scholarly journals Applications of Medical Devices in Healthcare Industry

2021 ◽  
Vol 10 (38) ◽  
pp. 3419-3423
Author(s):  
Chandan B.V. ◽  
Balamuralidhara V ◽  
Gowrav M.P ◽  
Vishakharaju Motupalli
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Patient Monitoring ◽  
Healthcare Industry ◽  
Health Care Market ◽  
Potential Growth ◽  
Regulatory Systems ◽  
A Company ◽  
Crucial Part

In the health-care industry, use of medical devices is becoming increasingly significant. There are currently over 8000 generic medical device categories, with some containing pharmaceutical active ingredients. The potential growth of the medical devices in the healthcare industry helps the healthcare system stupendously in diagnosis, treatment, pathogen tracking, patient monitoring and many more aspects of serving the human race in healthcare terms. Medical device utilization is becoming an increasingly crucial part of a healthcare professional's job. Personal users of medical devices must be taught and educated regularly to guarantee that they are proficient in the usage of equipment. Medical gadgets are becoming increasingly important in the health-care market. Keeping up with regulatory regulations and incorporating them into the process is one of the most difficult elements of creating and manufacturing medical devices. Tighter regulatory systems are needed to ensure that products entering the market are both safe and effective. Keeping up with regulatory regulations and incorporating them into the process is one of the most difficult elements of creating and manufacturing medical devices. A company that fails to succeed in this endeavour could lose thousands of dollars due to the amount of time it takes to do it. KEY WORDS Medical Device, Artificial Intelligence, Machine Learning, Design and Development, Diagnosis, Disease Management.

Features of use in practical health care of the device «Multi-layer mat with an adhesive surface according to TA 32.50.50-009-21109965-2019, WITH ACCESSORIES»

2021 ◽  
pp. 70-75
Author(s):  
Viktor Yurievich Kozlov ◽  
Larisa Arkadyevna Karaseva
Keyword(s):  
Health Care ◽  
Healthcare Professional ◽  
Medical Devices ◽  
Health Needs ◽  
Hospital Environment ◽  
Healthcare Industry ◽  
Adhesive Surface

A safe hospital environment should fully provide the patient and healthcare professional with the comfort and safety conditions that effectively address vital health needs. To this end, medical devices are manufactured for the healthcare industry to ensure the safety of the hospital environment for patients and medical workers [2, 3].

PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

2017 ◽  
Vol 33 (S1) ◽  
pp. 116-117
Author(s):  
Jana Hemmerling ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
Maike Gupta ◽  
Anna Ullraum ◽  
...  
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Small Body ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
European Network ◽  
Gemeinsamer Bundesausschuss ◽  
Real World Data ◽  
Clinical Reality

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

scholarly journals REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

2018 ◽  
Vol 6 (1) ◽  
pp. 8-12
Author(s):  
Vikaas Budhwaar ◽  
Yogesh Rohilla ◽  
Manjusha Choudhary ◽  
Prateek Kumar
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Indian Agent ◽  
Registered Office ◽  
A Company ◽  
Do So

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.

Trends in software as a medical device (Preprint)

2020 ◽  
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Health Care ◽  
Data Analysis ◽  
High Risk ◽  
Adverse Events ◽  
Medical Device ◽  
Empirical Analysis ◽  
Medical Devices ◽  
Digital Revolution ◽  
The Us ◽  
Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System

2010 ◽  
Vol 1 (2) ◽  
pp. 137-149
Author(s):  
Bernhard Lobmayr
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Condition ◽  
Regulatory Systems ◽  
Information Time ◽  
The Us ◽  
European System ◽  
Government Involvement ◽  
The Eu ◽  
Medical Device Regulation

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

Medical devices biomaterials – A review

2019 ◽  
Vol 234 (1) ◽  
pp. 218-228 ◽  
Author(s):  
AJ Festas ◽  
A Ramos ◽  
JP Davim
Keyword(s):  
Health Care ◽  
Life Expectancy ◽  
Medical Device ◽  
Population Health ◽  
Medical Devices ◽  
Methods And Techniques ◽  
Manufacturing Methods ◽  
Proper Material ◽  
Care Demands ◽  
Metal Polymer

Due to the increase in the life expectancy of world’s population, health care demands in terms of quality and accessibility are higher than ever before. Concerning the manufacturing of medical devices, the development of new biomaterials, new manufacturing methods and techniques have always been on researchers focus. In the development of a medical device, the choice of the proper material to be used is of the most importance, since its ability and capacity to fulfil the expected function will determine the success of the medical device itself. This work aims to do a review of those that are the most commonly used biomaterials. After an explanation on what are biomaterials and what defines them, a more in-depth approach is presented to each of the four major types of biomaterials: metal, polymer, ceramic, and composites, where their main characteristics and preferred applications in the area of medical devices are described.

scholarly journals Brief Talking about the Development of Medical Device Industry in China

2019 ◽  
Vol 2 (4) ◽  
pp. 24
Author(s):  
Yiling Bao
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Living Standards ◽  
Policy Support ◽  
Continuous Development ◽  
Medical Device Industry ◽  
Aging Society ◽  
China’S Economy ◽  
Device Industry

With the continuous development of China's economy and the improvement of Chinese’ living standards, people's awareness of health care has gradually increased, so the demand for medical devices products is also strengthen. In addition, China is gradually entering an aging society and policy support for the medical device industry. China's medical device industry is developing rapidly.

Sign in / Sign up

Export Citation Format

Share Document