Staying Connected - August 2009

Incorporating Connectors, Electronics and Enclosures

Many think of Affinity as a manufacturer of medical cable assemblies, which is only partially correct.  While designing and manufacturing medical cable assemblies is a large part of our business, we also design and manufacture custom medical connectors and custom enclosures that often incorporate cables, connectors and printed circuit boards.


Overmolded electronics package

External Electronic Assemblies

The Affinity engineering team is experiencing an increased need by device manufactures to incorporate electronics in external enclosures and interface those enclosures via cables and connectors.

Often the need arises to add electronic circuitry to a medical device without redesigning the device itself.  In this situation one option is to add the necessary electronic components in an external housing connected by a cable assembly. This is a common situation where legacy devices need to be made compatible with newer technologies.


Hybrid enclosure – inner clam shell
with overmolded outer surface

There also appears to be an increasing need to capture analog physiological signals, such as an ECG, digitize the information, and send the digital signal to a host device via a data cable or even wirelessly.  An external enclosure housing electronic circuitry is often employed.

Enclosure Options

The three most common methods used at Affinity to enclose electronic assemblies are:

  • Clam shell enclosures
  • Overmolded or encapsulated electronic circuits
  • Hybrid enclosures

The optimum enclosure method is dependent on a number of factors including size, durability, ingress protection requirements, cost, development time and the look and feel of the final assembly.


Custom clam shell enclosure
and cable assembly

Clam Shell Enclosures

The most common enclosure is a hard plastic clam shell with a top and bottom that are secured together once components have been installed.  This enclosure may be as simple as a box with a lid attached or more sophisticated with interlocking groves and a gasket to achieve a waterproof seal.

While stock clam shell enclosures are available from a variety of sources, they are rarely configured as needed.  Openings for cables or connectors may not be in the right location or of the desired size.  Rarely do stock enclosures have appropriate features in the desired location to mount PCB’s or provide anchor points for cables or wiring.


Interior of custom enclosure with
flexible strain relief and PCB standoffs

Custom clam shell enclosures can be designed and manufactured to allow them to be reopened or to be permanently sealed.  Often screws are used for reopenable enclosures and an adhesive or ultrasonic welding is used for permanently sealed enclosures.  If an enclosure is designed to be screwed shut, screw placement can often be hidden by labeling.  When a label is used to cover screws, it can also act as a deterrent to tampering because the label will not remain intact if the screws are removed to open the case.

Overmolded Electronics

Of the three options, overmolding active electronic components presents the greatest challenge for manufacturing.  Molding typically involves injecting hot material at high pressure into a cavity where the electronic assembly is suspended.  Any components that standoff from the surface of a PCB or have a high profile can be moved and damaged by the injected mold material.


PCB with active compolents
before molding

PCB after first
molding operation

An additional obstacle to overcome when overmolding electronics is the effect on components due to shrinkage of mold material as it cools.  Experience has taught us that this failure mode must be considered when specifying materials designing tooling and establishing mold parameters.

Overmolding directly over a PCB involves typically involves an inner and outer mold.  The inner mold adds mechanical strength and is commonly used to anchor any cables and connectors.  An outer overmold finishes the assembly adding the desired look and feel as well as providing space for branding or labeling.


Complete overmolded PCB assembly
adapts legacy device to new PC’s

Molding directly over electronic components adds additional opportunities for failures due to the temperatures and pressures associated with molding.  Because of this, it is generally advantageous to verify the electronics are functioning properly at various stages of the molding process, as well as a final functional test prior to shipment.

Even with the manufacturing challenges, encapsulating electronic components by overmolding can produce a part that is small, very strong, has an appealing look and feel and offers a high degree of ingress protection.

Hybrid Enclosures

Hybrid enclosures are a combination of hard plastic cases overmolded with a softer material such as TPE.  There are several advantages to this type of enclosure including protecting the electronic components from the temperature and pressure of insert molding.  Another advantage of a hybrid enclosure is that the look and feel of an overmolded enclosure can be achieved but without the weight of a solid molded assembly.


Clear clam shell case holds
and protects circuitry from
final overmolding operation

Finished assembly after overmolding
inner clam shell with softer
thermoplastic material

Summary

Incorporating electronic circuits into external enclosures can offer medical device manufacturers additional alternatives.  The Affinity engineering team has experience designing and manufacturing a wide variety of enclosures incorporating circuits, connectors and cable assemblies.

For more information on how Affinity can help you with external enclosures, custom cable assemblies and connectors, contact us at customercare2@affinitymed.com or call us at +1 949-477-9495.

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Meet Cindy Oldynski- Manager of Quality Assurance


Affinity Medical Quality
Manager Cindy Oldynski

Cindy Oldynski joined Affinity Medical Technologies as Quality and Distribution Supervisor In 2001.  Soon after, she was promoted to Manager of Quality reporting directly to President and CEO, Mary Phillipp.  Cindy came to affinity with a great deal of experience including quality and regulatory affairs, documentation control, distribution management, customer service and production.  Her position as Quality Manager allows Cindy to utilize her skills and experience to benefit Affinity and its customer partners.

