How To Plan The Design & Development of A Medical Device

How To Plan
The Design and

Development of a
Medical Device
| CONTENTS
HOW TO PLAN THE DESIGN & DEVELOPMENT OF YOUR MEDICAL DEVICE
Correct planning should be carried out to control the design & development of your
medical device.
However, many companies fall short when it comes to their documentation and overall approach to
planning. This guide aims to address some of the frequently asked questions about writing a design &
development plan, as well as the typical activities involved.
A design & development plan can be created for individual project phases, for example, a Phase 1 project
where a pharmaceutical company has an inkling about a technology and so would like to explore the area
to determine the value of investing in it or, a full device development project. Occasionally at HD, we’re
asked to write a project design & development plan for our clients as a singular activity rather than as
part of a full turnkey project so, in this eBook, we aim to address frequently asked questions to guide you
through some of the steps and tools involved when writing a design & development plan:
02 | INTRODUCTION
03 | A REGULATORY REQUIREMENT?
04 | A SINGULAR DOCUMENT?
05 | WHERE TO START & TYPICAL STEPS?
07 | A LIVING DOCUMENT?
08 | CAN YOU MAKE ASSUMPTIONS?
09 | ANY DESIGN WORK INVOLVED?
10 | TOOLS TO FORM THE PLAN
11 | THE TOP-LEVEL PLAN
13 | WHO TO INVOLVE?
14 | NEXT STEPS
W www.haughtondesign.co.uk
T +44 (0) 1785 243767
E enquiries@haughtondesign.co.uk
02
| A REGULATORY REQUIREMENT?
Is a medical device design & development plan a regulatory requirement? Yes!
To market and sell your medical device in Europe, you will need to comply with the Medical Device
Regulation [MDR], and in the United States, with title 21 Part 820 of the Code of Federal Regulations [CFR].
HD’s process and systems follow the international ISO 13485 standard & the Code of Federal Regulations in
the United States. According to 7.3.2 of ISO 13485, the international quality management system standard
for medical devices, and FDA 21 CFR Part 820.30 (b), the quality system regulation for medical devices in
the United States, plans for the design and development of a medical device shall be documented in a
Design and Development Plan. The Design & Development Plan is a living document and shall be reviewed,
updated, and approved as the project progresses.
ISO 13485 and the FDA’s CFR outline some loose guidelines for the development plan. The standard
dictates that you need procedures in place and, to an extent, the requirements of those procedures.
However, they don’t necessarily tell you what the

procedure needs to be. Therefore, you’re required to
write your own procedure. This is one of the reasons
that there is often a lot of confusion surrounding the
topic.
At HD, we have our own design & development

procedure for medical device projects. We created
this process internally utilising the experience of
our team paired with our network of industry
experts. Additionally, we have procedures in place
to cover the requirements of ISO 14971, Risk
Management for medical devices - another
important factor to consider when planning the
development of a medical device. We have also
previously assisted pharmaceutical and healthcare
clients with the development of their own set of
audited systems and procedures as an essential part
of developing and launching a medical device.
It’s important to note that a design development

