3PL for the Medical Device Industry
Supply chain management for medical device products is arguably one of the most critical and potentially challenging industries for the logistics sector. Proper storage, handling, inventory control, serial number & lot tracking and time-definite transportation solutions are all essential to providing a safe, accurate and quality product for the end consumer or patient.
WHAT ARE SOME OF THE REGISTRATIONS AND CERTIFICATIONS REQUIRED FOR MEDICAL DEVICE FULFILLMENT?
The medical device sector offer a wide variety of products that require specialized handling and care. From a vast number of SKUs with lot tracking requirements, to potential hazardous goods storage and handling compliance standards, to shipping bulk orders to big box retailers, to the fast order cycle demands of B2C e-commerce, order fulfillment has never been more critical to one of the fast growing and most competitive industries.
Any 3PL that stores, handles or provides value-added services for certain medical devices must have Class I or Class II certifications as well as up to date United States Food and Drug Administration (FDA) registrations for the fulfillment or distribution center.
AIB and/or HACCP is another vital warehouse certification. AIB and HACCP provide food-grade level safety audits, inspections, certifications, and education/training for manufacturers, distributors and third-party warehouse operators.
In addition, ISO quality certifications can also provide a solid foundation for any 3PL operating in the medical device supply chain.
HOW IMPORTANT IS REVERSE LOGISTICS FOR MEDICAL DEVICE FULFILLMENT?
Product recalls are expensive. The ability to maintain an accurate chain-of-custody from the manufacturer to the warehouse to the retailer or consumer/patient is vital to ensure compliance should a recall occur. Third-party logistics providers will often be asked to participate in “mock” recalls whereby on demand or adhoc reports are immediately produced for their customers that show where an individual lot may have shipped, unique lots are put on a systemic hold in the warehouse and cycle counts are initiated to confirm the right inventory quantities are in the warehouse.
Efficiently and effectively managing product recalls and returns can not only save money, but it can ensure that recalled, or otherwise unqualified product doesn’t re-enter the supply chain.
HAZARDOUS GOODS STORAGE & HANDLING COMPLIANCE IN THE MEDICAL DEVICE SUPPLY CHAIN
Medical device products may also require specialized storage and handling permits to comply with local, state and federal regulations related to medical devices that contain hazardous components like lithium batteries. Logistics providers may be required to have ESFR or in-rack sprinkler systems, physical cages, specialized training for staff to properly handle and package hazardous or ORMD items.
Warehouse management and parcel management systems must be able to accurately identify hazardous goods and have the internal logic to determine which items cannot ship together in the same box, which DOT compliant labeling is required and the best class of freight service for the goods contained within an order containing restricted items.
WHY IS SCALABILITY IMPORTANT IN MEDICAL DEVICE lOGISTICS?
Patients and consumers rely on accurate and timely delivery of their medical devices. Access to strategically located fulfillment centers, modern warehouse management systems and experienced, trained, professional staff are all important factors when choosing a 3PL.
The right third party fulfillment partner can drive superior performance by deploying proven industry systems and processes, applying its intimate knowledge of servicing Wholesalers, Distributors, B2B and E-Commerce retailers as well as direct to consumer (D2C) fulfillment, will ensure that your consumers or patients expectations are met each and every day.