Outsourced Cleanroom Kitting and Assembly Solution Provides Extensive Cost Savings | Life Sciences

2/29/2024 RRD

Cleanroom for pharmaceutical manufacturer

RRD’s supply chain solutions help leading medical device company avoid significant capital investment, gain cash flow advantages

CHALLENGE

A leading medical device company elected to focus on marketing, customer service, and research and development internally while outsourcing all manufacturing workflows. Due to a tight timeframe of six months for a particular product launch, the company sought an external supply chain partner with an FDA-registered Class 8 cleanroom.

The client also needed their partner to source and procure medical device product components and manage a quality assurance (QA) program. The QA program not only needed to comply with regulatory standards, but also needed to maintain crucial records such as the device history record (DHR) and device master record (DMR).

Additionally, they needed help developing an order entry system that could process orders directly from their sales force or from hospitals — and would ensure efficient pick, pack, and fulfillment services for the delivery of finished goods. Further, the partner needed the ability to manage an EO sterilization subcontractor, along with the necessary laboratory testing.

The client also needed support in process and software validation, warehousing, inventory management, the creation and fulfillment of marketing materials, product literature, and promotional items to support their device launch.

SOLUTION

RRD’s Supply Chain Solutions provided the expertise and engineering solutions to accomplish the quick ramp-up needed. RRD’s centrally located and FDA-registered, ISO 13485-accredited, and cGMP/QSR-compliant facility — including a 5,000 sq. ft., Class 8 cleanroom — provided the specialized space required by the company.

RRD developed and deployed IT solutions to manage the company’s supply chain complexities and integrated their ERP system with the company’s. RRD’s solutions enabled the client to scale volume upward, supporting their increasing global kitting and fulfillment needs. The solution included three key aspects.

1. Project management:

Overseeing multiple product launches
Designing packaging and labels
Lot-level track and traceability
Managing EO sterilization vendor and validations
Developing comprehensive inbound materials management, warehousing, and quality assurance programs

2. Procurement: Centralizing function to bring greater economies of scale by leveraging RRD- and customer-approved vendors

3. Fulfillment and distribution: Developing sales order processes, system setup, and management for distributing products directly to hospitals

RESULTS

By utilizing RRD’s best-in-class systems and facilities, 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
Asset avoidance
Ability to scale upward domestically or internationally without investing in facilities, systems, or related personnel

Additionally, RRD provided the regulatory compliance management required of medical device companies, relieving the company of a time-consuming yet important function.