• Feature ArticlesFeature Articles

    Risk Management in the Digital Healthcare Sector

    This article discusses the convergence of the information technology and the healthcare industries and the increased use of digital products connecting patients and healthcare professionals. The author reviews issues surrounding risk management, including the risk potential for “telemedicine” devices, regulatory expectations and cybersecurity concerns. Introduction The medical device and pharmaceutical industries have embarked on an advantageous, evolutionary journey fo...
  • Feature ArticlesFeature Articles

    Medical Device Risk Management

    This article focuses on risk management in the medical device industry and reviews organizational competencies, processes and resources as well as beliefs and behaviors. The authors conclude that, especially in the later phases of product development, not enough attention is paid to risk management tools. Introduction In our previous article, "Organizational Culture and Memory in Managing Risk in the Medical Device Industry" ( Regulatory Focus, August 2017), we discuss...