Medical devices are not easy to
start and are masked with layers of regulations. There are several reasons to
launch a new product to the market.
It may be because of a health
professional wants life to be easier for them during a medical procedure that
involves the innovation of a new device. It can be a completely new device that
will save thousands of lives or improve the quality of life of people with
health problems.
Whatever the case, there is a
benefit that will ultimately lead to patient safety. With this in mind, the
goal is to benefit others and, in doing so, keep patient and user risk to a
minimum.
With the increase in reported
incidents, the authorities have tightened regulations in recent years, with the
hope that manufacturers will incorporate quality while eliminating the risk
(to the extent possible) of a device.
So what is the good news?
First, there are experts who are
born out of necessity. For years and years of being in the industry, they have
seen the good, the bad and the ugly.
Medical device experts can help
you take your hand and make sure your product goes on the market and explain
the unimportant rules. Medical device experts are almost lawyers these days,
with the amount of legislation involved, there is a ton of legal language that
can bore you and scare you, and make you think: do I really want to do this?
So, the key point here is that,
if you have researched and there is a market for your device, then you do want
to do it, but taking a portion of the global market can not only be profitable
but also turn it into a philanthropist. However, trying to walk can only cost
you a lot, so seek advice.
How to do it?
We call the following flowchart
"Concept diagram to market", which I often put in front of new
companies, or those that are about to embark on the development of a new
medical device.
There are several ways to plan,
so I call it "an example" of what is required. At each end of the
phase, have a checklist and check that you have completed what you set out to
do.
The steps and stages are not
written in stone; however, they are a clear indication of the following:
PHASE I - INITIATION, OPPORTUNITY AND RISK ANALYSIS
Plan the development of your the device, remember to document this!
Think of all the work that will
involve and admit that you will not be able to follow this path alone.
Think about your financing
strategies, what markets you want to enter, where? Why? and how? This is
essential since each market has its own regulations and challenges. If you are
developing a new product that nobody has produced before, be sure to protect it
by requesting IP (intellectual property) and patent your idea.
Your market research is
essential, as it will lead to the following: are there equivalent devices in
the market that you can claim? Or do you need clinical trials for your product?
The difference between the two can make your company feasible or unfeasible due
to the high costs involved. Do not forget to document this.
Put in a QMS (Quality Management
System). Your QMS is the foundation of your company, which once-solid will
provide a good foundation to build everything. ISO 13485 is the standard
adopted by most medical device companies and is internationally recognized, so
put it into practice. The QMS will incorporate its procedures, forms, templates
of how it will block and control all activities in your company, therefore,
this should be taken very seriously.
PHASE II - FORMULATION, CONCEPT AND FEASIBILITY
The concept and the feasibility
stage is somewhat critical, as it will be the phase in which you have a device
in operation that demonstrates your idea.
Once you are convinced that your
device has a market position, it is viable and financially feasible, only then
put the ball in motion. You will need funds to prototype and test your device;
However, congratulations! If you have to prototype, you have succeeded beyond
Phase I, and your journey is beginning.
Start thinking about the risks
and requirements of the client early, at this stage you need to hear the voice
of the client and receive comments through surveys, competition analysis, market
research, etc. and adopt this in the design of your product. Oh, and don't
forget to document every step of the way!
In Phase II, you will develop the
concept and demonstrate that it works, so you must be prepared to go back and
again to review the design as necessary, and guess what, don't forget to
document the changes! Until you have reached the freezing of the design, at
this point you can put a stake on the ground and work with it.
PHASE III - DESIGN AND DEVELOPMENT - VERIFICATION, AND VALIDATION
Now your device is starting to
take shape, it has a prototype, it has performed some tests but it has not
really put the design to the test, it is about to validate and verify your
device and show that it really can withstand all the pressures of the real world.
Make sure you know what your acceptance criteria are for each test. Think
wisely.
A good way to do this is by
creating a matrix, called a design tracking matrix, that will ensure that you
have not lost track of your customers' requirements. You will have to translate
this into engineering requirements, that is, how you will make customer
requirements happen, what test mode to verify and validate, what processes you
need, what test equipment you will need. Have you started thinking about a
manufacturing and quality plan? Or will you outsource this?
You should really enter your risk
management at this stage. Point out all potential failures of what may go wrong
due to poor design, poor processor bad manufacturing, user failures due to
foreseeable misuse. What measures will you implement to control the damage of
these failures? Are we seeing the damage that can lead to death? Or are we looking
for the inconvenience for the user? Psychological damage? Be realistic and think
about this.
I cannot emphasize doing this thoroughly enough since your device
will not reach the market if it is considered to be a risk to patient safety.
Do you remember the bad news at the beginning of this article? Regulations are
established to increase patient safety and minimize risk.
Make sure you know the regulatory
requirements of the product and the regulatory requirements of the country / the region in which you are about to sell. The requirements in the US UU. They
differ from those in Europe, although there is a very strong overlap, the shipping
process is different. Your market research should have determined in which
region you want to launch your product first, so focus.
If you had previously determined
that you needed clinical trials for your product, you should start your
clinical plan and use the product for trials from its design freeze to actual
use in a clinical setting. Also look at what external approvals you will need,
such as an Ethics Committee.
PHASE IV - FINAL VALIDATION AND PREPARATION OF PRODUCT LAUNCH
We are already on the way, you
want to start thinking about marketing and branding now, Caution! - Be careful
what you put in your marketing literature, it must be supported by evidence.
The number of times my fingers bend when marketing experts make claims about
products that have no justification can be scary. My message is NO EVIDENCE =
NO CLAIM.
We should be collecting all our
data now. All validation and verification of our product should have passed!
Therefore, we should gather all our evidence of evidence: biocompatibility,
electrical safety, etc., etc. where appropriate,
Expand, well ... If we are
expanding, then we are really getting there. Wait ... if we made some
successful products, can we now replicate this in production?
I do all the stability tests,
shipping tests, very often I see that companies reach this stage to realize
that they did not do all the tests, why? Because they did not know the
regulatory requirements for the product, they took shortcuts or did not see the
real reason for testing. Well, the industry has put these tests in place for a
reason; don't throw the baby out of the bathwater
You should complete your
technical documentation now. Gather a file full of all the evidence required to
present to a competent authority that will review/audit your file to verify
that it is completed according to your expectations.
PHASE V - PRODUCT LAUNCH AND EVALUATION AFTER LAUNCH
Make a final verification of your
technical documentation, you may need to make updates.
Make sure you have plans for
"Post Market", you need a system to capture complaints, comments and
how this information will be treated. How will you return to your risk
management system?
Post-market: will you need to
update your design documentation, should you retest? Do you need to contact the
competent authorities to inform them of a significant change? Do you need to
withdraw a product from the market?
OK, guess what? I think we could
be ready now, your regulatory authorization, the technical file review is done
and if you have 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 want to sell products in Europe, you will need an "Authorized
Representative" appointed to represent your company in Europe.
Well, congratulations! If you
have passed all the phases involved, you have received the regulatory
authorization and your device is now earning sales, does the surveillance stop?
Not at all, now that you thought
the journey was over, the journey has just begun.
Your device is on the market, in
the hands of users, so are ready to receive comments, improvements and
continuously review your internal systems. Make sure you have a strong internal
quality audit system to review your records and ensure that:
Not cutting corners in production
Following your QMS
Make changes according to your
change control system
Follow your comments and
complaint system
Update all necessary technical
documentation as necessary
With the right resources
Continuous improvement
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