Staying Connected - January 2012

Establishing a Product Specification

One of the first steps in designing or developing a new medical cable assembly, connector, or other interconnect device is preparing a specification for the product.  The complexity of the proposed product dictates the level of detail required to be included in the product specification.

Product Description

It is helpful for a design team to understand what need the proposed product is intended to fulfill, who the product will be used by and how the product is expected to work.  As an example, the design of a cable would likely be different if the intended user is a patient verses the intended user being a clinician.



The product description should indicate
who the intended user of the product will be

The description may include statements regarding the environment in which the product is expected to be used.  A product designed to be used in a hospital setting would likely be designed differently than one intended to be used in an ambulance, even though both would likely be used by trained personnel.

A product description should help the team tasked with designing the product to understand the nature of the product and how it is intended to be used.

Product Appearance

It is helpful to the design team to understand what the finished device is expected to look like.  The appearance of a product will often be one of the key factors in determining how the user will perceive the product.  Some examples of descriptive statements that can help facilitate the design are:

  • Smooth edges and no sharp corners
  • Reduce features that can trap dirt and make cleaning difficult
  • Rigidity or pliability, hardness or softness of user interface surfaces: e.g. “soft rubbery feel”
  • A specific color (possibly to match corporate branding) or the desired effect of a color: e.g. “to reduce visible marks from normal handling”
  • Surface finish: e.g. “dull to eliminate glare or reflections”

Often the originator of a new product has a clear idea of what the finished device should look like.  If those ideas are not documented and made available to the design team, the product may not turn out as the originator expected.

Physical and Dimensional Characteristics

Once the general concept of the new device is established, the physical and dimensional characteristics can be addressed.  Physical and dimensional characteristics may include:

  • Desired size or size constraints
  • Length of cable and/or leads
  • Cable and/or leadwire diameter
  • Specific materials – if any
  • Cleaning, disinfecting and sterilization requirements
  • Branding
  • Desired or maximum weight
  • Locking mechanism – if any
  • Ergonomic features
  • Keying

Electrical

Because medical cables, connectors and interconnect systems typically carry a signal, power or both, electrical requirements are a significant part of the device specification.  Parameters that require definition and documentation include:

  • Number of conductors
  • Cable and wire shielding
  • Voltage and current
  • Resistance
  • Capacitance
  • Bandwidth
  • Defibrillation protection
  • Polarization


ANSI/AAMI EC53 provides minimum
electrical and mechanical performance
standards for ECG cables and leadwires

Mechanical

Along with electrical requirements, defining mechanical requirements for a cable assembly or connector is necessary before design work can begin.  Requirements that should be documented may include:

  • Flex life for each cable or wire termination point
  • Tensile strength for each cable or wire termination
  • Tensile strength of cable and wire material
  • Number of mate/un-mate cycles
  • Connector retention force
  • Wheel rollover
  • Ingress protection rating (IP rating)

Minimum mechanical requirements for ECG cables and leadwires are established in ANSI/AAMI EC53.  While the requirements contained in this standard may be suitable for the intended use, other applications may call for higher requirements.  EC53 is often used as a basis upon which to build a product specification.


Regulatory

Regulatory requirements should be evaluated and documented in the product specification.  Regulatory requirements may include compliance to:

  • FDA
  • Medical Device Directive
  • IEC
  • ANSI/AAMI EC53
  • RoHS
  • REACH
  • UL/CSA

Labeling and Packaging



Example of custom nameplate included
as part of product specification

Medical cables and wires require labeling and marking for identification and to comply with regulatory standards.  While some may not give these specification the same importance as mechanical or electrical requirements, products cannot be released without proper labeling and packaging.

Defining and documenting labeling, marking and packaging requirements as part of the original product specification will help ensure an on-time product release.  Typical labeling and marking requirements to be considered as part of the product specification include:

  • Brand labeling
  • Regulatory requirements labeling
  • Part number and lot or date code
  • Serialization – if required
  • IFU/DFU – instructions or directions for use
  • Required languages
  • Harmonized medical symbols
  • Bar coding
  • Packaging
  • Packaging for shipping

Characterization or programming requirements

For interconnect devices with active electronics, writing characterization or programming data to embedded electronics is becoming more common.  Defining what information must be recorded and how it will be verified should be part of the product specification.



If ESD protection is required it should
be part of the product specification

ESD Protection

With more passive and active electronics being incorporated into medical cables and interconnects, defining what level of Electro Static Discharge protection is required for manufacturing and packaging should be incorporated into the product specification.

