Mini Implantable Sensor Monitors Health
To ensure the technology’s future applicability, a significant portion of the project focuses on evaluating the developed prototype’s performance through specific lab tests, with careful consideration given to biocompatibility assessments and other medical aspects.
Innovative Iteration for Medical Device Design
Paragon Medical’s collaborative development approach fr […]
Rapid Prototyping Method for Microscale Spiral Devices
A new rapid prototyping method allows for precise and e […]
UDI at 10: Moving into The Future
This article presents a snapshot of the current state of the UDI and how the movement may evolve.
Part 2: Designing Piezo Handpieces for Ultrasonic Surgery
Ultrasonic handpieces are being used with growing frequency in medical applications, for example, with minimally invasive surgical procedures and in dentistry. These instruments, which include ultrasonic scalpels, phaco handpieces, and scalers, use acoustic waves to facilitate the processing of hard or soft tissue. Part 1 of this article, which ran in March 2023, looked at the general structure, design variants, and system design of ultrasonic medical handpieces. Part 2 now reviews driver design, special applications, drive electronics, and failure mechanisms.
Contact Lens Could Diagnose Glaucoma
UK and Turkey have developed a contact lens that can detect changes in eye pressure that signal possible glaucoma.
Plastic Gears Are Enabling Today’s Advanced Applications
In this article, we’ll take a look at some of the advancements that have enabled the conversion to plastic gears, the potential benefits, and the key design considerations, whether you’re converting metal gears from a legacy product or designing a novel device.
Seeing Double: What to Watch When Bringing Combination Products to the EU Market
Autoinjector pens, smart inhalers, syringes prefilled w […]
What You Need to Know About USP 661 Series on Plastic Packaging
The USP-NF is a combination of two compendia: the United States Pharmacopeia (USP) and the National Formulary (NF). When USP-NF set out to revise General Chapter <661>, Containers-Plastics in 2013 [published in Pharmacopeial Forum/PF 39(5)], one stated goal was to increase flexibility by going from prescribed tests and limits to a model where the drug manufacturer could apply tests based on risks associated with the packaging’s Materials of Construction (MoC) and the drug product dosage form.
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs).
