Regulations. Testing. Budget. Budget. Budget. Pharmaceutical and medical device packaging professionals share their biggest challenges during PMP News’s 2016-2017 Salary and Industry Outlook Survey. We asked these professionals to share their concerns anonymously about developing new packages and using packaging equipment, new and existing. We also asked what regulations and/or industry standards are presenting new challenges. Their eye-opening insights may help you prepare for your own upcoming product launches and capital expenditures.
Respondents to our survey, which include packaging engineers, production operators, quality personnel, and others involved in medical and pharmaceutical packaging, continue to grapple with cost. One respondent sums up the challenge when discussing new package development: “Ensuring it is developed on-time and within budget. Compliance is always #1.”
Another characterizes the challenge as balancing “customer needs versus willingness to pay.”
Several respondents mention being challenged by testing. They point to the realities of “stability testing” and “package integrity validation” as well as “testing costs,” “time to do all testing,” and “regulatory compliance through extensive testing and aging processes.”
Preparing for shipping appears to be a popular concern. “Creating a package that can consistently survive distribution testing” and surviving “international shipping stresses while maintaining package integrity” are two reported challenges. Others include:
- Meeting DOT.
- Selecting or designing the package that will meet ISTA shipping standards.
- Barrier seal integrity in shipping containers.
- Mechanical testing contractors.
Preparing for manufacturing is another challenge. One respondent points to the challenge of “integration into manufacturing,” and another “design for manufacturability.” This professional says that “our corporate packaging group doesn’t use this concept.”
“Functionality” is another hurdle. Respondents are grappling with “ensuring end user ability” and “end consumer changing requests.”
And final stresses include “long lead time for approval” and “getting all the players to agree on a concept.”
Whether they’re using existing packaging equipment or considering new equipment, respondents are facing challenges.
Respondents spoke of the “need to use existing packaging.” However, “equipment is old and tends to fail periodically,” says one professional. But oftentimes existing equipment is “not flexible enough.”
“Existing equipment is acceptable for a start-up but not suitable for large volumes,” adds one professional.
“Sometimes existing equipment needs [to be] modified or shared with other products,” writes another. “It’s a matter of whether it can be dedicated and whether it’s efficient and effective.”
For one, the challenge is that “company is slow to spend $ to replace old equipment.” And sometimes it is the market: “U.S. is a bottle legacy manufacturer, which limits change.”
A resulting challenge is “ensuring these is enough capacity to accommodate the new product.”
Other challenges with existing equipment include:
- Capability, speed, getting parts.
- Fitting change parts.
- Slow speed, lack of 100% reliability.
- Keeping footprint to a minimum.
- Too customized for new materials and improvements.
- Not always compatible with new materials.
- Automation is designed for high-volume production.
- Complying with current requirements.
New equipment may help address these challenges, but cost is a great concern. And some question the investment, specifically “cost and payback” and “SKU rationalization.” Says one respondent: “Cost and innovation—is it really better?”
Time, too, is an issue. There is a “need to test the materials. Time vs. cost,” reports one respondent. And another struggles with getting “validations completed in a timely manner.”
There’s “not enough time to fully research and do reference checks,” reports another respondent.
On-going support is needed. Some question “finding vendors that will support throughout lifecycle.” Another points to the challenge of “integration and support especially for new technologies on machines.”
Other concerns include:
- Access to parts, support.
- Variability from machine to machine.
- Longevity of the product.
- Finding automation at reasonable prices.
Regulations definitely impact package decision-making in the medical device and pharmaceutical industries. “FDA regulations affect the processing and packaging of our product,” writes one respondent.
And these professionals are now dealing with new challenges.
Labeling requirements are one. “Requirements for unique identification [are] very difficult, especially on small product,” writes one respondent. Add others: “UDI labeling has made everything very challenging” and “UDI requires better printing.”
Serialization is another. One respondent points to “drug serialization,” saying “UDI is easy.”
One professional mentions “data integrity,” adding that “it is new.”
USP 661.1 and 661.2 are also taxing respondents. “USP 661.1 and combination product guidance. Both are new; not sure regulators and the companies are on the same page,” says one professional. Another professional says of USP changes: “Show me where the old testing caused issues!”
Another respondent is concerned about “ICH drug aging requirements and specifically their application to devices combination products.”
Shipping requirements are also an issue for some. Respondents point to “ISTA requirements” and “revised ASTM D4169.”
Others are awaiting “updates to ISO 11607 and how that will impact our internal distribution testing standards.” One professional worries that “global interpretation of ISO 11607 by specific markets is still not unified.”
Europe’s new medical device regulations are anticipated to have “huge impact,” says one professional.
And biocompatibility and pyrogenicity expectations “have been expanded recently,” indicates another.
ISO 13485 is another concern. “The new ISO 13485:2016 standard will prompt major changes to our current quality system,” writes one respondent. Says another: “ISO 13485:2016 is a paradigm shift from its predecessor.”
And one professional sees challenges with “sterilization for medical devices that are designed to be re-used. Proving the method(s) the medical office will/may use is as effective vs the original sterilization method, i.e., radiation.”
Despite these challenges, some medical device and pharmaceutical packaging professionals aren’t too worried about any particular issues. When asked about challenges related to packaging development or packaging equipment, new or old, a few respondents say they face no challenges.
And when asked about regulatory challenges, one respondent says there’s “nothing too challenging. Most of the regulations are as Thomas Paine wrote—common sense.”
PMP News’s 2016-2017 Salary Survey and Industry Outlook also reveals a pretty stable, satisfied workforce, but employees and managers do have some concerns. In another article available for free download, “Satisfied and Stable, But a Little Stressed,” PMP News shares the results of an industry survey showing that salaries for pharmaceutical and medical packaging professionals are healthy, and few employees are actively looking for new jobs. These employees, however, continue to experience the corporate downsizing that we’ve noted in past survey articles, so they are likely managing more projects, with fewer resources.
For these perspectives as well as the average annual salaries for packaging professionals employed by pharmaceutical and medical device manufacturers, please download the article here.
PMP News conducted its 2016-2017 Salary Survey and Industry Outlook online from November 2016 through March 2017 and closed the survey with 265 professionals who reported working full time. After counting responses from only those professionals who reported working in pharmaceutical, biotech, medical device, IVD, or nutritional supplement packaging, the total number of qualified respondents numbered 129 professionals. Ninety-six professionals reported working for either a medical device or IVD manufacturer; 30 reported working for a pharmaceutical or biotechnology product manufacturer. Three professionals reported working for a nutritional supplement maker. Out of the 129 respondents, 79 indicated that they are male and 23 are female. (Twenty-seven professionals skipped the question.) In terms of job functions, 43 reported working in either research and development or package design; 42 reported working in production and manufacturing or quality assurance/quality control; and 23 reported working in engineering. (Ten of the 129 qualified respondents did not select a job function.) For more details, please see the salary survey article here.