sustainable packaging metric deserve more attention?
Cereal is one of more than 50 product categories this report researched.

When deciding the size of a product’s package—single serve versus multiserve or 12 versus 16 ounces, for example—brands typically consider consumer convenience, optimum shelf display or profitability. But perhaps sustainability should be higher up in that list. Here’s why.

“Larger product/packaging sizes are significantly more efficient than their smaller counterparts, regardless of material type.” This is one of five major findings in the 20th Anniversary Edition of “A Study of Packaging Efficiency, As It Relates to Waste Prevention” report from the editors of The ULS Report (ULS = use less stuff).

This conclusion is consistent with the two earlier groundbreaking studies done by ULS in 1995 and 2007. But the world has changed considerably, especially since the first study. It’s “greener” than it used to be. Not many packaging or marketing professionals talk about the product-to-package ratio, but it can be a critical measure of a product’s sustainability. And, intuitively, consumers often sense when the ratio is woefully out of whack, incorporating that into their purchase decision.

For foods or beverages, this ratio is just one aspect of a larger sustainability and packaging efficiency discussion. As the name of the report implies, waste prevention can be directly connected to sizing a package appropriately for the product’s use and the consumer’s lifestyle. Too big and the food might spoil before it can be completely eaten. Too small and you could be generating more packaging waste than your customers will accept.

How does package size compute when taking into consideration product waste? Robert Lilienfeld, ULS editor and Packaging Digest contributing writer, says, “The odds are good that larger sizes would generate more waste, if purchased by price per ounce rather than the number of portions needed.”

What if the number of portions needed is one, though? Aren’t single-serve packs inefficient from an overall sustainability perspective (energy used to produce, for example), not just looking at the product-to-package ratio? That’s what makes this a rather complex issue, despite the simplicity implied by the numbers. Portion control can aid consumers’ health/weight goals, provide hygienic assurance and enable on-the-go consumption or use—conveniences that often out-weigh sustainability objectives. “These consumer factors can be at least as important from an overall sustainability standpoint, compared to only looking at packaging-related information,” says Lilienfeld.

Let’s take a look inside some actual numbers.

This latest ULS report measured the product-to-package ratio and net discards in pounds for seven different foods. The numbers reported assume at-home use and disposal. What about away-from-home situations, which could represent a significant effect because of today’s on-the-go society? How might that skew the ratios and discard numbers? “The logical effect is that efficiency goes down for out of home, as the recycling rate would decline,” Lilienfeld explains.

The examples in the table below highlight how much more efficient large sizes can be than their smaller counterparts.

In most instances, the larger the package, the higher the product-to-package ratio. In two cases—for milk in high-density polyethylene bottles and soup in aseptic cartons—the ratio stays the same regardless of the package size. “Both sizes are large enough that efficiency is about equal,” Lilienfeld explains. “This is also due to rounding. For soup in aseptic cartons, the larger rounds down to 96% and the smaller rounds up.”

The multipack effect, shown in the cereal category, shows how this portion-control and on-the-go convenience takes a major sustainability hit.

And while larger sizes are more efficient despite the type of packaging material, material choice does influence the amount of net discards. Glass, not surprisingly, ranks highest by weight. Flexible packaging, as expected, often logs on the lowest end of the spectrum of discard weight.

Lilienfeld also points out how some product innovations, like the Tide Pods, create a product/package system that makes a sustainable comparison to the previous or competitive packages difficult. The newer product, detergent/stain remover/brightener-in-one, replaces two separate products (detergent and bleach), each in its own package. Additionally, the newer products are highly concentrated, saving more space and needing less packaging material to contain.

This type of product/package innovation—while a win-win in consumer convenience and sustainability—is the outlier. The report deduces that “Ultimately, packaging decisions are driven by consumer perceptions and lifestyle requirements. In many cases, these factors lead to more packaging rather than less.”

Two reasons support this conclusion (as cited in the report):

• “We tend to equate quality with quantity. A 500mL bottle of store brand water weighs 8.8 grams and has a retail price of $0.13. A 500mL bottle of a typical ‘performance brand’ weighs 27.3 grams and retails for $1.19. While the latter’s heavier weight and higher prices may increase quality perceptions among users, they generate greater environmental and economic costs for society.”

