Industry Perspectives - Design & Development

51. FMECA: Relevance In Context Of ISO 14971 & EU MDR Compliance 2/9/2022

    This article focuses on failure modes and effects and criticality analysis (FMECA) and the hazard-based approach in ISO 14971. It uses these definitions and discussions to illustrate EU MDR compliance, and how a top-down approach of FMEA can help.

52. AI & Intelligent Technologies: Finding The Right Fit For Your Pharma Or Medtech Company 1/14/2022

    This article takes a closer look at AI and intelligent technologies in biotech, medical devices, and pharma, and what we can expect to tackle in 2022 and beyond. The article also identifies some of the new concerns and challenges with disruptive technologies and risk management, and discusses a technology and generation timeline.

53. The Data Integrity Body of Knowledge Expands with New & Pending Guidances 12/20/2021

    Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.

54. Using System Risk Structures To Evaluate COVID-19 Pandemic Risks 12/15/2021

    This article's discussion demonstrates how system risk structures (SRS) can be used to understand complex risks and how SRS might be applied to understand the very complex risk landscape of the COVID-19 pandemic. It includes analysis of risk of personal infection, risk of disease progression or spreading, risk of vaccination, and more.

55. Principles And Concepts Of System Risk Structures For Understanding & Managing Risks 12/6/2021

    A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.

56. How To Enable Your Quality Risk Management Lifecycle 11/29/2021

    The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.

57. Attribute Vs. Variable Testing For Device Functionality: What They Are & When To Use Which 11/24/2021

    Testing performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the strategic approaches to selecting one over the other.

58. Risk-Benefit of Personally Identifiable Information in Extended Reality Medical Applications 11/15/2021

    The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential. 

59. Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements 11/2/2021

    Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.

60. How To Create A Pathway For Diversity In Medtech 10/20/2021

    When different perspectives and backgrounds come together, it sparks innovation that can drive significant technological advancement. The most diverse companies are now more likely to outperform their less diverse peers. Beyond company performance, ensuring adequate representation throughout the product development pipeline leads to better outcomes for patients in underserved and underrepresented communities.