A Study in Success:
Cleanroom Kitting and Assembly Solution for Medical Device Manufacturer

RRD’s customer, r4 Vascular, is a medical device company that elected to focus on research and development, marketing and customer service while outsourcing manufacturing activities. The company’s products include medical kits used for interventional procedures by cardiologists, radiologists and nephrologists.

Challenge

r4 Vascular wanted a relatively fast ramp-up of six months, which required an FDA registered ISO 14644-1 Class 8 cleanroom, Federal Standard 209. Specific challenges for r4 Vascular included providing:

  • Sourcing and procurement of product components
  • Quality assurance program management that addressed regulatory compliance issues, including maintaining a Device History Record (DHR) and Device Master Record (DMR)
  • Order entry system development for accepting orders directly from the sales force or hospitals and providing the pick, pack and fulfillment services required to deliver finished goods
  • EO sterilization sub-contractor and associated laboratory testing
  • Process and software validation
  • Warehousing and inventory management
  • Marketing collateral, product literature and promotional premiums, production and fulfillment management

Solution

RRD provided the supply chain expertise and engineering solutions to accomplish the quick ramp-up for a client with no existing infrastructure. RRD’s centrally located FDA registered, ISO 13485 accredited and cGMP/QSR compliant facility, which included a 5,000-sq.-ft. ISO 14644-1 Class 8 cleanroom, provided the specialized space required by the customer.

RRD developed the IT solutions required to manage the complexities of the supply chain and integrated their ERP system with that of the clients. RRD’s solution enabled r4 Vascular to scale volume upward and it supports their changing global kitting and fulfillment needs as business grows. Key aspects of the solution included:

Project Management

  • Oversaw multiple product launches
  • Designed packaging and label requirement setup as well as lot-level track and traceability
  • Managed EO sterilization vendor
  • Managed validations
  • Developed comprehensive inbound materials management, warehousing and quality assurance programs

Procurement

  • Centralized function to bring greater economies of scale by leveraging both RRD and customer-approved vendors

Fulfillment and Distribution

  • Developed sales order processes and system setup and management for distributing products directly to hospitals

Benefits

“RRD’s supply base management service eliminated significant headaches for us,” said Mark Kraus, Vice President of Operations at r4 Vascular, Inc. “Because of RRD, we did not have to expend time and money normally directed at supply chain development and human resources, thus allowing us to fully utilize our capital resources on the completion of product development as well as sales and marketing.” RRD provided the regulatory compliance management required of medical device companies, relieving the company of a time-consuming yet important function.

Results

By utilizing the existing world class systems and facilities of RRD, the customer was able to avoid significant capital investment and gain cash flow advantages. More specifically, outsourcing provided these financial advantages:

  • Lower direct and indirect labor costs
  • Fewer administrative requirements
  • Enabling of asset avoidance
  • Ability to scale upward domestically or internationally without investing in facilities, systems and related personnel

Benefits of Working with RRD

RRD’s core competencies, strategic direction and vertically integrated services can help to create a unique competitive advantage with the following benefits:

  • Reduced time-to-market for products with a single interface and global reach
  • Reduced total supply chain cost from design through to final product delivery
  • Aid in revenue generation with attractive product packaging
  • Streamline global processes with enhanced planning and forecasting

Supply Chain & Packaging Solutions

RRD Supply Chain & Packaging Solutions is a recognized global supply chain and packaging provider that delivers value-add solutions to multiple sectors. As part of RRD (NYSE:RRD), a broad suite of capabilities is offered including packaging design and production, sourcing, kitting and fulfillment services. Solution design, systems, processes and precise project execution can help customers to constantly improve their market share, profits and speed-to-market.