Designing and Manufacturing for the Global Medical Industry
Since 1997, Affinity has provided high-quality, U.S. based manufacturing of cable systems for OEM medical device manufacturers. Having been acquired by Molex in 2012, Affinity now has access to the world-wide resources of Molex which include additional engineering expertise, international materials sourcing and low-cost country manufacturing.
Engineering and Manufacturing Capabilities to Match
The Affinity Costa Mesa California facility is not only a manufacturing location, but also a design and development center. For new custom cable assembly projects, the Affinity engineering team typically becomes an extension of our OEM partners design team. The Affinity team has the option of designing cable assemblies, fabricating tooling, performing design verification testing and beginning production locally then transferring to a manufacturing site in a low-cost country if and when appropriate.
Molex offers over 40 manufacturing locations in 16 countries, with 5 plants within Molex’s Medical Business Unit being ISO-13485 certified: Affinity’s Costa Mesa, California plant, in addition to Thailand, Ireland, Arizona, and Mexico.
Pictured are ISO 13485 certified manufacturing facilities in California, Thailand and
Guadalajara (L-R). Not pictured are the Shannon, Ireland and Phoenix, Arizona locations
While the Molex operates over 40 global manufacturing locations, three currently offer specialization in medical cable assemblies:
Global Engineering Test Capabilities
Testing of medical cable assemblies is essential; as part of design verification, during production and as acceptance activities before shipment. Affinity and Molex offer the following test capabilities design verification and on-going quality assurance. Test requirements are typically driven by customer requirements and standards such as ANSI/AAMI EC53 or IEC 60601.
- Tensile strength
- Flex life
- Connector retention force
- Mate and un-mate cycle testing (typically done by hand to simulate realistic use)
- Wheel roll-over
- Abrasion resistance
- Dielectric withstand (Hipot) testing
- Defibrillation withstand
- Cable and contact resistance
- Tribo-electric noise
- Inductance, capacitance and continuity
- 3-Axis automated measuring
- Pre-conditioning (cleaning, disinfection and sterilization) prior to mechanical electrical testing
- High-resolution digital X-Ray
- Thermal cycling and humidity withstand
- High-speed signal integrity testing
- Electro-magnetic interface (EMI) testing
Automated flex testing allows
up to six cables to be tested
simultaneously while monitoring
electrical performance of each
Affinity Process Engineer, David Moreno,
performs tensile testing on cable assembly
Each Molex plant has test capabilities appropriate for the products being manufactured. In addition to plant oriented testing, Molex maintains a very large and sophisticated test lab at the corporate campus in Lisle Illinois. The Molex lab in Lisle has unique capabilities that can be accessed by all Molex plants for the benefit of OEM customers.
Material and Component Supply-Partners
One of the keys to the development of custom, high-quality medical connectors and cable assemblies is timely access to appropriate raw materials and components. In its 17 year history, Affinity has developed a strong base of reliable supply-partners. As part of Molex, Affinity’s supply base has broadened significantly to include many of Molex’s global supply-partners.
Working with the Molex supply chain group in Asia, Affinity’s engineering and sourcing teams have a greatly expanded base of suppliers. Supplier qualification and ongoing assessment is handled efficiently on a regional basis.
Molex – Much More Than a Connector Company
The identification, specification and integration of materials and components is one of the key aspects of designing medical cable assemblies. Teaming with other Molex divisions, the Affinity engineering team can now incorporate a greatly expanded array materials and components and tap technical resources for each:
Custom Cable Material: Located outside of Boston, Massachusetts, Temp-Flex® Specialty Wire and Cable Products designs and manufactures unique specialized custom wire and cable. While Temp-Flex manufactures for a variety of industries, medical wire and cable are the most significant focus of new product development and manufacturing.
Temp-Flex core capabilities include: design and domestic manufacturing of Coaxial, Bundled, Flat Ribbon, and Micro Miniature Wire and Cable. Expertise in material selection and processing allow Temp-Flex to produce medical-grade wire and cable suitable for implantation. When appropriate for the project and in conjunction with OEM partners, Affinity incorporates TempFlex wire and cable for applications that require very fine gauge wire.
Fiber Optics: Molex offers engineered fiber optic solutions through Molex Fiber Optics in Downers Grove, Illinois and Polymicro Technologies™ in Tempe, Arizona.