plan isn’t a ‘one size fits all’ activity neither for
specific projects or companies.
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03
| A SINGULAR DOCUMENT?
Is a medical device design & development plan a singular document? No...
There are several documents and activities that form a high-level design & development plan. For example,
there are various project planning documents such as Gantt charts, flow charts, a risk management plan, a
human factors engineering (HFE) plan, and various others that are completed to inform the overall design &
development plan.
The design & development plan will often reference these documents. If there is additional planning
information that is required but does not fit within the supplementary document, the design &
development plan provides a convenient place to store this information.
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04
| WHERE TO START & TYPICAL STEPS
Where to start and what are the typical steps involved?
The first thing to do is to block out the major milestones in the project – the first obvious one is the project
completion date as well as the deliverables stakeholders intend to receive at that point. Typically, we’ll
already have a good understanding of our client’s expectations, which are usually driven by factors such as
cost and time.
Usually, you’ll have a window of time to gain market share. For example, we recently worked on a drug-
delivery project for a pharmaceutical client where a technology had come off patent. Several of our client’s
competitors were working under time pressure to build the benefits of the newly available technology into
their own device(s) to launch into other markets and take advantage of the opportunity.
As do various locations, the U.S. market has its own exclusivity clause meaning that the first to enter the
market has exclusive rights for 6 months. Often, the volume of sales within those 6 months warrants
undertaking this kind of project.
Calculating and understanding various parameters typically determines whether the project is or isn’t
feasible. This then allows a date fixed in time for completion – this isn’t to say that all activity must be
overly condensed to meet this date, the date and work to do should be used to determine whether the
project is achievable or not within the time frame of ‘X’, to the budget of ‘X’, to meet ‘X’ deliverables.
From here, you should block out the major milestones and activities that need to happen to achieve your
goal.
Once the major milestones are determined and set, you will then begin exploring each of them in more
depth. It can help to do this by using tools such as flowcharts. For example, if your identified milestone is
a proof of principle (POP) prototype, you should then work backward from this point to identify the steps,
inputs, and activities required to reach that milestone.
With the example in question, one of the required activities is likely to include verification of prototypes.
So, you should identify what will be required to complete that activity - starting by creating a verification
plan. You know that it will also be necessary to manufacture the prototypes so, you should consider what is
needed to manufacture those prototypes? Perhaps soft tooling is required so, this will need to be designed,
procured, and manufactured which will take time and investment. It may also be necessary to trial the tools
as well as manufacture and assemble the components. If this activity will be undertaken overseas, then
there may be time required for shipping. As you can see, by taking this approach of working backward, a list
of things that need to be considered and built into the plan soon starts growing and becoming apparent.
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05
| WHERE TO START & TYPICAL STEPS
You should continue to work backward in this way for each of the major milestones...
You’ll then review this diagram on a weekly basis so that it forms part of monitoring your design &
development plan. Some of the important activities which should be considered when blocking out your
major milestones include:
• When do design reviews occur?
• When do you conduct Design for Manufacture (DFM) and Assembly (DFA) reviews with your
manufacturers? This will form part of your design transfer plan.
• Who will perform design validation and, when will you bring them on board?
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06
| TREAT IT AS A LIVING DOCUMENT
The design & development plan isn’t something that you’ll do once and complete...
The plan is something that will be continually tweaked as more information is gathered throughout a
project and, as you discuss it with the client, your team, and/or other stakeholders. Over this period, it will
continue to evolve until it’s a mature block diagram.
As stated, it’s incredibly important to review and update the plan on a regular basis. In the early stages of
the project, this may be in weekly meetings with your client and/or team and other stakeholders where
you should share the plan, talk through it in some detail and if required, agree on any changes to reflect
what is happening in the project. Naturally, things change unexpectedly during the development process
so careful monitoring and management will ensure time isn’t lost and will allow for necessary adjustments
to be made without jeopardising key milestone dates. As the project matures, reviews of the design &
development plan will be less frequent but, you must review the document as part of major design reviews.
T +44 (0) 1785 243767
07
| CAN YOU MAKE ASSUMPTIONS?
It’s fine to make some assumptions...
However, you must be mindful that with too many major assumptions, the plan risks becoming largely
inaccurate, ultimately leading to lost cost and time later in the development. Where possible, it’s best to
challenge assumptions from the offset to form the most accurate plan.
In particular for projects where the values are high, if your estimate of work is out by a margin of 10-
20%, for example, it’s worth investing appropriate time into developing a fully detailed and accurate
development plan to prevent budgetary and technical difficulties that affect key milestones and final
delivery.
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08
| IS THERE DESIGN WORK INVOLVED?
A big chunk of work in the early phase of the project is often identifying what needs to be
characterised, what needs to be optimised, and therefore, what needs to be verified?
Characterisation can involve things that are outside of your control for example, with an injector pen, we
know to expect back pressure when injecting. However, this isn’t a parameter that can be easily controlled
and so it’s a natural phenomenon which needs consideration.
This could be something that needs to be fully characterised, calculated, and accounted for before key
decisions can be made or specific work can commence. This is the kind of activity that might require some
ideation and broad-brush design as well as some engineering and math modelling to really understand
what needs to be characterised, what needs to be verified, and what can be optimised so that you can plan
and account for specific tasks/sub-tasks.
Generally, it’s likely that you will be doing some

design and engineering activity at this stage.
However, this work will be outside of design
controls. You’re likely to be undertaking quick design
sprints on problem areas, using the most efficient
tools to increase your understanding of the device,
component, or problem you’re trying to solve to
form the most accurate plan, with as few
assumptions as possible.
Determining when to switch on design controls is