• “We strive to achieve active, healthy lifestyles. This state of mind leads to the demand for packaging to deliver convenience, ease of use and portion control. Resulting packaging responses generally lead to inefficiencies, as they require smaller sizes or the increase functionality needed to deliver ready-to-eat, ready-to-serve and out-of-home product solutions.”

This is just a mere sample of the compelling data in the full 60-page report, published January 2016, which you can download for free. It includes expert analysis on five major findings, as well as raw data for 300+ products in more than 50 different product categories.

This is the level of detail I’ve come to expect, trust and appreciate from studies done by the leading consumer testing and rating magazine Consumer Reports.

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Learn about the latest developments in sustainable packaging at WestPack 2016, Feb. 9-11 in Anaheim, CA.

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5 ways to prevent packaging waste

5 ways to prevent packaging waste
How do different packages compare when the goal is to prevent waste?

Source reduction, recycling and “efficient” packaging continue to be go-to methods to minimize the amount of waste sent to landfills in the U.S.

The just-released 20th Anniversary Edition of “A Study of Packaging Efficiency, As It Relates to Waste Prevention” report, produced from the editors of The ULS Report (ULS = use less stuff), identifies key characteristics of product/package systems that add to their overall level of efficiency and sustainability. The data in this report can be used to ensure that cradle-to-grave analyses that compare packaging alternatives consider all relevant information.

Five major findings in the report are:

1. “The best way to reduce materials going to landfills (net discards) continues to be through the use of lighter weight packaging.”

2. “Recycling of primary packaging (defined as recovered material) plays a prominent and growing role in reducing discards.”

3. “Source reduction continues to play a significant role in the effort to reduce material usage and waste, even given the large amount of light weighting that occurred in the 1970s.”

4. “Larger product/packaging sizes are significantly more efficient than their smaller counterparts, regardless of material type.” (Packaging Digest took a deeper dive into this finding in “Does this often-overlooked sustainable packaging metric deserve more attention?”)

5. “Product packaging is more efficient for products that require more preparation by consumers” (such as concentrated products and mixes) versus ready-to-serve/use options.

Read conclusions drawn from the results by downloading this free 60-page report, published January 2016. It includes expert analysis, as well as raw data for 300+ products in more than 50 different product categories, from foods and beverages to personal care products and household goods.

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Learn about the latest developments in sustainable packaging at WestPack 2016, Feb. 9-11 in Anaheim, CA.

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Can you scale up production and please patients?

Can you scale up production and please patients?
Image courtesy Phillips-Medisize

Developing a combination product from concept to market can take years, observes Bill Welch, chief technology officer and vice president of engineering for Phillips-Medisize Corp. So how can a company increase its chances for success? Come up with a design that is both desirable to patients and manufacturable, says Welch.

Welch will be exploring strategies that balance both aspects in “Integrated development and scale-up of combination products” at Pharmapack Europe on February 10 in Paris. He will share a case study examining what makes a device successful in terms of manufacturing and assembly as well as patient acceptance. 

“Everything comes down to getting a better therapy in the hands of a patient,” says Welch. “A good device can help users adhere as well as avoid mistakes through simplicity and intuitiveness.” 

However, you can have a great device, but it could still fail, he warns. Desirability must be balanced with manufacturability, which entails developing a design that allows production scale up.

Welch advises “minimizing part variation” and following Quality by Design principles. “Driving out variability allows you to scale,” Welch tells PMP News. Doing so allows “individual components and the assembly process to be easily replicated and scaled so that high volume is possible.”

While manufacturability is important for any product, there are complexities to combination products that bring unique challenges. For inhalation devices, for instance, there's “a high degree of interaction between the drug formulation and the device itself that impacts the aerosolization of that drug,” Welch points out. Device design decisions therefore need to be made early during product development before the product goes through clinical trials. “It’s different for a typical injectable drug, which could go through a clinical trial with a typical vial and syringe,” he says. 

And because the device must be considered so early, so must design for manufacturing and assembly, he adds, stating that his case study will highlight such challenges.

Welch says that there are “tried and true methods for assembly and injection molding” that can promote manufacturability, for instance. But when asked whether they involve stock components, he says “its very tough to make stock components” for combination products.