Molex Fiber Optics supplies fiber optic cable assemblies and hybrid assemblies – those combining fiber and copper as well fiber optic connectors, adapters, backplanes and optical circuitry.
Polymicro is FDA QSR compliant and ISO 13485 certified. Polymicro manufactures optical fibers and capillary tubing. Optical fibers are manufactured in sizes ranging from 25µm to 2,000µm. Polyimide coated fused silica capillary tubing is available from Polymicro in standard and custom configurations.
Connector Solutions: While the Affinity engineering team has the capability to design custom connectors in any size or shape (rectangular, circular, right-angle, etc.), they can also access the vast portfolio of Molex connectors which have been developed over decades.
Launching in January 2015, Molex and Affinity will introduce the MediSpec™ MPC (Medical Plastic Circular) Connector. “The MediSpec™ MPC connector gives device makers a new and very attractive interconnect option,” said Affinity General Manager, Bob Frank. “While the MPC connector is new, the Molex LFH contact system used in the connector is a proven system. Employing the LFH contacts allows the MPC connector to be rated to 10,000 mate and un-mate cycles. That’s about twice that of competitive connectors. And even though performance will meet or exceed competitive connectors, the MPC connector will be an economically attractive alternative.”
The MPC family of connectors will be offered in four different sizes, with a 17 circuit configuration launching first. While designed to hold a maximum of 17 contacts, configurations with fewer contacts will be available. Additional sizes and contact configurations will be launched in 2015.
The new Molex MediSpec™
MPC connector – plug and receptacle
Molex Copper Flex assemblies offer great
design flexibility for medical devices
Flexible Printed Circuits (FPC): For Medical applications in which a rigid printed circuit board (PCB) is not appropriate, Molex offers design and manufacturing of custom flexible printed circuits. Molex Printed Circuit Products is a global leader and offers design, engineering and manufacturing of simple to complex printed circuits. Multi-discipline engineering expertise includes optimized electrical and mechanical performance as well as Design for Manufacturability (DFM). Printed circuits can contain up to 20 layers, can be designed to handle high speed data up to 10 gigabits per second and offer millions of flex cycles. Molex Printed Circuit Products is based in Minnesota, with ISO certified manufacturing locations in the U.S., Mexico, China and Taiwan.
Molex Sales Engineering in Every Corner of the World
At the forefront of customer success, is the Global Sales and Marketing team made up of hundreds of Sales Engineers. Included in this team are 8 dedicated Medical Account Managers strategically located in Medical OEM prevalent areas including Boston, Minneapolis/St. Paul, Seattle, Northern and Southern California as well as in Europe and Asia. Each Sales Engineer has a regional Product Manager and Engineering team prepared to respond quickly to customer inquiries and technical challenges, and able to provide technical support for the entire Molex product portfolio.
The Affinity and Molex teams are available to assist customers at any point in the design process. While the greatest value is offered when engaged at the conceptual stage, value is also provided for more fully defined and even build-to-print projects. “Our engineering resources are valuable,” commented Affinity Product Manager Emily Clark. “It is important that we apply those resources to projects where we can offer the most value to the customer. To make that assessment, we rely on the Molex Sales Engineers and Account Managers to interface with the customer. Besides the obvious need for technical specifications and requirements, we also need to understand the customer’s timeline, point-of-use and price expectations.”
Once engaged, regular and on-going communication between the OEM and Affinity design team is standard and leads to project success.
Manufacturing near Point of Use
Molex can design anywhere, manufacture anywhere and offer technical support to Medical OEM’s on a global basis. With Affinity Medical a part of the Molex global organization, it gives our customer-partners additional manufacturing options. If the point of use is in Europe or Asia, it may be advantageous for the product to be manufactured in the same region. From initial concept and product design through manufacturing, our product development and realization procedures ensures that maximum value is created for our OEM customers, regardless of the location.
The Affinity and Molex engineering teams have decades of experience designing medical cable assemblies that best meet customer technical, commercial and quality requirements on a global basis. Let us partner with you on your next new cable assembly or connector project.
For additional information, contact your local Molex Sales Engineer, Account Manager or call Affinity at +1 949.477.9495 or email us at email@example.com.
Todd has only been an employee of Affinity for about 4 months, but has worked on behalf of Affinity since the company was founded in 1997!
