Staying Connected - August 2011

Project Engineering Charges and Time Requirements for Custom Medical Cables and Connectors

Tool design review is just one facet of NRE costs

Part of the costs associated with a new cable or connector project are the one-time charges for engineering and tooling.  Non-reoccurring project engineering charges are commonly referred to as “NRE” and non-reoccurring tooling charges as “NRT.”  It is not uncommon for engineering time to be in the hundreds of hours or more to turn a concept into a product that can be reasonably and consistently manufactured.

Engineering work on a project begins as soon as a customer supplies preliminary product specifications.  At Affinity, our engineering team reviews preliminary requirements to determine if we have the necessary competencies to move forward and quote the project.

Business Compatibility

The Affinity team also tries to determine very early in the process whether the project is compatible with our business focus - that it is a good “business” fit.  Some of the characteristics of a good business fit with Affinity are:

  • Reasonable production volume – not in the millions of units, but also typically more than a few hundred units a year with anticipated ongoing production
  • Reasonable revenue – regardless of the volume, there has to be sufficient revenue to cover all of the costs associated with a project, especially those not charged to a customer
  • Reasonable demand for engineering resources –confidence that the number of engineering hours required are available and will not detract from other projects
  • High quality – because all of Affinity’s systems and resources are focused on producing the highest quality products possible, when high quality is not required, the product is better designed and manufactured elsewhere

Project Quotation

Once customer requirements are documented and agreed upon, a design concept is completed and a quotation is prepared.  Quotations typically include details regarding NRE, also described as project engineering costs and NRT, the costs to fabricate unique tooling.  Quotations also normally include estimates of unit pricing based on volume estimates provided by the customer and a preliminary project schedule.

Affinity attempts to complete quotations within two weeks of receiving customer requirements.  However, identifying, locating and obtaining quotations for raw materials and components can cause significant delays.

Non Reoccurring Engineering Charges

Project engineering costs (NRE) typically include:

  • Establishment of specifications
  • Creation of documentation – drawings, bill of materials, work instructions, test procedures
  • Sourcing of materials and components
  • Parts design and creation of 3D models
  • Tool design
  • Tool fabrication management
  • Mold trials
  • Pre-qualification part builds
  • Production of First Article parts
  • DVT testing and reporting
  • Project management, including a reasonable number of project meetings and design reviews

These charges are commonly estimated and included as part of a quotation or proposal.  Where the volume is sufficient, Affinity may offer to absorb some or all of these charges in exchange for a commitment to manufacture the quoted product.

Non Reoccurring Tooling Charges

Custom medical connector design
and 3D model – both components
of project engineering charges

The Affinity engineering team designs tooling and manages the fabrication of tooling at several approved suppliers.  “We apply our engineering resources to design tooling that is compatible with our production processes,” said Affinity Director of Engineering Bob Frank.  “We work with several long-time local suppliers who quote and then fabricate tooling.  They are experts at building the tools that we design.”

“Tooling is not a profit center at Affinity,” said Bob.  “We are generally happy if we break even on tooling charges.  We refer to tooling charges as third-party costs and include these in our quotation at our estimated cost.”

Typical Mold Tooling

At Affinity, most of our cable assemblies are designed to be manufactured using insert molding, also called overmolding.  Overmolding in two steps (first the inner mold and then an outer mold) allows us to manufacture rugged, reliable and ascetically pleasing cable assemblies.

Overmolded connectors typically include a hard plastic injection-molded insulator to hold pins or sockets and an inner and outer overmold.  For the inner overmold, a hard material such as polypropylene is often used.  The mold material flows into and fills open spaces, capturing the insulator, wires and other components.  When properly designed, the inner overmold will hold the various components firmly together producing a very strong sub assembly.  The outer overmold gives the part its final look and feel and can include customer logos or nameplates.

Hard plastic insulator after
molding with polypropylene

The same connector after molding
the outer body with a TPE material

Based on using similar construction, two or three tools are typically required for each end of a cable assembly.  More complex assemblies, such as those that include a latch mechanism, may require additional tooling.

The project engineer designs mold
tooling using SolidWorks

Tool Design

Once the part design is complete and approved by the customer, tool design can be started.  At Affinity, we generally assign the same engineer to do both the part design and tool design.  We find this to be efficient for two reasons.  First, the part designer will not design a part that is difficult to tool because he/she knows that will also be his responsibility.  Second, the tool designer will already be intimately familiar with the part because he/she was responsible for its design.

Tool design commonly takes about one week for each tool after approval of the part design.  Tool designs are carefully reviewed and approved by our Director of Engineering in consultation with the tool maker.  Once approved, tool fabrication by one of our approved tool makers is begun.  Tools designs are typically released to the tool maker as each tool design is approved.

Tool Fabrication

Affinity tooling partner cutting steel tool

Bottom half of mold tooling
for custom medical connector

The length of time needed to fabricate tooling depends on a number of factors including:

  • The number of tools required for the part
  • The complexity of each of the tools
  • Workload of our tooling partners
  • Holidays – our toolmakers typically close for Christmas through New Years

“We are always asked how long it will take to fabricate tools,” said Affinity Business Development Manager, Hank Mancini.  “Our experience has shown that the first tool will take about four weeks to fabricate and each subsequent tool an additional two weeks.  This means that for a cable assembly with five tools – three for the monitor end connector (insulator, inner, and outer) and two for the opposite end (inner and outer) – up to twelve weeks may be required.”