It’s more about the “integration of disciplines, such as human factors and electrical engineering,” for instance, he says. “All have to be on the same page for manufacturing. I’ve seen a lot of innovation in inhalation devices—the use of electronics and electromechanics are critical to the function of the device.” 

Also, “it takes a lot of upfront cooperation,” he adds.

A desirable, manufacturable device could be welcomed by the market. “Inhalation devices have the greatest potential for misuse,” he says. “Next-generation devices can sense breathing and can time drug delivery with it, even if shallow or faint. You can reach a group of patients who didn’t have such a device before, such as young children, unconscious patients, or the very ill.” 

In addition to speaking, Welch will be on hand at Phillips-Medisize’s Booth #616 at Pharmapack Europe February 10-11

Phillips-Medisize will also be exhibiting at MD&M West in Anaheim February 9-10 in Booth #3011.

Welch spoke about designing smarter and smaller drug-delivery devices before at Pharmapack North America in June 2015.

Surprising developments in HPP packaged foods

Surprising developments in HPP packaged foods
Bolthouse Salad Dressings in PET bottles have been HPP pasteurized since 2012.

High pressure processing (HPP) is a non-thermal, post-packaged process that is a viable alternative to heat and other food processing methods. It’s a globally recognized natural process that provides food safety and extended shelf-life without damage to nutrients. HPP has become mainstream as more food categories and package options are offered to the market. 

A mid-September visit to the Avure Technologies booth at Process Expo revealed a breakthrough development on the equipment side as well as a surprising range of products and packaging that were treated using high-pressure processing, a cold pasteurization treatment.

On the packaged products side, the company's booth displayed the following foods that are HPP pasteurized:

  • Hormel Natural Choice lunchmeats, which have been HPP treated since 2007, has introduced new packaging;
  • Instinct Raw pet food pouches;
  • 1915 brand juices (shown on the next page), introduced in 2015, are the latest among a growing number of HPP-pasteurized “cold-pressed” beverages;
  • Guacamole products (and salsas for that matter) have been associated with HPP for years, including products for Sabra, Peak Perfection and Wholly Guacamole brands; and
  • Bolthouse Farms salad dressings, packed in PET bottles, were among the most surprising packaged products on display.

Guacamole products in sealed tray packaging have been an HPP staple for years.

We take an inside look at what’s happening in the HPP market from the perspective of Lisa Pitzer, Avure Technologies’ marketing director, who responds to our questions starting with one that points to the company’s new AV-X series of equipment. The AV-X (shown below) is billed as the “world’s first expandable HPP machine,” a system that grows with the processor’s needs. It is available in AV-40X to AV-70X versions, with each number signifying the millions of pounds of product that can be processed yearly by the system from 40 to 70 million.

 

What’s the reaction to your new modular system?

Pitzer: The interest for the AV-X Series of Machinery has been outstanding—we have discussed it with numerous customers. The new machines will enable a producer to buy the machine that best suits their current needs, but as their company grows and their volume expands, the machine can be upgraded to keep up with increased demand.

These upgradable machines have a flexible design with a smaller footprint to suit individual production needs. The new design also reduces energy consumption by as much as 50%, resulting in lower energy bills for the customer. This is the biggest development in HPP since Avure created the first commercial high pressure processing system more than 60 years ago.

Next: The HPP market, product benefits and packaging...

One of the latest HPP products is in the HPP-dominated cold-pressed juice category: 1915 Juices were introduced this year.

How would you characterize the HPP market?

Pitzer: The HPP Market is still in the growth stage for both HPP end products and HPP equipment. The HPP products market is projected by to grow to $12 billion dollars and for HPP Equipment to grow to $6 billion by 2018, according to a Markets and Markets study.

It is an exciting time for HPP as interest and demand are growing exponentially each year. HPP is moving away from being a novel process to being a normal process. Ten years ago the question surrounding HPP was, “What is this technology?” Five years ago, the question changed to, “Can I afford it?”

Now, it is seen as a normal, not novel, technology so the questions are changing to typical food manufacturing questions. The equipment looks like and feels like other food processing machinery in a food plant. HPP machines can now be evaluated on throughput, cost to operate, and reliability, just like all other food processing equipment.

Has there been an uptick in HPP used for pet foods?

Pitzer: The reason for the pet food trend in HPP is that in recent years the FDA has enacted regulations for pet food. Salmonella is the main culprit, which will not hurt the pet, but pet foods are often handled in the home and could result in secondary contamination to moms, dads or kids.

