New Products &

Medical Devices:
The Benefits of
a Structured
Development
Process
| Contents
New Products & Medical Devices: The Benefits of a
Structured Development Process

Innovative, market-leading products don’t just ‘happen’, they need effective planning
and development which is why following a well-structured new product design and
development process is beneficial.

Although there are several recognised design processes, we’ve developed our own to specifically meet our
clients needs. Our history of challenging, fast turnaround, product, medical device and engineering projects
for a broad range of industries, meant we recognised the value of developing a new product in a structured
way.

This guide gives insight into the basics of Haughton Design’s own process, the benefits of each stage and
some of the typical activities undertaken to ensure each ‘gate’ is navigated in the most time and cost-
effective way.

03 | Introduction

05 | Discovery & Design Immersion

06 | Concept Design

07 | Feasibility Studies

08 | Prototype Design Development

09 | Prototype Manufacturing Data

10 | Prototype Build & Testing

11 | Design for Volume

12 | Manufacturing Data for Volume

13 | Final Prototype, Tooling & Validation

14 | Product Industrialisation

15 | Conclusion

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| Introduction
New Products & Medical Devices: The Benefits of a
Structured Development Process

Why bother with a process, isn’t design all about creativity?

Without doubt design is about creativity but the sparks and ideas generated in the early stages need to be
captured, properly assessed and then managed to ensure they are properly exploited and commercialised.
Prototype development and engineering also needs to be structured to minimise iterations, ensure designs
are robust, that they can be manufactured effectively and ultimately, control costs.

Designers and engineers naturally want to keep generating ideas and continuously improve designs, it’s
in their DNA. However, what often isn’t discussed in the design world is that development is part of a
commercial process so, making money is the primary driver and what instigates the design / development
process in the first place.

Of course, there are many other motives for developing a new product or device such as helping users
and patients have the best experience as possible. However, projects need to be delivered on time and to
budget so having an effective process which still affords creativity and fresh thinking is vital to stand any
chance of meeting both project and commercial objectives.

Creating a process that is simple and highly visual brings huge benefits to a project. It makes it simple for
all stakeholders to appreciate the work involved and if done correctly, ensures all parties understand their
responsibilities together with key milestones and delivery dates to ensure the project’s success.

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| Introduction
New Products & Medical Devices: The Benefits of a
Structured Development Process

So, what is Haughton Design’s development process and, how do we ensure it’s clear and
efficient for all stakeholders?

All involved typically need to know what work needs to be done, who is responsible for the tasks involved,
to clearly understand the investment required and when to expect delivery - using a highly visual and clear
process diagram is perfect for that!

We’ve taken time out to carefully consider the various regulatory requirements and standards in the
industries we serve, but this can be done by any design team. HD makes its money purely through design,
development and engineering so we must do this efficiently to stay in business, we’ve therefore redesigned
and honed our process a number of times. We have two, medical and general, they are optimised to suit
each sector.

Affording some time and resource for your own team

to review, optimise and visualise your development
process is always a worthwhile investment. It’s not
easy, but the benefits of improved efficiency over
the medium and long term far outweigh the initial
investment in organising a process.

HD’s workflow was created to enable every project

stakeholder, to easily see what needs doing and
when. It’s used from our very first client meeting
until our involvement in the project is complete. It’s a
relatively simple document, which makes a project’s
requirements crystal clear with key information in
one place.
Our clients quickly understand that they can enter or leave at any phase or stage of the development
process. They can also access just one or two services to complete their projects faster or, work with us on
their full product or medical device project from concept to manufacture. The bonus for our own project
managers and design team is that such a document makes it just as clear to them!

It enables everyone to work together toward the same, clear, goal. Combining this approach with our ISO
systems means we can develop products and medical devices more efficiently, robustly and to the correct
standards.

Our general process is broken down into 10 clear stages. However, no two projects are the same therefore,
we create a bespoke workflow with tailored tasks and deliverables for each project we undertake. Everyone
who’s used it loves its simplicity, and the logic it brings to a project.

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| Discovery & Design Immersion
“Kick start your project with clear inputs for rapid start-up
& design delivery”

Thorough discovery and design immersion will

kick start your project with a solid foundation
and clear inputs for rapid start-up. It is essential
to understand user requirements, conduct
technical research, identify risks, and review
regulatory requirements. We may also research
your competitor’s products, investigate patents,
and undertake focus groups to generate a detailed
Project Input Document.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Project Kick Off Discussion of Brief & User

• Basic Risk Assessment & Planning
• On-site Knowledge Transfer
• Set-Up Design Binder
• Project Input
• Design History File
• Market & User Profiling
• Market Research
• Technical Investigation
• Regulatory Review
• Design Validation Plan
• Workshop Sessions
• Patent Review
• Specialist Support / Consulting
• User Centred Design Study
• Material Analysis
• CE Marking Analysis
• Design Stage Review

