03.28.23 -- The FDA Regulatory Landscape For AI In Medical Devices

The adoption of 3D printing technologies for implantable medical devices has been relatively slow and largely confined to metal-based implants traditionally used for hip, knee, and spine reconstruction applications. This has been due to challenges in sourcing the right biocompatible materials, validating processes, and adhering to quality and regulatory requirements.

The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time-to-market.

Manufacturability describes the degree to which a product can be effectively manufactured, given its design, cost, and distribution requirements. However, it’s a part of the entire process of bringing a new component or medical device to market. 

This article explores the industrywide challenges associated with electronic component selection for medical devices as well as some of the application-specific decisions medical device designers need to make to ensure these devices function consistently and reliably for the long term.

A cryogenic storage facility can face many challenges while maintaining the correct temperatures for tissue samples. Using a highly durable RFID tag designed for harsh environments with acceptable frequencies, Cryogatt Systems Ltd. worked with HID Global to develop an RFID tagging system to identify and deliver a detailed audit of cryogenically stored items quickly and accurately.