Component Qualification, Process Performance Qualification, Design Transfer

Employee Spotlight - Clayton Cole

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

 

Introduction

Maintaining product quality and performance over time is crucial in the competitive and highly regulated medical device industry. Sustaining engineering and continuous improvement are integral processes that ensure ongoing product reliability and adherence to regulatory standards. Meddux deploys a unique approach to translating high-level device functional requirements down to the constituent operations throughout the manufacturing process.  We call this Critical Parameter Management (CPM), and we implement this systematic approach to ensure ongoing product quality in manufacturing through appropriate controls and monitoring.

Critical Parameter Management (CPM)

We utilize a systems-engineering approach that starts with identifying Critical Functional Requirements (CFRs) that directly impact device safety and performance.  We then identify and link Critical-to-Function (CTF) attributes from a top-down perspective.  The overall objective is to implement robust manufacturing process controls that ensure consistency across the system, subsystem, component, and manufacturing process.  These are linked in a documentation format that traces high-level requirements to ongoing quality controls in manufacturing.  CPM is an essential part of our quality control approach, ensuring that critical parameters are meticulously managed throughout the product lifecycle.

Key steps in the CPM process include:

  1. Identification of Critical Functional Requirements: We focus on “the critical few” – typically 3 to 5, and no more than 10.
  2. Cross-reference CFRs throughout the components and processes: We identify where a sub-assembly, component, or process is strongly associated with a CFR, and identify one or more related Critical-to-Function (CTF) parameters.
  3. Risk-based approach:  The CTF’s become the focus of component qualification, process validation, test method validation (TMV), and process performance qualification (PPQ).
  4. Implement ongoing controls:  Control Plans applying statistical process control (SPC) are used to monitor and maintain quality by suppliers of critical components as well as at Meddux in the finished device manufacturing process.

Sustaining Engineering

Once the product has moved beyond design transfer and is in commercial manufacturing, ongoing quality is in the hands of the sustaining engineering team.  It involves activities such as monitoring key performance indicators (KPI’s) for the manufacturing process, such as yield, throughput, and on-time delivery.  It includes accountability to the Control Plans that are in place to monitor and analyze manufacturing quality control inspection points identified by the CPM process.  Tools such as control charts, Pareto analysis, and process mapping can help visualize data and highlight areas that need attention.  Inevitably, it includes troubleshooting for work-stoppages related to components, equipment, and process variation. It also includes responding to post-market surveillance, including field complaints and performance issues.  The goal of sustaining engineering is to ensure that products continue to perform reliably and meet customer needs throughout their lifecycle.

Continuous Improvement

A pillar of the Quality Policy at Meddux is our commitment to “maintaining a constancy of purpose to improve”.  Continuous improvement thinking is encouraged across the organization.  Some continuous improvement opportunities are driven by market feedback; others are identified internally as part of the manufacturing process.  Meddux systems ensure that all proposed changes are carefully reviewed and approved to ensure they do not negatively impact product quality or regulatory compliance.  This involves impact assessment and verification and/or validation of any proposed changes.

Meddux is also committed to the principles of Lean Manufacturing, which focuses on eliminating waste and improving efficiency.  This involves streamlining processes and optimizing workflows to enhance productivity and quality.  Aspects of the manufacturing process during initial product launch often need to be revisited periodically to incorporate improvements identified by operators and manufacturing engineers.  Successful continuous improvement requires the involvement and engagement of the whole team. This involves fostering a culture where employees are encouraged to identify areas for improvement and contribute creative solutions.

Conclusion

Critical Parameter Management (CPM), sustaining engineering, and continuous improvement are essential practices for maintaining medical device quality, reliability, and compliance. Meddux implements these methodologies rigorously to ensure that the products we manufacture exactly meet their requirements.  Our approach helps us continuously enhance our processes and ensures that our products deliver exceptional performance throughout their lifecycle.

Key Takeaways:

  • Critical Parameter Management: Identifying and controlling the essential critical-to-function parameters ensures consistent product performance and quality.
  • Sustaining Engineering: Continuous data-driven monitoring of KPI’s and accountability to control plans ensures product reliability throughout its lifecycle.
  • Continuous Improvement: Targeted efforts to improve processes and products drive efficiency and quality.

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