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| Concept Design
“Generate valuable intellectual property by creating
innovative products to keep ahead of your competitors”

Blending engineering and manufacturing know

how with design creativity generates innovative
concepts and develops valuable intellectual
property for you to exploit. Start by producing
ideas, which are formed into hand sketches
and broad-brush designs to review. Levering
stakeholders’ expertise develops the strongest
ideas to a more refined level, 3D CAD models are
built, and photo realistic renders or animations
generated to bring a product to life. Proof of
principle and styling prototypes are often built to
gather feedback from stakeholders, reduce risk and
identify areas for further development.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• IP Generation
• Broad-Brush Design
• Brand Identity / Development
• Basic Technology / Material Identification
• Human Factors Engineering
• Refined Concepts
• Design Visualisation
• Preliminary Prototypes
• IP rights & Protection
• Initial Calculations & FEA
• Design FMEA / FTA
• Production of Design Specification
• Verification Plan
• Design Stage Review

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| Feasibility Studies
“Reduce project risk by checking feasibility before a
major investment is made”

Feasibility
Gathering costings and identifying potential Studies
suppliers allows the project’s feasibility to
be confirmed before committing to further
development and investment. As many designs
will be highly innovative, some projects may need
further technical research to ensure concepts are
feasible before full scale development.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Key Feature Specification

• Outline Drawings for Quotation
• Tolerance Analysis
• Bill of Materials
• Identification of Potential Suppliers
• Technical Feasibility
• Commercial Feasibility
• Risk Analysis
• Environmental Impact Investigation
• Freedom to Operate IP Review
• Prototype Build
• Prototype Testing
• Draft Design and Development Plan
• Design Stage Review

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| Prototype Design Development
“Design prototypes to prove concept principles & check
functionality”

Concepts are developed to a detailed level

so prototypes or, one-off bespoke pieces of
equipment can be manufactured. Designs should
be engineered with consideration for manufacture
from the outset, utilising 3D CAD and simulation
techniques to ensure it is fit for purpose. At this
stage, it is important to develop designs swiftly,
with a right first-time mentality. Often blending
traditional manufacturing and 3D methodologies
for the best balance of cost / performance, it is
common to make numerous prototypes for novel
and complex projects, often using soft tooling.
Activities may need to suit regulatory requirements
and the detailed scope of work.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Mechanical Design for Prototype

Manufacture
• Electronics Design for Prototype Manufacture
• Brainstorming Session(s)
• 2D Iterative Design Development
• Material / Process Selection
• 3D CAD Engineering
• 3D Design Review
• Design Calculations
• Stress / FE Analysis
• Supplier & Technology Selection
• Tolerance Analysis
• Design FMEA
• Design Robustness
• Critical Dimensions & Feature Specification
• Assembly Analysis
• TRIZ - Creative Problem Solving
• Design Stage Review

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| Prototype Manufacturing Data
“Clear prototype data for manufacture at the best prices
and shortest timescales”

Drawings are produced and supplied with 3D or 2D

data to a level suitable for prototype manufacture.
With dimensions, materials, heat treatments and
finishes detailed, the drawings allow designs to
be easily manufactured through various sources.
Prototypes for additive or CNC manufacturing or
soft tooling may not require sophisticated drawings
so a design intent document could be supplied as
an alternative.

Some of the following activities are included in this

phase include but are not limited to:

• Drawing Production
• Issue Drawings & Data
• Drawing Control (Revisions Etc.)
• Prototype Specification
• Manufacturing Liaison & Support
• Design Stage Review
• Project Management

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| Prototype Build & Testing
“Manufacture, build & test prototypes for leaner product and
medical device development”

The manufacture, build and testing of prototypes

allows concepts to be proven and early-stage
products to be developed quickly. Some concept
and novel projects may require several iterations of
prototypes to achieve the breakthrough required.
Prototype mechanical parts, purchased items and
basic PCB or breadboard components gathers
knowledge for volume manufacturing. Prototype
test rigs and external test houses may be utilised to
gather key performance data and results.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Mechanical Design for Prototype Manufacture

• Prototype Supplier & Manufacturing Liaison
• Prototype Procurement
• Prototype Build
• Prototype Testing
• Prototype Analysis
• Formative HFE Study
• CE Marking Review
• Test Rig / Fixture Supply
• Risk Assessment of Equipment / Installation
• Electronics
• On-site Support & Problem Solving
• Quality Control Measures & Support
• Sales Materials
• FMEA - Update & Review
• Design Stage Review

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| Design for Volume
“Robustly designed products that are cost effective to
manufacture”

Design optimisation through detailed development

and thorough engineering is used to ensure the
product is robust and cost effective to manufacture
in higher volumes. The prototype design is rebuilt
to suit volume production techniques and to
suit the manufacturing methods selected for
each component. This stage is likely to include
advanced CAD techniques, such as FEA, tolerance
analysis and automated assembly considerations.
Development activities may be monitored and
managed using techniques such as DFMEA’s
and FTA to ensure compliance with regulatory
requirements.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Mechanical Design for Volume Manufacture

