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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...

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...

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...

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...

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...

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...

Full Spectrum is often engaged to assess software cybersecurity for our clients.  So, when the FDA issued its new draft guidance to the MedDevice industry (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA - April 8. 2022) we expected the FDA to reinforce its stated policy to be ‘vigilant and responsive’ to the cyber-security issues related to medical devices.    However,...

Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years. In March of 2020, when Covid cases started spiking and emergency orders closed offices and manufacturing plants across the country and around the globe, most executives didn’t focus on the impact on their product development efforts first.   The crisis...