DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Table of Contents

Introduction 2

Step 1 – Product Concept 4

Step 2 – Product Requirements 5

Step 3 – Proof of Concept (Alpha Prototype) 6

Step 4 – Product Design (Beta Prototype) 7

Step 5 – Verification & Validation 8

Step 6 – Manufacturing Process Design 10

Step 7 – Manufacturing 11

Step 8 – Sustaining Services 12

How can we help? 13

About Product Resources 14

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Introduction
Launching a new product is no small task.
No matter what size your business, creating a
product from scratch is a major commitment of
time, money and resources.
It’s not something you can afford to take lightly.
Not if you want to be successful.
Too often though, a product launch doesn’t get the commitment or focus it needs.
It always starts with good intentions and realistic expectations, but at some point,
the process falls apart. Deadlines are missed. Priorities get rearranged. Budgets
get reallocated.

Why complex products are different

Every product launch is challenging, but when your product also requires complex
technology and engineering, the product development process is even more
complicated.

In our experience developing complex instrumentation and devices for the medical,
pharmaceutical and life sciences industries, the need for electro-mechanical
engineering, automation and integrated systems has taken on even greater importance.

This technical complexity applies not only to the design and engineering process but
also to manufacturing where we rely on highly trained technicians to assemble and test
the finished product.

Our Product Development Guide

In this guide, we’ve tapped into our many years of design, engineering and
manufacturing experience to provide you with an outline of the product development
process – as we see it.
Every product development project starts with identifying your market and defining
your product capabilities, and it ends with product sales and distribution.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing
In between is a process that takes your product idea from initial concept and design to
prototype and manufacturing. This process often combines specialized engineering
skills with advanced manufacturing technology and capabilities.

Not all product launches are the same. We understand that. But we believe this
process can provide almost every project with a useful roadmap from concept
to delivery.

In-house vs. outsourced

Every company wrestles with this same question: Can we do this in-house and or
should we outsource?

How you answer this question will depend on several factors:

 the complexity of the project,
 your own in-house skills and resources, and
 your timetable and the availability of your in-house skills and resources
Even in large companies with robust internal skills and resources, there are times when
outsourcing is the better option.
This is especially true with projects that require highly specialized engineering skills that2
are typically not part of an in-house engineering team.
Of course, the manufacturing part of this process is always farmed out to a contract
manufacturer. But finding the right match is essential.
You will need to find a contract manufacturer that not only understands the engineering
complexity of your product, but is also well-suited for the product quantity and quality
you need.

As you read through this guide, I hope you will keep Product Resources in mind as a
potential resource for you. We bring many years of experience to the product
development process – from highly specialized engineering design to contract
manufacturing.
To explore partnership opportunities with Product Resources, please contact CEO John
Erickson at 978-524-8500 x313 or Paul Ermanski at x335.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 1 – Product Concept

You start with an idea
Ideas come and go. The better ideas stick around awhile. The very best reach this
stage in the process.
When you have an idea for a new product, you need to share it. It could be anything
from a sketch on a napkin to a detailed schematic.

Be prepared for a few basic questions:

 What will this product do?
 Will it be a new product or an improvement of an existing product?
 Who will use it?
 What market will it serve and what market requirements will you face?
 What will it replace?
 How will they use it?
 What will they be willing to pay for it?
 What will it cost you to produce?
These questions will help you define the “form, fit and function” of your new product –
and its overall viability as a profit-making product.
At this stage in the product development process, you will want access to latest design
tools (CAD modeling or 3-D simulations) to generate a conceptual rendering.

What you should expect

By the end of this step, you should have some type of conceptual rendering in hand.
This may include a CAD model or a 3-D simulation depending on the design tools that
are available.
You should also have an outline of the market requirements in the form of a User
Requirements Specification (URS) or a Product Requirements Document (PRD).

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 2 – Product Specifications

Working out the details
You know what you want to build. You’ve shared it with others, you have a consensus
and you have a rendering.
Now let’s get down to the details.

 What are the functional specifications of this product? Beyond the primary
function, what else will it do? What additional features should the product
have? How will it operate? How will it be powered?

