The RSRC are currently collaborating with Aerogen on The Medical Device Software Framework Lero Project. The main goal of this research collaboration is to develop a fully validated best practice medical device software and cybersecurity testing framework for the development of medical device products. The RSRC will work closely with the Aerogen team to investigate the specific challenges posed by their existing software development environment in relation to the development of products containing evolving technology and software that are now subject to regulation within the medical device domain. This will form the basis for the development and validation of a best practice Framework (including integrating usability and agile practices etc.) for medical device software processes (including development of wireless medical devices). This framework will then be introduced into the medical device software development lifecycle within Aerogen. In addition, this research will also focus on the Development and Validation of a medical device security feature testing framework for ensuring that effective security testing processes in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new product lifecycle within Aerogen that will assist their products to comply with the latest medical device cybersecurity regulations. The research conducted on medical device software processes and cybersecurity processes will then be combined into a single integrated framework. The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within Aerogen.
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