Regulatory Considerations for AI in MedTech

As artificial intelligence continues to revolutionize the medical technology industry, navigating the evolving regulatory landscape is crucial for success. This webinar will provide insights into key regulatory considerations for AI-driven medical devices, including FDA requirements, risk assessment, validation strategies, and emerging global regulatory trends.

Join Jennifer Palinchik, Vivek Ganesh and Fehmida Kapadia as they discuss best practices for bringing AI-powered MedTech innovations to market while ensuring safety, efficacy, and compliance. Whether you're a startup, an established MedTech company, or a regulatory professional, this session will equip you with the knowledge to navigate regulatory challenges effectively.

Key Takeaways:

• The role of regulatory bodies in AI development for medical devices.
• Key challenges and strategies for achieving compliance.
• Future trends & evolving regulatory guidance.
• How to align business strategy with regulatory requirements.
• Best practices for ensuring patient safety and product efficacy.
• Insights into the future of AI regulation in the MedTech industry.

Why You Should Attend: This event is a must-attend for anyone involved in the development, approval, or commercialization of AI-powered medical technologies. Don't miss the opportunity to hear from one of the Top Women in MedTech and learn strategies to navigate the rapidly evolving field of AI in healthcare.

Featured Speakers -

Jennifer Palinchik is an accomplished business leader and biomedical engineer with over 20 years of experience in the medical device industry. With extensive product development and market research experience she has led and contributed to more than 130 medical device clearances and has success in growing and sustaining a profitable organization. Her expertise is in providing business strategy consulting to senior executives in large corporations, startups, academic institutions, and healthcare organizations, focusing on strategic business and regulatory decisions. She holds a Bachelor of Science in Biomedical Engineering from the University of Toledo and a Master of Business in Executive Entrepreneurship from Ashland University. Jennifer's contributions have been recognized through prestigious accolades, including Crain's Cleveland Business Top 40 under 40 and multiple honors as one of the Top Women in MedTech. She has also been a guest speaker at the Cleveland Clinic Innovations Summit, Ohio State Senate, and other Medtech conferences.

Vivek Ganesh is the Co-Founder and Chief Technology Officer of Neurava Inc., where he leads the development and commercialization of AI-powered wearable devices designed to monitor seizures and cardiorespiratory dysfunction in people with epilepsy at risk for sudden unexpected death (SUDEP). Since founding Neurava in 2019, he has built strategic industry partnerships, raised over $3 million in funding, developed high-performing business and technology teams, overseen clinical collaborations, and led regulatory strategy with the FDA. He has extensive experience driving the development of cutting-edge hardware and integrated machine learning algorithms for biomedical applications. Vivek completed his Ph.D. in Electrical and Computer Engineering at Purdue University and Johns Hopkins University, specializing in embedded systems, closed-loop electroceuticals, and physiologic monitoring. His prior experience includes technology development roles at startups and on Apple’s Health Technology team (Apple Watch), shaping human health sensor platforms. Today, he combines deep technical expertise with business strategy to bring AI-driven medical innovations to market and improve outcomes for people living with chronic neurological diseases.

Moderator -

Dr. Fehmida Kapadia is an expert in entrepreneurship, business strategy, and technology commercialization. As the Founder and President of Kapamed Consulting and Amplify MedTech, she has guided over 100 startups in their journey to success. With a PhD in Biochemistry and a master’s in Biotechnology Entrepreneurship, Dr. Kapadia specializes in strategic partnerships, fundraising, and biomedical product development.

What is the Amplify MedTech Hub?

The Amplify MedTech Hub is building a collaborative MedTech ecosystem in the DMV region. The Hub aims to drive innovation, foster collaboration, and support the development of groundbreaking healthcare solutions. By connecting entrepreneurs, startups, investors, service providers, economic development agencies, and researchers, the Amplify MedTech Hub seeks to revolutionize patient care locally and globally.

Sponsorship Opportunities

Interested in sponsoring the MedTech Hub? We offer several sponsorship packages to help you gain visibility and connect with key players in the DMV MedTech ecosystem.

Contact us to learn more.

amplifymedtech@gmail.com

fehmidak@kapamedinc.com