What role does packaging play in HPP?

Pitzer: The package is critical to HPP success. All the products are in their final package—HPP is a post-packaging process. The package must be a flexible package. Pouches, plastic bottles, cups, trays and tubes all work under HPP. Avure has packaging expertise in house. Correct barrier properties such as OTR, MVTR and UV of the package are critical. The design of the package is also important to prevent damage and optimize throughput.

Also, all HPP products are in the refrigerated space.

The three key advantages that hold true for all HPP-treated products are: food safety to inactivate pathogens such as listeria, E. coli, and salmonella; added shelf life to increase distribution possibilities and decreases costs; and the ability to introduce new products, for example, clean-label foods.

Avure Technologies

In September, we reported on the launch of bottled gazpacho soup that is HPP pasteurized.

You can read Packaging Digest’s other high-pressure-processing news and articles by clicking here.

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Devoted to packaging developments? Learn about the latest packaging innovations at SouthPack 2015, Nov. 18-19, in Orlando, FL.

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Change is coming to pharma packaging, predicts Pharmapack Europe speaker. Are you ready?

Change is coming to pharma packaging, predicts Pharmapack Europe speaker. Are you ready?
Peter Schmitt, Montesino Associates

Healthcare systems around the world are under severe pressure to improve patient outcomes while reducing costs. Over the years we’ve shared many insights from packaging experts suggesting that patient-centric packaging (in one format or another) that enables patients to care for themselves as directed could reduce overall healthcare spending.

It’s difficult to disagree, but changing to such patient-centric packaging has been a gradual, almost linear evolution, so the gains may not be keeping up enough to relieve the pressure. Such change typically comes about only after a specific push, such as the design opportunity a new drug or medical device brings, a specific customer or payer request, or regulation. 

But there may be another source of change, and it may not be as gradual. Peter Schmitt, managing director of Montesino Associates, urges the industry to prepare for external drivers of change. He speaks about the growing tension between changes sought by Millennials and the status quo defended by Boomers (incumbents), and he also points out that significant societal changes brought about by disrupters Apple, Google, Amazon, and others may also change healthcare, and therefore change packaging. 

Schmitt will be speaking at Pharmapack Europe February 10 in the presentation, “Boomers, millennials, and the future of packaging materials.”

“Boomers are frustrated about change,” he observes. “But millennials are frustrated that things are changing so slowly.”

First speaking about this phenomenon at Pharmapack North America 2015, Schmitt calls it the “Molecule Centric/Blockbusters versus Patient-Centric/User Interface.” (Read our article on disruption here.)

“Since the 1980s, pharmaceutical packaging supported a molecule-centric business model, one that looked to develop, launch, and maintain new blockbuster molecules in a globally harmonized marketplace,” he says. “As such, the focus of packaging was to remain ‘off of the critical path’ and, rather than focus on ease of use, or new developments that saw packaging supporting compliance or adherence, the primary focus of packaging was accelerating and supporting molecule approvals.” 

But we’re in a different world now, not only because healthcare systems are seeking improved quality in care, but also because patients are, too. Today’s patients are also today’s consumers who are now used to just-in-time, user-centered product innovations that make life easier and more convenient. These patient/consumers are also used to living a connected existence, where information is available at their fingertips.

Pharmaceutical and medical device packaging will need to serve these patient/consumers differently than it has ever done before.

When it comes to packaging materials, Schmitt wonders whether the traditional emphasis on approvals and regulatory concerns may change. “For over 25 years, pharmaceutical packaging materials focused on supporting stability testing and regulatory approval. There are voices today calling for that focus to shift. Will the voices be heard?”

Packaging design, too, may need to focus primarily on the patient and promote safety, compliance, and ease of use. “In the world of Apple, Google, Elon Musk, and others, design and innovation are now critical tools in gaining competitive advantage. Will those voices impact pharmaceutical packaging?” Schmitt asks.

Schmitt will also explore future trends to watch, such as potential shifts to outsourcing to support the search for innovation, the ongoing dilemmas for solid oral doses of rigid versus flexible and bottles versus blisters, and the emerging roles that intelligent packaging could play. “The drive for packaging to communicate with patient and healthcare professional is growing rapidly. Whether driven by regulatory agencies (serialization and traceability) or consumer groups, voices are demanding intelligence and communication in packaging. Will the Internet of Things include pharmaceutical packages?” he asks.

