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Medical Device
Translation And Compliance
Dr. Manoj Komath
Scientist G, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences and
Technology,
Trivandrum – 695012. E-mail :
manoj@sctimst.ac.in |
The advancement of science and
technology caused a phenomenal impact on healthcare in
the previous decades. The major share of this impact
happened through the dissemination of medical devices.
Biomedical research has led to the realisation of a
huge number of implantable devices which append or
substitute the functions of natural organs. By the
definition of WHO, a medical device can be any
instrument, apparatus, implement, machine, appliance,
implant, reagent for in vitro use, software, material,
or other similar or related article, intended by the
manufacturer to be used, alone or in combination for a
medical purpose.
As of today, there are an estimated
2 million different kinds of medical devices on the
world market, categorized into more than 7000 generic
device groups. The market size in this area in India
is estimated to be USD 11 billion. Our country largely
imports which comes to 80% of the domestic
requirement. Research on medical devices and the
translation of related products are promoted
worldwide, because access to good quality, affordable,
and appropriate health products is the key to
healthier populations.. |
Development of Medical Devices
The design and development process of a medical device is
basically a translation activity of converting the
requirements of an unmet need into a physical product. To
ensure consistent translation, a set of policies and
practices could be adopted, known as the ‘medical device
design controls’. Good design controls help to reduce
product risks and to ensure the fitness of the product for
the purpose. The standard ISO 13485 sets out a series of
requirements for design controls to be adopted for medical
devices. Figure 1 shows the various steps of the Design
Control Process.
It starts from an ‘Unmet Need’ or the requirement put
forward by the user (primarily a medical professional).
The requirement may be for a totally new product or for a
substitute of a product that is not available or
affordable in a particular geographic region.
Figure 1 : The work flow of design development of a
medical device.
In the second step, the ‘Design Input’ is formulated after
carefully evaluating the needs of the customer.
Thereafter, the logical, functional, and performance
features of the product, along with other parameters, are
defined. Subsequently, the essential features, design
protocols, and methodologies are documented. This is not a
single-time process but is iterative in nature.
The third step is the ‘Design Process’, which includes all
the methods, techniques, and modalities that convert the
design inputs into an acceptable and technologically
viable output. It leads to the fourth step of establishing
the ‘Design Output’ which compiles the functional
specification, design plan, drawings, flow charts, service
specification, etc.
The fifth step of making the Medical Device Prototype will
be done after the ‘verification process’. It confirms
whether the specifications are satisfying requirements or
not. For this purpose, it should be ensured that the
output should be - (i) a verifiable parameter, (ii)
validated against the requirements, and (iii) in proper
approval format. In case revisions are needed, the output
will be fed as the input, and the process will go on until
the Design Output is aligned with the Design Input.
Once the final design is ready, it is transmitted to the
production facility for pilot production. The design
control regulation mandates a ‘Design History File’ (DHF),
which illustrates the entire product development process.
It should be noted that the design control process doesn’t
end with transferring the final design output to the pilot
production phase. It is rather a holistic approach,
incorporating the feedback from manufacturing processes,
and it considers necessary changes from usage patterns as
well as failed product analysis. Overall it ensures an
appropriate product with the highest quality and gives
scope for improvement in the product and the manufacturing
process.
Concepts of Review, Verification, and Validation in the
Device Development Process
In the medical device design controls, the appropriateness
or completeness of each step is ensured through the
‘Review Process’. This activity will help to make sure
that the design is on the right track. At each step, the
review checkpoints are identified and the team can decide
when and how the reviews could be conducted. The early
detection of the errors in design review will help in
fixing errors before it goes to the final product/service,
wherein the corrections will be difficult and expensive.
Therefore, procedures should be created to follow the
review outputs closely for errors and corrections, and for
implementing the corrections back in the design.
The ‘Verification Process’ evaluates whether a design
output meets the requirements, specifications, or
regulations defined in the design input. Or it answers the
question “Did we do the right thing?”. The process
essentially determines whether the design and the
specifications will result in the desired product or not.
In order to establish this, a thorough review of the
design should be done at the design output stage for all
the activities or features. The team has to verify the
correctness of the design features against original
requirements, record the review findings, and take
necessary corrective actions. It is important to document
any design change proposed so that it is appropriately
carried out without fail.
The ‘Validation process’ evaluates if the product delivers
benefits, according to the needs of targeted users or not.
Or it deals with the question “Did we do it right?”. The
process practically examines the product as to whether it
does what it is supposed to do. Typically, this is done
before the delivery or implementation of the product. The
results of the activities should be documented so as to
take necessary corrective actions in time. |