Cleaning and Sterilization Requirements

Unless designed for single use, medical cables and leads will need to be cleaned.  Even cables or leads designed for single use may require sterilization prior to being used.
Depending upon the use, cleaning may range from a simple wipe down with soap to the elimination of all micro-organisms by sterilization.  Cleaning and disinfection requirements must be considered in the early product design so that appropriate materials and production processes will be specified.



If the product will be sterilized, the
acceptable methods must be included
in the product specification

Common cleaning, disinfection and sterilization methods include:

  • Green soap or alcohol-free hand soap
  • 2% glutaraldehyde
  • Sodium hypochlorite (bleach) solution
  • Isopropyl Alcohol 70 or 100%
  • Autoclave
  • Ethylene oxide
  • Gama radiation
  • Sterrad (gas plasma)

In order for the finished device to successfully survive cleaning, disinfection and sterilization, these requirements must be included in the product specification in order for the design team to address them when materials and components are selected.

Component Specification

For a device to function as intended it may be necessary to require one or more approved components to be used.  When this is the case, any required components, including manufactures name and part number should be listed and included in the product specification.


Design verification testing confirms that
the part meets the product specification

Reliability

What are the expectations for product reliability?  How long is the product expected to last under normal use?  It is nearly impossible to control how a product is used once it is manufactured.  Because of this, the reliability of a product should be defined in specifications that can be verified by testing.

When a product fails, reliability is often questioned.  If the number of failures is higher than expected or deemed acceptable, the product specification may need to be re-evaluated which may lead to a redesign of the product.

Summary

Preparing a detailed product specification and obtaining approval by all relevant parties at the start of a project will generally shorten the overall project timeline.  Equally important, a well prepared product specification will often reduce the overall cost by reducing or eliminating expensive mid-project design changes.

The Affinity engineering team can assist you in developing your product specification.  To take advantage of our experience and expertise contact Affinity Medical at +1 949-477-9495 or email customercare2@affinitymed.com.

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Affinity Quality Manager to Retire



Cindy Oldynski

Cindy Oldynski, Affinity’s Quality Manager, has will retire on February 3rd, 2012.

Cindy began her career with Affinity in December of 2001, joining the company as its first full-time Quality Supervisor and was quickly promoted to Quality Manager.  When Cindy joined Affinity in 2001, the company was less than 4 years old and only had about 40 employees.

While Cindy only joined Affinity ten years ago, she was well known by company President and CEO Mary Phillipp.  Cindy had worked for Tronomed since 1989 where Mary was the President.

In 1998 the Tronomed plant where Cindy worked was consolidated into a Tyco plant in Huntington Beach.  Cindy was offered a position with Tyco she accepted moving from Customer Service Supervisor to Technical Services Supervisor.

“It was a pleasure working with Cindy,” said Hank Mancini, who ran the Tyco plant.  “She brought a lot of experience and contributed immediately to the success of our operation.  Besides her work, everyone in the plant enjoyed working with her.  But, after two years, she decided to accept a position with Cardiac Science and I was sorry to see her leave.”

Cindy’s career with Cardiac Science was cut short when that company acquired Burdick and consolidated most of their operations to the Midwest.  It was probably fortunate that things worked out the way they did because that is when Cindy joined Affinity.

“When Cindy became available for employment, we were thrilled,” said Mary.  “After working with Cindy at Tronomed, we knew that her can-do attitude, willingness to learn new things and to take on any challenge was exactly the resource we needed at Affinity.  We have not regretted our decision for one minute.  Cindy has built a first class Quality team that we are all proud of.”

When asked about her early days at Affinity, Cindy commented, “It was really nice to be part of a growing company where what you did was recognized and appreciated.  Everyone at Affinity was on the same team, striving to give our customers the best quality and service that we could.  Mary instilled the attitude that quality was everybody’s responsibility, not just mine as Quality Manager.”

During her ten year career at Affinity, Cindy saw the company grow from 40 to over 250 employees.  During that time, she took part in well over 100 quality audits, including customer audits, ISO audits and FDA audits.  “We’ve learned from each audit and our quality system is more effective because of that,” said Cindy.  “We’ve got a great quality team and that has made my job easy.”

Affinity Director of Engineering, Bob Frank, who has also worked with Cindy for over twenty years commented, “We are so fortunate to have had Cindy on the Affinity Team.


Cindy and Chuck at their home
in southern Utah

Most people see Cindy as a happy and caring individual who loves the people around her almost as much as the cat’s she rescues.  When she was battling “the Big C” years ago, we saw what a fighter she can be. She has been a great coworker, and a true friend.  Our lives are richer for having known her.”

