As the development and use of combination products increases, the FDA realizes it needs to establish specific guidelines to oversee this technology. This article explores some of the pivotal issues pertaining to how a combination drug-device, drug-biologic, or device-biologic is regulated.
Creating a contaminant and/or vacuum-free drug delivery device, such as an inhaler, nasal pump, or eye dropper, is a difficult task. This article examines a venting option that enables a closed, equalized system for multiunit-dose drug packaging.
Companies need to move rapidly to take advantage of developing trends in healthcare treatment modalities. This article examines many of the factors combination product manufacturers need to consider to accelerate their product’s time to market.
This article describes how a design-centered company leveraged its innovative consumer design expertise from the audio-visual world and transferred this knowledge to its drug delivery device affiliate, while receiving the collaborative assistance from a computer technology leader.
Dissolvable films are currently used in a variety of applications such as consumer breath freshener products and as vehicles for over-the-counter drug delivery. Manufacturers are also exploring the technology’s unique characteristics for use with in vitro diagnostic devices.
Medical device manufacturers require device components to be produced quickly to ensure their products are available to the marketplace as soon as possible. However, quality cannot be sacrificed in this effort. Rapid prototype tooling is a unique option that satisfies both of these two criteria.
Since most manufacturers do not staff experts in every area of technology they may need to create a finished medical device, collaborating with professionals who are can be the ideal formula for success.
Lean manufacturing is commonly associated with automotive manufacturers but medical device makers are rapidly discovering the advantages of using it in their marketplace.
Thomas Engineering Company’s Quality Management System has been certified as compliant with ISO 9001:2000. Bureau Veritas Certification (NA) has been chosen as the company’s partner in this process.
The Misumi website features enhanced product search capability. Parts can be searched by part number prefix(type), part categories as presented in the 2006 Metric Custom Mechanical Components catalog, and by part families.
The Optomechanical Instrument Register is an information database for Optmechanical Instruments (scientific, medical, technical, and others) with text descriptions and functional illustrations, as well as industrial products.
Makino offers free, easy-to-view online seminars that focus on cutting edge machining techniques and processes such as machining Compacted Graphite Iron, titanium, large molds and lean cellular automation.
Bosch Rexroth Corp. has developed a “Tools and Downloads” website with downloadable CAD files, calculators, configurators, literature, software, and more to help engineers save time in their design work.
On its website, Universal Flow Monitors Inc. provides a chart that enables site visitors to select the appropriate flowmeter technology for the type of fluid they are using. The flowmeter technology selection chart shows the technology that provides best value in a typical application of a fluid.
Technology might finally be keeping pace with rehab patients whose spirits and energy require a sturdier wheelchair to explore the world and enjoy the outdoors, beyond the confines of a smooth hospital hallway.