Leading innovation and systems advancement in regulatory affairs, healthcare informatics, and clinical IT
Addwin Consulting Corporation is an innovative firm started in Stanford, California with over 15 years of leading experience and expertise in regulatory affairs, medical devices regulation and compliance, clinical trials, clinical informatics, health IT, electronic health record (EHR) system development, process and quality improvement, program effectiveness, and healthcare policy implementation. Addwin Consulting has had exxtensive experience in serving the medical device industry and in implementation and 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.
- Medical device clinical trials design, regulatory approvals and strategy
- Health data integration and analytics
- Healthcare cybersecurity, biodefense
- EHR design and development
--> Health System Transformations
--> Clinical quality and analytics
--> Health information technology
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, CEO of Addwin Consulting, is a recognized leader in the medical device industry with 23 years of professional experience in domestic and international regulatory affairs with a focus on business strategic goals. Ms. Advani has worked with small and large medical device companies to develop regulatory and clinical strategies, focusing on the appropriate development of corporate and product development strategy together with regulatory and clinical affairs. Mona has successfully obtained marketing clearance for a variety of medical devices, both in the United States and internationally, including the European Union (EU), Japan and Canada. Mona and her team work diligently to prepare and represent clients in regulatory meetings with FDA and other Regulatory Agencies, including FDA panel meetings and FDA presubmission interactions. The Addwin regulatory practice team have expertly prepared numerous 510(k) and IDE Applications, and assisted in responses to FDA compliance actions and 483 letters.
Ms. Advani has had extensive experience 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. In addition, Mona is fluent in written and spoken Japanese. 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. Mona 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 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.