The transition between R&D and manufacturing is a common source of program delays due to manufacturability issues, unstable production processes, or inadequate transfer of design intent between the two groups. Another source of delay can simply be the time it takes the contract manufacturer (CM) to onboard a new program before producing units for verification and validation (V&V) purposes. NOVO addresses both of these concerns by with our on-site, pre-production manufacturing services.

Our pre-production manufacturing services complement our product development services. We maintain a controlled build area, operating under our ISO 13485/9001:2016 certification, for producing limited pre-production runs. Our quality system includes a complete set of templates for generating the manufacturing documentation required to support design transfer. These pre-production units are suitable for any purpose other than sale to end-users, including verification testing, preclinical or clinical trials, beta testing, expanded market testing, compliance testing, or regulatory testing. Build documentation is generated according to the intended use of the devices (see below).

One of the primary benefits of staging short production-like runs adjacent to our R&D team is the availability of the original developers to ensure that the device functionality are not affected by manufacturing and assembly processes. Representatives from the production CM are present during these builds to ensure that direct communication of critical parameters and original design intent occurs. These builds also serve to create valuable personal relationships between the manufacturing team and the design team.

Our pre-production lines include key assembly and quality control jigs and fixtures. These may be manual, semi-automated, or fully automated depending on the throughput and criticality of each operation. The workflow and scope of work for each station is balanced and optimized allowing the CM to provide more accurate quotes for manufacturing scale up.

A final benefit of performing pre-production manufacturing operations onsite with CM representatives present is the opportunity it provides for manufacturing and R&D personnel to identify and discuss ideas for future cost reduction and automation to improve yield and reduce costs.

It has been our experience that the benefits of performing pre-production builds at NOVO for V&V purposes can be compelling and we encourage our clients to take advantage of these additional services.

See how our pre-production manufacturing services benefited a medical device product development effort.

Typical Pilot Manufacturing Documentation and Activities

  • Design master records (DMRs)
    • BOM
    • Component and assembly models and drawings
    • Device specifications
    • Packaging and labeling specifications
    • Software specifications, binaries, configuration files
    • Manufacturing process instructions (MPIs, WIs, SOPs)
    • Tool and equipment specifications
    • IQ, OQ, PQ
    • Gage R&R
    • Calibration requirements
    • Maintenance requirements
    • Tool and equipment specifications
  • Device history record (DHR)
    • Lot history records (LHRs)
    • Lot inspection reports
    • First article inspection records (FAIRs)
  • General
    • Material traceability
    • Training records