When approaching these issues, Schmitt urges packaging designers to think a little differently. He points to a January 2016 blog by Tor Bair, “Your Life Is Tetris. Stop Playing It Like Chess,” musing that “Pharmaceutical packaging is Tetris. Stop playing it like chess.” 

Schmitt applies Bair's observations to pharmaceutical packaging: “[Bair observes that] chess wires us to think causally. It consists of singular movements; there is a winner and a loser, an 'other' (innovator vs. generic, for example), etc.," says Schmitt. "[As Bair states,] in the game of Tetris, things don’t get harder; they just get faster. As we look at pharmaceutical packaging, Tetris with its many inputs and ever faster changing play offers a strong analogy for the future of pharmaceutical packaging.” 

Schmitt points to “a number of factors accelerating in a direction and randomness continuing to play on a roll, more like Tetris than the famous chessboard.” He points to these factors and asks the following questions:

  • Amazon versus Walmart: what is the future of pharmacies in the distribution of medicine in the United States and globally? 
  • Apple, Google, Facebook: the coming of new players. They want in. Will they succeed? 
  • Smart packaging and regulatory authorities: how will information traditionally conveyed by printing changes and how disruptive will new regulations be to pharmaceutical packaging? 
  • How will packaging interface with smart phones and the Internet of Things? 
  • The User Interface: how will the package itself change, both as a more important part of drug-delivery systems (combination products), and as a way to make it easier for the patient to take drugs?

“If our market moves like the Tetris game flow rather than chess, we may indeed see change and have to (finally) cope with a speed of change that’s new to the industry,” he says.

Attend Pharmapack Europe to hear Schmitt’s presentation along with several other thought-provoking sessions. Schmitt will also be joining me as I moderate a roundtable on packaging innovation.

Interactive 3D tools assist packaging development

Interactive 3D tools assist packaging development
3D concept Mark-up and Heatmaps apps indicate consumer preferences for conceptual packages.

3D technology provider ConceptSauce leverages cloud-based interactive applications for virtual shopping, 3D animations, concept visualisation and, most importantly for this audience, real-time online tools for package development and consumer research for retail markets. Abs Chamali, CEO of ConceptSauce, responds to our questions.

What is your technology and what does it do?

Chamali: ConceptSauce’s technology offering is a cloud-based platform for 3D graphics creation. Our solutions do not require any plugins (such as Flash) to run, allowing them to be used across multiple platforms. The technology enables rapid testing and visualisation of concepts in a 3D shopping environment, and allows clients to add videos and create concept Heatmaps as part of the 3D shopping journey.

On top of this, ConceptSauce also creates custom 3D animations for use in a 3D shopping environment as well as externally.

Our goal is to supply clients with all of their 3D graphics needs, from interactive virtual apps to 3D animated video and static visualisations.

How can it help in packaging and packaging development?

Chamali: Our solutions allow clients to visualise packaging design concepts in a store environment. The process of uploading concepts to the 3D store environment is very quick and intuitive, making it ideal for use in iterative design development. It is also possible to insert the store scenarios into online survey platforms, for use in consumer research, with very rapid results.

Multiple scenarios can be setup in seconds, allowing more than one pack design or shelf layout to be tested. This also allows for pack design testing across retail environment options in multiple markets.

We also offer a Heatmap solution. Embedded in surveys for consumer testing, Heatmaps allow consumers to indicate the areas of the pack design that they like and dislike. They can also comment on aspects of the concept, to help designers to discover the ‘why’ behind successful aspects of a particular design.  These Heatmaps and annotations can also work effectively internally, when used as part of a company-wide collaboration in the design process, enabling all stakeholders to feed in to the ultimate design concept.

What makes it unique or better than alternatives?

Chamali: The cloud-based interactive solutions offered by ConceptSauce do not use any plugins and are usable across different platforms and in different markets. A key feature of our solutions is the quick set up time of each solution. Our 2.5D and 3D shopping scenarios and virtual shopping environments take just minutes to setup, and we offer a 1-2 day turnaround.

The 3D virtual shopping environments also offer brands an agile and very cost effective solution, especially when used as an alternative to merchandising trials or central location tests.

