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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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Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software development for safety-critical software. The medical-device industry is an additional player now leading the charge toward adopting such terminology, as...

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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  So, when the FDA issued its new draft guidance to the MedDevice industry (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA - April 8. 2022) we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,...

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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...

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