It is obvious that first of all you need to have an
effective product. In the world of consumer products, that's the biggest part
of the challenge. Not so in medical devices. In medical devices, you must
thoroughly test the effectiveness of your device because, more than most
consumer electronics, people's lives are often at stake. The FDA takes a
gradual approach to this risk depending on the nature of the product, but in
all cases the way it demonstrates the effectiveness of your device is through
documented evidence. Your documentation is ultimately what will be approved or
disapproved when it comes to bringing a device to market.
The general rule of the FDA is that if it is not documented,
it will not happen. So, for example, if you have a product whose stated purpose
is to make "x", "y" and "z", how do you show that
it really does? Answer: documented evidence. These engineering tests are called
"protocols" and there are several main phases that involve them in
the development process.
STEP 1: Design development. Design development begins by
creating a prototype. All new devices are ultimately prototypes when they are
in the development phase (before being transferred to manufacturing). That
said, there are often also a series of component parts within a prototype
device that qualify as "prototypes." In general, any new device or
component that is not a current commercial part (COTS) must first be
prototyped. The amount of time the design and engineering process takes depends
on how complicated your device is, how experienced your engineering team is,
and how well your staff works as a team. Some devices may have hundreds or thousands
of parts (both customized and COTS), assemblies of printed circuit boards
(PCBA) and a large number of software to accompany them. Others may consist of
only a few mechanical parts (for example, a medical stent). Development can
take less than a year or a whole decade. It completely depends on the details
of your project.
STEP 2: Design verification. Once your team has developed a
functional prototype, the process goes to what is known as "design
verification." Verification is what it sounds like: verify that the design
works as intended. The process involves making sure that the device as a whole
and the individual components and subsets achieve the desired results
(engineering results). This is done by writing detailed test protocols and then
evaluating the performance of your machine against them. An important part of
the verification process is the traceability matrix. The traceability matrix is
a table that links different aspects of the design with the different tests
that have been run to verify it. Think of it as an index for all tests and
documentation of risks related to your medical device. The development of a
traceability matrix is the way in which it tracks all the verification work
carried out during the design development process.
STEP 3: Perform risk analysis. Each device has its points of
failure (things that can go wrong and possible consequences in case something
goes wrong). The risk analysis focuses on identifying possible negative results
and establishing controls that mitigate the consequences. One of the most
structured and widely accepted methodologies for assessing and managing risk is
the Analysis of failure modes and effects.
dFMEA: The "d" means "design." The
Analysis of Modes and Effects of Design Failures (dFMEA) is the process of
evaluating components, subsets and the largest set to identify places where
things could go wrong. The idea is to assume that things will go wrong, see
what the logical sequence of events would be if they did not occur, classify
the magnitude of the consequences and mitigate them when they are particularly
negative.
pFMEA: The "p" means "process." Process
Failure Mode and Effects Analysis (pFMEA) is the process of evaluating
manufacturing procedures and the human beings and / or machines that drive them
to identify where things can go wrong.
Control plan: the control plan is really your mitigation
plan. Controls are the various procedures, redundancies, warning signs and
backup engineers implemented to mitigate the risks that have been identified.
STEP 4: Develop the device master record (DMR). The device
master record is a controlled document that tells you everything you need to
know about your medical device. It is the collection of part drawings, the
various lists of materials (BOM), the flow chart of the manufacturing process
that generally details all the procedures used to build the device, and the
evidence record (verification and validation documentation) that Together they
demonstrate the effectiveness of their design. If the FDA is going to audit
your device, the first place they will go is to your DMR (or DMR index).
STEP 5: Presentation of 510k. Once the device has been fully
examined, it is ready for submission to the FDA. This is what all your product
development work is leading to. For more information about this process, read
here.
STEP 6: Design transfer. After successfully examining your
design with the regulatory agencies, you will transfer your product to
manufacturing. The main parts of your manufacturing process will have been
examined along with the device itself. These include important elements such as
validation and verification (Facilities and services IQ / OQ, Equipment IQ / OQ
/ PPQ, Process OQ / PPQ and Validation of test methods)
Now you are ready to ...
Start production and update the design history file (DHF) as
the device is built. The design history file (DHF) is a formal document created
for each medical device. The DHF is a collection of several records generated
in the actual production process. If you need to know something about the
history of a specific device, then DHF is your destination. DHF can be physical
in the case of paper or digital records in the case of electronic records (or
some combination of the two). It is the main repository for finding information
about the specific serial numbered device.
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