Another unique feature is that clients can setup multiple scenarios with one click and add a countdown timer. That way scenario tasks can be timed and configured to ask respondents to locate products fitting certain criteria, for example, healthy products or products that stand out the most.

What are the steps involved?

Chamali: Each project type and process is fully documented for our clients’ use. We take each new client step-by-step through the initial setup. For 2D pack concepts, clients simply upload the visuals of their concepts using our Asset Manager tool. We then use the client’s concepts to create a 3D shopping environment in a few clicks. The whole process takes a few minutes.

What should users know about the requirements to use ConceptSauce?

Chamali: Turnaround times are specified in our online client Knowledge Space (online Wiki). In terms of pricing, we offer a three-tier solution: Pay and Go, Subscription Normal and Subscription Advanced. Our subscription plans offer real cost savings to clients needing to implement multiple projects, whilst our Pay and Go plan is a cost-effective solution for ad-hoc needs.

Next are case study examples for major brands...

Browser-based 3D virtual shopping permits conceptual packaging to be placed into an interactive retail environment.

Do you have any case study examples of customers using it for packaging?

Chamali: We have completed a wide variety of projects for major brands. Here are a few short examples to illustrate how the tool is used for packaging research and indeed packaging proofing. Due to client confidentiality issues, the case studies are anonymous:

Australian grocery retailer study: The retailer created a number of pack concept routes for a particular category and wanted to test which was best for consumers. For the project we created 3D Animations to virtually ‘walk’ 1500 research respondents through a virtual store. At the end of their virtual journey they were presented with our Liveplano interactive 3D shelf tool, displaying the product category in question. Respondents were able to use the tool to pick up and rotate products, read the packaging, etc. Their behaviour at shelf was recorded using our platform, which had been embedded in a wider online survey. Our platform passed the respondent’s behavioural data through to the online survey provider using our Application Program Interface (API). 

Our client, a market research agency, used the data generated by our interactive shelf tool to build a picture of consumers’ behaviour. As a result, they were able to make recommendations regarding the most effective concepts for use in the category to the retailer.

Toilet Care Case Study: Our market research client needed 3D visuals of toilet care accessories to use in a conjoint study. Provided as sketches, we converted the initial concepts to life-like 3D visuals that were positioned inside a virtual toilet bowl. We also created virtual benchmark products (competitor brands) in a number of different colours and designs.

The study enabled the agency to recommend the best aesthetics (in terms of customer preference) to their Fast-Moving Consumer Goods client and the manufacturer used the recommendations to create their new product range.

3D Interactive Dairy Category: We created an interactive 3D planogram of the yogurt category for one of our main research clients using new product concepts. Also, competitor products were bought and photographed to be placed in the 3D virtual environment so that survey respondents could select from within a full category range. Conceptsauce also took the pack concepts and produced full 3D products, to allow respondents to examine the products closely by zooming and rotating each concept.

How does it compare with another technology we reported on in this area (see Augmented reality offers real-world value)?

Chamali: Our tools are cloud-based and provide a more cost-effective solution. What we offer allows clients to:

- Upload concepts to our platform

- Adjust virtual shelf layouts very easily

- Rapidly test concepts on a 3D shelf

- Reuse 3D pack visuals that we create or 3D shelf planograms in a market research study.

- Agile development of tools and rapid deployment of customised apps as per clients’ needs.

- Extendable platform, allowing the use of Video, Heatmaps, ratings, 3D and 2D virtual tools.

When used in a survey environment, our platform allows full API access to all the apps, such as the 3D Liveplano shelf solution, which offers full data recording so that the behaviour of respondents is monitored and recorded. We record actions such as hover over, pick up pack, rotated pack, bought pack and removed from basket. We also record how long each action takes to complete.

For more information, visit http://www.conceptsauce.io or email [email protected]

Abs Chamali, CEO of ConceptSauce.

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Driven by design? You’ll find two diverse days of packaging conferences and aisles loaded with design ideas at WestPack 2016, Feb. 9-11, in Anaheim, CA.

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Seventh Generation switches to recyclable pouches for dishwasher detergent

Seventh Generation switches to recyclable pouches for dishwasher detergent
Multilayer polyethylene pouch is recyclable and includes How2Recycle information for consumers.

