Blogs Archives - Page 19 of 24

Indian Perspective on Digital Health Technology

Digital health technology has gained significant momentum in India, revolutionizing healthcare delivery and improving accessibility and efficiency. It acts as a fundamental support for providing value-based care throughout the healthcare system. Various digital health technologies, including telemedicine and health monitoring apps, are transforming the healthcare landscape in India.The Indian Prime Minister introduced the National Digital […]

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Challenges With Medical Devices and Digital Health Technologies

All Category, Blogs, Medical Device / development

Currently, there are over 2 million diverse types of medical devices accessible in the global market, which are further classified into more than 7000 generic device groups. As of 2021, the worldwide medical devices market was valued at USD 488.98 billion and is predicted to grow at a compound annual growth rate (CAGR) of 5.5%

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Risk-Based Approach to Monitoring Clinical Trials

All Category, Blogs, Pharmacovigilance / development

Introduction Clinical trial sponsors for pharmaceutical products (drugs and/or biologics for human use, medical devices, combination products etc) are required to provide the oversight for monitoring a clinical trial to help make sure that the rights, safety, and welfare of trial participants are protected. For this, sponsors are required to implement a system that manages

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Digital Future of Healthcare

All Category, Blogs, Medical Device / development

Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve

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Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device

All Category, Blogs, Medical Device / development

Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and

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WHO Pre-qualification pathway: advancing access to vaccines

All Category, Blogs / development

Introduction Malaria is one of the biggest and most pressing tropical and infectious diseases that pose a significant threat to public health- particularly children. In 2019, a study analysis found that malaria caused 643,000 deaths globally with children <5 years of age living in Africa and exhibiting the highest disease burden [1]. According to the

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DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions

All Category, Blogs / development

The European Medicines Agency (EMA) has created a sustainable network called DARWIN EU, which aims to generate real-world evidence to support regulatory decision-making in the European Union. This coordination centre network uses data analysis techniques and real-world interrogation methods to extract information and insights from various data sources, including structured and unstructured sources. Its main

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Real-Time Remote Inspections – The New Normal

All Category, Blogs, Pharmacovigilance / development

IntroductionThe onset of the pandemic was one of the most hard-hitting events that impacted millions of people around the globe. On one hand it brought along life-changing repercussions and challenges that were first of many, but it also triggered industries to adopt innovative solutions in their everyday practices. One of these many solutions was instigating

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Rise of Digital Applications in the Healthcare Sector

All Category, Blogs, Medical Device, Pharmacovigilance / development

The healthcare sector has been significantly impacted by technology, with the rapid growth of digital health applications projected to continue due to increased demand for remote healthcare services, especially during the COVID-19 pandemic [1]. According to the US FDA, software-based medical devices are increasingly being used for diagnosing, treating, and monitoring complex diseases. The adoption

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Benefits of randomized control trials in accelerated approvals for oncology therapeutics

All Category, Blogs / development

In 1992 the US FDA established the accelerated approval pathway for drug development as treatment options for serious or life-threatening conditions like cancer based on the effect the drug has on surrogate measures or an intermediate clinical end-point that could predict the real endpoint. However, these investigational drugs are subjected to post-approval confirmatory studies which

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