A world class NPI process to bring high quality products to market quickly and efficiently.

Our New Product Introduction (NPI) team are experts on how to manufacture high quality, regulated healthtech products so they can be brought to market quickly and cost effectively. This includes supply chain establishment, designing the method of assembly and developing and implementing process controls. We can establish contract manufacturing at any of our FDA-registered and ISO 13485 compliant sites in Melbourne, Australia or Irvine, California.

Underpinning our new product introduction process is PI’s Seamless Transfer™ approach to design transfer, which provides faster results by performing manufacturing transfer activities in parallel with product development. Manufacturing experts are embedded in design projects from day one to ensure alignment around production strategy and enable a smooth transition from design to manufacturing. Design team members remain embedded during initial manufacturing to ensure quick decision making and issue resolution consistent with design intent.

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Manufacturing Readiness Review

Manufacturing readiness is a critical part of our process, based on a comprehensive 75-point checklist developed to support ISO 13485 and ISO 9001 requirements. It ensures milestones are being met throughout the development process so that you can be confident that you have met all your manufacturing requirements to allow products to be ready for launch on time and budget.

Design for Excellence

Design for Excellence (DFX)

During the early stages of product development, our new product introduction experts work closely with the design team to define the design specifications and manufacturing requirements to deliver on the commercial value proposition in the market. We provide recommendations to reduce production risk using best practice DfX (Design for Excellence) including DfA (Design for Assembly) and DfM (Design for Manufacture) principles. Creating alignment around production strategy early avoids costly design changes at later stages.

Risk assessment for future-proofing

At PI, we take a risk-based approach to new production introduction. We use methods such as PFMEA (Process Failure Mode Effects Analysis), part criticality and supplier assessment, and obsolescence planning (using the Silicon Expert tool) to identify key technical risks in both supply chain and manufacturing processes. Considering these risks upfront allows us to future proof manufacturing to assure the long-term viability of your product.

Establishing Supply Chain

Supply chain selection and qualification is a key element to a successful new product introduction. PI has access to a responsive and quality-focused supplier base, that includes low-cost region suppliers.

We also recommend proactive obsolescence planning (using the Silicon Expert tool) to identify key technical risks in the supply chain that help inform risk mitigation strategies.

Establishing process controls

We are experienced in developing and implementing process controls to meet regulatory standards and bring products to market quickly and cost effectively. This includes the following activities:

  • Supply chain establishment and qualification
  • Build cell design, fabrication and qualification
  • Controlled equipment design, commissioning and registration
  • Work instructions, test procedures and qualification methods
  • Pre-production unit builds and process validation

Specialist process capabilities

We are experienced in transferring both regulated instruments and consumables to manufacture. Some specialist process capabilities include:

  • Cleanroom consumable solvent bonding, ultrasonic welding, leak testing, air particle testing, heat sealing
  • Instrument high precision optics stage assembly and repeatability testing

Related Capabilities

PI has experts across all aspects of product commercialization from initial product definition to achieving market success. We start with in-depth market analysis and MVP definition, then follow through with actionable plans covering regulatory compliance, clinical development, marketing and product launch.

PI’s quality team are experienced in quality design assurance for regulated and non-regulated medical devices. Our robust quality management system is certified to ISO 13485:2016. We also have regulatory experts who can provide tailored regulatory advice for developing medical products.

At our FDA registered and ISO 13485:2016 compliant manufacturing facilities, we can produce anything from low-complexity devices to large floor-standing in vitro and clinical chemistry instruments, in quantities ranging from small batches to high-volume builds.