Guest Columns
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Emerging Trends In Microneedle Drug Delivery Systems
9/22/2023
Patients are increasingly looking for treatments that don't involve injections or other intrusive procedures. Microneedle drug delivery systems have emerged as a solution to meet this demand, as they are designed to penetrate the skin’s surface painlessly and deliver medications directly into the tissue. This article shares the emerging trends and developments in the space.
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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.
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?
9/18/2023
The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?
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A Brief Guide To ISO 13485’s Design Controls In Medical Device Development
9/15/2023
Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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Biosensing Technology: Where Is the Field Headed?
9/13/2023
Biosensing technologies have been used for decades in healthcare for such things as glucose monitoring. More recently, DNA-based sensing is emerging as a way to track multiple targets continuously, providing real-time data, with key applications in diagnostics.
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Global Market Trends For Drug–Device Combination Products
9/12/2023
Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.
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The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic
9/11/2023
The Dominican Republic, a Caribbean nation with over 11 million people, is experiencing an upward trend in attracting medical device clinical trials. Let's look at how its healthcare system is constructed, as well as advantages and challenges of conducting medtech clinical research in the country.
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Surgical Camera Systems: Are 3D Systems A Niche Product Or the New Standard?
9/7/2023
In the U.S., surgical camera systems are one of the biggest markets in video and integrated operating room equipment. Examining new market research, let's look at HD camera systems, 4K camera systems and 3D camera systems.