ARTICLES

Technical articles focused on the design, development, and commercialization of single-use regulated devices. 

Recent Articles

Applications of Flexible Materials in Health Care

In Brief

Flexible materials combined with emerging technologies are at the forefront of health care innovations. Guiding recent advances are cost concerns, mass-production, and improved patient outcomes.

 

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7 Steps to Effectively Dual Source a Supply Chain for Medical Devices

In Brief

Dual sourcing is considered a hassle by some traditional medical device manufacturers. After all, the procurement process is faster and more straightforward when you only have to issue purchase orders and receive components from one vendor. Adding a second supplier to your list of approved vendors takes time and creates additional work for your accounts payable staff. 

 

In reality, dual sourcing can be accomplished efficiently and can be a win-win solution if you follow a few key measures. Below is a look at some of the benefits of dual sourcing and your seven-step guide to effectively dual sourcing a supply chain for medical devices. 

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Development of Paper-Based Microfluidics Devices for Point-of-Care Testing

In Brief

Developments in the in vitro diagnostics (IVD) industry have been driven by global trends such as the prevalence of chronic diseases, an aging population, the increase in the occurrence of contagious diseases, and the influence of technology innovators. These trends, plus the desire for ease of use and a general acceptance of personalized care by consumers in developed and developing countries, have influenced IVD developments.

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White Paper: Bridging the Gap from Batch to Continuous Bioprocessing

Abstract

For years, traditional batch manufacturing has dominated the biopharma industry. Recently, however, continuous bioprocessing has gained traction among biopharma manufacturers. Below is a look at some of the key differences between these two types of bioprocessing and the resources required for each. Finally, this paper will examine the ways that industry regulations have adapted to the advent of continuous bioprocessing and the ways that continuous production has impacted the single-use market.

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White paper: FDA Regulated Sterilization Methods

The FDA regulates four critical forms of sterilization: autoclave, dry heat, ethylene oxide, and irradiation. Irradiation includes both gamma ray and electron beam methods. While there are other forms of sterilization, including hydrogen peroxide, high intensity light, and sound waves, these methods are not regulated or approved for use by the FDA at this time. Appropriate, FDA-approved sterilization methods ensure that products are consumable, healthier, and safer for everyone who uses them.

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