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.
Key services we provide during the NPI process:
- device master record development
- manufacturing layout design and set up
- process failure mode effects analysis (FMEA)
- process validation plans and reports
- equipment specifications and files for calibration and preventative maintenance
- process qualification protocols and reports (IQ/OQ/PQ)
- manufacturing cost reduction analysis and fixed priced modeling
- supply chain selection, approval, and management
- gauge R&R (repeatability and reproducability) studies
- manufacturing fixture and tool design and fabrication
- and more
Key services we support your team with during the NPI process:
- design history file remediation
- product specification definition
- risk management file documentation
- usability and human factors development (engineering lab services) performance tests executed against specification
- performance V&V protocol development, execution, and reporting
- third party management of sterilization, biocompatibility and packing validations
- and more