Staying Connected - December 2007

Designing a Custom Cable

Designing and producing custom cables and connectors for medical device manufacturers is what we do every day at Affinity Medical Technologies.

When we start a project to develop a new cable, one of our first priorities is to gather information so that we clearly understand the customer’s requirements and expectations.  To facilitate this activity and to help ensure that we gather all required information, we use a document that we call our “Product Specification Worksheet.”

Some customers come to us with detailed, fully developed specifications, providing most of the information that we need.  This can significantly shorten the development process.  Others have a general idea of what they want and require assistance to define product specifications and requirements.

Customer input is outlined as product requirements for medical cable assemblies and connectors as follows:

  • Mechanical
  • Electrical
  • Environmental
  • Regulatory
  • Labeling and Packaging
  • Validation and Testing

ANSI/AAMI EC53 is often used as
a basis for establishing minimum
performance requirements

Mechanical

The ANSI/AAMI EC-53 standard is often used by our customers to define the minimum mechanical requirements such as flex life, tensile strength, mate and un-mate cycles, and connector retention force.  Other mechanical requirements that need definition for cable projects are length, flexibility, color and jacket material.

Electrical

Like mechanical, our customers often look to EC-53 to define the minimum electrical performance requirements for their new design.  Dielectric withstand, sink current, defibrillation withstand, resistance, and capacitance are the most common electrical characteristics specified.  When a customer specifies low triboelectric noise, selection of suitable cable material becomes one of the more important design considerations.


Cleaning and sterilization
requirements must be defined
and documented

Environmental

The environment that a cable or connector will be used in is important to understand very early in the development phase.  If moisture resistance is required, we work with our customers to define what level of ingress protection is necessary.

Material selection requires a clear definition of cleaning, disinfection, and sterilization requirements.  Packaging and labeling can also be affected by cleaning and sterilization and needs to be defined and documented as part of design input.

Regulatory

Being a FDA registered Medical Device Manufacturer and ISO 13485 registered, Affinity is especially aware of regulatory issues and how they affect product design.  Early in the development process we work with our customers to determine which regulatory requirements pertain to the product and then design to comply with those requirements.

Labeling and Packaging

Labeling and packaging are often two aspects of a project that are either overlooked or given low priority.  We try to address these issues early in the product development cycle so that they do not become a roadblock to product release.

Because lead-time to obtain custom nameplates and packaging can equal or exceed production lead-time, labeling and packaging needs to be defined early in the project.

Validation and Testing

One of the services that Affinity offers its customers is Validation and Verification testing.  The Affinity test lab can perform required testing and write the validation report taking the burden of this work off of our customers. 


Example of a solid model
that is shared during
on-line design reviews

Project Management

In addition to requirements for the product, we also define requirements for the project as a whole including Affinity deliverables, customer requirements, and a timeline with milestones.  In order to stay on-schedule, we typically schedule weekly team meetings, normally in the form of a conference call.  When designs need to be reviewed, the meeting is held on-line so that design details can be reviewed by all team members.

Summary

At Affinity we judge our success by our customer’s success.  By using our well defined design and development process and communicating regularly with our customers, we keep our projects on schedule and ensure that what we produce meets or exceeds our customers’ expectations.

^ back to top

 

Meet Bob Frank – Director of Engineering


Bob Frank
Affinity Medical Technologies
Director of Engineering

There is a lot of positive energy at Affinity Medical Technologies, and a sizeable amount of it can be attributed to Bob Frank, the Director of Engineering.  Bob’s imposing stature; unmistakable laugh and genuine enthusiasm are synonymous to Affinity Medical. 

Bob Frank has devoted his entire professional career of 25 years to the medical cable manufacturing industry.  After graduating from high school, Bob joined Tronomed, a large medical cable manufacturer as a draftsman.  While working full time, Bob received his Bachelor of Science degree in Business Management.

During his “Tronomed days,” Bob worked closely with Mary Phillipp, the President of the company.  They established a strong professional bond and long term friendship.  When Tronomed was closed Bob jumped at the opportunity to become one of the founders of Affinity.

While in its “infancy,” Affinity Medical landed a major OEM account.  Bob and his wife Joanne worked alongside Mary Phillip, her family and other team members for long hours doing whatever it took to get Affinity up to speed on the project.  Bob recalled the time he and Dave Johnson, (Mary’s husband) were running mold machines from midnight to 6:00am. “We would take a short break, retreat to our cars in Affinity’s parking lot, and catch a couple of hours of sleep.  Then, we’d start the process all over again!”

Ten years later,   Bob is still as enthusiastic about Affinity Medical Technologies.  He shares his positive attitude with all members of the team while supporting a challenging and exciting working environment that is geared to the future success of Affinity Medical.  Bob can be quoted as saying, “We all work hard at Affinity, but we also have a lot of fun.”


Bob at Affinity’s
10th Anniversary Picnic

Bob Frank is a more than the Director of Engineering at Affinity.  His vast knowledge of every aspect of medical cable design and manufacturing is an extremely helpful resource to not only our customers but everyone at Affinity Medical Technologies. In fact, Bob co-authored the EC53 AAMI guidelines that are recognized as the industry standard.

When asked what he enjoys most about his position at Affinity, Bob said, “I value the relationships I have developed over the years with customers, suppliers and employees.  This industry allows me to be exposed to new and exciting technology that helps bring life saving devices to the marketplace resulting in better healthcare solutions.”

^ back to top

 

Modular Connector


Custom modular connector
system with panel mount
for four connectors

At Affinity, we love challenges.  A few years ago a customer approached us with the need for a custom modular connector system.

Customer requirements included a panel mount for up to four connectors, mechanical keying so that the plug would only fit the appropriate receptacle, and color keying to the proper receptacle.  In addition, the connector needed to have a positive lock, but one which would un-mate if a cable was pulled, without damage to either the instrument or cable.

 


Connector features mechanical
keying and color coding


Positive latch allows
disconnect without damage

The customers design goals were a challenge, but one that the Affinity engineering team was able to meet.  The completed modular connector system was intuitive to use, robust, and met the design requirements.

Affinity has expertise and experience in designing and manufacturing custom modular connectors.  If you would like more information on modular connectors or any of our other products, please contact Affinity Medical Customer Care at 949-477-9495 or email to CustomerCare2@affinitymed.com.

^ back to top

 

Affinity Secrets Reveled for Holidays

As we reach the end of 2007, and in the spirit of the season, we thought we would share a couple of the secrets of why Affinity cables are so good.


Quality starts with our
dedicated team of Elves
.

Every cable is 100% inspected.
We start training our quality
inspectors early
.

^ back to top

 

Announcements and Information

AFFINITY MEDICAL   2007 HOLIDAY SCHEDULE
Affinity Medical Technologies will be closed Monday, December 24th and Tuesday, December 25th for the Christmas Holiday.  We will reopen on Wednesday, December 26th.

For New Years we will have very limited staffing on Monday December 31st and will be closed Tuesday the 1st for New Years.

From all of us at Affinity Medical, “May your Holidays be Merry!”




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.

^ back to top

 

 

Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: 949-477-9495
Fax: 949-477-9499
Contact Us