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Experienced Manufacturing Partners

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Discover our Manufacturing Capabilities

Download our Manufacturing Transfer Guide

Our Expertise

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 experience includes balloon catheters, steerable catheters/delivery systems, braid & coil reinforced catheters and ablation & mapping catheters.

The 4 Track System

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

Assess suppliers

Design for manufacturing opportunities

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 assembly

Pilot manufacturing

Onboarding and training line resources

Production ramp plan

Draft control plan

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