The Affinity engineer assigned to the project is also responsible for managing tool fabrication.  This will generally entail regular communication with the toolmaker to make sure the tooling schedule is met.  As the tool fabrication nears completion, the project engineer will schedule mold trials and prequalification runs at Affinity.

Affinity Manufacturing Manager,
Kevin Kom and Project Engineer,
Mayuri Patel evaluating mold trial

Mold Trials

Included in tooling lead time is the time needed to perform mold trials after the tools are received from the mold shop.  Mold trials prove that the tool works as expected and will produce acceptable part.  It is common for minor modifications to be required as a result of running mold trials.  Because most tooling is fabricated locally, minor adjustments to tooling typically only take a few days.  Once any adjustments are made, mold trials are rerun to confirm that the tool produces the desired parts.  Mold trials and adjustments commonly take one week per tool.

Prequalification and First Article Production

Once mold trials are complete and the tooling has been shown to produce good molded parts, one or more prequalification production runs can be scheduled.  During the “prequal” phase, the Affinity engineering team will attempt to build the product using the various processes, materials and documentation identified during the development stage of the project.

It is common for several prequalification runs to be needed in order to further test tooling and the various manufacturing processes.  Parts manufactured during this phase are typically not shared with the customer.  The prequalification phase is generally scheduled over two weeks, but that can lengthen based on the complexity of the product.

Flex testing is an important
part of many DVT protocols

Output from the Fist Article phase should be complete, manufactured assemblies that meet all customer specifications.  First Article parts are typically shared with the customer and may also be used for DVT testing. 

Design verification and validation is an integral part of the new product development process.   Some customers elect to do DVT work themselves while others ask Affinity to perform validation and verification testing and reporting.  The length of time to complete the DVT phase can range from a week to several months based on the amount of testing agreed upon.


Nonrecurring project engineering charges, NRE, and tooling charges, NRT, are part of almost any new cable or connector project.  At Affinity we do our best to detail what these charges will be up-front so that there are no unpleasant surprises later.  We also do our best to provide a realistic timeline for projects and hold regularly scheduled team meetings to keep the project on schedule.

For projects where on-going production volume is large enough, Affinity may be able to absorb some of the project engineering charges (NRE) in exchange for a volume commitment for the product.

Let Affinity help design and develop your new medical cable assembly or connector.  We’ll use our experience and expertise in parts and tool design to shorten your project timeline and will work hard to meet all of your expectations.  For more information, contact Affinity Customer Care at 949-477-9495 or email to

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Meet Jennifer Bird - Affinity Human Resources

Jennifer Bird –
Affinity Human Resources

Jennifer is one of Affinity’s newest team members, joining the company in June 2011.

Human resource issues at Affinity had been largely handled by Lorie Jacobs who split her time between HR and finance.  When the company grew to over 200 employees, the human resources workload became so large that company President and CEO, Mary Phillipp, concluded that a dedicated HR resource was needed.

“We interviewed a number of candidates and while they were all very good, Jennifer stood out,” said Mary.  Jennifer has very quickly become an integral component of our Team.  She genuinely likes people and strives to achieve the best accommodation for all Parties.   She is a great listener and incredibly intuitive about people.  She brings a wealth of knowledge and experience of laws, rules and situation.  We are SO happy to have her on our Team.  Her happy smile is welcoming to everyone.”

Jennifer is part of the Affinity HR and Finance team which includes Laurie Jacobs
(upper right), Syeda Meherunnisa (lower left) with company President, Mary Phillipp

Jennifer is a hands-on Human Resources professional and brings over 10 years of experience in managing all aspects of HR:  employee relations, labor relations, recruiting, organizational development, benefits, training, conflict resolution, and performance management.  She uses goal setting, communication and empowerment to help the Affinity balance both company and the employee’s needs.

When asked what attracted her to Affinity, Jennifer replied, “After my initial interview with Mary and the management team, I was very impressed by the value Affinity places on both its employees and customers.  Everyone seems motivated to help the company succeed.  I am passionate about our team members.  I really enjoy helping them be as happy and productive as possible.” 

Jennifer discussing job duties
with Jeanette Cortes

Jennifer was asked about her initial impression of Affinity and she commented, “I am very impressed with the upbeat spirit at Affinity and the team building environment.  In today’s organizations it is very important to be able to contribute to the development and the accomplishments of an organization.  Affinity provides a work environment in which team members choose to be motivated, contributing, engaged and productive.”

”In the short term, I want to continue to learn Affinity as an organization.  Having a deeper understanding of the company will allow me to contribute more,” said Jennifer.  “In the longer term, I want to implement more efficient ways to handle HR issues such as recruitment, selection, training and the cost of employee benefits.  Affinity is a great place to work and I only want to make it even better.”

Jennifer grew up in nearby Laguna Niguel.  She graduated from Pepperdine University in Malibu earning a BA in Communications and Business Management.   She and her husband Brian have been married for seven years.  They live in Orange County and have two “beautiful children.”  Their son, Tyler is four and their daughter Avery is one.  Jennifer says “they are my pride and joy.”

“The family keeps me very busy,” Jennifer said.  “We really enjoy hanging out together, whether it’s riding bikes, going to the beach, swimming or just laughing and telling funny stories. It just what you do, when you are a Mom.”

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