Tag Archives: software

Brian Greene, HMD Labs
Soapbox

Smart Device Startup Data Challenge: Synch Building with Funding

By Brian Greene
Brian Greene, HMD Labs

To achieve success, a medical device startup must build a sophisticated data architecture specifically designed to deliver maximum value for its customers’ use cases. However, it’s extremely difficult to build such an architecture—especially given early-stage budget constraints. That’s why startups must wisely synch their data architecture spending with their funding rounds.

Continue reading

Dave Locke, ACSYS
MEDdesign

Laser Automation and Robotics Support Medical Device Design Innovations

By David Locke
Dave Locke, ACSYS

Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.

Continue reading

Artificial intelligence, medical devices

The Regulatory Aspects of AI/ML-based SaMD

By Zuhal Reed
Artificial intelligence, medical devices

Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.

Continue reading

National Cancer Institute

Cybersecurity by Design in Medical Devices

National Cancer Institute

Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.

Continue reading