 What are the design specifications? Will this be a hand-held tool, a desktop
product or a standalone? What size and weight factors need to be considered?
How will it be stored? What are the color options?

 What are the regulatory requirements? Have you considered the different
safety, quality and package design requirements for different countries?

 What environmental factors should you consider? Will the product be used
around water or in hot or cold temperatures? What about explosive
environments? Will power limitations be a concern?

 And how does it fit your budget? Can the product meet all of the specifications
and still meet your target cost? As you make your list of specifications, how
many are “must haves” and which are simply “nice to haves.”
By committing your product specifications and requirements to paper, every member of
your team will understand the tasks and expectations.

What you should expect

At the end of this step, you should have an objective, documented standard available to
qualify the product function and design.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 3 – Proof of Concept

How feasible is the product
With your rendering and user specifications in place, it’s time to prove your concept –
to demonstrate that your product will actually work as intended.

This alpha prototype is not a finished design. It’s often a group of off-the-shelf
components integrated to perform the basic function of the product.

In most cases, the alpha prototype bears little resemblance to what the final product
will look like, but it does help to demonstrate the viability of the product.

The alpha prototype allows you to test performance and determine which features
and design elements are feasible and likely to be included in the final product.

The alpha prototype can reveal unexpected problems in the concept or design early
enough in the process to avoid unnecessary costs.

It is expected that the alpha prototype will be modified extensively before the product
goes to manufacturing.

What you should expect

By the end of this step, you should expect to be working with an alpha prototype to
verify the overall viability of the product’s concept, and determine which features and
designs are likely to be included in the finished product.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 4 – Product Design

Take a closer look at your design components
Product Design takes your initial prototype to the next level with a more finished and
more functional version of your product.

This beta prototype takes into account the more complete user experience – and will
bear a closer resemblance to the end product. It will not be an exact replica, however.

In this phase, the prototype should reflect what was outlined in Product Requirements
(Step 2).

The beta design will help you assess individual components of the product – for their
performance, manufacturing suitability and costs.

Depending on the type of product being developed, the beta prototype may be tested
by an internal team, or, in some cases, by third party users.

What you should expect

By the end of the step, you should have fully functional prototype for testing. This
prototype should bear a strong resemblance to the finished product, but will not be an
exact replica.

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Step 5 – Verification & Validation

Will it work and will it comply?
This is hold-your-breath time as your prototype gets put to the test. In this step, we
have two areas of review – design verification and product validation.

Design Verification
The design verification is one of the most significant quality steps in the product
development process.

Your product design will be examined to show that the new product, as designed,
will meet the product specifications, performance expectations and all applicable
regulatory requirements.

This verification activity includes design reviews, testing, and regulatory approval.

Regulatory compliance
As part of the Design Verification process, your product must also be designed with
an eye on regulatory compliance.

Which regulatory agencies and requirements you face will depend on your product
and where you plan to distribute it.

Requirements for health, safety and environmental compliance will vary in the United
States, Europe, Canada and other global locations.

Every effort should be made to engage with the appropriate regulatory agencies
early in the design process.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing
Product Validation
At the same time, the product needs to be validated against the marketing expectations.
It is important to test the product to be sure that it performs its intended function as
originally described by marketing. Product validation may occur in a laboratory
environment or under field conditions.
This is an often overlooked, but critical, part of product development process
because it can uncover inconsistencies between the product specifications and the
marketing claims.

What you should expect

By the end of this step, you show know whether your latest prototype was able to meet
user needs, performance expectations and regulatory requirements – and whether your
finished product will be able to deliver on marketing claims.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 6 – Manufacturing Process Design

Matching your needs to the right manufacturer
Manufacturing Process Design lays the groundwork for your manufacturing partnership.
If you consider the manufacturing facility to be the machine that produces your product,
it stands to reason that you want this machine to be properly designed, easily
maintained, and flexible.
Above all else, it must meet the highest quality standards. You need to know that the
last product off the line is exactly the same as the first.

