Manufacturing Transfer

Manufacturing Transfer for Medical Devices

Midwest Interventional Systems works as an extension of your team during the entire Manufacturing Transfer Process and throughout steady-state production. We have experience in a broad range of manufacturing transfers – from single-component, single-process operations to fully assembled complex delivery systems that are packaged, labeled, and ready for sterilization. Our expertise in completing successful manufacturing transfers includes the following device types:

  • Balloon catheters
  • Braid and coil reinforced catheters
  • Steerable catheters/delivery systems
  • Ablation and mapping catheters

By leveraging our years of experience in leading manufacturing transfers for medical devices, we have identified and developed a streamlined Manufacturing Transfer Process. Our four-track Manufacturing Transfer Process is designed to expedite the relocation, expansion, or strategic positioning of your manufacturing line. The track system allows our manufacturing transfer team to complete deliverables on multiple tracks in parallel. This ensures a holistic approach to understanding and executing the transfer activities while reducing the overall timeline required to achieve steady-state production. Learn more about the individual tracks below:

Track 1 – Understanding Customer Needs

The first step in a successful manufacturing partnership is fully understanding the customer needs. Based on initial program feedback from our clients, we coordinate a call with the appropriate MIS experts to gain a comprehensive understanding of the scope of the manufacturing transfer and to identify a clear path forward to ensure we meet the client’s needs. By executing on Track 1 deliverables, a clear path is outlined on how to successfully drive the manufacturing transfer to completion. The activities in this initial track include:

  • Align timelines
  • Review prints
  • Assess capabilities
  • Design for Manufacturing opportunities
  • Assess suppliers
  • Align inspection methods
  • Assess equivalency
  • Review COGS
  • Analyze supply chain efficiencies
  • Testing strategy
  • Generate proposal

Track 2 – Process Equivalency

The second track in our Manufacturing Transfer Process is Process Equivalency. MIS Engineering and Manufacturing teams’ partner during this phase to begin process development while ensuring all device requirements are met. At the completion of this phase, MIS will provide a process equivalency report demonstrating the MIS design and processes are substantially equivalent. Activities in this track include:

  • Confirm timeline
  • Draft component and assembly level documentation
  • Draft MPIs, routers
  • Equipment transfer/equipment equivalency studies
  • Order or transfer material, tooling
  • Process development
  • Process equivalency testing

Track 3 – Process Validation

The third track in our Manufacturing Transfer Process is Process Validation. These activities are driven by customer certification requirements that are non-verifiable. While it is most common to execute Process Validation, MIS is also able to support lot release testing for product release and certification to meet our customers’ needs and cost targets. The deliverables we complete during this phase typically include:

  • Draft OQ/PQ plans
  • Product builds
  • Execute OQ/PQ testing for processes
  • Generate reports

Track 4 – Transfer to Production

The fourth and final track in our Manufacturing Transfer Process is Transfer to Production. This phase is dedicated to production preparedness. Upon completion of this track, MIS continues support of the production line with planned ramp strategies, aggressive OEE targets, and a robust VIP program to achieve short- and long-term cost targets. Activities in this phase include:

  • Production Line Analysis
  • Pilot Manufacturing
  • Onboarding and Training Line Resources
  • Production Ramp Plan
  • Draft Control Plan

Curious to know more about our process, what makes MIS a leading catheter manufacturer, or if your program is the right fit with MIS? Connect with our technical staff today. (Seriously! An engineer will receive and respond to your inquiry!) – info@midwestint.com

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Manufacturing Transfer
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