Seventh Generation is committed to achieving zero waste by 2020, and sustainable packaging is a key element in its strategy. Most recently, the company switched to a packaging design for dishwasher-detergent pods that offers all the functionality of conventional flexible packaging—and is also 100% recyclable.

The new package for Seventh Generation Natural Dishwasher Detergent Packs is a resealable stand-up pouch made entirely from polyethylene. Accredo Packaging Inc. makes the pouches using existing pouch-making equipment and decorates them using reverse-print flexography. Resin and the RecycleReady Technology for the packaging was developed by Dow Chemical Co.

The film for the pouches comprises “multiple layers of polyethylene,” explains Stacy Fields, North American director for packaging solutions at Dow. “There’s a combination of high-density, low-density or linear low.”

By combining HDPE, LDPE or LLDPE in the package structure, Seventh Generation Inc. and its partners achieved the sealability, toughness, stiffness and aesthetics required for the pouch—plus recyclability.

The back of each pouch is printed with the How2Recycle Store Drop-off label from GreenBlue’s Sustainable Packaging Coalition (SPC). This graphic explains to consumers that clean, dry pouches can be recycled at plastic-bag and -film drop-off locations at supermarkets and other retail stores.

The recyclable pouch, now in national distribution, launched in September 2015 in a 20-count format. A 45-count pouch is rolling out currently.

“Before we launched this pack, about 8% of our consumer complaints were around non-recyclability of the pack, so this addresses a good portion of our consumer complaints” about the product, says Derrick Lawrence, director of packaging development for Seventh Generation. He adds that the old package “was a PET/LLDPE adhesive laminate structure, a more typical stand-up pouch structure.”

Malcolm Cohn, director of sustainability at Accredo, explains, “The significance of that is a polyester/polyethylene lamination, as a co-mingled structure, or a multimaterial structure, cannot be recycled. It has to go to landfill.” In contrast, “the new structures used by Seventh Generation can be recycled through store drop-off.”

And yet, seen from the front, the old and new pouches look nearly identical. Polyethylene is ordinarily hazier than polyester, which could have affected the transparency of the pouch’s window and dulled its print finish.

To overcome that challenge, “Accredo did a lot of work with Dow to get the resin mix right—to get it as bright and shiny as possible so it would be less noticeable to the consumer that we made a change,” Lawrence says.

The next phase of the project, a redesign of the pouch’s graphics, is expected to roll out in March. When that happens, Seventh Generation will add educational information to its website to get consumers up to speed on the pouch’s recyclability. SPC is expected to add consumer-facing info about the package to its site, as well.

Seventh Generation had previously communicated to its consumers the various sustainability benefits of stand-up pouches. But until now, the company could not tout the package’s recyclability. “We spent lots of time educating consumers on why we were in that pack,” Lawrence says. The addition of recyclability “helps us button up the story on the end of life for that pack, as well.”

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See a host of new ideas and solutions in sustainable packaging at WestPack 2016, Feb. 9-11 in Anaheim, CA.

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Use your influence to give patients the best pack possible, says Pharmapack Europe speaker

Use your influence to give patients the best pack possible, says Pharmapack Europe speaker
Phill Marley, Packaging Intelligence Manager for AstraZeneca and Chair of HCPC Europe

We’ve all been talking about poor patient compliance for years. Why is it still a lingering issue? PMP News asked Phill Marley, Packaging Intelligence Manager for AstraZeneca and Chair of the Healthcare Compliance Packaging Council Europe (HCPC Europe), this question and more.

Marley will be speaking about patient-friendly packaging at Pharmapack Europe on February 11 in Paris, where he will discuss HCPC Europe’s new white paper, “Patient Friendly Pharmaceutical Pack Design.”

Why is patient compliance still an issue?

Marley: Patient compliance is still an issue because observed compliance rates for many therapeutic areas are poor. This leads to reduced efficacy of medicines, poorer outcomes for patients, and increased costs for payers in healthcare. 

Many packs on the market today provide little assistance to the patient—in some cases they prevent the patient from having a good experience and therefore have an adverse effect on compliance. The ethical pharmaceutical market is one of the few areas where the patient has no choice in the type of pack received as products are prescribed by a healthcare provider. It is therefore imperative that pharma packs are designed from a patient perspective, to provide the best possible pack for the patient. 

