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UNDERSTANDING THE 5 PHASES OF MEDICAL

DEVICE DEVELOPMENT
By Adnan Ashfaq, March 5, 2018 , in Medical Device Development and Product Development

Do you have a medical device to launch?

Well I have good news for you and I have bad news for you.

Here is the bad news first:

Medical devices are not easy to launch and are masked with layers of regulations. There are several
reasons for launching a new product into the market.

It may be due to a healthcare practitioner wanting life to be easier for them during a medical
procedure which involves the innovation of a new device. It may be a completely new device that will
save thousands of lives or improve the quality of lifestyle of those with health issues.

Whatever the case, there is benefit which will ultimately lead to patient safety. With this in mind the
focus is to benefit others, and in doing so keeping patient and user risk at a minimum.

With reported incidents on the rise, authorities have tightened up regulations over the past few years,
hoping that manufacturers will build quality in, while taking risk out (as far as possible) of a device.

So, what’s the good news?

Firstly, there are experts out there who are born out of necessity. Over years and years of being in the
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industry they have seen the good, the bad and the ugly.

Medical device experts can help hold your hand and make sure you get your product to market and
explain the regulations bit for you. Medical device experts are almost lawyers these days, with the
amount of legislation involved there is a tonne of legal language that can bore and scare you, and
make you think – do I really want to do this?

So the take home point here is, if you have done your research and there is a market for your device,
then yes you want to do this, but taking a slice of the global market can not only be profitable but also
make you a philanthropist. However, trying to walk the journey alone can cost you heavily, so seek
advice.

How to do it?

I call the following flowchart “Concept to Market” diagram, which I often put in front of start-ups, or
those about to embark on developing a new Medical device.

There are several ways to plan, which is why I call it “an example” of what is required. At each end of
phase, have a checklist and review you have completed what you set out to do.

The steps and stages are not set in stone; however they are a clear indication of the following –

 
PHASE I – INITIATION, OPPORTUNITY AND RISK ANALYSIS
 Plan the development of your device, remember to document this!
Think about all the work that will be involved and admit that you will not be able to tread MENU
this path
alone.
Think about your funding strategies, which markets you want to enter – where? Why? and How?
This is fundamental as each market has its own regulations and challenges. If you are developing
a new product that no one has produced before , make sure you protect it by filing for IP
(Intellectual Property) and patent your idea.
Your market research is fundamental as it will lead to the following – are there equivalent devices
on the market you can claim? Or do you need Clinical trials for your product? The difference
between the two can make your venture feasible or unfeasible due to the high costs involved.
Don’t forget to document this.
Put in a QMS (Quality Management System). Your QMS is the foundation to your company, which
once solid will provide a good base to build everything on. ISO 13485 is the standard that is
adopted by most medical device companies and is internationally recognised, so get this in place.
The QMS will incorporate your procedures, forms, templates of how you will lock down and
control all activity in your company, therefore this must be taken very seriously.

 
PHASE II - FORMULATION, CONCEPT AND FEASIBILITY
The Concept and feasibility stage in a way is critical as it will be the phase in which you have a
working device that proves your idea
Once you are convinced that your device has a market position, is viable and financially feasible,
only then set the ball in motion. You will need funding for prototyping and trialling your device –
however congratulations! If you have got to prototyping you have succeeded past Phase I, and
your journey is beginning.
Start thinking about risks and customer requirements early, at this stage you need to hear the
voice of the customer and take feedback via surveys, competitor analysis, market research etc
and adopt this into the design of your product. Oh, and don’t forget to document each step of the
way!
At Phase II you will be developing the concept and proving that it works, so you need to be
prepared to go back over and over to revise the design as needed, and guess what – don’t forget
to document the changes! Until you have reached design freeze, at this point you can put a stake
in the ground and work with it.

 
PHASE III - DESIGN AND DEVELOPMENT – VERIFICATION &
VALIDATION
Now your device is beginning to take shape, you have a prototype, you have done some trials but
you haven’t really put the design through its paces, you are about to go into validation and
verification of your device and prove that it will really withstand all the pressures of the real world.
Make sure you know what your acceptance criteria are for each test. Think this through.
A good way of doing this is by setting up a matrix, called a design trace matrix which will ensure
you have not lost track of your customer requirements. You will need to translate this into
engineering requirements i.e how will you actually make the customer requirement happen, what
mode of testing to verify and validate, what processes do you need, what test equipment will you
 need? Have you started to think about a manufacturing and quality plan? Or will you outsource
this? MENU

