Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.
Market research and forecasting help ensure that you are investing in a device or drug that is needed and will be well received. In this article, Sanobar Syed, Associate Director of Forecasting, Market Insights and Strategies, BeiGene, highlights strategies to support data collection for forecasting in emerging markets.
Veeva has launched a new tool to help MedTech developers identify and engage with healthcare experts and key opinion leaders.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
Business strategy and forecasting influence several functional areas within an organization, including R&D, pipeline planning, revenue planning, inventory, resource and budget allocation, project prioritization, compensation plans, market access efforts, and more. These varied uses reflect the first major challenge of forecasting: meeting the needs of varied and diverse stakeholders. Following are three steps to make your forecasting efforts more effective.
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
Akido is focused on addressing the systemic inequities that lead to chronic illness and vulnerability through early interventions designed around social determinants of health (SDoH), best-in-class care and human-centered technology.
“Francis Medical has a powerfully simple and differentiated technology, supported by an outstanding team. I’m excited to add my knowledge and experience to the group and make a meaningful impact as we strive to bring this transformational technology to urologists and their patients.”
By deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.
