Leading innovation and systems advancement in medical devices, regulatory affairs, healthcare informatics, and IT
Addwin Consulting Corporation is an innovative firm started in Stanford, California with over 15 years of leading experience and expertise in informatics, health IT, electronic health record (EHR) system development, process and quality improvement, program effectiveness, clinical trials, and medical device regulation and compliance. Addwin Consulting has achieved strategic health IT engagements with USA government agencies (VA, HHS, DoE, DoD), commercial entities, and nonprofit health concerns. Our staff brings extensive experience at the Veterans Administration in developing innovative health IT applications, including the first guideline-based decision support system successfully deployed clinically at the VA for over 10 years. We bring unique expertise combining informatics, health policy/regulatory expertise, human factors engineering, and EHR systems design. Our efforts also include voluntary service on federal committees including the VA HSR&D Informatics FACA.
Healthcare cybersecurity, biodefense
Health data integration and analytics
EHR design and development
Health System Transformations
Clinical quality and analytics
Health information technology
Regulatory & Clinical Consulting
FDA medical device approvals (presubmission, 510(k), IDE, PMA)
Clinical study strategy
International regulatory agency communication and strategy
FDA pre-meetings and interface
Primary regulatory contact on behalf of startup companies to FDA
Regulatory document development
OnDemand Care Suite of Products including:
Healthcare blockchain/ethereum, cybersecurity and privacy solution with mobile and telehealth toolkit
Real-time expert system to predict health risks and costs
Automated healthcare natural language clinical documents, imaging, and forms processing
Care coordination capacity modeling and referral routing across healthcare network(s) to route patients and optimize revenue & cost
Real-time mobile health data interoperability, digital health, and analytics solutions
Mona Advani, MS, MBA
Mona is an accomplished consultant in the medical device industry with over 20 years of professional experience in domestic and international regulatory affairs. She has worked with startup and and large medical device companies to develop regulatory and clinical strategies. Mona focuses on business strategy primarily, integrating the appropriate development of corporate and product development strategy together with regulatory and clinical affairs. Ms. Advani has successfully obtained marketing clearance for a variety of medical devices, including cardiovascular, peripheral, neuro, dental, and software applications. International agency work has involved detailed work including with the European Union (EU), Japan and Canada. She works to represent clients in regulatory meetings with FDA and other Regulatory Agencies, including FDA panel meetings and FDA presubmission interactions. She has prepared numerous 510(k) and IDE Applications. Mona has worked on PMA applications, responses to FDA compliance actions and 483 letters.
Ms. Advani has worked in the medical device industry holding the titles of Senior Director of Regulatory Affairs and Clinical Research, Manager of Business Development, Manager of U.S. Regulatory Affairs, Manager of International Regulatory Affairs, and Regulatory Affairs Coordinator. She is currently CEO of Addwin Consulting Corporation.
Ms. Advani earned her MBA degree from San Francisco State University, her MS degree in Immunology and Infectious Disease from the University of London, and her BS degree in Biology from Brown University. She has organized international regulatory affairs workshops; presented at the RAPS Annual Regulatory Affairs Professionals Society Meeting; and published articles in the Regulatory Affairs Focus magazine.
Dr. Aneel Advani
Dr. Advani is a board-certified physician informaticist and a leader in applying health information technology to improve the health of communities and populations and advance public health and population medicine. Dr. Advani is Chairman of Global Virtual Group and President of Addwin Consulting Corporation. Dr. Advani also serves as an adjunct professor of Health Policy and Management and teaches healthcare strategy and policy at Johns Hopkins University. Dr. Advani has served as the Associate Director for Informatics/CMIO at the Indian Health Service, Associate Director for Technology/CTO at the National Center for Public Health Informatics at the CDC, and senior steering group on Health IT R&D under the White House Office of Science and Technology Policy.