• Electronics Design for Volume Manufacture
• Brainstorming Session(s)
• 2D Iterative Design Development
• Detailed Material / Process Selection
• 3D CAD Engineering
• 3D Design Review
• Design Calculations
• Stress / FE Analysis
• Supplier and Technology Selection
• Basic Tolerance Analysis
• Advanced Tolerance Analysis
• Advanced DFMEA / FTA
• TRIZ - Creative Problem Solving
• Assembly Analysis
• Design Stage Review
• Project Management

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| Manufacturing Data for Volume
“High quality data output & detailed drawings for pain free
manufacture”

Manufacturing drawings are produced and

supplied with 2D or 3D data, for efficient
manufacture of parts and assemblies. With critical
dimensions and toleranced features, materials,
heat treatments and finishes, the drawings allow
designs to be cost effectively manufactured and
assembled in high volumes. It is important to liaise
with suppliers throughout the design optimisation
process to ensure robust design and manufacturing
requirements are achieved to move to prototype
build and test.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Drawing Production
• Issue of Drawings & Data
• Drawing Control (Revisions etc.)
• Material Specification
• Production Specification
• Manufacturing Liaison & Support
• Tooling Review
• Tooling Sign Off
• Design Stage Review

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| Final Prototype, Tooling & Validation
“Ensure designs are reliable, safe & of the highest quality”

Production intent prototypes are manufactured

initially from soft tooling then built and tested to
confirm functionality and performance. We liaise
with suppliers during tooling manufacture and
provide support whilst trials are conducted, to
ensure all design requirements are met. First-off
components and assemblies are checked to ensure
designs can be tested and verified. Products and
medical devices can then be validated through
summative user testing.

Some of the activities that can be beneficial in this

phase include but are not limited to:

• Tooling Procurement
• Prototype Build
• Prototype Evaluation
• Performance & Accelerated Life Testing
• Test Rig Design
• Verification Testing
• Validation / Summative Usability Testing
• CE Marking Support Requirements
• Electronics
• Manufacturing Liaison & Support
• FMEA - Update & Review
• Design Stage Review

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| Industrialisation
“Support right through into the industrialisation process”

The design is transferred during industrialisation

through delivery of a final data pack and provision
of support for all stakeholders. It’s important
for the design team to liaise with toolmakers,
suppliers, and the manufacturing team to ensure
the transfer is smooth. This ensures the product
can be fully industrialised and marketed as
efficiently as possible.

Some of the following activities are included in this

phase include but are not limited to:

• Supplier & Manufacturing Liaison

• On-site Support & Problem Solving
• Quality Control Measures & Support
• Production of Manuals
• Production Support
• Tooling Supply
• Test Rig / Fixture Supply
• Risk Assessment of Equipment / Installation
• Sample & Manufacturing Review
• Process FMEA
• Supply of Manufactured Items
• Final Risk Assessment
• Design Transfer / Design Binder
• Archive Drawings & Data Control
• Sales Materials
• Final Design Review

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| Conclusion
New Products & Medical Devices: The Benefits of a
Structured Development Process

Developing new products and medical devices can be time consuming and expensive...

Adopting a suitable workflow and development process will provide a clear structure of what needs to
be done, when it needs to be done, reduce iterations and minimise design loops. HD’s process is bespoke
but based upon BS.7000-2 with adaptations to suit learning from many projects over 20 years of design
and engineering work. If you are considering new product development for the first time, it’s well worth
spending some time getting to know the standard and our process before you start. If you have a team
of designers who are regularly developing new products, then creating a bespoke workflow should be
considered as this enables the whole team work to an effective process. This ensures more flexibility for
people to move across projects as it’s much easier to pick up a project in a standardised workflow process
than manage multiple project’s running in different ways.

We recognise there are times for a less structured, sprint and an agile approach so we do use this approach
in some circumstances too. When used correctly, this can bring rapid gains and is excellent for very
innovative projects where a ‘fail fast’ mindset can quickly identify the most promising ideas to develop.
However, this is usually for early-stage design work, and not suitable projects under design controls in
highly regulated industries. Although sprints can be very useful these activities still need to be incorporated
into a structured and controlled process.

In the previous pages, you have seen the basics of HD’s general development process which works
incredibly well. However, we urge you to build your own to reap the benefits of increased efficiency with
faster development times and reduced costs.

Here at HD, we offer services spanning the entire process. Whilst we can provide full development from
concept through to manufacture, we can also offer individual services to suit your projects needs.

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| Get in Touch
New Products & Medical Devices: The Benefits of a
Structured Development Process

What next?
We are here to help reduce development
times for your products and devices. Get in
touch to discuss how we can help with your
new product or medical device development!

Contact Us:
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