Key questions to ask:

 Is the manufacturer well suit for the type of products you need produced?
 Does it have the in-house capability to meet all your needs?
 Will your production volume be the right fit for the manufacturer?
 What systems will be in place to ensure consistent quality?
 Are suppliers in place to provide the necessary raw materials?
 What is the turnaround time on production?
 What testing and calibration will take place before product is complete?
 Will the manufacturer handle inventory?
 What is the packaging and shipping process?
 Will the manufacturer be expected to handle accessories, spare parts
and repair?

What you should expect

By the end of this step, you should have a manufacturer selected that can meet all of
your production and post-production needs. You should also have a list of expectations
that are shared with the manufacturer.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

Step 7 – Manufacturing
You’re ready to go
If you’ve done your due diligence, you’re ready to move your project on to the
manufacturing facility.
This transition needs to be seamless and completely free of the types of problems you
might expect when a product is designed by one organization and manufactured by
another.

At the manufacturing facility, you will want to oversee:

 procurement of raw materials
 management of suppliers
 product assembly
 quality assurance
 packing for shipment

Depending on your project, you will also want to pay close attention to your designated
facility section. The manufacturer will set aside some work stations or selected
machinery for your project.
Regardless of the manufacturing process, you want to be sure that the personnel
working on your product are properly trained.

What you should expect

At the end of this step, you should have confidence that the manufacturer understands
your expectations and has all the people and process in place to meet those
expectations.

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Step 8 – Sustaining Services

Preparing for product service and support
Your responsibility for your product doesn’t end when it leaves the factory.

You will be expected to provide a range of sustaining services for product maintenance
and repair.

You will need to have a fully equipped and staffed service and repair division, which is
available to perform both in-warranty and out-of-warranty service, repair, and
calibration.

Technicians will need to be fully trained to perform fast, reliable repair and re-
calibration of your product.

You will also need to set up and maintain an inventory of spare parts and consumable
replacement components.

In some cases, you will need a Field Service team – personnel trained, ready and able to
go to your customer’s facility and perform field maintenance and service.

What you should expect

Whether it’s through your manufacturer or your own company, your product will
require some post-production support – for repair, replacement and calibration.

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 DESIGN - ENGINEER - BUILD: An OEM’s Guide to COMPLEX Product Development & Manufacturing

How can we help?

If you are considering a product development and contract manufacturing firm, tell us
about your product plans.
Let’s see if there is a fit. Like you, we want to be sure our capabilities are compatible
with your needs.
But let’s get acquainted first.

Request a Telephone Consultation

We can start with a phone call to discuss your project. If you are local, we’d be happy
to meet in person, but generally an initial discussion can be done by phone.
We have a few questions for you, and no doubt, you have a few questions for us.

Review our Certifications

Quality is important to you so take a few minutes to review our quality certifications.
We are ISO 9001 approved for engineering design, development, manufacturing and
service, ISO 13485 approved for medical device manufacturing and service. Both
approvals are certified by TUV.
We are also ISO/IEC 80079-34 approved for design, manufacturing and service, audited
by TRaC Global, for equipment and instrumentation used in explosive atmospheres.

Review our Capabilities

We have put together a list of our engineering expertise and manufacturing capabilities.

Request a Proposal
When you decide it’s time to explore a potential partnership with Product Resources,
we are happy to prepare a detailed proposal for you.

Questions?
If you have any questions about our capabilities, our facility or our process, please
contact our CEO, John Erickson, at 978-524-8500 x313 or Paul Ermanski at x335.

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About Product Resources

Product Resources is a total design, engineering and manufacturing services provider.
Much more than a contract manufacturer, we have the electrical and mechanical
engineering and industrial design capability to create entire products from concept to
final execution.
We specialize in low to medium volume complex products such as scientific, medical
and industrial instrumentation, but can be equally effective with almost any industrial
product.

Our turnkey approach includes:

 Product Concept
 Industrial Design
 Multi-Discipline Engineering
 Regulatory Compliance
 Quality
 Continuous Improvement
 Manufacturing
 Sustaining Service

We invite you to visit us and take a tour of our newly remodeled 33,000 square-foot
facility in Newburyport, Massachusetts
To learn more, please contact our CEO, John Erickson at 978-524-8500 x313 or Paul
Ermanski at x335.

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