Staying Connected - September 2009

Domestic vs. Offshore Cable Manufacturing

Designing and manufacturing medical cables, connectors, and interfaces is done worldwide.  With labor costs being less in Mexico and even less in Asia, it may be surprising to some that domestic manufacturing is increasing as customers shift production back to the United States.

Affinity Irvine California plant offers advantages of domestic production

Price vs. Cost

One reason for dissatisfaction with offshore manufacturing is that expected cost savings are often not achieved.  When comparing pricing from offshore manufacturers to those of domestic manufacturers, a number of factors should be considered.  It is generally accepted that there are additional costs when purchasing from offshore manufacturers, but often all of the additional costs are not readily apparent.

Supply Chain Costs and Issues

Anything that decreases the efficiency of the supply chain will likely add cost to the product.  Added costs due to supply chain inefficiency are often hidden or overlooked when initial pricing is negotiated.

Most of our customers have implemented programs to minimize their investment in inventory.  For such programs to be successful, short lead times and reliable dock dates are required.  With delays for goods to clear U.S. Customs, shipments from any offshore manufacturer will take longer than from a domestic producer.  And, when buying from an Asian manufacturer, you are faced with either air freight shipping costs or long surface transit times.

As lead time to receive product increases, so does the need to maintain safety stock or buffer inventory.  Additionally, if there is any uncertainty over an offshore supplier’s ability to meet delivery commitments, even greater inventory may be required.  The cost to hold additional inventory can quickly cut into, or eliminate, any price advantage of manufacturing offshore.

Quality System and On-site Audits

ISO certification – an important consideration in supplier selection

An important consideration when choosing a manufacturing partner is their Quality System.  If they are an ISO registered company, you can have confidence that minimum common standards are met.  However, without conducting an on-site quality audit of the prospective supplier, the effectiveness of their quality system is difficult to gauge.

The ability to conduct initial and follow-up on-site quality audits may be an important consideration in supplier selection.  An on-site audit is typically easier and more efficient if the supplier to be audited is located in the same country.  When auditing an offshore supplier, time and expenses are increased while the effectiveness of the audit may be reduced due to language differences in verbal communication and documentation.

Standards and Regulatory Experience and Knowledge

Affinity’s Bob Frank helped
author EC53 standard

A prospective supplier may be of additional value to you if they have experience and knowledge of recognized standards such as ANSI, AAMI and IEC.  While anyone can read the various standards, understanding how they are appropriately applied is enhanced with experience.   Similarly, experience with regulatory issues associated with the U.S. Food and Drug Administration may be of benefit and help especially in the design and development stage of a project.

Affinity offers our OEM partners the advantage of being an FDA registered medical device manufacturer as well as having experience obtaining a 510k for cable assemblies.  We understand some of the challenges of meeting regulatory requirements.  In addition, Affinity’s Director of Engineering, Bob Frank, was a member of the AAMI committee that established EC53, the only standard that specifically applies to medical cables.  His intimate knowledge of this standard and how it is applied to medical cables often proves valuable to our OEM partners.

Reducing labor content and
operator dependency begins at
the design stage of a project

Design for Manufacturing – Reducing Labor Content

Part of any good design process is consideration and planning for how the product will be manufactured.  To some, this is more about resources (people and machines) rather than how the product can be built with minimum labor and operator dependence.

One of the reasons that Affinity successfully competes with offshore manufacturers is that our engineering team aggressively “designs the labor out” of the products we build.  Not only does this help us compete on a price basis, but also increases throughput and decreases lead times.  Reduced labor content and improved throughput help Affinity compete on a worldwide basis.

Design Validation Testing

Affinity offers its OEM partners
complete Design Validation Testing

When selecting a supplier, domestic or international, evaluating the value of the supplier’s additional capabilities can be important.  Many OEM’s have gone through restructuring resulting in internal resources being reduced.  A supplier that can write and execute your validation protocol may save a great deal of time and expense.  Few foreign suppliers have the resources and knowledge to assume the validation responsibility.  This is a service that Affinity commonly offers our OEM partners.

Understand OEM Partner’s Business

We constantly hear from our OEM partners how important it is that we not only know how to manufacture their products, but also understand their business.  Because we understand their business and how the products we design and manufacture will be used, we often are able to offer a higher level of assistance than other suppliers can.

Affinity’s sole focus is designing and manufacturing medical cables, connectors and interfaces.  Each member of the Affinity management team has several decades’ experience that is applied to providing unique interconnect solutions to our OEM partners.  Understanding how medical cables are intended to be used, and, how they are typically used, allows us to provide additional value by shortening design time, anticipating potential user problems, and reducing risk.

Control of Intellectual Property

Some projects that we participate in are highly confidential and any disclosure of the nature of the product could be detrimental to our OEM partners.  Some within the industry have expressed concerns that safeguarding intellectual property may not be viewed with the same degree of importance by offshore manufacturers as it is with domestic producers.

Besides the obligations and restrictions covered by Non-disclosure and Confidentiality agreements, we guard our customer’s intellectual property because our reputation and future business depends upon it.

Communicating across a dozen
time zones can be difficult

Time Zone Issues

Collaborating on the design and specifications for a medical cable assembly or custom connector generally requires a great deal of two-way communication.  Communication is more efficient when there is no language barrier.  Communication is easier to schedule when the normal business day of all parties is similar.

