FEATURED EDITORIAL
The 2 Things Investors Want To See In Your Medtech — & How To Show Them
The host of the MedTech Gurus podcast recaps two recent episodes and shares the two things that his guests agreed that investors want to see before they will loosen their purse strings for your new medtech product. The article also describes how to make your pitch to those investors.
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Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
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Medical device manufacturers are well positioned to capitalize on the opportunity of developing wearable devices. However, to deliver devices useful for clinicians and patients, wearable technologies must advance further. This article describes three areas for manufacturers to focus on for success in the market.
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Despite a substantial reduction in the number of inspections that the FDA conducted in FY 2021, the 483s that the agency issued are still very important for the medical device industry to take note of. What were the top 3 citations, and how do the rest of the top 10 compare? This author shares all the data, as well as the 4 priority takeaways.
INDUSTRY INSIGHTS
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Small Regulatory Steps For AI In SaMD
Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.
Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.
The landscape for the regulation of personalized medicine continues to evolve as the innovation in personalized medicine increases. Here are a few ways that companies in personalized medicine can approach regulatory as opportunities instead of obstacles.
This article discusses implementation of a phase-appropriate QMS and the importance of starting early in the product development life cycle, the disadvantages of using a manual paper-based QMS in the early phases and advantages to your company by using a digital QMS.
Product development in the life sciences is a multimillion-dollar process. With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential. In this blog we give a general overview of the seven steps companies need to take to successfully complete and document CAPA.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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