Packaging professionals are preparing for regulatory changes while addressing cost concerns and meeting deadlines. How much opportunity is there for new product development and innovation?
Serialization and track and trace. Changes to U.S. Pharmacopeia packaging chapters. Changing regulations for global distribution. Development and validation costs. Post-approval regulatory changes. Changeover. Cost and budget constraints. Adapting existing equipment to new materials and to new format parts. Lead time, cost, flexibility, and scalability of new equipment. And did we mention cost?
These are the myriad challenges expressed by pharmaceutical and medical device packaging professionals responding to our 2015 Salary and Industry Outlook survey. (For our feature covering salaries and employment for pharmaceutical and medical device packaging professionals, please see the article beginning on page 13 of our digitial edition.)
These professionals are running into challenges as they work to ensure their packages comply with new regulations and standards as well as meet stringent requirements for product protection. Respondents also tell us about challenges in new product development, such as finding time and support.
In addition, to understand the purchasing objectives that motivate packaging professionals, we asked 499 respondents to our 2015 Market Segment Study why they are investing in new equipment, materials, and services. Respondents were allowed multiple answers to the three questions we share in this article, and more than half (54%) indicated they were motivated to increase manufacturing capacity, 49% were motivated to increase profitability, and 46% were motivated to comply with FDA regulations. These objectives were ahead of upgrading packaging materials (29%) and competing in a global marketplace (22%). (Please see the two figures below to see the demand for particular packaging equipment and supplies.)
Given such investment objectives, regulatory priorities, and cost concerns, are packaging professionals finding the opportunity to explore new materials and potential designs?
Above: Percentages of 499 respondents to the PMP News 2015 Market Segment Study who purchase, recommend, specify, select, approve, or authorize the listed packaging materials/containers.
Above: Percentages of 499 respondents to the PMP News 2015 Market Segment Study who purchase, recommend, specify, select, approve, or authorize the listed packaging machinery.
Wrapped up in the Requirements?
Changing regulatory requirements are introducing a significant amount of work in pharmaceutical and medical device packaging.
Pharmaceutical companies are working to meet requirements that are phasing in around the world for serialization. And medical device firms are busy with Unique Device Identification rules. (Interestingly, printers are the number-one machine mentioned in the Market Segment Study (see image above).
In addition to preparing for serialization, pharma packaging professionals are following changes to several packaging-related chapters of the U.S. Pharmacopeia. (See our story "U.S. Pharmacopeia Changes Are Unfolding.")
These changes are concerning our survey respondents. For instance, in terms of serialization, one respondent to our Industry Outlook and Salary Survey speaks of a lack of in-house technical expertise. “Serialization with aggregation is a disruptive technology,” writes one respondent.
Another points out that “newly proposed USP <661.1> and <661.2> requires significantly more extractables and leachables documentation for pharma containers and their materials of construction.”
And another says the “biggest challenges are always from interpretations of existing standards, primarily ISO 11607, and primarily issues from European regulatory bodies.”
Or as one professional says, “same standards, same challenges.”
As challenging as these regulatory and technical issues may be, packaging professionals are also trying to squeeze in new package development. Namely, “showing the value add to the business, ROI, NPV, getting operations to buy into the vision for a new packaging system and make the investment,” says one professional in the Salary and Industry Outlook survey.
In addition, they are working at “appeasing marketing while making the best decisions for cost, user friendliness, ease of manufacturing, and environmentally correct,” says another respondent.
Other challenges include “scheduling time on production lines to actually run product qualification orders,” says one professional.
Says another: “Timing, getting a frozen design, fighting with management over what is the best solution for a short term project versus what packaging management is looking to ‘standardize.’ Management being a [hindrance] and micromanaging your work.”
And yet another respondent describes this challenge: “Preventing a new platform from being tied to NPD project launch in order to provide the timing required to develop the system properly.”
So, when striving to meet all regulations and launch deadlines, do packaging professionals even have time for innovation?
“When packaging patented medicines, packagers don’t want to get in the way of an approval or launch, so they focus on barrier, stability testing, etc. It is all about the molecule and its successful launch. Once launched, they don’t want to put the supply chain at risk,” said Peter Schmitt, managing director of Montesino Associates, who spoke earlier this year at Pharmapack Europe about trends during the North America Packaging Trends Networking Breakfast. As a result, he sees little focus on the patient/consumer outside of regulatory requirements. “The focus for child resistance and senior friendliness, for instance, is on meeting requirements, rather than on innovation or differentiation,” he says.
Also, the typical U.S. pharmaceutical supply chain hasn’t demanded innovation, instead relying significantly on pharmacy repackaging for patients’ prescriptions. And the growth of mail-order pharmacies has fostered demand for packaging efficiency and standardization, I pointed out during the Pharmapack Europe breakfast.
Demand for package innovation may be materializing, however. The Centers for Medicare and Medicaid Services is instituting patient outcome and experience measures, such as ratings for patient safety and medication adherence, I pointed out. And more and more pharmacy retailers are looking for packaging that drives adherence and differentiates their offerings while lowering supply-chain costs, added Schmitt. “There’s an opportunity for contract packagers/outsourced suppliers to develop creative, even disruptive packaging,” he said.
