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Cleanroom Kitting and Assembly Solution for Medical Device Manufacturer | Healthcare

Cleanroom for pharmaceutical manufacturer

Existing world class systems and facilities avoid significant capital investment and gain cash flow advantages

CHALLENGE

RRD’s client, a medical device company, elected to focus on research and development as well as marketing and customer service while outsourcing its manufacturing activities. This required a relatively fast ramp-up of six months, which needed an FDA registered ISO 14644-1 Class 8 cleanroom, Federal Standard 209. 

Specific challenges for the client 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 the client to scale volume upward, supporting their changing global kitting and fulfillment needs as business grows. The solution included three key aspects. 

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

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

“RRD’s supply base management service eliminated significant headaches for us,” said our client’s VP of Operations. “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.