Drug Delivery

What is 21 CFR Part 211? The Code of Federal Regulations Title 21 Part 211 refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. These requirements are meant to ensure that finished drug product is handled in a way that does...

The way in which a drug enters the body can have a vast effect on the efficacy of a drug, impacting where it is released, how much can be absorbed, and how long it remains in circulation. Innovations in methods of drug delivery have led many companies...

[embed]https://vimeo.com/461522190[/embed] Human-centered design is a core part of the Gilero process.  We strongly believe that by bringing user needs into focus early within the medical device design and development process, we can deliver products that users readily embrace and can be operated safely in real-world conditions.  The...

Transferring a medical device into manufacturing can be challenging. There is a high demand to manufacture devices efficiently, affordably and with a faster time-to-market than ever before. Medical device manufacturers must find innovative solutions to meet these needs while following best practices and regulatory guidelines to ensure...

What is a Combination Product? A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. A combination product will combine at least two of these product categories and sometimes combines all three. Some of the most common types include traditional...

What is a Cleanroom? A cleanroom is a controlled environment in which the number of airborne particles is kept to a minimum. These particles could include contaminants such as dust, airborne microbes, aerosol particles and chemical vapors. The contamination level in a cleanroom is specified by the...

For centuries, drugs have been used to treat ailments, improve health and extend the lives of both humans and animals. The substances used as drugs have evolved greatly from the mixtures of medicinal plants and other ingredients found in ancient times. As the science of drugs and...

As medical and drug delivery devices grow increasingly complex, regulatory agencies continue to place a greater emphasis on ensuring the safety and effectiveness of these devices through user research and human factors testing.  Anyone using a medical device, whether clinician or patient, should be able to do...

This is an excerpt from the article Delivering the Goods: The Evolving World of Combination Products, written by Sam Brusco, Associate Editor of Medical Product Outsourcing. The full article can be found here. The drug delivery and combination products market is technically made up of several different...

By: David Orenstein, Product Development Engineer for Gilero It can be difficult sometimes to see the value in usability testing. As devices are developed they seem so simple to the engineering team developing them; or the complexities are so justified it wouldn’t make sense to do it...