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Author: Foxpoint Media

Pressure continues to mount to reduce the use of in-hospital resources in order to improve the cost performance of healthcare. Developing more cost-effective methods of addressing cardiac-related illness, still the number one cause of death in the US, is a high priority. Remote monitoring and diagnostics are seen as providing tremendous advantages to cardiologists and patients, including the promise of earlier detection, while also keeping...

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Connectivity in medical devices has become ubiquitous. No longer a novelty, the ability to gather and exchange data across a network of devices is often a required part of any modern system.   Devices with more sophisticated connectivity offer extensive potential improvements: data collection allows manufacturers to improve patient outcomes by analyzing usage patterns, augmenting device behavior with off-device functionality, such as AI. By uncovering opportunities for...

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Artificial Intelligence in Medical Imaging: Architecture, Interoperability, and other Key Considerations   After a period of relative calm in the medical imaging market, we are now in the early stages of another era of rapid evolution. Efforts are underway on multiple fronts, to improve the effectiveness of treatment, reduce costs, and prevent diagnostic errors.   At the same time there is a push to facilitate interoperability of different...

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The radiation oncology (RO) market continues to change rapidly. Efforts with the goals of improving the effectiveness of treatment, while reducing costs, and preventable treatment errors is driving the new capabilities into both delivery and treatment planning systems. In a change from recent years, a very large percentage of product value creation is coming from the development of sophisticated software capabilities, in yet another example...

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As anyone responsible for the development of new products knows, software engineers come in two distinct flavors; engineers that work at the application level and engineers comfortable working at the hardware level.    While this is, obviously, a gross oversimplification, the basic division is true. The application software engineers work in a space that has dramatically expanded over the past several decades; workstation, then PC, then mobile...

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The topic of cybersecurity for medical devices has steadily grown since 2001.  In that year, after September 11, there were a number of technically philosophical talks and papers warning that cyber terrorism, later dubbed cybersecurity could become an issue for medical devices.  At the time it was considered to be of mild interest, but few imagined that anyone could be so twisted as to attack...

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Medical device manufacturers might consider outsourcing product development or product testing activities for a number of reasons. In general, if an outsource provider has specific experience that you lack, has more resources available, or doesn’t carry all the overhead of a large corporation, then you may be better off outsourcing. By outsourcing, manufacturers can often eliminate both direct and indirect development costs. These costs can...

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You saw the prototype working. The preliminary clinical data looked promising. There was a huge market need for the product. It looked like a sure thing. Then, two years later than anticipated, the product fi nally gets to market. Development costs millions more than expected. Worst of all, because it took so long to get to market, you now have three competitors that didn’t exist...

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The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem that luck has more to do with success than anything else. Why do companies with similar products sometimes take very different amounts of time to launch new products, and why do they have very different success rates? The performance differences are so consistent that it suggests that...

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FDA’s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true. Understanding and following the good engineering and project management principles outlined in the QSR can help manufacturers shorten the development cycle. Not only...

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