Hi friends!!!
In our previous blog we have discussed about Telemedicine. Please check out for the link below.
Today we are going to discuss about Medical Device Product Life Cycle
Being a healthcare professional, its important to know in detail about Medical Device Product Life Cycle.
Let's get into the topic.
MEDICAL DEVICE
PRODUCT LIFE
CYCLE
The concept of Product Life Cycle (PLC) is common for
products across different industries. The Life Cycle of Medical Device is a
concept derived from broader concept of PLC.
The Medical Devices need to be handled differently in
each stage of its product life cycle. In olden stages, there were series of
regulations which focused only on certain important stages of product life
cycle like Design and Development. But in recent times due to the development
of standards like ISO 13485:2016 and EU MDR 2017/745 the emphasis is spread
equally on all the stages of Medical Device Product Life Cycle.
Let’s take a detailed look into each stage of Medical
Device Product Life Cycle.
PHASES OF
MEDICAL DEVICE
LIFE CYCLE
The Medical Device goes through six phases in its
entire life span. The following are the six phases of Medical Device Life
Cycle.
CONCEPT
In the Concept phase, a medical device exists in an idea
form. It is every important to evaluate the idea. The idea is evaluated by
conducting feasibility study and by analyzing the potential risks. The
potential markets and target customer groups are identified. The intended use
of the medical device is defined.
PLANNING
In planning phase, the user requirements were captured
and converted into technical specification. Later on, prototypes will be developed
based on the technical specifications. Several tests will be performed on
initial prototypes. The user feedback will be obtained. The project plan and
timeline will be defined. The roles and responsibilities of each personnel will
be defined as per the project plan.
DESIGN
The Design & Development stage has to be carried
out with following factors in mind. Manufacturing limitations, ease of
component assembly, cost efficiency of processing, intended use, serviceability
etc. In this stage, the design verification and design validation will be made.
The Design & Development stage shall follow a risk-based approach using
tools like FMEA. In this stage, the medical device is designed, tested, review
and designed again for further improvement.
VALIDATION
During Validation phase, the process validation is
conducted. In process validation, machine parameters are defined by conducting
operational and performance qualification. The medical device is testing in a
real time clinical setup like hospitals and clinics. It is called as clinical
validation. The medical device is
labelled and initiation for regulatory submissions will be made.
LAUNCH
After obtaining all the regulatory approvals and
certifications, the medical device is launched into the market. The medical
device is distributed to healthcare providers, hospitals and clinics. All the
sales and marketing activities will be initiated. Product demo’s and clinician
training will be given.
POST MARKET
The Post Market stage is gaining more importance in current
regulatory setup. Once the product is launched into the market, the post market
surveillance activities begin. The medical device adverse events will be
recorded and necessary actions will be initiated. The adverse events will also
be reported to applicable regulatory authorities. Product improvement is made
based on the feedback obtained during post market phase. Clinical follow-up
visits will be carried.
Now I hope you have acquired some knowledge about Medical Device Product Life Cycle. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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