What’s Next for Pharma?
The notion of disruption in pharmaceutical packaging was examined during the conference at Pharmapack North America in June.
During the June 9 panel discussion “What’s Next for Pharma?” moderators Schmitt and Frank Bieganousky (also managing director of Montesino Associates) noted that FDA is increasingly interested in how patients are taking their medications. Self medication is more prevalent, and there’s an interest in making administration easier for the patient and helping them with compliance.
Before the discussion Schmitt mused whether packaging change would happen through disruption rather than evolution, while Bieganousky wondered whether some pharmaceutical companies might be turning to outsourcing and partnerships to increase their chances of developing an effective package. “So how will packaging get smart?” they asked panelists Siong Ho, senior director, packaging science & technology, Shire; Jim Powers, senior director of package engineering for Teva Pharmaceuticals; and Walter Berghahn, Executive Director, Healthcare Compliance Packaging Council.
“There will be controlled disruptive change,” said Powers. “There’ll be evolution in packaging presentations.”
That evolution has already started. “Fifteen to 20 years ago, [the industry] was not primarily focused on how patients would use packaging,” said Powers. “Now we are conducting focus groups early on in development and sharing concept designs for feedback and then incorporating this feedback into final packaging. The key is to engage early.”
Ho, however, believes change comes with more-complex products, such as those that might be considered combination products. “There’s no question about traditional oral drugs,” answered Ho. “Everyone knows how to pour liquid into a dosing cup. But when an injectable syringe (as an example of a combination product) is involved, it becomes more complex. These worlds are colliding.”
Nonetheless, “I don’t think that we’ll see disruption,” said Ho.
In the meantime, pharma packaging professionals are focusing on regulatory compliance, packaging science, and cost efficiency.
“Regulatory landscapes will force some change,” Ho continued. The real challenge, he said, is answering this question: “How do I comply with the regulations in each country?”
Ho would like to see more external support. “To suppliers, I say, you need to learn regulatory requirements globally. Helping you get educated helps me do what I need to do—to focus on getting drugs to market.” In particular, Ho pointed to the EU’s Falsified Medicines Directive, which includes requirements for tamper evidence and serialization.
Added Powers: “We are spending more time interpreting the regulations and how we are going to comply. Consider glued-end cartons for the EU directive—component suppliers can help us with packaging that can meet many of these regulations.”
“Contract manufacturing and packaging can help us through,” he added.
Such external support may also help packaging professionals manage reduced internal resources. “Resources are constrained,” explained Ho. “There are no more 40 or 50 in a packaging development group—those days are gone. There is some outsourcing, but you lose some knowledge.”
Packaging performance is critical, and manufacturing must be flexible. “We also need better barrier packaging and still get the product to patients fast,” said Powers. “And manufacturing will be moving more towards on demand, instead of manufacturing to inventory.
“We could standardize our packages on a global basis, qualifying them for the most aggressive regulatory or stability requirements,” he added. “We could do more with less and focus our resources.”
Berghahn would like to see an increase in manufacturers’ original packaging. Even when “we see full enactment of DQSA, we’ll still see counterfeits because we are still repackaging and [manufacturers’ original packaging] stops at the pharmacy dock door,” he said.
Sustainability is also “high on our list,” added Powers. “When we develop new packaging, we look to lower our carbon footprint.”
Based on such perspectives, it seems that the pharma industry is evolving incrementally toward a more patient-focused package, but development of such packages cannot hold up product launches, and regulatory compliance definitely comes first. And as the industry introduces packaging innovation, it looks for support from suppliers, contract service providers, and others to help them manage regulatory compliance, speed to market, and cost-effectiveness.
That’s not to say that disruption won’t happen outside the industry. In July, pharmaceuticals and other medical supplies were carried on a flight authorized by the FAA and operated by NASA. The drone, a hexacopter operated by Flirtey Inc., delivered the products to a free clinic run by Remote Area Medical and the Health Wagon at the Wise County Fairgrounds in Virginia, it was reported in a news release.
Even with such disruption, though, packaging will likely play a role. When asked whether disruption will be the catalyst for change, Kumar Nanavati, a 30-year packaging industry veteran, says that “everything I can think of requires packaging expertise.” (Nanavati has worked for Bristol-Myers Squibb, Pfizer, Wyeth, and Novartis and is currently a managing director of Kuma Packaging Solutions LLC.)
James F. Lynch, president of Regional Personnel, a recruiting firm specializing in staffing in the pharmaceutical, medical device, and other industries, expects the on-going problem with patient adherence to be one catalyst. “The pharma industry is starting to increase spending on the importance of adherence, for example field-based certified diabetes trainers, oncology nurses, etc. If adherence can be increased, in a measurable way, through more innovative packaging, the medical community, caregivers, and managed care will be interested, and pharma companies will invest in these packaging innovations.”
And Nanavati expects that on-demand, digital printing on production lines will result in innovation. Such analysis brings us full circle, because digital printing could help satisfy one of the concerns expressed by one of our survey respondents earlier in this article: “Serialization with aggregation is a disruptive technology.”