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Technology is posing several Challenges in the Medical Device Industry

Technology is essential to the survival of modern society. It facilitates people’s interaction and collaboration, increases efficiency, and aids in resolving complicated problems—a statement that is especially true in the healthcare industry. Through the maturation of non-invasive techniques and home monitoring devices, recent advances in medical Technology have improved device functionality and made healthcare more widely accessible to the general public while also fueling more stringent and standardized regulations, thus improving patient outcomes care.

The FDA, for example, has recently released draught guidance on the Content of Premarket Submissions for Device Software Functions. It includes both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) in the hopes of promoting the safe and effective development of medical devices that use software functions.

However, before the final product is manufactured, design engineers must address several problematic issues. This helps create a high-performing and reliable medical device that combines all of this new, applied Technology, as well as fresh iterations of the highly regulated landscape.Eric Steuben, SVP of operations at Calyxo, will address these and other issues at the next BIOMEDevice Silicon Valley Smart Event.

The must-attend regional event, which will take place in person on December 8 and 9 at the San Jose McEnery Convention Center, aims to further digital health and personal diagnostics development and will feature instructional content from some of the industry’s most critical influential players. With the event approaching, I sat down with Eric to discuss his forthcoming presentation, “Panel: Essentials for Design Strategy – Be an Effective Front-end Collaborator,” as well as what participants can expect to learn.

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