From Material Selection to Patient Safety: Building a Risk-Based Evidence

Dive into how smart material choices can seriously boost patient safety with a risk-based approach.

Selecting a medical-grade material is only the beginning of demonstrating device safety. Clinical exposure conditions, duration of contact, manufacturing processes, and the final device configuration can significantly influence the evidence required to support safe use.

This session explores how developers can connect material selection and characterization with biological evaluation, device-level risk management, and clinical evidence generation. Using a practical, risk-based framework, it examines how ISO principles, risk management, and FDA and EU regulatory expectations inform development decisions.

Particular emphasis will be placed on collaboration between materials engineers, clinical teams, regulatory affairs, and product development to identify safety questions early and avoid fragmented testing strategies.

Attendees will leave with a structured approach for identifying evidence needs and communicating safety considerations across multidisciplinary development teams.

About Speaker

Dr. Sparshika Chhaperia is a family physician and medtech professional whose work spans frontline patient care, clinical research, and healthcare innovation. She has cared for patients in tertiary hospitals and resource-limited rural clinics, giving her firsthand insight into the real-world challenges healthcare technologies must address to achieve meaningful impact.

Her work spans medical devices, digital health, clinical strategy, regulatory affairs, and quality systems, with a focus on translating unmet clinical needs into practical, scalable healthcare solutions. Bridging the gap between clinicians, engineers, and innovators, she brings a patient-centered perspective to product development and technology adoption.