Count on our expertise in New Product Introduction (NPI) to take your concept to market. From supporting design development with your team to developing your manufacturing process, to testing pre-production builds, to production launch, we’ll take the necessary steps to ensure your medical device is regulatory compliant, cost effective to produce, consistent and reliable, scalable, and built to your performance requirements.
At PLS, manufacturability is a key factor in the equation from day one. We start by taking the time to fully understand your vision. Then, we work with you to establish effective designs for manufacturability techniques and solutions; test and improve production methods; and develop cost effective, efficient manufacturing process instructions – all while keeping focused on your budget and schedule. By maintaining process controls, we help ensure your product meets regulatory, quality, performance, and cost requirements.
Changes happen during NPI. Especially in the early stages. We’re patient with the process – because going through different iterations is part of learning, growth, and improvement. That’s also why we have no production minimums at the NPI stage. Throughout the new product introduction process, you’ll find the PLS team is both responsive and flexible as your vision and needs evolve.
During the PRODUCT DEVELOPMENT phase of NPI, our ProSuite services encompass:
- project management
- design history file (DHF) and technical file development
- general safety & performance requirements
- design specification development
- risk analysis and management
- usability/human factors
- design verification & validation (V&V)
- contract sterilization validation (EO, gamma, e-beam, x-ray, steam)
- packaging design and validation
- contract biocompatibility validation
- performance verification and validation
- contract electrical safety and performance testing
- usability validation
- and more
During the MANUFACTURING TRANSFER phase of NPI, our ProSuite services encompass:
- DFX evaluation (design for manufacturability, assembly, and testing
- component receiving inspection
- visual inspection system
- first article inspection
- custom manual inspection
- device master record (DMR) development
- label design and in-house printing
- UDI application and implementation
- part definition and specifications
- manufacturing process instructions
- quality inspection procedures
- device / lot history records
- equipment files and processes
- IQ, OQ, PQ, PPQ
- gauge R&R studies
- calibration and preventative maintenance
- packaging
- Tyvek pouch, standard & custom
- tray, standard & custom
- poly bags, standard & custom
- scale up to automated assembly
- and more