Guest Columns
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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.
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Driving Forces In The Laparoscopic Device Global Market
1/4/2024
Laparoscopic surgery is a type of minimally invasive surgery that enables surgical procedures to be performed through small incisions, aided by cameras and specialized instruments. This article delves into the drivers fueling the growth of the laparoscopic device market, including the increasing use of direct energy devices and the role played by ultrasonic devices.
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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.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3
12/20/2023
This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.
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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.
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Key Regulatory-Fueled Updates On Combination Products As We Enter 2024
12/15/2023
In late November, AFDO/RAPS held their annual Combination Products Summit in Fort Worth, TX. The meeting is co-sponsored by the FDA with heavy involvement from the Office of Combination Products, and its representatives covered several themes on the subject as we prepare to enter 2024.
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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.
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Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices
12/14/2023
You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.
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Midline Catheters Show Fastest Growth Rate In Vascular Access: A Global Market Analysis
12/12/2023
In many situations, midline catheters present a superior choice compared to short peripheral catheters, which are suitable for brief indwelling periods, and PICCs, which carry a higher risk of central line-associated bloodstream infection (CLABSI) and are more complex to insert. Let's examine new market research.
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Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices
12/11/2023
The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.