Like many others at Affinity, Cindy previously worked with Affinity founders Mary Phillipp and Bob Frank at Tronomed which also produced medical cable assemblies.  Cindy also worked for Tyco Healthcare and Cardiac Science.

As Manager of Quality Assurance, Cindy oversees all daily quality activities at Affinity.  She is responsible for keeping Affinity’s Quality System in full compliance with FDA and ISO requirements.  Cindy leads a team of 22 including a supervisor who helps maintain the company’s high quality standards.  Cindy’s responsibilities also include quarterly Management Review meetings, Internal Quality Audits, and the rare customer complaint.

Cindy is the primary contact at Affinity for audits conducted by customers, the FDA, and BSI for ISO audits.  “Because we have over 100 active customers, we are often audited several times a month” said Cindy.  “It’s a lot of work, but our Quality System is stronger because of the frequent audits.”



Cindy conferring with
Quality Supervisor Luis Soriano

Besides being responsible for quality, Cindy is Co-coordinator of Affinity’s Lean Manufacturing team and is actively involved with the implementation of “lean” programs throughout the company.  Affinity recently implemented a “Cell Champion” program.  Manufacturing associates who demonstrated a high level of expertise, reliability and leadership were invited participate in “Cell Champion” training.  After completing the course, associates were offered the opportunity to become leaders in their work cells.

Always cheerful, you might even hear Cindy whistling a happy tune while on her way to the production floor.  When asked what she likes most about her job at Affinity Cindy replied, “The people.  I also appreciate the great support I receive from upper management.  Mary Phillipp, our president and CEO expects everyone to take responsibility for quality.  After all, quality is every employee’s job.  Our culture at Affinity truly reflects this philosophy.”

Cindy volunteers her free time to an animal rescue organization that assists in finding good homes for abandoned cats and kittens. She is very serious about who adopts the animals and thoroughly screens all applicants.  Cindy and her husband enjoy spending as much time as possible at their second home near St. George Utah.  They both enjoy hiking and exploring and other outdoor activities.

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Design Verification and Validation


Affinity lab manager
Bob Evans performs
dielectric withstand testing

One of the services that Affinity Medical offers to its customer partners is Design Verification Testing (DVT) and reporting.  Design verification confirms that the product meets all requirements established during the design input phase of the project.  Design validation ensures that the device will operate correctly for its intended application. 

At Affinity, we include design verification and validation as an integral part of our new product development process.   As we work with our customer partners to establish specifications, we understand that we will need the means to verify these requirements.  Considering validation and verification from the beginning of a project allows time to plan these activities and acquire or build test devices or equipment necessary to perform verification and validation testing.

Good planning helps ensure verification and validation activities do not slow down or hinder new product deployment.  Planning entails writing a Verification and Validation Protocol.  Each Protocol should include well defined steps which will lead to the confirmation of the design.  Once the verification and validation protocol is shared and approved by the customer, it becomes part of the Device History file along with subsequent test results and a test summary.


Flex testing is one of the
mechanical tests executed as
part of most test protocols

Depending upon the nature of the product, pre-conditioning may be included as part of the test plan.  Pre-conditioning may include sterilization or cleaning.  Because of the amount of time that may be required for each sterilization cycle, pre-conditioning can take longer than actual testing and must be considered in the overall project schedule.

Once any pre-conditioning is complete, electrical and mechanical testing can be performed.  Two aspects of mechanical testing, mate/un-mate and flex testing, typically take the greatest amount of time.  If the test plan calls for a large number of samples to be flex tested to failure, weeks of lab time may be required.  Similarly, if the number of mate and un-mate cycles and the sample size is large, many hours may be required.  At Affinity, we typically perform all mate and un-mate testing by hand because it more accurately reflects how medical cable assemblies and connectors will be used.

Verification and validation helps ensure the functionality and manufacturability of newly developed products.  Affinity can not only help design and develop your new medical cable assembly but save you time and resources by completing verification and validation requirements. For more information, contact Affinity Customer Care at +1 949-477-9495 or email to customercare2@affinitymed.com.

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Announcements and Information

Labor Day Holiday

Affinity will be closed Monday, September 7th in observance of Labor Day.

Labor Day is observed as a Federal Holiday in the United States on the first Monday in September.

Labor Day has been celebrated in the United States since September 5th, 1882 and honors the social and economic achievements of American workers.  It is an annual tribute to the contributions workers have made to the strength, prosperity, and well-being of our country.  To many, Labor Day signifies the end of summer and return to school.

Trivia


Caesar Augustus reigned
from 27 BC to AD 14 –
image source Wikipedia

August – the month

August was originally named Sextilis in Latin because it was the six month of the year in the ancient Roman calendar.  It only became the 8th month after the addition of January and February as the first two months of the year about 700 BC!  The name was change about 8 BC to honor Augustus

Silent Movie

In the 1967 Mel Brooks film, Silent Movie, world-famous mime Marcel Marceau has the only speaking role saying the single French word “non” or no.

 


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
Email: CustomerCare2@affinitymed.com
Website: www.affinitymed.com