Industry Perspectives - Design & Development
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Harnessing Connectivity In Medical Device Design
11/15/2023
Unfortunately, putting a datalogger in a device and connecting it to a networked database is not a panacea. You’ll need to consider the trade-offs, and you'll need to make the most of your data. And if you are thinking of using AI to help, you'll need to consider that extra layer of complexity.
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FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products
10/31/2023
Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
10/27/2023
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
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The Positive Impact Of The Voluntary U.S. Cyber Trust Mark On IoMT Devices
10/17/2023
The recently proposed U.S. Cyber Trust Mark is a voluntary cybersecurity labeling program operated by the FCC. It will initially provide IoT manufacturers with a certification label that signifies their compliance with cybersecurity guidelines and best practices.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1
10/6/2023
All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.
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A Risk-Based Approach To Assess Particulate Generation For Cardiovascular Devices
10/3/2023
The therapeutic and/or diagnostic uses of cardiovascular devices are broad, and the total length of time that a device remains within the cardiovascular system can range from minutes to the patient’s lifetime. This article examines risk evaluation of particulate matter generated by a device and introduced into the circulatory system.
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Two Key Security Precautions To Protect Your Device — And Your Patients
9/25/2023
A physically secure device doesn't ensure data security, just as shoring up data connectivity vulnerabilities doesn't preclude bad actors from physically damaging a device. But, a vulnerability assessment and penetration test can greatly improve your understanding of how safe a device is from a cybersecurity standpoint.
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?
9/18/2023
The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?
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A Brief Guide To ISO 13485’s Design Controls In Medical Device Development
9/15/2023
Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.