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White Paper | Shattering Barriers: Advancing Healthcare Equity by Enhancing Diversity in Clinical Trials for a Future of Inclusive Innovation

The Future of Inclusive Healthcare Innovation

Healthcare equity is a goal we can achieve—by transforming how we conduct clinical trials. This white paper, "Shattering Barriers: Advancing Healthcare Equity by Enhancing Diversity in Clinical Trials for a Future of Inclusive Innovation," authored by Jaishankar Kutty, Ph.D., presents a realistic roadmap for increasing diversity in clinical trials. It provides actionable insights towards strategies and tactics based on FDA perspective and industry best practices that pave the way for more inclusive and equitable healthcare innovations.

Why Read This White Paper? 

Medical devices and in vitro diagnostics (IVDs) must be safe and effective for everyone, regardless of demographic or socioeconomic background. Yet, for too long, clinical trials have fallen short in representing the diversity of the populations they aim to serve. This paper delves into the crucial need to improve diversity in clinical trials, aligning with FDA guidance and industry best practices to ensure that all individuals benefit from the latest medical advancements.

What you'll Learn

• FDA's Perspective & Global Alignment: Understand the regulatory framework and the FDA's commitment to advancing healthcare equity through improved diversity in clinical trials.  Learn how aligning with international regulatory standards can enhance trial outcomes and position your products for global success.
• RQM+ Strategies and Operational Recommendations: Discover practical, actionable strategies from RQM+ experts for overcoming the challenges of implementing diverse clinical trials. Get insights into the practicalities of recruiting diverse populations, managing complex data, and utilizing adaptive trial designs to meet inclusivity goals without compromising trial integrity.

Who should read this?

This white paper is essential for medical device manufacturers, clinical researchers, regulatory professionals, and healthcare leaders committed to advancing healthcare equity through innovation. Whether you're navigating the complexities of FDA regulations or looking to enhance global trial outcomes, this comprehensive guide offers the expertise and strategies you need to succeed.

Meet the author

Dr. Jaishankar Kutty, a visionary in the medical device industry, brings over two decades of transformative leadership in clinical and regulatory affairs. As Vice President of Global Regulatory Affairs at RQM+, he spearheads strategies that guide global manufacturers through complex regulatory landscapes, ensuring both compliance and innovation.

Dr. Kutty's distinguished career includes pivotal roles at BSI, where he led CE marking efforts for groundbreaking cardiovascular technologies, and at St. Jude Medical, where his work in surgical and transcatheter heart valve technologies, renal denervation, and percutaneous closure technologies set new industry standards.  A thought leader in clinical research, Dr. Kutty has made significant contributions to the development of clinical strategies that drive successful trial outcomes.  

In this white paper, Dr. Kutty brings his deep expertise in clinical strategy and study design to bear on the critical issue of increasing diversity in clinical trials. His insights are essential for anyone seeking to enhance trial outcomes while promoting healthcare equity and innovation.