The Value Of Systems Engineering In Medical Device Development

Systems engineering is a comprehensive management and technical discipline that ensures efficient product development by systematically transforming user, business, and regulatory needs into effective solutions. It plays a critical role in industries developing complex products, such as aerospace, consumer electronics, and medical devices. Established in the 1950s, systems engineering has been proven to improve cost compliance, schedule adherence, and product quality.

A key aspect of systems engineering is risk management, addressing technical, user, and regulatory challenges to meet project and product objectives. By considering all aspects of a system from the outset, systems engineering reduces costs, minimizes redesigns, and enhances system performance. The INCOSE Systems Engineering Effectiveness Study found that projects implementing strong systems engineering practices were three times more likely to succeed.

Product development is inherently non-linear, with early-stage decisions impacting later phases like testing, manufacturing, and integration. A study by the Lean Aerospace Initiative at MIT demonstrated that effective systems engineering reduces project cost growth by 18% and improves schedule performance by 30%.

At Battelle, systems engineers come from diverse scientific and engineering backgrounds, enabling them to solve complex technical challenges. They balance technical details with a broader project perspective, ensuring sound decision-making throughout development. Future discussions will explore the role of systems engineering in medical device development.

With structured processes and risk-focused strategies, systems engineering remains a key driver of successful, efficient, and high-quality product development.