Guest Columns
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Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?
11/28/2023
For decades, biosensor researchers dreamed about having affinity biosensors that were reversible, but most of us thought this was impossible. The key to achieving this was a new class of affinity biomolecule called an aptamer, which are sequences of DNA that do not bind to other nucleic acids but rather bind to small molecules and proteins like antibodies.
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Human Factors Considerations For Your Emergency Use Drug Delivery Device
11/27/2023
Emergency use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved with who is using the device and how it is accessed.
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Understanding The FDA's New Medical Device Cybersecurity Guidelines
11/20/2023
The FDA cybersecurity requirements for medical “cyber devices” went into effect on Oct. 1, 2023. The FDA has made it clear that it cannot even accept submissions that don’t contain the cybersecurity requirements. This article shares 4 steps to navigate the new requirements.
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A Brief Introduction To Environmental Monitoring For Startups
11/17/2023
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
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4 Key Trends And 2 Attention Areas For Medtech Success In 2024
11/17/2023
After a brief recap of medtech performance in the past year, these Ernst & Young experts share their perspective on the four key trends for medtechs to consider in 2024 (smart connectivity and more), as well as the two focus areas for medtech companies to take strategic action.
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How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products
11/16/2023
This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.
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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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Biochips: The Small Devices With Big Promise
11/14/2023
Biochips are small medical devices with microarrays for carrying out biochemical processes. Biosensors enable the screening of different biological materials like enzymes, proteins, DNA, biological molecules, and more, and are used in drug discovery and research. They can also be implanted in the body for targeted drug delivery or to track health data.
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Growth Strategies Pushing The Next Wave Of Surgical Robotics
11/8/2023
Surgical robotics companies secured four of the largest medtech raises to date. Analyzing the venture financings of these next-generation developers highlights the different capital requirements to bring surgical robotic technologies to market.
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Liquid Biopsy: The Next Evolution In Personalized Prostate Cancer Screening
11/7/2023
The prostate-specific antigen (PSA) blood test has long been the gold standard in prostate cancer diagnostics. More recently, liquid biopsy, which includes the analysis of circulating tumor material in the blood or urine, has emerged as a promising non-invasive tool.