Guest Columns
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Deciphering New U.S. Laws Around Predetermined Change Control Plans
10/10/2023
As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing laws and use of legal terminology that can be cryptic. Here's our interpretation of key passages relevant to postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) products.
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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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Emerging Market Trends For Drug Delivery Devices
10/5/2023
The market for drug delivery devices is growing and it is estimated to reach a market size of $541.5 billion by 2035. This article shares new market research, including segmentation by product type (inhalers, smart pills, drug-eluting stents, and more), routes of administration, regional analysis, and more.
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Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance
10/4/2023
Many medical device manufacturers will continue to make changes after the initial commercialization of the device, and such postmarket changes can be planned or unplanned. As the first article in a three-part series about predetermined change control plans, this article discusses the six steps involved with postmarket change controls and current FDA guidance regarding 510(k) device software modifications.
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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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India Aims To Boost Medical Device Industry With New Initiative
9/29/2023
India's government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a "Sunrise Sector." The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit.
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5 Smart Manufacturing Strategies For Medical Device Startups
9/28/2023
Large medical device companies with deep pockets can afford to employ technology and automation. Startups have to think differently and need to employ true strategic thinking and careful decisions. This article outlines five smart manufacturing strategies that will benefit medical device startups.
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EU Medtech Labeling Compliance & The Competitive Advantage Of A Digitalized Process
9/26/2023
In the medtech industry where time and regulatory compliance are crucial, optimizing and digitalizing your labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers in the EU.
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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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Emerging Trends In Infusion/IV Therapy
9/20/2023
The infusion therapy market in the U.S. is growing rapidly, driven by an aging population and the increasing prevalence of chronic diseases. This article shares new market research, with a look at macro trends as well as trends in infusion pumps, IV sets, needleless connectors, stopcocks, IV filters, and blood transfusion sets.