Home healthcare and remote monitoring are driving growth within the medical device industry, where companies are innovating at a rapid pace to accommodate an aging population with widespread needs.
From home mobility aids like walkers and wheelchairs to diagnostic and monitoring devices like blood pressure cuffs and sleep monitoring devices, the home healthcare market is primed for continued growth as consumers look to at-home solutions to provide the same features, functionality and safety that would be provided in an in-patient setting. The U.S. leads the charge in medical device innovation, but this booming industry is bound by changing trends and rigorous compliance guidelines that extend well beyond the product to its packaging, making it far more challenging to get a new product introduced and adopted in the marketplace.
Meeting Regulation Guidelines Leads to Longer Development Times
According to studies, the average development time for a new medical device is three to seven years from concept through final approval. The U.S., also at the forefront of regulatory science, is committed to ensuring that medical device products and their packaging meet the highest possible standards. Accordingly, product development must follow rigorous guidelines and criteria set forth by organizations like the Food and Drug Administration (FDA) and the International Standards Organization (ISO). From addressing quality standards that ensure that medical devices meet compliance laws to safety policies that govern everything from device components to final packaging, these recognized standards help to foster uniformity, quality and safety across industries, but they can add weeks to years onto product development timelines.
Simplifying Compliance With Corrugated Packaging
One of the final steps in medical device product development is determining how the new product will be packaged. Even at this later stage of development, it’s necessary to adhere to specific guidelines. Oftentimes packaging used for medical devices must be non-toxic and made from known and traceable materials.
Corrugated packaging is an excellent option for medical devices, as it can be tailored to meet various application needs. Inherently non-toxic, the materials used in the manufacture of corrugated along with its manufacturing process ensure that the paper used for corrugated is heated multiple times, helping to destroy the presence of germs or bacteria. Additionally, many corrugated manufacturers also provide packaging for the food industry, adhering to Global Food Safety Initiative (GFSI) standards. Their production processes undergo regular inspections to ensure consistent compliance with stringent regulations.
Plus, corrugated manufacturers, like PCA, can verify where their materials are sourced from. With sourcing certifications from organizations like the Sustainable Forestry Initiative (SFI) and Forest Stewardship Council (FSC), PCA can demonstrate chain of custody, ensuring transparency and accountability regarding the origin and handling of the materials used in the manufacture of corrugated to fulfill regulatory guidelines.
Package Testing And Validation
Once final packaging materials have been designed and verified to meet all necessary regulations, it must clear another hurdle. Medical device packaging must also be deemed to withstand the rigors of shipping and handling, safeguarding the device from damage during storage, handling, distribution and processing. In 2016, the FDA accepted testing standards for medical device packaging. These standards, determined by the International Safe Transit Association (ISTA), are designed to minimize product damage through the effective design and testing of packages. Testing evaluates the performance of packaged products related to vibrations, shocks and other stresses normally encountered during handling and transportation. Through ISTA testing standards 3A, 3B and 3E, medical device manufacturers can determine how to best package their product, so it remains undamaged throughout the distribution cycle.
Accommodating Medical Device Market Demands – The PCA Process
As a corrugated packaging supplier, PCA understands that medical device packaging is a highly regulated industry that requires customization and compliance. Before designing any packaging solution for the medical device industry, PCA will first get a thorough understanding of a customer’s challenges, objectives and goals, including compliance standards. PCA examines:
- Product weight, shape and fragility
- Setup and packing methods
- Distribution and storage
- Regulatory issues and labeling requirements
- Business and marketing goals
- Customer requirements
Once an optimized solution is designed to meet a customer’s needs that complies with all regulatory guidelines, PCA can test the finished boxes and unit loads (with and without contents) in accordance with ISTA test procedures that meet ISO and FDA guidelines, ensuring that the corrugated packaging meets the specified guidelines and performs as it was intended.
If you are looking for a medical device packaging solution to help meet your rigorous demands, complete the form below and talk to one of our local packaging experts.
