This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...

This article discusses the opportunities and challenges of creating and maintaining a regulatory intelligence program across regulated industry. The authors suggest a regulatory framework and best practice considerations to implement intelligence strategies in lieu of a standardized approach or framework.   Introduction   The pharmaceutical and medical device industries are faced with many challenges associated with the development lifecycle and overall sustainabil...

This article discusses the opportunities and challenges of creating and maintaining a regulatory intelligence program across regulated industry. The authors suggest a regulatory framework and best practice considerations to implement intelligence strategies in lieu of a standardized approach or framework.   Introduction   The pharmaceutical and medical device industries are faced with many challenges associated with the development lifecycle and overall sustainability...

This article explores the challenges of digital health solutions and emphasizes the appropriate controls necessary to help mitigate the risks and ensure companies are adhering to the growing needs of regulators and industry best practices.   Introduction   The opportunities and challenges in technology are driving explosive breakthroughs for digital health solutions in our technologically focused society. The accessibility, convenience and mobility of digital healt...

This article discusses the challenges and opportunities within the digital health technology postmarketing safety and surveillance arena faced by many manufactures. The authors discuss the opportunities and challenges these devices and technologies may present, compared to the traditional healthcare products in the regulated arena.   Introduction   The term digital health solution is used to categorize technology available through a multitude of devices which provi...

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...

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...

This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality." Introduction According to the Italian Renaissan...