4 Ways IVD Product Development Can Navigate the EUA in the Time of COVID-19
COVID-19 has changed the way companies of all sizes approachIVD product development. Before the emergence of SARV-CoV-2, IVD developers and manufacturers seeking approval in the U.S. were focused on meeting the stringent requirements of the FDA using the design for regulatory (DfR) concept. But as the global impact of the pandemic increased, with no approved…
Selecting the Right Materials for Your Medical Device
How do developers determine the best material for a particular product? Learn more with this guide to selecting the right materials for your medical device.
The Applications of Immunoassays
Immunoassays are biochemical tests that study antibody-antigen reactions to detect and quantify specific target molecules within a biological sample. This bioanalytical method has been a popular and reliable process since its development in the 1950s. Today, medical professionals use immunoassays in a wide variety of processes, including diagnostics, treatment and monitoring, and drug development. Furthermore,…
Microfluidic Plasma Separation for Medical Diagnostics
Human blood is made up of red and white blood cells, platelets, and plasma. Plasma comprises about 55% of blood volume. It carries all elements of blood in suspension throughout the body. Plasma also carries nutrients, hormones, and proteins to where they’re needed in the body, and carries cell waste products away. Antibodies, proteins, and…
Sustainability in Disposable Medical Device Design
Single-use medical devices improve infection control, but create waste and emissions. Sustainability in disposable medical device design is becoming essential.
The Advantages of Rapid Prototyping
Rapid prototyping is a modern product development technique. This method uses 3D printing and other cutting-edge technology to streamline the prototyping process, decreasing the time between designing a product and mass-producing it. The goal of rapid prototyping is to quickly create a physical model of a concept so that manufacturers, designers, and even end users…
The Advantages of Stereolithography
Stereolithography is one of the oldest types of 3D printing. The process applies laser light to photosensitive polymers (resins) to form models or prototypes under computer controls. The process helps medical device designers and other industrial creators visualize their concepts in three dimensions and refine their ideas as a result. The advantages of stereolithography include…
Manifolds
The instruments we engineer at Gener8 are designed to replicate biotechnology functions quickly and accurately. Many of these biotech processes require the use of reagents in precise and varying amounts to aid in a particular reaction to test or detect a critical parameter. To develop and execute these recipes, scientists will use pipettes to aspirate…
Why You Need To Verify and Validate Medical Device Design
Products from software to autos are subject to strict quality assurance processes, as well as design verification and validation. Products produced for a highly regulated market must meet stringent requirements and provide documentation of their quality assurance processes, as well as the steps they have taken to verify and validate their designs. Nowhere is…