BLOOM Workshop: Dr Geetha Rao
BLOOM Workshop: Dr Geetha Rao
Join Dr. Geetha Rao, a leading expert in life sciences regulatory strategy and biotech commercialization, for an essential workshop on the BLOOM framework—a revolutionary approach that helps innovators answer “What is the best value to create?” rather than simply “How do I execute this product idea?”
In this comprehensive session, you’ll discover how to strategically map your innovation foundation, assess critical risk factors across regulatory, reimbursement, and clinical adoption pathways, and develop dynamic commercialization strategies for therapeutics, diagnostics, medical devices, or digital health solutions. Dr. Rao demonstrates how to navigate the three key “governors” of market success—regulatory approval, revenue models, and clinical adoption—while providing practical tools including a comprehensive Excel worksheet for characterizing your innovation and identifying unmet clinical needs.
This workshop matters because it addresses the fundamental strategic questions that many startups overlook, helping you avoid costly pivots, optimize resource allocation, and build credibility with investors and regulatory bodies. Walk away with actionable frameworks for right-sizing your strategy, developing claim escalation pathways, and creating adaptable product strategies that balance innovation potential with feasible risk profiles.
Learning Objective
• Apply the BLOOM Innovation Framework, Foundation, Risk Reduction, and Strategy, to determine which value to create, not merely how to build a predetermined product.
• Construct a BLOOM Innovation Foundation by characterizing novel aspects, identifying IP creation and protection opportunities, mapping unmet clinical needs and alternate practices, and documenting potential clinical claims.
• Assess innovation risk factors specific to their product type (therapeutic, device, or digital health) by mapping required risk-reduction steps including safety, efficacy, manufacturability, cybersecurity, and QMS compliance.
• Design a BLOOM Innovation Strategy by developing claim escalation and diversification pathways, evaluating regulatory approval routes, and identifying reimbursement models and clinical adoption levers appropriate to their product vertical.
• Recognize that regulatory approval is often the easiest commercial hurdle, and that reimbursement and clinical adoption are the more complex governors, and use this insight to prioritize early strategic decisions.
Geetha Rao
Dr. Rao is an executive and strategic advisor on innovation and regulation of medical technology platforms, and connected health systems. Her particular focus is on digital transformation with specific application to agile compliance strategies for rapid commercialization.
She provides the vision for her company, as it enables clients to rapidly and cost-effectively meet compliance requirements and move their products to market. She also provides clients with regulatory and legal problem-solving related to submissions, contractual issues in quality and risk, audit findings, and adverse events.
She is an internationally recognized expert in interoperability and risk management for health software, supporting international regulation policy and standards development. She leads standardization efforts for assuring safe and secure interoperable medical systems.
She has addressed numerous industry forums on issues of emerging health technologies and innovation trends for connected medical technologies and mentored numerous startups on regulatory and market strategy.
Ester Carrasco
Ester Carrasco is the Head of Client Services at Springborne Life Sciences, a leading compliance service provider supporting early to mid-stage Digital Health and Medical Device companies. At Springborne, she specializes in supporting these companies navigate the complexities of their compliance journey to enable rapid commercialization of innovative healthcare products.
Her responsibilities include regulatory strategy, compliance planning, and leading regulatory filings including FDA submissions.
Ester completed her MEng in Biomedical Engineering from the University of Toronto.
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