Process Development and Validation

Process Development & Validation

Ensuring products are manufactured to meet highest standards

Medical devices and components must be manufactured to comply with the highest standards. For this reason, we take product quality into consideration at every step along the way from initial concept development to final serial production. Our Healthcare & Medical engineers work together with customers to design, test, validate and produce the highest quality medical devices and components.

Concept Development

  • Black box development
  • Value engineering of customer concept or existing product
  • Creating ideas
  • Design for Manufacture (DFM)

Product Specification

  • Drawings
  • 3D models
  • Critical criteria
  • Cleanliness
  • Special surface finish or treatments
  • Special packaging
  • Product testing

Feasibility Analysis

  • FEA simulation
  • Manufacturing feasibility
  • Tool design models
  • Supply chain considerations
  • Feed-to-line concepts

Concept Validation

  • Flow simulation
  • Quick prototyping (additive manufacturing)
  • Quick sampling
  • Material evaluation

Testing & Validation

  • Dimensions
  • Material properties
  • Functional product testing
  • Surface cleanliness
  • Special testing, e.g. bioburden

Product Optimization & Design Freeze

  • Pre-serial trails
  • Design of Experiment (DOE)

Industrialization

  • Construction of molding and demolding tools and automated handling units
  • Closed loop fully automated cells for high volumes
  • Finalization of serial process in suitable environment

Serial Validation

  • Part and material validation package to suit customer requirements
  • Run@Rate studies
  • Dimensional capability
  • In-line inspection
  • Process audit

Scale-up Production

  • Scaled-up tools
  • Scaled-up production cells
  • Advanced automation techniques
  • Direct Line Feed (DLF) programs
  • Ready-to-use product packaging and supply systems