Typical Tooling Requirements for Medical Cables
Example of custom
At Affinity, most of our cable assemblies are designed to be manufactured using insert molding, also called overmolding. Overmolding in two steps (first the inner and then an outer) allows us to manufacture rugged, reliable and ascetically pleasing cable assemblies. Overmolded connectors and strain reliefs offer superior ingress protection when compared to off-the-shelf connectors and can also be a more cost effective option.
Custom connector wired and
ready for inner mold
Once customer requirements are documented and agreed upon, a design concept is completed and a quotation is prepared. Quotations typically include project engineering costs as well as estimates of unit pricing and lead-time estimates.
Project engineering costs (NRE) include parts design, tool design, tool fabrication, mold trials, production of first articles and DVT testing. Of the various cost components in NRE, tool fabrication is often the largest.
Custom connector after
inner mold applied
Overmolded connectors typically include a hard plastic insulator to hold pins or sockets and an inner and outer overmold. For the inner overmold, a hard material such as polypropylene is often used. The mold material flows into and fills open spaces, capturing the insulator, wires and other components. When properly designed, the inner overmold will hold everything firmly together producing a very strong sub assembly.
The outer overmold gives the part its look and feel and can include customer logos or nameplates. Santoprene, polyurethane, or PVC, in a softer durometer, are typically used for the outer overmold to make the connector easy to grip and give a good tactile feel.
Affinity tool design using
Once the part design is complete and approved by the customer, tool design can be started. At Affinity, we generally assign the same engineer to do both the part design and tool design. We find this to be efficient for two reasons. First, the part designer will not design a part too difficult or impossible to tool because he/she knows that will be his responsibility also. Second, the tool designer will already be intimately familiar with the part because he/she was responsible for its design at the previous stage of the project.
Tool designs are typically not shared with the customer, rather are carefully reviewed and approved by our Director of Engineering. Once approved, our tool maker begins fabricating the tooling.
Hardened steel production tooling
The time to fabricate tooling depends on a number of factors including the number of tools required for the complete part and the complexity of the tooling. We have designed cables that require between two and twelve tools. As a “rule of thumb,” we typically estimate that each tool will take two weeks to fabricate. This means that for a cable assembly with five tools – three for the monitor end connector (insulator, inner, and outer) and two for the opposite end (inner and outer) - ten weeks may be required.
Part of the time needed to complete tooling is performing mold trials after initial tool fabrication. Mold trials prove that the tool produces an acceptable part. It is common for minor tooling modifications to be required as a result of running mold trials. Where parts must fit together and mate/un-mate, tooling is designed to be “tool safe.” That means that tooling will initially produce parts that fit together loosely. Metal can be removed from the tool in small increments until the desired mate/un-mate force or feel is achieved.
Once mold trials are complete and the tooling has been proven to produce good parts, the tools can be hardened by heat-treating. At Affinity, we use hardened steel production tools almost exclusively. Part of our commitment to our customer is that we maintain tooling in proper working order at our expense, including fabrication of replacement tooling if that ever becomes necessary.
Tool design and fabrication are important parts of medical interconnect projects. Let Affinity help design and develop your new medical cable assembly. We’ll use our experience and expertise in parts and tool design to shorten your project timeline. For more information, contact Affinity Customer Care at 949-477-9495 or email to firstname.lastname@example.org.
Nannette manages Affinity’s
network, email, and IT systems
“Nannette, would you please help me? My computer files have disappeared!” This type of question is very familiar to Nannette Filbeck, IT Systems Administrator, (aka “Computer Goddess) at Affinity Medical.
When Nannette re-entered the work force after raising three children, she started at the Castrol Oil Company and moved quickly into such diverse positions as Customer Service, Sales Analysis, Purchasing and Information Technology.
Many of the folks at Affinity were well acquainted with Nannette Filbeck before she joined the team three years ago. While working at Tronomed, a medical cable manufacturer in Southern California, Nannette met and formed a lasting professional relationship with both Mary Phillipp and Bob Frank, the founders of Affinity Medical Technologies. Therefore, Nannette seemed like the perfect fit when Mary and Bob were looking for a savvy computer specialist at Affinity.
Nannette is always smiling
Nannette is responsible for Affinity’s entire computer system including network and system applications. She also writes programs to make additions and improvements to our existing custom software. While adhering to a very busy daily schedule, Nannette is working on launching Affinity’s online catalog which will allow users to search for and view standard and custom connectors designed by Affinity.
When asked what she likes most about working at Affinity, Nannette answered, “I like helping people and dealing with diverse situations. Every day at Affinity Medical is different and offers a new and exciting challenge to me.” For someone who was just starting a career in IT many years ago and had to ask her eight year old daughter how to start the computer, Nannette’s expertise and resourcefulness is greatly appreciated by everyone at Affinity Medical today. Her philosophy about computers is simple. “Just remember that a computer is only a box with many plastic pieces. Do not fear it!”
Nannette and her husband Leon live in Lake Forest (about fifteen minutes from the Affinity plant). Nannette is an avid artist who enjoys oil painting. She also enjoys camping trips with her husband, a former professional baseball player. Nannette has lived in many different states and has visited every state in America except Alaska. Nannette and Leon also had the opportunity to live in Guasave, Sinaloa Mexico when Leon played professional baseball in a winter league.
Baseball runs in the Filbeck family with their son Ryan also having played professional baseball. In addition to Ryan, Nannette has two daughters, Amber and Andi and spends as much time as possible with her extended family while being a devoted “grandma” to her two beautiful baby grandsons.
When a telemetry manufacturer asked for help designing a patient cable Bob Frank and the Affinity engineering team partnered with the customer and came up with a unique and creative solution.
The customer’s requirements were for a low profile connector that could not be removed accidentally by the patient but could be easily changed by a technician. The cable also had to be robust enough to be left with a patient for three weeks or longer and withstand any and all conditions encountered in day-to-day life. Finally, the cable had to be lightweight, very flexible, shielded to reduce electrical noise and meet AAMI low noise and defibrillation requirements.
Understanding the customer requirements, the Affinity engineering team devised an innovative, unique design that met all of the requirements and was cost effective for the customer.
To keep size at a minimum and reduce cost, the connector was designed to plug directly into the monitor circuit board. The device manufacturer had only to include six sockets on the PCB, eliminating the cost of a mating connector. An access door that is screwed shut keeps cable plugged into the board, yet allows easily replacement by a technician.
3-Lead Captive Cable solved
Captive Cable electrode snaps with
built-in defib protection resistors
The final product is a 3-lead fully shielded cable with defibrillation protection resistors molded into the snap ends of the cable. The cable is lightweight for patient comfort, yet rugged enough to withstand the month-long monitoring.
For more information on how we can help solve your medical interconnect problems or for samples of cables produced by Affinity contact Customer Care at 949-477-9495 or email to email@example.com
Mothers Day is Sunday, May 11th
“The heart of a mother is a deep abyss. At the bottom of which you will always find Forgiveness.”
Memorial Day at
Arlington National Cemetery
Memorial Day is Monday May 26th
Memorial Day commemorates U.S. men and women who have died in military service to their country. It is also a national holiday. Affinity Medical will be closed on Monday, May 26th.
Suzann Sitka and Candy Golding
the Affinity Customer Care team
Affinity Customer Care - Hours of Operation
Affinity Medical Technologies customer care specialists are available from 7:00 A.M. until 4:00 P.M. Pacific time.
You may reach us by phone at 949-477-9495 or email to firstname.lastname@example.org.
Affinity Medical Technologies
1732 Reynolds Ave
Irvine, CA 92614 USA