Guest Columns

31. Infusion Therapy: Growth In Home And Alternate Care Sectors Supports Market 10/19/2020

    The U.S. infusion therapy device market is a fairly saturated space, but that doesn’t mean opportunities for growth do not exist.

32. ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices 10/19/2020

    Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.

33. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

34. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

35. How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices 10/7/2020

    What objective evidence is necessary to show that your medical device performs as intended for its specific purpose, when needed, with operational resiliency, and without unwanted behaviors or exploitable vulnerabilities? These suggested activities will provide the type of information and objective evidence regulators require to prove the trustworthiness of a device.

36. ISO’s Updated 22442 Animal Tissue Standards — What Changed? 9/29/2020

    This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

37. ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices 9/28/2020

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

38. Hazmat Regulations: What Life Sciences Companies Need To Know 9/25/2020

    It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

39. A Methodology For Developing Injection-Molded Plastic Parts For Your Medical Device 9/21/2020

    This article describes a methodology that addresses the questions that have a reputation for being “troublemakers” in the process of injected plastic product development, without compromising innovation and creativity.

40. Generate The Right Input Data For A Quality Management Review System 9/21/2020

    In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.