Medical device packaging has truly become a global endeavor. Given the international collaboration behind ISO 11607, many medical device packaging professionals have had a global view for years. But packaging requirements have been increasing around the world, thanks to the emergence of Europe’s Medical Device Regulations and the global interest in Unique Device Identification. Another globalization driver includes the sheer nature of the multinational medical device manufacturing industry.
To align with these trends, DuPont Medical Packaging is implementing some organizational changes and adding new team members to help support the medical device community, reports Lori A. Gettelfinger, global communications and brand leader, DuPont Tyvek. These changes unfolded as DuPont kicked off its celebration of the 50th anniversary of Tyvek. DuPont will be on hand at the upcoming Medical Design & Manufacturing East 2017 expo June 13-15 to discuss these changes and the evolution of Tyvek over the years.
“The medical device industry—and also the sterile packaging manufacturing industry—is trending global, so we said, ‘let’s go global’ in how we are resourced to support the industry,” Meg Pyers, global marketing manager for Tyvek Medical & Pharmaceutical Packaging, tells PMP News. DuPont is also integrating with Dow this summer, so she said “it’s an opportunity to better match how the market operates.”
Pyers points to the increasing globalization of the industry, citing as an example the path of one medical device: “A product is developed in Israel, materials acquired in Germany, manufactured in Malaysia, and shipped back to the EU for sterilization,” she says. “You have to achieve safety and sterility throughout. It requires a balance of innovation, safety, and cost.”
There’s also ongoing consolidation through mergers and acquisitions among medical packaging converters. “We want to be where the market is and support them,” she says.
Globalization isn’t new for DuPont. It has maintained a global team for years, serving customers in three regions: the Americas; Europe, the Middle East, and Africa (EMEA); and Asia Pacific. “We have been present in these markets with technical, regulatory, and quality teams, even if we haven’t been selling in them,” Pyers explains. DuPont is now deepening that industry support, particularly in developing markets, she says. “We have invested to educate and support industry, so we want to share our knowledge,” she says.
Leslie Love is now serving as global sales leader, and Jose Arevalo is coordinating a global packaging science effort as business development manager at DuPont Tyvek Medical & Pharmaceutical Packaging. DuPont is also increasing the number of medical packaging specialists on its team. “We’re bringing in people from industry from Boston Scientific, Smiths Medical, and Nelson Laboratories,” she says.
“The knowledge base in the United States and Europe is deep, so we are exploring how to bring knowledge and expertise to emerging markets,” says Pyers.
Pyers says there is a hunger for knowledge on “regulations and proven standards,” especially in emerging markets. “They want to learn how to compete internationally and follow international standards,” she adds. “Part of our role is to ask, ‘what can we do to help emerging countries scale up?’ They are moving at a faster pace and urgency.”
There’s also an increase in requirements around the world. In addition to the aforementioned EU regulations, India has new regulations phasing in July 2017, Pyers notes. “We want to help the industry execute them without too much burden,” she says.
And there are new engineers entering the medical device industry. “We want to enable and equip them,” she says.
DuPont’s goals to deepen its technical support could be seen as a continuation of its efforts to support industry during the Medical Packaging Transition Project (MPTP), which provided data to regulators and industry on the functional equivalence of Tyvek 1073B and 1059B produced on new manufacturing lines. “We invested a lot in the MPTP team,” says Pyers. “Lessons learned included having a dialogue with FDA and other regulators. As you look at things, you develop a relationship with regulators, so there are no surprises at the end. We partnered to support the development of safe medical devices.”
In addition, because the MPTP involved deep technical analysis, it fostered the use of “evidence-based analysis” in the industry, which also plays a role in healthcare, she adds.
The DuPont team is now looking at “what is next for the medical packaging industry, such as package optimization and sustainability,” she says. “For instance, we support the HPRC [Healthcare Plastics Recycling Council], so we are helping figure out how to tackle the issue of waste. There’s complexity with comixed polymers and contamination. These are important issues to consider over the next 20 years.”
In addition, the healthcare system is dealing with “patient safety and healthcare-associated infections,” she adds. And she sees growth in biopharma and therefore prefilled syringes. “Zero particulates and proven materials” are in demand, she says.
“We can bring our science and innovation and help address these issues,” she concludes.
For more details, visit DuPont at MD&M East Booth #1629.