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For centuries, record-keeping productivity depended on the number of humans writing down data at any given time. Clay tablets in museums and huge archive rooms filled with aging paper folders show us the limits of pre-electronic data storage. When computers and the internet began to go mainstream in the 1980s, one of the promises of […]

Healthcare data security has been a concern since the early days of electronic health records. Over time, healthcare delivery organizations (HDOs) built up huge databases of patient data. When the internet arrived on the scene, those databases became lucrative targets for hacking. Today, the growth of connected medical devices is further straining early systems

Many global factors are converging to increase the demand for advanced medical devices in the next decade. At the same time, industry stakeholders know that taking a medical device from concept to market is a very expensive and complex process. Not surprisingly, outsourcing is emerging as an important option for advanced medical device development. Grandview [&

Some of the first of many complexities that medical device startups must manage are design controls. While design controls can seem confusing, arbitrary, or even restrictive, they flow from regulatory agencies’ mandate to ensure public safety. Agencies use design controls to ensure the safety and efficacy of connected medical devices. Medical device startups

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