Communicating with technical resources as far away as Asia is particularly problematic. Asian countries start their workday after the U.S. workday has ended and the U.S. workday begins and ends during their night.  While Asian manufacturers often try to minimize the impact of the time difference, communication without advance scheduling is often difficult.

Supply Partner – Not Competitor

For some OEM’s, an important consideration is whether or not a prospective manufacturer competes for the same business.  Some domestic and offshore manufacturers produce interconnects for OEM’s, but also sell the same or similar products to end users or distributors.  Competing with our OEM partners is not something that we do at Affinity.  Our sole focus is on helping our partners be as successful as possible.

Affinity plant in Irvine California

Proud U.S. Manufacturer

Affinity Medical Technologies is proud to manufacture in the United States and we’re proud that we offer good jobs to our hard-working team members.

Besides being proud that we manufacture in the United States, we are very successful at manufacturing domestically.  Our success reinforces our belief that we made the right decision by strengthening our design and manufacturing capabilities here, rather than developing those capabilities offshore.

“Thanks to our customers, Affinity’s business has been strong and we have been hiring all year,” said Manufacturing Manager, Kevin Kom.  “With unemployment at record levels, we feel very fortunate to be able to offer good jobs to good people.”

Affinity Asian Partner

For some high volume products with high labor content and locally available raw materials and components, manufacturing in Asia may make sense.  Because a handful of our products fit these parameters, Affinity has an Asian manufacturing partner.  Each of our products manufactured in Asia was first developed, validated and put into production in the U.S.  Only after we have successfully manufactured the product in our Irvine plant have we considered transferring manufacturing to Asia.  When it has made sense to transfer a product to Asia, we have been successful in maintaining the same level of quality, lead times and logistics for our OEM partners.

Balancing Quality, Lead Times and Price

One of the reasons our business is strong is that many of our new customers have decided to buy domestically after experiencing problems sourcing in Asia.  There is a saying in the industry that seems to be proving true.  Offshore manufacturers can offer a good price, high quality and fast delivery – pick one.  At Affinity, we do our best to offer our OEM partners all three and it seems to be paying off.  We continue to take on new projects that had previously been transferred to Asia.


When deciding whether to develop your interconnect project domestically or offshore, it will benefit you to consider all of the advantages and disadvantages of either strategy.  If you have gone offshore and are not enjoying the expected savings or are experiencing service or quality issues, the Affinity team is ready and willing to help.  Contact us at +1 949-477-9495 or at

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Meet Luis Soriano – Quality Management Supervisor

Lius Soriano

Luis rejoined Affinity just over six months ago after a three-year break when he worked for a well known eyewear manufacturer while earning his MBA.  During his previous stint at Affinity, Luis was Production Supervisor.  He returned as Quality Management Supervisor and reports to Quality Manager, Cindy Oldynski.

While working away from Affinity, Luis gained additional experience in dealing with FDA regulations, quality controls, regulatory affairs and quality measurement systems.  After returning to Affinity, he became certified to train to IPC soldering standards.

Besides quality, Luis supervises Affinity’s molding operations.  He mentors the mold machine operators and inspectors to ensure that each and every cable produced meets our customer’s requirements.  He also supervises shipping and receiving, works closely with engineering and interfaces with sales and customer service.

Lius conducting training for
the Affinity production team

When asked what he likes most about his job at Affinity Medical, Luis said; “I enjoy the constant change and variety of activity on a daily basis.  I enjoy working with the people and feel there is a good rapport at every level and in all departments.  It is exciting to be part of a growing company and experience the positive movement.  I look forward to the future at Affinity Medical Technologies.”

Luis attended “Lean Manufacturing” training and participates in Affinity’s on-going lean initiatives.  He was part of the Cell Champion program and is happy to see those who finished the program taking leadership roles in their individual work cells.  Luis appreciates the support of management empowering Cell Champions and allowing them to make decisions for managing their work cells efficiently.

Luis and his wife, Susan enjoys playing tennis and are “extreme” LA Kings hockey fans and season tickets holders.  They try to attend all home games.  Luis supports Susan in her many hours of charity work with homeless shelters in the Los Angeles and Orange County areas.         

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Announcements and Information

Columbus Day

Affinity will be NOT be closed on Columbus Day, Monday, October 12th,.

September Trivia

Babe Ruth –
The Bambino
- image source

Babe Ruth
As we get ready for the Major League Baseball playoffs, some may remember Babe (George Herman) Ruth.  It was widely reported that when it was hot, he wore a cabbage leaf under his baseball cap to keep his head cool.  He changed it every few innings.

Plastic Flamingos
There are more plastic flamingos than real ones in the United States.  Don Featherstone is attributed to be the designer and more than twenty million have been sold since 1957.



Suzann Sitka, Cesar Jara and Candy Golding
- the Affinity Customer Care Team

Affinity Customer Care -
Hours of Operation

Affinity Medical Technologies customer care specialists are available to assist you from 7:00 A.M. until 4:00 P.M., U.S. Pacific Time, except holidays.

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Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: +1 949 477 9495
Fax: +1 949 477 9499