which requires a very good understanding of each other’s systems, whether they be engineering, quality or sourcing.
10. MPO: What role do emerging markets play in a
full-service outsourcing model?
McCourtney: Several of our customers are trying to figure out
a strategy for utilizing emerging markets as a source of supply for
more generic and cost sensitive and/or commodity-type products.
That can create many challenges for them in terms of logistical issues and intellectual property concerns. As a contract manufacturer,
we have sources in Central America and Asia for tooling, molding
and assembly. These resources are used typically for higher volume
opportunities where there is a certain amount of labor required and
no cost-effective means for automating the assembly process.
Fischer: Emerging markets help to provide cost savings and
additional support. Developing and maintaining relationships
offshore is beneficial when material costs increase. By using these
alternatives, you are able to pass the savings on to the customer.
Kuo: Emerging markets provide competitive cost and capacity.
11. MPO: How do you maintain quality in a full-service outsourcing setting? How do you tie your quality
systems with your clients’ systems?
Kim Goodwin: We established our quality system based on the
customary quality-system requirements of the medical device industry, with the ultimate goal of exceeding customer expectations,
not just their requirements. We try to look beyond their requirements and anticipate the customer’s next request. Each customer’s
specifications are unique to the customer and their products. As we
begin to develop relationships with customers, we integrate the
customer’s specifications as our specifications. Our goal is to duplicate the customers expected internal performance with our external
performance. As customer requirements may change over time, our
goal is to adjust our systems to satisfy their evolving requirements.
McCourtney: We have a robust quality management system
based upon ISO 13485 and are FDA-registered. We don’t really
tie to our customer quality systems as much as we all tend to
conform to the same standards and processes/procedures. We are
audited by many of our customers on a regular basis and have
many individual companies in our facilities each month.
Fischer: We take the time to learn as much as we can about
the product before development even begins. It is imperative to
determine the customer’s needs and expectations from the very
beginning and make sure that all expectations are clear.
Schoeplein: We maintain quality in a full-service outsourcing setting by careful training of all team members in the unique
At Parker Precision Fluidics we understand the need to keep patients active and to improve recovery rates. In order to get the most
out of life, patients need light weight, low power, portable medical solutions. From the laboratory and operating room to home health
care, Parker develops innovative solutions for health care success. Proven technical expertise and a reputation for quality at Parker
Precision Fluidics ensures you will keep your technical risks low and your business results high.
For more visit www.parker.com/precisionfluidics/products
Together, we can create more innovative medical devices so
people get more out of life.
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Together, we can improve medical device portability without sacrificing performance.
Introducing the Series MX solenoid valve. We understand the challenges you face developing medical devices. You need a
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Learn more http://solutions.parker.com/ppf-series-mx-sample
Discover the smallest solenoid valve with the highest flow rates and lowest pressure drop on the market.
•;Unparalleded flow in a 10 mm valve - capable of
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•;Helps bring your product to market quickly and