Until the business was acquired by Affinity, Todd worked for Engineering Today in Torrance California. Engineering Today was Affinity’s primary tooling partner, fabricating a large percentage of mold tooling run at Affinity.
Todd grew up in Las Vegas working in the family’s window manufacturing business. “My dad would pick me up after school and was expected to work,” said Todd. “I worked in the family business until I was 23 when I moved to Southern California to go to school.”
After graduating from El Camino College with an Associate in Science degree in Machine Tool Technology, Todd went to work in Aerospace working for several companies. “I worked at TRW in the model shop. We made anything that engineering wanted. I completed two years of a four-year apprentice program before being laid off.” Layoffs were common in the industry and Todd wanted to find a job that he and his family could depend on.
“I was the first person to answer an ad for a machinist position at Engineering Today. The owner, Doug Henry, said there was no way he was going to hire the first person to answer the ad,” commented Todd, “so I started as a contractor. After two weeks of watching Doug interview others I finally was hired.” Todd worked at Engineering Today for 22 years until the business was acquired and folded into Affinity Medical.
Asked what kept him at the same job for so long Todd answered, “At the large aerospace companies you are just a number. The industry goes through boom and bust. The medical industry has proven to be much more stable. At Engineering Today I had the freedom to apply my skills and just get the job done. And, my contribution was appreciated.”
With the addition to Affinity completed in June, Todd and his two co-workers Sal Camarena and Richard Salce moved their operation into Affinity and became employees on July 10th of this year.
Moving from the small tool shop to Affinity Todd was asked about what he thought about the transition. “There were three of us in Torrance and now I work with over 300 people! I appreciate the extra space, the climate control and the additional benefits that Molex offers.”
Asked about what drew him into tool making, Todd replied, “It is my kind of art. I enjoy taking a block of material and by sawing, drilling machining and grinding it is turned into something of value – a tool! Some of the work is done on a programmable CNC, but we still do a lot of work by hand and I enjoy that.”
Todd and his wife live in not-so-far-away Torrance, California. Todd’s wife teaches third grade. They have three grown children that all live in Southern California.
Asked what he does outside of work Todd said “I am a Bishop in the Mormon Church and that is a big part of my life and our family’s life. Having been an Eagle Scout I still love the outdoors, camping and fishing. And, when there is time, we work on remodeling our home.”
Visit Affinity and Molex at Medica/Compamed
Mid-November always finds the Affinity team in Dusseldorf at Medica/Compamed the world’s largest medical exhibition. Like last year, Affinity will be exhibiting at Compamed as part of the Molex exhibit in hall 8b, booth N03.
Wayne Shockloss, Bob Frank, Jim Itkin, Emily Clark and Greg VanHecke will represent not only the Affinity plant, but Molex medical cable manufacturing capabilities on a global basis.
“I think this is Affinity’s tenth year to exhibit at Medica/Compamed,” said General Manager, Bob Frank. “Not only do we meet prospective customers, but it is always great to see many of our long-term customer-partners at the show.”
If you would like to schedule a meeting with the Affinity or Molex team at Medica/Compamed, email to CustCare2@molex.com and we will contact you to schedule your appointment.
Daylight Savings Time – Fall Back
In 2014, Daylight Savings Time ends in most of Europe on Sunday, October 26th and in the United States on Sunday, November 2nd.
Don’t forget to set your clocks back one hour Sunday morning, October 26th or November 2nd!
Jack O’ Lantern – believed to have originated in Ireland where candles were placed in hollowed-out turnips or mangel-wurzel to keep away ghosts and spirits.
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Samhain – Modern Halloween traces its origin to the Celtic holiday called Samhain (pronounced sa win), meaning “end of summer.” Custom has it that masks were worn so that the roaming ghosts and spirits would not recognize those wearing masks.
Souling – Trick or treating dates to the 9th century when, on All Soul’s Day, when the poor would go door to door begging for food. The common treat was called “soul cakes” and was a bread-like pastry made with currants.
First Halloween - Anoka Minnesota, located in the United States, held the first city-wide Halloween celebration in 1921
Candy Dollars - Halloween has grown in popularity to become the second most popular holiday in the U.S. in terms of dollars spent. Approximately two billion dollars will be spent this year on Halloween candy alone!