Medical / Health Care

The safety, performance and durability of medical devices depends upon strict design control and comprehensive quality systems, as outlined in ISO/DIS 13485 and FDA regulations. A successful process development process depends upon reliable definition of user needs, design input requirements, design verification and device validation. Additionally, concurrent engineering approaches, involving production and service staff, help to insure the manufacturability and performance of the device. Our advanced engineering, modeling and simulation capabilities facilitate these design controls; reducing the time and cost of design and development, improving the reliability and safety of the device, and reducing risk.

Engineering Services

Gatekey℠ provides advanced engineering services throughout the design, development and manufacturing phases of medical devices, and provides evaluation of inadequacies if they occur. Our services include:

  • Product design and development assistance
  • Design Review
  • Design input requirement review
  • Product Specification review
  • Design verification
  • Concurrent engineering
  • Determining operating windows and robustness of the device
  • Modeling of solids, liquids and interfaces
  • Materials selection and testing
  • Analysis of implanted devices for fatigue performance
  • Failure analysis
  • Forensic services and court appearances

Our focus in medical products is illustrated by projects our engineers have been involved with, such as:

  • Simulation of Fluid Flow and Stress Analysis of Drug Delivery Devices
  • Fatigue Testing of Medical Device Components
  • Analysis of Implanted Medical Devices for Fatigue Performance

Lean Technology Services

Our consultants employ process maps to accurately depict the current practices, methods, and procedures used by a Health Care organization to conduct work activities. Then, by analyzing the Value Added / Non Value Added activities, our consultants design a progressive plan to reduce identified wastes and improve productivity. This process is highly successful in achieving measurable results when previous efforts have failed. This technique, when coupled with visual controls, balanced scorecards, and Hoshin plans, offers a method to make clear progress all can respect and appreciate.

Once the initial analysis is completed, improvements in Health Care organizations are most successfully achieved through the assignment of Kaizen teams under the direction of experienced Lean practitioners. Our consultants perform this role and simultaneously train in-house personnel to perform these duties on an on-going basis.

Support is offered to our clients as the improvements are implemented and realized, and new improvement opportunities are uncovered. The transition can take years and our consultants will remain available to assist with the development of a self-sustaining Continuous Improvement process.