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.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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Friday, April 9, 2021

TELEMEDICINE

 Hi friends!!!


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


Infant Incubator


Today we are going to discuss about Telemedicine.


Telemedicine is one of the emerging concepts in the field of healthcare.  Therefore it is important for every healthcare professional to know in detail about Telemedicine.


Let’s get into the topic. 

WHAT IS TELEMEDICINE?


The Telemedicine is an emerging technology by which healthcare professionals can evaluate, diagnose and treat patients at a distance without being in direct contact with them. The concept of telemedicine is very much useful in case of rural areas and difficult to reach areas where doctors may not be available all the time. Telemedicine uses a telecommunication technology to provide healthcare remotely. Telemedicine has become possible due to internet age which high quality video transmission possible.



Image courtesy: Wikimedia commons
Licensed under: CC Share Alike


WHAT ARE THE TYPES OF

TELEMEDICINE?


The following are the three important types of telemedicine.


INTERACTIVE MEDICINE


In interactive medicine, the patients and clinician interact in real time using video conference software while maintaining HIPAA compliance. The examples of interactive medicine include Phone calls, online video conference etc.


STORE AND FORWARD


It is also known as asynchronous telemedicine. In store and forward type, there will be a service provider (eg: Testing labs) who stores the patient information and forward it to the doctor present in different location. Eg: A doctor in a rural area can store patient data and can send it to a specialist doctor in city to gain deeper insights about patients illness.


REMOTE PATIENT MONITORING


In remote patient monitoring, patients are provided with some kind of wearable medical devices which monitors & collects patient data and transfers it to the doctor. Eg: Wearable watches or patches which monitor and send data about blood glucose and blood pressure to doctors in different locations.


WHAT ARE THE BENEFITS OF TELEMEDICINE?


The Telemedicine is an alternative for in house hospital visits. So, telemedicine has many benefits for both patients as well as clinicians.


BENEFITS TO PATIENTS


1. No time and money loss due to travelling.

2. No contact with other infectious patients.

3. Better privacy.

4. Easy access.


BENEFITS TO CLINICIANS


1. Increased revenue.

2. Lesser or no money spend on office space.

3. Chance to cover missed appointments and cancellations.   


HIPAA COMPLIANCE


All telemedicine software should be in compliance with Health Insurance Portability and Accountability Act (HIPAA). The HIPAA compliant is a guideline to protect patient safety. It prevents breach of any personal patient data. While there are some software’s meant for normal communication which is easy for doctors to interact with patients and provide guidance. Eg: Skype. However using such software for healthcare purpose may not provide compliance for HIPAA in protecting patient data.


FEATURES OF TELEMEDICINE SOFTWARE


Many countries now started to provide reimbursement for healthcare service offered via telemedicine software. But in order to receive reimbursement, the details of telemedicine visit shall be documented and submitted to approving authorities.


There are some telemedicine software’s which allow easy documentation of telemedicine visits. These documents can latter be imported and stored to Electronic Health Records.


In some telemedicine software’s, EHR is integrated to facilitate automatic storing and retrieval of details about telemedicine visits.


DIFFERENCE BETWEEN TELEMEDICINE AND

TELEHEALTH


Telemedicine can be used to provide specific and focused remote clinical services. The services include all kinds of medical, diagnostics and treatments related to a specific illness. Telemedicine is a narrower field whereas Telehealth refers to a broader scope of remote health services beyond doctor-patient relationship. Telehealth provides remote non clinical services. The examples of Telehealth include healthcare education, remote health information services.


Now I hope you have acquired some knowledge about Telemedicine. 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.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend!