In an ever evolving regulatory landscape, with patient safety as a top priority, many medical devices companies are willing to adopt single-use, sterile devices.

If single use devices offer many advantages (and market opportunities), a total switch would not address the challenges of the industry.

Worse, it could be a missed opportunity to embrace the digital era and unleash the potential of field data.

Let’s discuss why.

One of the many pain points of the medical devices industry is to ensure regulatory compliance with challenging approval processes, device performance, patient safety while staying competitive. With surgical instruments that must be repeatedly cleaned and sterilized, the risks of human errors leading to infection or instruments that no longer comply with the latest regulations are high. Hence a growing interest in switching to single-use, sterile medical devices. Amongst the frequently mentioned advantages of single use medical devices are the following:

  • There’s no risk for error in the sterilization process and, therefore, patients are less likely to catch an infection while they are receiving care.
  • The inventory process is made easier, no need to pick up trays after surgery
  • For surgeons, no need to wonder about the sterilization process. They just have to pull a new kit off-the-shelf and discard it afterward.
  • With new and stricter requirements regarding reusable devices and sterilization, single-use sterile devices seem not just a viable option to the medical devices industry, but a convenient one.


The potential of field data

But what if such a switch would be a simple but short-sighted strategy?

With Big Data transforming the industry and the manufacturing sector, it is worth discussing the question.

Through Big Data, companies can improve traceability, better manage their supply chain, enhance efficiency, allocate costs more wisely and ultimately make smarter decisions. This is also true to the medical devices industry.

Thanks to embedded technologies in medical instruments or surgical trays, invisible field data including location records, usage or unexpected events that occured, surfaces.

For patients, it means that everything that happens in the O.R is tracked and recorded, thus improving transparency.

For surgeons, it provides valuable insights about how they’ve used medical devices and performed surgery.


So, the question should not be whether to switch to single-use sterile medical devices or not but how to make the most out of this massive amount of field data.

Thanks to a combination of smart devices and advanced analytics, the medical devices industry has a unique opportunity to address most of its challenges while contributing to the future of healthcare.