Guest Columns
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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.
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The U.S., EU, Or U.K.: Which Medical Device Market Should I Enter First?
11/6/2023
This is a time of major regulatory changes, and for many, it's been difficult to keep up. This article shares a brief overview and comparison of the regulatory frameworks in the U.S., EU, and U.K., along with key considerations to keep in mind when choosing your first market.
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Regulation Of Digital Health Technologies After Unwinding Of Pandemic Guidances
11/1/2023
As a result of COVID-19 pandemic, the FDA loosened restrictions on the oversight of digital health technologies (DHTs), and even began to encourage their use in certain settings. The expiration of the public health emergency means that a few of the relevant DHT guidances may sunset this month (November).
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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.