Let’s start right here: Manufacturing medical devices is a
challenge. To begin with, the stakes that come with building devices implanted
in a human body are much higher than the stakes that come with manufacturing
devices that get implanted in the dash of your vehicle. A faulty medical device
can kill someone.
As a result, there are extraordinary moral and monetary liabilities that come from making medical equipment and devices. Those liabilities are reflected in the processes associated with medical manufacturing. Higher quality standards, government regulations, constant setups for short runs, specially outfitted plant floors, and a host of other requirements and obstacles are baked into building things that can make the difference between life and death. However, those challenges have all been around in one form or another for some time.
Now, there are new requirements.
Increasingly, healthcare providers must maintain a “device data chain of custody” that stretches throughout the device’s entire life cycle, going all the way back to the plant floor where the product was built. Manufacturers need to be able to quickly understand the fundamental reason a device failed or malfunctioned. Experts argue that such a thorough chain of custody may prevent large-scale recalls, and instead allow for a scenario-by-scenario approach that is cheaper for providers and manufacturers while also better serving patients.
What does that mean for manufacturers?
Chain of Custody Demands Are Gaining Momentum
It means that manually collecting data and having the
operator enter the information into your ERP terminal simply won’t cut it.
Precise, transparent, accurate, real-time data has become essential for
For many small discrete manufacturers, installing systems that give access to that level of pinpoint data has proven too costly, effectively locking them out of the profitable (and very rewarding) business of building devices that save lives.
Alora for JobBOSS is the manufacturing intelligence platform that gives small discrete manufacturers the ability to compete and thrive in the world of healthcare. Our easy-to-use operator interface allows your team to provide updates through their tablets right at the workstation. Operators can send real-time, accurate data in full context right to your plant’s ERP—syncing up nearly instantly. With a better understanding of your shop floor, setting up short runs, installing “clean” environments, and building products that exceed customer and regulatory standards become far more strategic and profitable.
And if something goes wrong in a device? Small discrete manufacturers using Alora can better pinpoint what went wrong and why without having to do a recall that can put them out of business.
Interested in learning more about how your medical device manufacturing business can leverage Alora by Data Inventions to be more competitive in the healthcare market? Schedule a demo today.