Lifecycle Health Consulting
From concept to clinic, and beyond.
Expert guidance across the full lifecycle of healthcare and health technology innovation: development strategy, clinical validation, regulatory pathways, and real-world deployment.
About
Lifecycle Health Consulting helps organizations turn emerging technologies into clinically viable, regulatorily sound products. We focus on AI/ML-enabled diagnostic and clinical decision support tools, where scientific, regulatory, and operational challenges meet.
We bring perspective from both sides of the process: the regulator evaluating a new technology, and the clinical institution building and deploying it.
What We Do
Regulatory Strategy & FDA Engagement
We help you plan and run productive interactions with FDA, including Pre-Submissions and other Q-Submission meetings. We define a regulatory pathway early so it shapes development instead of slowing it down.
Clinical Trial & Validation Study Design
We design studies that generate the evidence regulators expect and clinicians trust, and that match your product’s intended use and risk profile.
Development Strategy
We give strategic guidance from early concept onward, so your clinical, technical, and regulatory decisions support one another.
Implementation, Governance & Post-Market Monitoring
We advise on the operational and governance work needed to deploy AI tools safely in clinical settings, including workflow integration, oversight structures, and ongoing performance monitoring after launch.
Leadership
Krishna Juluru, MD | Founder & Principal
Dr. Juluru has spent his career where medicine, technology, and regulation meet.
- FDA, Digital Health Center of Excellence: As a Medical Officer, he focused on digital health policy and on building strategic partnerships with industry.
- White House Presidential Innovation Fellow: He coordinated cross-agency federal digital health initiatives spanning NIH, CDC, FDA, ONC, and HHS.
- Academic Leadership: He has held faculty and leadership roles at Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, and the University of Pennsylvania, and has served in leadership positions in national medical societies, including the Radiological Society of North America (RSNA).
Who We Work With
We partner with academic medical centers, research institutions, and healthcare technology developers on a project or ongoing advisory basis. Each engagement is tailored to its specific regulatory and clinical development needs.
Contact
Ready to discuss your project?