Industry Perspectives - Design & Development

31. Using Relational Risk Analysis To Control Procedure Failures 2/15/2024

    In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

32. Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity 2/8/2024

    It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

33. 5 Focus Areas For Medtech Business Success In 2024 2/8/2024

    Medtech manufacturers able to manage today's uncertainty and change will seize on new opportunities through innovation. Successfully navigating this landscape requires proactive consideration of these 5 focus areas.

34. Use-Related Risk Analysis For Combination Products 2/7/2024

    One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.

35. Foundational Human Factors Engineering Concepts For The Design Of Combination Products 2/5/2024

    How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.

36. Secure By Design And Default: Compliant Medical Device Development 1/8/2024

    The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA. 

37. The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA 12/21/2023

    The U.S. FDA, Health Canada (HC), and the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) have come together and identified 10 guiding principles, with the aim of developing good machine learning practices (GMLP) that will address the unique nature of AI/ML-driven medical devices.

38. How To Operate In The AI Compliance Vacuum 12/19/2023

    The rapid incorporation of AI into healthcare systems raises significant legal compliance concerns, particularly for technology developers, medtech companies, and users. This article focuses on implications from state practice of medicine laws; the FDA’s regulation of medical devices; the HIPAA Privacy Rule; and the recently issued Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.

39. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

40. The Secret To Medical Device Development Success: A Mindset For Continuous Learning 12/4/2023

    We all want our development teams to get better. But when will we make time to learn and improve? It's much simpler and more available than you think. You don’t need to sign up for a course or order a book. You can learn from the work you’re already doing on development teams.