Introducing SurModics Serene™ lubricious coatings
for endovascular medical devices.
With growing regulatory awareness of particulate
generation, Serene coatings are a breakthrough technology
that delivers lubricity and durability while significantly
reducing particulates. Serene coatings have been
successfully optimized for a wide range of medical devices
and substrates. They’re also backed by SurModics’
outstanding quality, service and support. Coat your
devices with confidence—SurModics Serene coatings.
New product introduction requires a clear process
to prevent missteps and costly errors.
stresses quality as part of their culture. Rigorous
quality metrics should be built into the CM’s production process and available for review.
6. The level of quality, speed, and service often
vary from one location to the next (especially locations in “low-cost” countries), creating the need to
aggregate projects at certain plants. In doing this,
they are cheating their partners of important productivity efficiencies. For example, not being able to use
the nearest production facility adds transportation
and logistical costs. Differences in reporting systems
create project management headaches and loss of
time. A vendor with a standardized, across-the-board production process simplifies the project oversight, increases time efficiency, and reduces costs.
7. New product introductions (NPI) require a clear
process to prevent missteps and costly errors. Effort
must be invested initially in understanding and articulating the desired characteristics and requirements of
the finished unit. It is essential that review milestones
are set throughout the prototyping and manufacturing process. A contract manufacturer with a rigorous
production system eliminates these NPI missteps.
8. Lack of supply chain experience and knowledge increases the end product price when lower
cost materials are not utilized. Many opportunities
arise to substitute parts without compromising
performance and quality. In-house experts with
multiple years of supply chain management, market and demand forecasting, sophisticated reporting and industry knowledge provide an advantage
throughout the life of the product.
The process matters to ensure that the
complexities of a project are addressed while
minimizing costs. To ensure a successful contract
Evaluate a potential contract manufacturer’s
Establish utilization of lean methods and deter-
mine if a lean culture is apparent
Request and review safety procedures
Review metric targets and actual results versus
benchmarked industry or peer standards
Schedule a facility tour and look for clutter and
Pose the tough questions—understand the answers