1. No category

CARDIAC CATHETERS
Cardiac catheters are used for both diagnostic and interventional
purposes. During diagnostic procedures, catheters monitor
blood flow and pressure within the heart, as well as provide a
conduit to deliver radiopaque media that enables visualization
of the vascular system.
Integra Biotechnical, LLC
2731 Loker Ave West
Carlsbad, CA 92010
Phone 760.931.1844
Fax 760.931.1753
www.integrabio.com
Manufacturing Issue
Product was manufactured in the US at a customer facility constrained for
growth, and due to the high labor content was less competitive in the
global marketplace.
Program Results
Produced over 300 SKUs,
including small, custom
production runs
The Challenge
Integra was tasked to carry out the following initiatives:
• Take over manufacturing of legacy product line in order to free up
capacity in existing customer facility
• Provide a lower cost near-shore solution that would allow the
customer to compete on a global scale and improve margins
Integra’s Advantage
Flexibility in manufacturing processes is essential when transferring
projects with large numbers of SKUs and a combination of large and small
production runs. The ability to be flexible in order to meet the customer’s
needs is what sets Integra apart.
Integra is uniquely positioned to provide unparalleled quality along with
the economic benefits of near-shore manufacturing. This, coupled with
dedication to continuous improvement through critical activities, such as
value stream analysis and regular Kaizan events, made the overall manufacturing process more cost effective and allowed the customer to be more
competitive.
©Copyright Providien, LLC. All rights reserved. Integra Biotechnical, LLC is a division of Providien, LLC
www.providienmedical.com
Increased production by 50%
month-over-month during six
month ramp-up
Continuous improvement
through value stream analysis
and regular Kaizan events
Integra’s Advantage
Crucial Success Factors
Flexibility in manufacturing processes is essential when transferring
projects with large numbers of SKUs and a combination of large and small
production runs. The ability to be flexible in order to meet the customer’s
needs is what sets Integra apart.
Integra is uniquely positioned to provide unparalleled quality along with
the economic benefits of near-shore manufacturing. This, coupled with
dedication to continuous improvement through critical activities, such as
value stream analysis and regular Kaizan events, made the overall
manufacturing process more cost effective and allowed the customer to
be more competitive.
Implementation
Experience and technical expertise have enabled Integra to develop a
systematic approach to successfully execute manufacturing transfers.
Benchmarking current processes and capturing best practices, completing
detailed equipment and process qualifications, as well as providing
engineering support and training, insured a seamless transition to the new
manufacturing line.
Once the transfer was effectively completed, workflow optimization was
achieved by converting all production lines from the original batch process
to one-piece flow. This improvement resulted in program wide waste
reduction and more efficient manufacturing processes across all SKUs.
In addition to meeting the customer’s large daily scheduled production
needs, Integra simultaneously produced highly specialized, low-volume
custom products that are essential to the customer’s business model.
Catheter Line Operations
Integra produces a wide range of catheters utilizing the following
operations:
•
•
•
•
Tipping
Hole Punching
Skiving
Hub Assembly
•
•
•
•
Balloon Placement
Tip curving
Packaging
Sterilization Management
©Copyright Providien, LLC. All rights reserved. Integra Biotechnical, LLC is a division of Providien, LLC
www.providienmedical.com
Ability to reduce
manufacturing costs while
also maintaining high quality
standards
Agility to take on extensive
number of SKUs while also
handling small custom runs
Implementation of continuous
improvement programs to
reduce waste and provide
cost savings