AstraZeneca is actively working in this area and recognizes that there is a strong shift towards patient-centricity.  The assessment of new product pack requirements comes at a very early stage, immediately after the packaging materials have been selected. Where appropriate, prototypes of proposed packs can then be tested for functionality and understanding with patients and other players in the supply chain like physicians and pharmacists. In this way, we aim to ensure that we will produce a pack that is patient focused and supports favourable outcomes.

What role should packaging play in promoting compliance? 

Marley: Packaging has a key role to play in promoting compliance—in many cases the packaging is the last (and in some cases, only) contact that the patient has following diagnosis and visit to their physician. The packaging provides a strong communication link directly to the patient and should be used to enhance the compliance, adherence, and persistence aspects that the patient has with their medication regimen. The use of optimized packaging supports the patient and increases their confidence on the journey through acceptance, control, and ultimately to an optimal quality of life.

In some cases, dosing regimens can be difficult to comply with, for example, taking multiple tablet strengths, or intermittent dosing, e.g., every other day, and special attention in the design of the packaging for products of this nature should be taken.

What will you discuss during your presentation?

Marley: Patient-friendly packaging versus regulations, the opportunity out there to use packaging to contribute to increased compliance, the Healthcare Compliance Packaging Council of Europe (HCPC), the HCPC White Paper, key aspects of packs required for patients, factors to include to design good packs, and some examples of [what] award-winning packs look like.

How will emerging technologies outside of pharma, such as digital and smart technologies, impact patient compliance and pharma packaging?

Marley: Emerging technologies are already providing benefits in the field of improved compliance for example in the areas of Smartphone Apps, QR codes, and reminder aids. We are also seeing the emergence of exciting technologies like 3-D printing and printed electronics, which are also likely to provide additional benefits within the compliance arena.

What future pharmaceutical packaging and drug-delivery innovations do you predict? Hope for?

Marley: At AstraZeneca and HCPC, and indeed across the pharma industry, we are all seeking to provide medications that are easy to take, coupled with an effective way of prompting patients to take their medication on time, in full, because the best drug in the world is not effective if not taken correctly. 

My hope is that effective medicines will continue to be developed, along with presentational packs and devices that by their nature add to the ritual of dosing in such a way that they greatly enhance the patient experience, making compliance become more like second nature. This will increase the effectiveness of good drugs and provide better patient outcomes. AstraZeneca has a number of smart devices and packs in the development phase, so it promises to be an exciting future!

What do you need more from packaging material suppliers? Container or device suppliers? Machinery suppliers? Service providers? Regulators? Standards bodies?

Marley:

  • From material/component suppliers – an openness and willingness to work collaboratively with pharma and discuss new ideas, materials, and technologies to meet patient friendly pack requirements going forwards.
  • From machinery suppliers – an understanding that pharma packs are becoming more and more complex and that their machinery offerings need to take this into account and respond accordingly…
  • From regulators and standards bodies – a broader acceptance of features that will provide patients with a better experience when taking medication and therefore an increased likelihood of attaining compliance and adherence. This one is critical—more flexibility from regulatory authorities like the FDA, EMA, etc. will ultimately facilitate the design of better packs by pharma companies, which will assist in the quest for better patient outcomes.

Do you see traditional pharmaceutical packaging intersecting at all with functional medical devices, such as with drug-delivery devices? If so, will this help compliance? What are the challenges? 

Marley: There is an indistinct line between packaging and device delivery system already, and both should be designed to assist wherever possible with the patients overall experience and improving compliance, adherence, and persistence. For devices, Instructions for Use (IFUs) for the device are of critical importance, and we foresee the use of QR codes with links to instructional materials also becoming more widespread.

What is the first thing pharmaceutical professionals should do after listening to your presentation to encourage patient compliance?

Marley: Download and read the HCPC White Paper (at www.HCPC-Europe.org ). This gives some excellent examples of how and what to design into a pharmaceutical pack to make it patient friendly and assist in the desire for good compliance and adherence.

And after that, adopt a patient-centric mentality and use their influence in wherever they work to ensure that patients are getting the best pack possible—we are all patients!!!

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Don't miss Marley's presentation on patient-friendly packaging at Pharmapack Europe on February 11. The conference and exhibition will take place in Paris February 11-12.