Staying Connected - January 2009

Anatomy of a Custom Cable Development Project

Here at Affinity we start several new custom cable projects each month.  As we begin to work with a customer on a new project one of the first questions we are asked is “how long will this take?”  Until the complete scope of the project is understood, the question cannot be answered accurately.

Affinity has developed systems and procedures that allow projects to be completed in a timely manner and ensure that the finished product meet customer specifications and expectations.  As an FDA Registered Medical Device manufacturer, our Design Control and Product Realization procedures are also in compliance with applicable elements of our ISO 13485-2003 registration and FDA QSR requirements.

Design Input

Each project begins with input from the customer.  Sophisticated customers often have detailed drawings and specifications.  Others often only have an idea with little or no documentation.  Regardless, we must have a clear understanding and document what the final product will be and how it will be required to perform before we can proceed.

Team Meetings


The Affinity Medical Technologies engineering team

Affinity procedures specify that regular team meetings be held during the course of new product development projects.  The Affinity team generally consists of a project leader, a lead engineer, representatives from quality and manufacturing departments, a Customer Care representative, and often the Business Development Manager. 

Once the project has begun Affinity will lead team meetings, generally via telephone or on-line, weekly or bi-weekly as the complexity of the project dictates.  For our European and Middle Eastern customers meetings are typically scheduled at the start of our day and for our Asian and Australian customers at the end of our day.

The Customer Care representative generally acts as Scribe and publishes meeting minutes and action item status to all team members.  Our experience has been that regularly scheduled communication keeps projects on track and eliminates unpleasant surprises.

Quotation

For most projects, a quotation is divided into two parts: one-time engineering charges (NRE) and pricing for production parts.  NRE charges typically include:

  • Design and specification consultation
  • Part design
  • Tool design
  • Tool fabrication
  • Tool trials
  • Production of First Article Parts
  • Design Validation Testing and reporting

Included is “design and specification consultation” at no additional charge for a reasonable number of hours for meetings and conference calls throughout the project.

When there is an understanding or agreement that Affinity will manufacture production parts, Project Engineering Charges are quoted at our estimated cost without markup.

Quotations for NRE and production parts are based on the design at the time the quotation is prepared.  Changes to the design may result in revised pricing.


Using SolidWorks the Affinity
engineering team uses
3D modeling to help design
custom medical connectors

Part Design

Once we have sufficient design input we can begin parts design.  Affinity uses SolidWorks 3D mechanical CAD software for part and tooling design.  When a customer uses different CAD software we have the ability to send or receive in compatible formats.

Customer Approval

Affinity is a contract manufacturer and builds products to our customer’s specifications.  As our engineering team prepares specifications, drawings and solid models, each is shared with our customer for their written approval, generally transmitted via email.

Tool Design


Affinity uses SolidWorks
for part and tool design

After the part design is approved Affinity engineers begin tool design.  Most connectors require three tools: an insulator which holds the pins or sockets, an inner mold tool and an outer mold tool.  Time to design set of three tools is generally about two weeks, which includes consultation and review with the tool maker.  As each tool design is complete it is released to one of our tool-maker partners for fabrication.

Tool Fabrication

The time to fabricate tooling is largely dependent on the number of tools and the complexity of each tool.  One recent cable project required eleven different tools which increased the project timeline.  To reduce the tooling lead time Affinity often uses more than one of our approved toolmakers simultaneously.


Affinity Production Manager
Kevin Kom running mold-trials
for new connector

Mold Trials

Once molds are received from the tool maker, Affinity completes mold trials.  Mold trials prove that the tooling will produce molded parts that meet all dimensional and cosmetic specifications.  We expect tooling to need minor modification and the time for rework is included as part of the lead time we quote for tooling.  Once mold trials are complete - that is acceptable parts are produced - tooling is heat treated to make it more resistant to wear and damage.

 

First Article Parts


Affinity Engineer Brian
Schwenke checking first
article parts in Affinity lab

Early in the design input stage we reach agreement with the customer regarding how many First Article parts the customer will require.  The quantities of First Article parts that are produced include those required by the customer as well as the number required by Affinity to perform Design Validation Testing.

Customers typically approve first article parts because they have been completely involved throughout the project.  At each stage, they have approved designs and specifications and therefore there should be no surprises.


Affinity lab technician Bob Evans
performs dielectric withstand testing
as part of Design Verification Testing
for a newly developed medical cable

Design Verification Testing

One of the services offered by Affinity, and included with most projects, is Design Verification Testing.  Affinity engineers normally write a test protocol which confirms that the finished product meets the customer’s specifications.  With the test protocol approved by the customer, the Affinity test lab executes the various tests required, records data and passes the information back to engineering.  The project engineer then writes the Test Report and submits it to the customer for approval.

Production

Once our customer has approved First Article parts and the Design Verification Test Report, Affinity can release the product to manufacturing.  Because representatives from production planning and manufacturing have been part of the project team, the plant is ready to begin regular production.  Materials and components will be staged and manufacturing team members have been trained on any production steps unique for the product.  Production parts are typically shipped three to four weeks after final approval by the customer.