About six years ago Cindy and her husband Chuck visited friends who had relocated to southern Utah and they fell in love with the area.  It did not take them long for them to decide they wanted to retire there.  “We love the wide-open feeling and natural beauty of southern Utah.  It is a beautiful area with many National Parks close by,” said Cindy.  We’ve had our home there for several years and I can hardly wait to be living there full time.”

For the past nine years, Cindy has been involved as a volunteer with the OC Animal League, a local agency that rescues stray, abandoned and owner-released cats.  Cindy loves cats so much that she and her husband have built an addition onto their house that will be a home to some of the cats that Cindy has rescued.

“While we are only now announcing Cindy’s retirement, she let us know more than six months in advance what her intentions were.  She wanted us to have ample time to hire and train a new Quality Manager,” said Mary.  “I appreciated that and due to the smooth transition from Cindy to Cecille Vickers, I know that our customers will appreciate it also.  I’ll miss working with Cindy, but wish her and Chuck the best in their retirement and move to Utah.”

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Affinity Welcomes Cecille Vickers – Quality Manager



Cecille Vickers
Affinity’s new Quality Manager

After Affinity started searching for a replacement for retiring Quality Manager, Cindy Oldynski, one of our long-time OEM partners recommended Cecille for the position.  Having worked very closely with the Affinity team on a number of projects and having worked with Cecille in the past, he saw a good fit.

Cecile went through the interview process with the Affinity team and it was apparent to all that she was well qualified and, even more importantly, would fit well with the entire Affinity team.  Cecil started at Affinity in early December to give her about two months overlap working Cindy before Cindy retired.

Cecile came to Affinity with over ten years experience in quality management.  Her most recent position was with a pharmaceutical company, but she also has experience working for device manufacturers.  Asked what she thought the main difference in quality procedures was she commented, “Pharmaceutical manufacturing seems to have stricter policies and procedures, but device manufacturing is overall more structured.”

Cecille was born in the Philippines and moved to Guam when she was four years old.  She lived in the Guam for about ten years before moving to the states.  Cecille graduated from UCLA with a bachelor’s degree in biology.  She and her husband of 18 years, Larry, live in Chino Hills and have a 9 ½ year old son.

Asked about what she likes to do away from work, Cecille replied, “Our son is in Cub Scouts and our whole family is very involved.  Both Larry and I are involved in scouting and our son’s activities and that keeps us busy.  When I have time, I like to read science fiction and am currently reading the Twilight Series.”


Affinity’s new Quality Manager, Cecille
Vickers, with retiring Cindy Oldynski

Cecile commented, “I was attracted to Affinity as soon as I walked through the front door.  I could sense that this would be a good place to work.  And, my feelings have been confirmed, this is a good place to work.  Everyone works together.”

Asked about if she was surprised by anything she said, “I was surprised the knowledge of our Quality Inspectors and at how many manufacturing fixtures Affinity uses.  All of our inspectors seem to have a similar level of knowledge and experience which tells me that their training has been effective.”

“We have a number of audits coming up, including our semi-annual ISO audit,” said Cecille.  “Cindy will be here for one more customer audit and then it will be Heather Hibben, our Quality Engineer and me.  Affinity’s Quality System is robust and well tested due to the many customer audits that happen each year, so I am not concerned.”

Cindy, who will be retiring on February 3rd commented, “We were very fortunate to find Cecille.  She has the knowledge, experience and personality to lead Affinity’s quality team.  I will be able to retire confident that Affinity’s Quality Systems is in good hands.”

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Announcements, Information and Trivia

MD&M West – February 14th – 16th 2012 Anaheim Convention Center

Affinity will once again exhibit at MD&M West, booth 1665.  Either Hank Mancini, Affinity Business Development Manager or Jim Itkin, OEM Sales Manager will be at the booth.  They will be joined by Affinity’s engineering team and we expect Affinity’s customer care team also.  Affinity’s President and CEO, Mary Phillipp, will also attend the exhibit, but on a more limited schedule.



Dr. Martin Luther King, Jr.

MARTIN LUTHER KING, JR DAY

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.



Senjin no Hi celebrates
adulthood in Japan


Sidney Harbor on Australia Day
- photo courtesy of
Phil Whitehouse,
Wikimedia commons

January Trivia

In Japan, the 2nd Monday of January is 成人の日 (Senjin no Hi) or Coming of Age Day, which celebrates those who have reached 20 years old and become adults in the past year.

In the U.S., January is “National Soup Month.”  So, on a cold winter day warm up with a bowl of hot soup!

In Czechoslovakia, January is “Leden” which means “Ice Month”

The founding of Australia in 1788 is celebrated January 26th as “Australia Day”

January 26th is also celebrated in India as Republic Day which commemorates the date that the Constitution became effective which replaced the Government of India Act of 1935