Sean Riley, Senior Director, Media and Industry Communications, PMMI04.19.22
New technologies are creating efficiencies in medical device manufacturing operations throughout the supply chain. In facilities, operations are becoming more automated and interconnected. According to four out of five respondents to the Pharmaceutical & Medical Devices Trends and Opportunities in Packaging Operations white paper from PMMI, The Association for Packaging and Processing Technologies, automation and related technological advances are one of the biggest changes in manufacturing in recent years.
These advancements require significant capital investments – which medical device makers are poised to make. Three out of four medical device producers responding to the PMMI white paper say their companies are looking to make the capital investments needed to refurbish their old tooling or purchase new equipment. Technology, automation, regulation, cost and ROI will drive these decisions.
Over 60% of responding companies said that they would choose to automate their operations if given the opportunity, and remote access has increasingly become more a necessity. Companies are already investing in advanced machinery to increase packaging speed and improve efficiency. Examples of automated line equipment include:
Labeling systems that apply wraparound film or paper labels onto a package at speeds up to 600+ per minute.
Form/fill/seal technology, which uses a single piece of equipment to form a plastic container, fill the container and provide an air-tight seal.
Digital technology, IoT and blockchain that help companies connect their machinery to smart devices, troubleshoot and report errors, optimize operations, gain insights into data across machines, and record data across the supply chain.
Connecting with customers and patients through a variety of different services and technologies has also reinvented how the medical device market operates.
Advancements related to equipment and software provide healthcare services beyond the walls of medical centers. Technologies such as wearables, smart devices, IoT, and cloud-based analytics are becoming more widely used in the industry, requiring medical device companies to adapt. Digitalized packaging that communicates directly to the consumer to ensure medical monitoring and improve patient outcomes is also a growing trend, according to PMMI’s white paper. These shifts from traditional business models to smart models can give companies a competitive advantage.
As a result, flexible production, where machines can change from one product size to another, is becoming increasingly sought out by packaging companies as product variations continue to proliferate. Respondents pointed out that machines that are portable or suitable for small batches will grow in usage and preference, as the medical device industry handles more unique sizes and dimensions.
At the same time, sustainability is a key focus for many companies as they look to reduce waste and improve cost efficiency. Packaging is becoming more environmentally friendly, with a greater focus on material and recyclability. This also calls for flexible machinery that can handle different materials.
When fully implemented, the labels on most devices will include a UDI in human-readable and machine-readable form on the device itself. Device labelers must also submit certain information about each device to the FDA’s Global Unique Device Identification Database (GUDID). UDI requirements have been implemented in stages, beginning with Class III (highest-risk) devices. Due to the impact of COVID-19, the final stage of implementation – for Class I (low risk) devices – has been postponed until later this year (Sept. 2022).
These regulatory changes are creating operational challenges for medical device manufacturers. High product volume makes the manual data entry or uploads of UDI data too slow. Since printing more data, such as bar codes and embedded images, on the exterior of packages is required to meet the new regulations, the increased flow of new variants in devices requires frequent changeovers, again slowing down operations.
Additionally, white paper respondents report that the regulations are not always clear about what packaging tests are acceptable. In addition to the UDI requirements, safety-related and environmental changes and pressures continue to add pressure, all of which underscores the importance of cutting-edge technological solutions and the right equipment investments.
From connecting with colleagues and hearing from experts to seeing new technologies, materials and machinery-in-action, PACK EXPO International is the most efficient and effective way to discover packaging and processing solutions for over 40 vertical markets. No other event this year will showcase entire production line solutions and offer attendees everything needed to compete in a changing marketplace.
These advancements require significant capital investments – which medical device makers are poised to make. Three out of four medical device producers responding to the PMMI white paper say their companies are looking to make the capital investments needed to refurbish their old tooling or purchase new equipment. Technology, automation, regulation, cost and ROI will drive these decisions.
