Guest Columns
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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5 Focus Areas For Medtech Business Success In 2024
2/8/2024
Medtech manufacturers able to manage today's uncertainty and change will seize on new opportunities through innovation. Successfully navigating this landscape requires proactive consideration of these 5 focus areas.
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Use-Related Risk Analysis For Combination Products
2/7/2024
One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
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Foundational Human Factors Engineering Concepts For The Design Of Combination Products
2/5/2024
How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.
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EEG Technologies Grow Beyond Traditional Diagnostics
2/1/2024
A variety of nontraditional electroencephalography (EEG) methods and technologies popularized in recent years have created a buzz in this once predictable market.
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Auto-injectors: Global Trends & Market Forecast
1/30/2024
Auto-injectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more.
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Tips To Overcome 4 Challenges In The Neurotech Startup World
1/22/2024
These authors have seen that the downfall of neuroscience startups often arises from complex factors. They share tips related to regulatory, financial, clinical, and commercial challenges.
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The Emerging Business Models For Digital Therapeutics
1/16/2024
Digital therapeutics (DTx) leverage technology to deliver evidence-based treatments. Due to reimbursement barriers and slow market adoption, players in the space are pivoting to new business models. This article shares details.
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Product Liability Considerations For AI-Enabled Medtech
1/10/2024
This article explores how and under what circumstances a medtech manufacturer potentially could be held liable under traditional product liability theories for AI-enabled products, as well as possible available defenses.