crucial when writing your design & development
plan. Switch them on too early and you’ll bog
down the development effort with unnecessary
administration but, switch them on too late and you
may not have sufficient evidence to evidence that
the design is safe and effective. You should also bear
in mind that design controls can be switched on for
certain aspects of the design before others. There’s
no clear line in the sand where design controls can
be switched on for the full project. It needs to be
assessed on a case-by-case basis as well as from a
strategic standpoint.
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09
| TOOLS TO FORM THE PLAN
The software used is not defined by regulations so, you can use whatever works best for
you...
During the early sprints, it’s typical to do quick sketches in brainstorming sessions, some early CAD work in
SolidWorks or, some Simulation work utilising motion or FEA studies. We typically start planning by using
simple Excel flow charts.
It’s also important to have a QMS system in place. Depending on your budget, resource, and scale of
project(s), you can build or buy a QMS system. For start-ups on a lean budget, we might recommend the
likes of Qualio or, for larger companies who are handling several device development projects, examples
such as GreenlightGuru might be a better solution. The development plan is a controlled set of documents
so, having a robust Application Life Cycle Management tool, such as Aligned Elements, will help streamline
the management of the project’s controlled documentation.
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10
| THE TOP-LEVEL DEVELOPMENT PLAN
Alongside the flowchart and other documentation, you will be writing the top-level plan:
This too will be a live document that you will be writing alongside your flow chart, Gantt chart, and other
supporting documentation. Essentially, this is the launchpad to those other documents and so you would
list them as external references.
So, this is the high-level master document that executives can read to understand how much the project
is going to cost, how long it’s going to take, and ultimately, if it will be feasible. Typically, a pharmaceutical
company will take this document and process it through its financial system to govern the financials,
understand the return on investment and market share before deciding whether to progress and plan it
into the budget for the next financial year.
There’s an art to writing these documents and remaining concise...
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11
| THE TOP-LEVEL DEVELOPMENT PLAN
The design & development plan is not limited to but should follow a loose structure of;
1. Overview:
An overview of the project and its purpose.
2. Scope:
The intended use of the device.
3. Major deliverables
The outputs and deliverables for the project.
4. Exclusions:
These are important to outline from the offset.
5. Assumptions:
It’s fine to make assumptions if everybody involved Please get in touch to request a copy of HD’s ISO 13485 development process
knows what areas your assumptions lie in.
This allows you to evaluate what assumptions were incorrect and spot deviations to recoup some budget
when problems arise.
6. Project team/structure:
This gives an idea of who’s working on the project, how big the team is and how the team works together.
This is crucial in multi-disciplinary teams or where external subcontractors are involved.
The plan needs to clearly demonstrate who is responsible for what as well as the relationships between
stakeholders. This will help prevent finger-pointing when challenges arise.
7. Required resources:
These include the external resources you will require such as your test houses, manufacturers, and
validation Partners.
8. Accreditation, documentation, procedures & necessary competencies:

This will demonstrate that you have the right certifications, procedures and a robust QMS system in place.
9. Flow Chart Outputs:

These get migrated into a Gantt chart where you will list all line items and start assigning time and cost to
each item. This is where the research as well as discussions with your identified resources will happen to
gain costs, timeframes, and other parameters to build into the Gantt chart. The results from the flow and
Gantt chart work will usually be distilled into a list of major milestones including information such as who’s
responsible for these milestones and, when these milestones will be delivered.
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12
| WHO TO INVOLVE?
We would recommend involving a variety of stakeholders throughout the process of

writing the design & development plan:
1. The Client and possibly the drug developer:

This would also include Clinicians and other Experts in the condition and/or therapy. They are typically the
expert in their product, industry, and business area so they hold a lot of information and invaluable insight.
2. Key manufacturers and suppliers:

Where possible, we would also involve the identified additional resources for the project. Typically, large
projects are under strict confidentiality therefore we’re unable to share enough information to gather
accurate quotes and advice. However, major suppliers will form a large part of the cost so, it’s useful to
gather as accurate costs as possible by sharing a rough idea of part counts and features.
3. Test houses:
Those that will be undertaking the characterisation
and verification work that you may not be able to
undertake in-house. These will also be significant
factors for timescales and costs so may need to be
booked well in advance.
4. Validation partners:
Those that will assess that the final device satisfies
the user needs.
5. Haughton Design:
Typically, we involve the full team at HD to provide
feedback and advice on the development plan as it
matures.
The activities that form the plan will likely require

several of the team working on them at some point
during the 2+ years of the device development so,
their inputs and experience provide key insight to
forming an accurate plan.
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13
| GET IN TOUCH
What next?
As a company that has 20+ years of
experience in developing devices for
healthcare and pharma companies globally,
HD is your one stop shop to help develop
and launch a new medical device. Please
get in touch for further support with your
development planning or, to discuss how
we can help with your project.
Contact Us:
T +44 (0) 1785 243767
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How To Plan

The Design and

05 | WHERE TO START & TYPICAL STEPS?

08 | CAN YOU MAKE ASSUMPTIONS?

09 | ANY DESIGN WORK INVOLVED?

10 | TOOLS TO FORM THE PLAN

11 | THE TOP-LEVEL PLAN

Is a medical device design & development plan a regulatory requirement? Yes!

However, they don’t necessarily tell you what the

At HD, we have our own design & development

It’s important to note that a design development

Is a medical device design & development plan a singular document? No...

Where to start and what are the typical steps involved?

• When do design reviews occur?

It’s fine to make some assumptions...

Generally, it’s likely that you will be doing some

Determining when to switch on design controls is

There’s an art to writing these documents and remaining concise...

knows what areas your assumptions lie in.

8. Accreditation, documentation, procedures & necessary competencies:

9. Flow Chart Outputs:

We would recommend involving a variety of stakeholders throughout the process of

1. The Client and possibly the drug developer:

2. Key manufacturers and suppliers:

The activities that form the plan will likely require

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