Summary

To answer the original question of how long it takes to develop a new custom medical cable, the following chart is an example of a recent project which required designing new custom connectors.

Weeks

Activity or Deliverable

Total Weeks

0

Project kick-off

0

2

Part design

2

2

Tooling design

4

6

Tooling Fabrication

10

2

Mold Trials

12

2

Produce First Article parts and Design Validation Testing

14

4

Production and first shipment

18

In the above example, production parts were shipped to the customer 18 weeks after project kick-off.  Depending upon the complexity and customer resources to approve each stage of a project, some are completed in less time and others take longer.

By following established procedures Affinity is able to consistently complete projects on-time and to the complete satisfaction of our customer partners.  If you would like more information on how Team Affinity can assist with your interconnect projects call Customer Care at +1 949-477-9495 or email to CustomerCare2@affinitymed.com.  You’ll be glad you did!

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Meet Laura Ramirez – Affinity Engineering Assistant


Laura Ramirez,
Affinity Engineering Assistant

When a new customer project is launched at Affinity Medical Technologies there are many steps and procedures that need to be followed before production begins.  Laura Ramirez, an Engineering Assistant, plays an important role in this process.

Laura joined Affinity Medical eight years ago as a Manufacturing Associate.  She soon moved up to Quality Control and Inspection.  A little over a year ago, Laura was promoted to Engineering Assistant reporting to Bob Frank, Director of Engineering.

During her employment at Affinity Medical, Laura received certification in soldering in addition to a great deal of process specific job training.  Laura took advantage of other training opportunities completing “English as Second Language” and “Lean Manufacturing.”


Laura Ramirez updates
Affinity documents as part
of Engineering Change Notice
(ECN) procedure


Laura’s position as Engineering Assistant involves many tasks including managing Engineering Change Notices, updating engineering drawings, Document Control as well as maintaining Affinity’s parts master file.  She often uses her expertise in manufacturing to assist the project engineers and the production team with First Articles and initial production runs of new products.

Since Laura speaks both Spanish and English, her translation skills are frequently called upon to assist with applicants and phone inquiries.  She is always willing to help wherever she is needed.

When asked what she likes most about her job at Affinity Medical Laura replied, “I have had many opportunities to learn new skills and advance in the company.  I continue to receive lots of support from all of the managers and other team members at Affinity.”

Soon after moving to California from Mexico, Laura met her husband and settled down near Los Angeles.  She stays busy with four active children and enjoys hiking with her family in many beautiful locations throughout Southern California.   When Laura does get some time to relax, she likes to work with arts and crafts and create mosaics out of various materials.

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Multi-channel Cable Systems



Common jumble of
wires in ICU

Hospital patients are often monitored simultaneously for multiple physiological parameters. This generally means that there are three or more cables connected between monitors and the patient.  Add to this an IV line and possibly an oxygen line there can be a “tangle of wires” as one nurse described it.

One option to reduce the number of lines running to the patient is to use a cable management system where one cable carries signals from different sensors on the patient to the monitor.  The typical configuration is one trunk cable with multiple monitor connectors on one end and multiple sensor connectors on the distal end.

Affinity Medical Technologies has developed and manufactured a number of variations of multi-channel cable systems including bifurcated and trifurcated versions.


Affinity Trifurcated cable
carries three discrete
signals on a single trunk cable

Depending upon the nature of signals to be carried, the raw cable material may be simple, meaning a number of conductors within an outer jacket or complex meaning there are multiple discrete cables, typically shielded or isolated, within the outer jacket; “cables within a cable.”

The Affinity Medical engineering team can assist with design of cable management systems.  Contacting us early in your product development cycle allows you to take maximum advantage of our experience and expertise in cable design.

If you would like to see a sample of an Affinity bifurcated or trifurcated multi-channel cable, contact Affinity Medical Customer Care at +1 949-477-9495 or email to customercare2@affinitymed.com.

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Announcements and Information


Dr. Martin Luther King Jr.
Image source: Wikipedia

MARTIN LUTHER KING, JR DAY
Monday, January 19, 2009

Martin Luther King Jr. Day is a national holiday observed each year in the United States on the third Monday in January, a day that falls on or near King’s birthday of January 15.  It is one of only three federal holidays to honor a single person.

The campaign for a federal holiday in King's honor began soon after his assassination in 1968. Ronald Reagan signed the holiday into law in 1983, and it was first observed in 1986. Some states initially resisted observing Martin Luther King, Jr. Day as a holiday. It was officially observed as a federal holiday in all 50 states for the first time in 2000.
Trivia

Popcorn as Breakfast Cereal?

Early American settlers were first introduced to popcorn by the Native Americans.  The colonists enjoyed their popcorn in milk and topped with sugar.  This was probably the first American breakfast cereal.

Why is a Marathon Race 26 Miles, 385 Yards?

For the 1908 games held in London the British Olympic committee decided to have the race start at the Royal Residence at Windsor Castle and end in front of the Royal Box in the stadium in London, a distance of 26 miles 385 yards.  This distance was standardized at the 1924 Olympics and has been used ever since.


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.

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Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: +1 949 477 9495
Fax: +1 949 477 9499
Email: CustomerCare2@affinitymed.com