Medical

In Vitro Diagnostics

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

Challenges of Diagnostic Equipment Development

Although diagnostic equipment is making advanced technological strides, there are still challenges companies are working to address. Diagnostic equipment failure is one of the most serious types of medical equipment failure due to its importance in properly diagnosing a patient and ensuring correct treatment. Common challenges in this tech adoption include:

Mechanical Accuracy

An IVD device takes a human sample (blood, saliva, etc.) and places it to be scanned and analyzed. If the positioning of this sample is off, even by a minuscule amount, the results of the test can be wrong or invalid.

Temperature Control

Diagnostic and analytical instrumentation require temperature controls to keep equipment working reliably and efficiently. The trend towards smaller and more compact devices can also present thermal challenges.

Data & Regulatory Requirements

Major changes in In Vitro Diagnostic medical device regulation (IVDR) present as challenges for IVD manufacturers (classification system changes, clinical and performance evaluation requirements, etc.).

Solutions

Mechanical Design

Ease of use, mechanical positioning in relation to optics, cartridge movement, and more are key in device accuracy. Mechanical design and DFX expertise provides reliable and accurate device function.

Control & Embedded Systems

Temperature control of both a sample and the environment can be achieved by incorporating sensors within the device system, software with safety components, hardware shutoffs, and more.

Design for Regulatory Requirements

Have a strict quality management system in place, a process for testing and analysis, and a connected product for post-market-surveillance initiatives.