Sunday, April 25, 2021

Medical Device Product Life Cycle


Hi friends!!!


In our previous blog we have discussed about Telemedicine. Please check out for the link below.


Telemedicine


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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