Medical Device Solutions Fact Sheet

Battelle offers comprehensive medical device development services that span the entire product lifecycle—from concept to commercialization. With decades of experience in engineering, applied science, and human-centered design, Battelle helps companies turn complex medical technology ideas into market-ready solutions. Their approach integrates device design, prototyping, usability, regulatory strategy, risk management, verification, validation, and manufacturing support.

Working across various therapeutic areas—including drug delivery, diagnostics, surgical tools, and wearable health tech—Battelle collaborates with clients to solve pressing technical and user challenges. The team includes mechanical, electrical, and software engineers; industrial designers; human factors specialists; and regulatory experts. Their deep expertise enables seamless development of Class I, II, and III devices in compliance with FDA and international standards.

Key capabilities include systems engineering, design controls, risk analysis, design verification and validation (V&V), and support for FDA submissions. Battelle also excels at integrating digital health solutions, data analytics, and wireless connectivity into modern devices, helping clients address evolving market expectations and regulatory demands.

In addition to technical execution, Battelle emphasizes usability and patient-centric design to improve outcomes and ensure device adoption. Their human factors team conducts usability studies to minimize user error and meet regulatory expectations for safety and effectiveness.

By combining multidisciplinary expertise with agile processes, Battelle accelerates time-to-market while reducing development risks. Whether clients need support for a single phase or full-cycle development, Battelle delivers tailored solutions to meet today’s complex healthcare innovation demands.