Abstract
New product development (NPD) in the medical device industry is critical for advancing healthcare technology and improving patient outcomes. Due to high usage of automated processes and applications in healthcare, the medical devices are not limited to products but have expanded to software as medical device. However, the failure rate of NPD projects in this sector remains high due to various challenges. This article explores the complex NPD process, which includes concept development, feasibility studies, design, and development, verification and validation, regulatory approval, and commercialization. Major reasons for project failures are identified, such as regulatory challenges, Change Management issues, market misalignment, communication failures, and insufficient risk management. Addressing these failure points requires a multifaceted approach. Regulatory pathways should be navigated with careful planning and compliance, and market needs must be thoroughly understood through comprehensive research. Resource allocation should be optimized to avoid constraints, and effective communication channels should be established to align all project participants. Finally, implementing rigorous risk management strategies, such as Failure Modes and Effects Analysis (FMEA), can help mitigate potential risks early in the development process. By adopting these strategies, medical device companies can improve their NPD processes, reduce the failure rate of projects, and bring innovative and effective medical devices to market successfully.
Published Version
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