ABOUT

​​​​I collaborated with multidisciplinary teams to translate complex medical imaging challenges into well-defined research questions, applying advanced mathematical frameworks and computational approaches. Beyond the FDA, I spearheaded research collaborations with leading academic institutions to advance regulatory science in breast imaging, leveraging statistical and computational methods to improve the assessment of technologies such as digital breast tomosynthesis (DBT) for breast cancer detection and diagnosis.

​

Through these efforts, I played a key role in shaping evidence-driven regulatory science for emerging medical imaging technologies, helping establish rigorous, scientifically grounded methodologies for regulatory evaluation.

​​​​

FDA Regulatory Leadership

​

As a scientific lead reviewer in the FDA’s pre-market office (Division of Radiological Health - DRH), I led cross-functional teams, collaborating with clinicians, physicists, statisticians, and engineers to evaluate regulatory submissions for Class II and III medical imaging systems and AI-enabled SaMDs. I managed the DRH working group on guidance development for the clinical assessment of medical imaging devices, and served as an SME in the working group for digital breast tomosynthesis (DBT) down-classification and the Center for Devices and Radiological Health’s (CDRH) regulatory strategy development for AI-enabled software devices.

​

My work spanned a range of technologies, including:

• Digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) systems, critical for breast cancer screening

• Diagnostic ultrasound and CT systems

• General and dental Medical Image Management and Processing Systems (MIMPS)

• Mobile, desktop, and virtual-reality medical displays

• AI-enabled SaMD and CDS for disease detection, diagnosis, and patient management

​​

In addition to my pre-market role, I served as a scientific lead reviewer in the FDA’s post-market office (Division of Epidemiology), overseeing post-market approval study (PAS) protocols for high-risk Class III cardiovascular and in vitro diagnostic (IVD) devices. I developed expertise in evaluating real-world data (RWD) and real-world evidence (RWE), and providing critical insights for the regulatory evaluation of both new and updated medical technologies.

 

​My comprehensive experience at the FDA, spanning both pre-market and post-market regulatory processes, equips me to help Medtech companies navigate the complex regulatory landscape of AI-enabled healthcare software. With expertise in diverse, cutting-edge digital health technologies, such as AI-enabled SaMD and CDS devices, and a deep understanding of RWD/RWE and regulatory strategy, I provide strategic guidance tailored to each company’s unique needs. Whether assisting with product development, submission strategies, or post-market compliance, my goal is to help companies bring innovative solutions to market while ensuring regulatory compliance and patient safety.

​

Industry and Consulting Experience

​​

Transitioning to industry, I have applied my regulatory and scientific expertise to guide AI-enabled SaMD and medical imaging companies through the entire product lifecycle, from early-stage development and FDA submission to post-market compliance.

 

My work has involved:

• Developing regulatory strategies tailored to AI-driven healthcare software, including Pre-Determined Change Control Plans (PCCP)

• Defining clinical validation pathways to support FDA regulatory clearance and market adoption

• Navigating complex regulatory challenges in AI-enabled SaMD and imaging-based medical devices

• Engaging with regulatory bodies such as the U.S. FDA and international authorities for global market registration

• Ensuring regulatory compliance by distinguishing between non-medical device CDS and medical device CDS

• Collaborating with diverse technical teams for product development aligned with regulatory and clinical assessment strategies

 

Through my consulting practice, I help companies anticipate and address regulatory challenges early, accelerating their path to market, while ensuring compliance with evolving regulations.

​

Why Work with Me?

​

With firsthand experience at the FDA and in the digital health industry, I offer a strategic, evidence-driven approach that bridges regulatory compliance and product innovation. By combining scientific rigor with practical regulatory strategy, I help clients navigate the complexities of FDA pathways and bring their AI-enabled healthcare products to market efficiently.

​

What I Bring to My Clients:

• Firsthand FDA experience in evaluating AI-enabled SaMD and digital health technologies

• Proven expertise in clinical validation and regulatory strategy for AI-enabled SaMD and CDS

• A highly personalized, hands-on approach tailored to your product’s unique challenges

• Strong collaboration with technical teams to navigate complex regulatory and clinical issues

• A track record of delivering innovative, data-driven solutions that meet regulatory expectations

 

Whether you need strategic regulatory planning, guidance on FDA submissions, or support in clinical assessment methodologies, I am committed to providing tailored, evidence-driven solutions that streamline regulatory pathways and accelerate product registrations.