Staying Connected - January 2010

The Product Specification

One of the first steps in designing or developing a new medical cable, connector, or other interconnect device is preparing a specification for the product.  The complexity of the proposed produce 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.  The design of a cable would likely be different the intended user is a patient verses being intended for use by a healthcare professional.


If a cable will be subject to scuffing
or marks a darker color can be
suggested and include in
the product specification

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.

General Appearance

It is helpful to describe what the finished device is expected to look like.  Some examples of helpful descriptive statements are:

  • No sharp corners to help eliminate snagging
  • Reduce features that can trap dirt
  • Soft, rubbery feel
  • Dark color to reduce visible marks from handling

Often the originator of a new product has a clear idea of what the finished device will 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.


Locking requirements should be
included in product specifications

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
  • Branding
  • Desired or maximum weight
  • Locking mechanism – if any
  • Ergonomic features
  • Keying

Electrical Requirements

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 performance
standards for ECG
cables and leadwires

Mechanical Requirements

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
  • 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 roll-over
  • 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 Requirements

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
  • UL/CSA

Labeling and Packaging Requirements

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.


Example of AHA and IEC lead
designations on cable yoke label

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 shippping

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.


ESD protection levels should be
defined in the product specification

ESD protection requirements

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.

Environmental

The majority of medical cables and connectors are used in situations that do not require environmental conditions to be specified.  However if the device is intended or likely to be used in harsh or unusual conditions, temperature, humidity and altitude requirements may need to be included in 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 specific components to be used.  When this is the case, any required components should be listed and included in the product specification.

Reliability

What are the expectations for product reliability?  How long is the product expected to last under normal use?


DVT testing confirms the part
meets the product specifications

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 correlated to specifications that can be tested and validated.

At Affinity we occasionally receive a damaged cable back from a customer for root cause analysis.  Often we can confirm the failure mode, but not why the failure occurred.  In the example of a broken lead wire we were able to confirm that the lead was open, but could not determine, after the fact, what caused the failure.  Because validation testing had confirmed that the tensile strength of the leadwire met the product specification, the conclusion of our test lab was that the lead was stressed beyond design limits.

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

Testing Requirements

Any test required to be performed as part of the manufacturing process should be included in the product specification.  Defining and documenting test requirements early in the specification process is should allow time to acquire any necessary test equipment before it is needed.

Change Requirements

Documenting change requirements in the product specification is important.  Some device manufacturers will allow changes as long as they do not affect form, fit or function.  Others may not allow any changes without prior approval.  Including the method to initiate a change in the product specification is also desirable.


A well-prepared product specification
will help ensure that the finished product
meets all customer requirements

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 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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Meet Didier Chabault – Affinity European Business Development


Didier Chabault

Since 2008, Didier Chabault has been consulting for Affinity in a European Business Development role.  Based in France, Didier has more than 20 years experience in electronics, interconnects and medical devices.   He holds an MSc equivalent diploma in Electronics.

Didier began his career in 1975 with EPS, a division of Schlumberger in France where he held several positions in the quality department.  After EPS, he held various positions with Souriau and FCI Interconnections, from Product Manager to Marketing Manager.

Didier joined HYPERTAC France (Smiths Group) in 2001 as Marketing Manager.  In 2003 he was appointed Business Development Director for Hypertac Europe where his main focus was on the medical market and management of the dedicated European Sales Force.  It was during this period that he first met Mary Phillipp and Bob Frank from Affinity.  In 2005 reorganization caused him to return to Hypertac France and change career paths.


Didier and Affinity Director of Engineering
consult at Medica

“We knew and worked with Didier when he was with Hypertac” said Affinity President Mary Phillipp.  “We were really happy when circumstances allowed Didier to join the Affinity team in 2008.  His experience working with European device manufactures is valuable to Affinity.”

Working from his home office in France, Didier travels to visit device manufactures throughout Western Europe.  Twice a year he is joined by Affinity President Mary Phillipp and Director of Engineering Bob Frank.

“It’s a real pleasure to work with Didier” said Affinity Business Development Manager Hank Mancini.  “He has a tremendous amount of experience and an excellent reputation in the industry.  Besides that, he is a real gentleman.”


Didier and family enjoy spending time
at their vacation cabin in Cap Ferret

Affinity exhibits at Medica in Dusseldorf each November and Didier is an important member of the Affinity team at the show.  “Having an experienced member of the Affinity team in Europe helps us make connections with prospective device manufactures as well as stay connected with our existing OEM partners” said Mancini.

Didier lives a few kilometres from the Palace at Versailles, outside of Paris with his wife Dominique.  He has two grown children and two grandchildren.  He and his wife enjoy walking in the park at Versailles on weekends.  They also enjoy a spending time in their vacation cabin in Le Cap Ferret, on the Atlantic coast.

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Announcements, Information, and Trivia

Winter Olympics Trivia

Curling – Curling is one of only four winter Olympic sports contested indoors. The other three indoor sports are figure skating, speed skating and ice hockey.

South of the Equator – two interesting facts:

  • No country south of the Equator has ever hosted a Winter Olympic games
  • Only two countries located south of the Equator have ever won medals in the Winter Olympics: Australia and New Zealand.

Ice Hockey is one of the most popular
events in the Winter Olympics

Ice hockey – Strangely enough, Ice hockey made its Olympic debut at the 1920 Summer Olympics which were held in Belgium.  The reason…the first Winter Olympics didn't take place until 1924!






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