There’s been a big increase in artificial intelligence (AI) within digital health technologies. The cross between medical technology and AI requires that products be evaluated in accordance with domestic and international regulations. These technologies include interacting hybrids of software and hardware, stand-alone software, and software as a medical device interfacing with medical administrative systems.

The FDA’s Digital Health Department recommends using digital health criteria and traditional software guidance to carry out specific design approaches as needed per the technology. Both the FDA and the Medicine and Healthcare products Regulation Agency (MHRA) have expressed the need for machine-learning transparency and further explanation of validating an algorithm that is continually learning, changing, and improving itself.

With an evolving regulatory environment and an ever-expanding digital health market, there’s a need to find new approaches to address compliance around AI software.¹ This wouldn’t exclude the need to ensure compliance to computer software regulations such as 21 CFR Part 11 and Annex 11 for audit trails, electronic records, and signatures.

(Hexagon Manufacturing Intelligence: North Kingstown, RI) -- Hexagon’s Manufacturing Intelligence division announced the opening of a new OEM laboratory at its Precision Center in Oakville, Ontario, Canada. The calibration lab will serve as the main Canadian center to support and service Absolute Arms used for high-end portable measurement and inspection applications.

Hexagon technicians will perform testing and calibration procedures traceable to national and international standards, ensuring customers receive reliable results and consistent data. Hexagon’s investment in the Oakville Precision Center also adds a large training facility equipped with Absolute Arms for customer use, as well as a new shipping and receiving bay. The training area will also support Hexagon’s metrology software portfolio—PC-DMIS, REcreate, and Inspire—for data acquisition and management, analysis, reporting and reverse engineering applications.

There’s no better time than now. As a species, we need to mitigate the effect we have on our planet. There are many ways to do this—namely, through green and eco-friendly initiatives—but one sector is having the biggest impact of all: the industrial and manufacturing sector. In the 2010s, the industrial sector accounted for nearly 50 percent of the world’s total energy consumption, and during the last 60 years, that has almost doubled.

Manufacturing isn’t just energy-intensive, however. It’s also responsible for harmful emissions and is a huge producer of waste. Establishing more energy-aware manufacturing processes and systems would be a massive step in the right direction. It could mean the difference between slowing climate change or stepping over our fast-approaching tipping point.