FDA Compliance, Simplified Shipping
EFFICIENT SHIPPING MANAGEMENT AND COMPLIANCE WITH FDA REQUIREMENTS
For more than 25 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. Today, with more than 25,000 employees and 26 manufacturing, distribution and technology centers, Boston Scientific is a market leader in less-invasive medical devices delivering more than 13,000 products to clinicians in over 45 countries.
Boston Scientific's Challenges
Boston Scientific’s transportation logistics management faced various hurdles, including:
- Strict FDA regulation
Because of the kinds of products the company manufactures, Boston Scientific is highly regulated by the FDA. These regulations seep into all facets of the company’s business, including its shipping operations. Lack of compliance can result in a business shut-down until compliance is restored. - FedEx compliance
The company ships up to 10,000 daily packages and is one of FedEx’s highest-volume East Coast shippers. The medical device manufacturer elected to use FedEx Ship Manager Server as its compliance engine for the carrier. Therefore, any new shipping solution would need to be compatible with the FedEx compliance engine. - SAP Interface
New shipping solution needed to integrate with SAP interface.
"Boston Scientific depends on CMS WorldLink to ensure efficient shipping management and FDA compliance. Because of the nature of many of the shipments — like heart catheters being shipped to meet patients’ scheduled surgery dates — this manufacturer cannot afford shipping mistakes; on-time delivery is a must."
Wil Fekeci
President, CMS GlobalSoft
The Solution
By implementing CMS WorldLink (a multi-carrier shipping solution) and the e-Motion add-on module, Boston Scientific has overcome the many challenges related to strict FDA compliance.
- Simplified shipping processes
To avoid FDA or delivery problems, Boston Scientific required a high level of customization to simplify its shipping processes. In turn, the company used CMS WorldLink’s existing user documentation as a springboard to create highly detailed supply-chain documentation extending well beyond CMS WorldLink’s functionality. These efforts resulted in a flattened learning curve for new shippers. - FedEx Ship Manager Server compatibility
As a multi-carrier shipping solution and a FedEx certified solution partner, CMS WorldLink offered Boston Scientific several key advantages including FedEx compliance, FedEx Express and Ground shipping services to all US and international locations, high-speed processing, a dedicated connection between its warehouse and FedEx operations giving the company enhanced security and the opportunity to bypass the Internet and its real-world traffic. - Productivity enhancements
With up to 64 daily shippers, the Per-user shipping activity reports generated by CMS WorldLink provide management with the ability to monitor per-user activity. Productivity reports include number of shipments per user, route, and customer. Additionally, CMS WorldLink monitors supply usage of cartons and boxes (by specific DIM size). When supplies drop below prescribed levels, CMS WorldLink alerts employees of the need to restock.
The Outcome
CMS WorldLink allows Boston Scientific to meet its extraordinary shipping needs in a very straightforward and highly efficient manner, saving time, resources and money.
"Despite stringent FDA requirements Boston Scientific must comply with, the implementation of CMS WorldLink has simplified the company’s shipping processes enterprise-wide."
Wil Fekeci
President, CMS GlobalSoft
Add-on module in use by Boston Scientific today
e-Motion
CMS WorldLink’s e-Motion module is the industry’s first enterprise, in-motion shipping application that weighs, labels, manifests, and sorts parcels. For packages requiring labels, e-Motion’s sophisticated technology manages a stunning 1,200 to 1,500 packages per hour on a single conveyor belt – and there are no limitations on the number of conveyors e-Motion can manage.
ROI: A hands-free environment allowing you to ship large quantities at a rapid speed without human intervention, thus allowing for reduced labor costs.




