Abstract
This paper presents an exploration of strategies undertaken by a consortium of clinical teams and manufacturers to proactively prepare and support use of new categories of medical devices. Potential avenues of exploration include leveraging other domains, such as the US Space program, providing innovative methods of training and research and development in known areas of concern such as systems integration. By a commitment to creating a safer system, we are committing to providing safer care to patients. We believe incorporating the ‘lessons learned’ from the largest possible set of real-world scenarios, into the design and use of medical devices, will accelerate success.
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