ABOUT US
MedTech Strategy Advisors, LLC is a consulting team dedicated to providing specialized strategic guidance and regulatory support for medical device companies. We have over 45 years of combined experience in FDA and global regulatory strategy development and execution from concept through commercialization.
Nada Hanafi, MSc., MPH, has over 23 years of experience across the public and private sectors. She spent over 12 years at FDA, serving in roles of increasing responsibility and ultimately as a Senior Science Health Advisor in the Center for Devices and Radiological Health (CDRH), where she led cross-Center and Agency programs, including as Co-Founder of the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She served as CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH). She also served as a Senior Advisor to National Institutes of Health (NIH) Office of Women's Health (OWH). Following her tenure at FDA and NIH, Nada became Chief Strategy Officer at Experian Group (later Veranex, Inc.), advising a variety of companies and representing them with FDA.
Kelly Carty, MSc., has over 25 years of experience in the medical device industry at companies ranging from small startups to large, well-established companies with a wide variety of devices and complex issues. She held positions of increasing responsibility, ultimately ending as the Head of Regulatory Strategy – Body Aesthetics for Allergan Aesthetics, an Abbvie Company. Following her time in industry, Kelly moved into consulting at Veranex, Inc. where she worked closely with her Co-Founder, Nada Hanafi.
OUR SERVICES
REGULATORY STRATEGY
Regulatory Strategy is our specialty.
We provide expert guidance to navigate complex regulatory requirements, defining the most efficient submission pathway and evidence generation strategy to meet your business goals at every stage of the product lifecycle.
Expanding globally? We can help you build a global strategy from day one so you don't have to reinvent it, market by market.
EARLY AGENCY INTERACTIONS
You never get a second chance to make a first impression.
How and when you engage with regulatory agencies can define your entire program.
We provide tailored strategic consulting services to guide you in when, how, and how frequently to ensure you gain the robust, actionable feedback you need to move forward with confidence.
We help you build productive relationships with your review team from the very first interaction, ensuring your company's long-term success.
SUBMISSIONS
A great submission is more than a document, it's a strategy.
A successful submission requires solid planning, compelling explanation, supportive data, and active engagement with the health authority. Whether it is a Pre-submission (Pre-Sub), an IDE, 510(k), De Novo, or PMA, we manage the full process from data to submission and through review and approval.
SPECIALTY AREAS
Devices: Digital Health · SaMD · SiMD · CDS · Patient Decision Support · Implantables · Wearables
Medical Specialties: Women's health · Pediatrics · Cardiovascular · Urology · Neurology · Imaging · Respiratory · General Surgery · Plastic & Reconstructive Surgery.