The EnGenius Mission
The healthcare system is broken, burdened by inefficiency, high costs, and limited access to quality care. Technology offers hope as a solution through telemedicine, big data, AI and much more. The importance of technological adoption is a moral obligation for equitable access to care and a reimagined, inclusive healthcare model. Yet embracing these solutions - the development of which often requires agile and iterative development models - has always been slower than desired due in part to a lack of optimized, scalable, tailored medical device development processes within the Quality Management System.
Our mission is to streamline safe and sustainable integration of technology into the healthcare sector. With a focus on innovation and efficiency in addition to safety, quality and compliance we tailor solutions designed to simplify adoption of technology into the health care ecosystem generally and the medical device space specifically in order to enable bridging of the gap between the current healthcare practices and modern technological advancements.
This mission demands Engineering and Genius, and EnGenius is up to the task.
Meet the Founder
Ashkon Rasooli
Ashkon is a medical device Quality Management Systems strategist with over 12 years of experience and a focus on software as SaMD or SiMD. His unique background boasts first-hand experience in a variety of roles including product management, development, testing, QMS and regulatory and in a variety of business environments including established medical device companies with high-risk products such as Edwards LifeSciences, established tech companies with best-in-class software practices such as Alphabet's Verily, and a number of VC-backed startups at the forefront of such health tech sectors as digital therapeutics, wearables, and disease management platforms.
He is a Summa Cum Laude graduate of University of California, Irvine with a Master of Science in Biomedical Engineering and a minor in management. His master's thesis involved development of signal processing algorithms for extra-cortical recordings based on which an academic paper has been published.
With a keen interest in emerging SaMD/SiMD technologies and in particular AI, his latest activities in this area include a speakership on AI/ML applications at MD&M West 2024 and a podcast on applications of machine learning in medical devices. He is currently a member of the AFDO/RAPS Healthcare Collaborative working group on Good Machine Learning Practices (GMLP). In 2024, the working group is working on preparing a mock FDA submission for an AI-enabled device as a reference for the industry.
His detailed background can be found on LinkedIn.