The Importance of Technology & Automation
Medical device companies continue to seek innovative ways to improve their packaging operations and create efficient processes. Regulations and COVID-19 responses and disruptions have driven demand for innovative, advanced equipment. Here are a few of the top trends influencing new equipment investments as outlined in the PMMI white paper:Over 60% of responding companies said that they would choose to automate their operations if given the opportunity, and remote access has increasingly become more a necessity. Companies are already investing in advanced machinery to increase packaging speed and improve efficiency. Examples of automated line equipment include:
Labeling systems that apply wraparound film or paper labels onto a package at speeds up to 600+ per minute.
Form/fill/seal technology, which uses a single piece of equipment to form a plastic container, fill the container and provide an air-tight seal.
Digital technology, IoT and blockchain that help companies connect their machinery to smart devices, troubleshoot and report errors, optimize operations, gain insights into data across machines, and record data across the supply chain.
Connecting with customers and patients through a variety of different services and technologies has also reinvented how the medical device market operates.
Advancements related to equipment and software provide healthcare services beyond the walls of medical centers. Technologies such as wearables, smart devices, IoT, and cloud-based analytics are becoming more widely used in the industry, requiring medical device companies to adapt. Digitalized packaging that communicates directly to the consumer to ensure medical monitoring and improve patient outcomes is also a growing trend, according to PMMI’s white paper. These shifts from traditional business models to smart models can give companies a competitive advantage.
Flexibility is Vital
Medical device manufacturers are streamlining their processes and adding more flexible solutions to their operations. Companies continue to focus on ROI and want to cut costs, reduce waste, and invest in machinery that can meet several needs simultaneously. Supply chain challenges, shorter lead times and staffing issues have only reinforced the need for solutions that solve multiple challenges.As a result, flexible production, where machines can change from one product size to another, is becoming increasingly sought out by packaging companies as product variations continue to proliferate. Respondents pointed out that machines that are portable or suitable for small batches will grow in usage and preference, as the medical device industry handles more unique sizes and dimensions.
At the same time, sustainability is a key focus for many companies as they look to reduce waste and improve cost efficiency. Packaging is becoming more environmentally friendly, with a greater focus on material and recyclability. This also calls for flexible machinery that can handle different materials.
Meeting Regulatory Changes
On the regulatory side, the FDA established unique device identification (UDI) requirements in 2014 to improve patient safety by identifying devices sold in the U.S, beginning with manufacturing and continuing through distribution and patient use.When fully implemented, the labels on most devices will include a UDI in human-readable and machine-readable form on the device itself. Device labelers must also submit certain information about each device to the FDA’s Global Unique Device Identification Database (GUDID). UDI requirements have been implemented in stages, beginning with Class III (highest-risk) devices. Due to the impact of COVID-19, the final stage of implementation – for Class I (low risk) devices – has been postponed until later this year (Sept. 2022).
These regulatory changes are creating operational challenges for medical device manufacturers. High product volume makes the manual data entry or uploads of UDI data too slow. Since printing more data, such as bar codes and embedded images, on the exterior of packages is required to meet the new regulations, the increased flow of new variants in devices requires frequent changeovers, again slowing down operations.
Additionally, white paper respondents report that the regulations are not always clear about what packaging tests are acceptable. In addition to the UDI requirements, safety-related and environmental changes and pressures continue to add pressure, all of which underscores the importance of cutting-edge technological solutions and the right equipment investments.
Find Solutions at PACK EXPO International
It is more important than ever that the packaging and processing industries come together to share insights and innovations, and the best place to do that is PACK EXPO International (Oct. 23-26, 2022; McCormick Place, Chicago) – the most comprehensive packaging and processing show in the world in 2022.From connecting with colleagues and hearing from experts to seeing new technologies, materials and machinery-in-action, PACK EXPO International is the most efficient and effective way to discover packaging and processing solutions for over 40 vertical markets. No other event this year will showcase entire production line solutions and offer attendees everything needed to compete in a changing marketplace.
