Drug-device combination (DDC) products are increasingly demonstrating the value they bring in diagnosing, treating, and curing complex diseases. The growth of the DDC market is driven by several factors including an increase in chronic diseases, a well-established medical technology industry, a rise in surgical procedures, the availability of funding for research and innovation etc. As …
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% …
Challenges With Medical Devices and Digital Health Technologies Read More »
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 …
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 …
Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device Read More »
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 …
Rise of Digital Applications in the Healthcare Sector Read More »
Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1]. More often the development of combination products helps to enhance the function of an …
The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the …
The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw …
Mitigating medical device shortages in public health emergencies Read More »
Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European …
Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER) Read More »
According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important …
Overview on Cardiovascular Medical Device Regulation by the FDA Read More »
