Guest Columns
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What To Expect When You Move Into Production For The First Time
6/17/2025
In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.
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Key Regulatory Landscapes For SaMD Around The World
6/13/2025
As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are evolving to keep pace.
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A Look At Elsa, The FDA's New AI Digital Assistant
6/12/2025
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
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Bracing For The Impact Of The Federal Workforce Reduction
6/9/2025
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.
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Neuromodulation Dominates The U.S. Market For Neurological Devices
6/6/2025
Neuromodulation devices are used to manage conditions such as chronic pain, neurological disorders, epilepsy, and more. New market research shares U.S. market trends.
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Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
6/6/2025
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
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China's Medical Device Market: A Land Of Opportunity And Challenges
6/3/2025
Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in China.
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A Road Map For Transitioning From A Research-Focused To Commercialization Mindset
6/3/2025
As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?
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Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis
6/2/2025
Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.
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Connected Drug Delivery Devices: Emerging Market Trends
5/29/2025
Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration tools. New market research shares emerging growth and trends.