You should really get into your Risk management at this stage. Call out all the potential failures of
what can go wrong due to bad design, poor process or bad manufacturing, user failures by
foreseeable misuse. What measures will you put in place to control the harms from these failures?
Are we looking at harms that can lead to death? Or are we looking at inconvenience to the user?
Psychological harm? Be realistic and think this through. I cannot emphasis doing this thoroughly
enough, as your device will not make it to market if the device is seen to be a risk to patient
safety. Remember the bad news at the start of this article? The regulations are in place to increase
patient safety and minimise risk.
Ensure you know the regulatory requirements of the product and the regulatory requirements of
the country/region you are about to sell in. The requirements in the US differ to those in Europe
although there is very strong overlap, the submissions process is different. Your market research
should have determined which region you wish to launch your product in first, so focus.
If you had determined earlier that you needed Clinical trials for your product, you should begin
your Clinical plan and use product for the trials from your design freeze through actual use in a
clinical environment. Also look at what external approvals you will need, such as an Ethics
Committee.

 
PHASE IV - FINAL VALIDATION AND PRODUCT LAUNCH
PREPARATION
We are well on our way now, you want to start thinking about marketing and branding now,
Caution! - be careful what you put in your marketing literature, it must be backed by evidence. The
number of times my toes curl when marketing experts make claims on products that have no
justification can be frightening. My message is NO EVIDENCE = NO CLAIM.
We should be gathering all our data now. All the Validation and Verification of our product should
have passed! So we should be gathering all our evidence of testing - biocompatibility, electrical
safety etc. etc. where applicable,
Scale Up, nice…. If we are scaling up then we really are getting there. Wait…if we made a few
successful products can we now replicate this in production?
Perform all the stability testing, shipping trials, very often I see companies get to this stage to only
realise they didn’t do all the testing, why? Because they didn’t know the regulatory requirements
for the product, took shortcuts or didn’t see the real reason to do the test. Well the industry has
put these tests in place for a reason; don’t just throw the baby out of the bath water.
You should be completing your technical documentation now. Bringing together a file full of all the
evidence required to put in front of a competent authority that will review/ audit your file for
completeness against their expectations.

 
PHASE V - PRODUCT LAUNCH AND POST LAUNCH ASSESSMENT
Do a final check of your technical documentation, you may need to make updates.
Make sure you have plans in place for “Post Market”, you need a system to capture complaints,
feedback and how will this information be treated? How will it loop back into your risk
management system?
 Post Market - Will you need to update your design documentation, do you need to re-test? Do you
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need to get back in touch with the competent authorities to inform them of a significant change?
Do you need to recall product from the market?
OK, guess what? I think we could be ready now, your regulatory clearance, technical file review is
done and if you got the auditor on a good day you are ready to launch your product. Once you
have your license or certificate you can place your device on the market.
If you are based outside the EU and you wish to sell product in Europe you will need an
“Authorised Representative” who is appointed to represent your business in Europe.

Well congratulations! If you have made it through all the phases involved, you have received
regulatory clearance and your device is now gaining sales, does the vigilance stop?

Not at all, now when you thought the journey ended, the journey has just begun.

Your device is in the market, in the hands of users so be ready for feedback, improvements and
continuously reviewing your internal systems. Make sure you have a robust internal quality auditing
system to review your records and ensure you are:

Not cutting corners in production

Following your QMS
Making changes according to your change control system
Following your feedback and complaints system
Updating all necessary technical documentation as required
Adequately resourced
Continuously improving

Making a medical device can be both financially rewarding and solve complex day to day health
problems. By no means should the process be rushed as the authorities will be watchful for vigilance,
following regulations and complying with standards as necessary.

If you have followed the path indicated in figure 2.0 you will have a good chance of getting a product
to market safely and successfully.

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Adnan Ashfaq

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in
Medical Device, Biotech and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has
since been supporting Medical device companies around the labyrinth of regulations and assisting
them in flying through successful audits. He has been working with start up companies and
multinationals in developing new products since 1999. With regulations tightening up, especially in
Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure
manufacturers reach their desired market, and stay in the market.

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Cliff Thornton
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8 months ago

Adnan - I think you did a great job on this piece, not only with the specificity and offering many bits of
practical advice regarding this process, but in balancing market and launch success with the need to also
focus on patient safety and meeting regulatory requirements. In that fashion, the phases are realistic and
sustainable. We must remember that we are in the business of addressing a patient's clinical condition and
helping to either relieve symptoms of a disease process or remove or reverse them with a certain medical
device and/or system. Ideally, that device should achieve this without causing harm or causing another
medical condition which is worse than the condition that we are setting out to address. And of course just
as Doctors take the Hippocratic Oath to "First do no harm", nor should the medical device in question. Given
this, I think your article is consistent with this frame of thought.
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