Author: John Campbell | October 8, 2021
While ensuring secure medical devices has always been a priority among regulatory bodies and medical manufacturers alike, the issue of security has taken center stage of late. As distributed healthcare continues to expand, so too does the need for the technology that supports it—particularly in our pandemic-induced socially distant world.
The proliferation of technology, smart devices, and interconnectivity in healthcare offers a range of life-saving benefits. It also opens the door for more frequent and more damaging cyberattacks. Cybersecurity attacks have the power to shut down hospital networks, disrupt the delivery of patient care, and delay treatment—which can ultimately cause patient harm.
While medical device manufacturers are responsible for staying on top of potential cybersecurity risks and hazards related to their devices, many don’t know exactly what that looks like or where cybersecurity fits into the medical device product development lifecycle. If this sounds like you, you’re not alone.
Cybersecurity and the product development lifecycle process
Many medical device manufacturers approach cybersecurity as an afterthought; they put it off until the final stage of product development, which can render disastrous results. Sure, on the surface, this may seem like the quickest path to market—but the opposite is more likely to be true. Think about it: let’s say you do your security check just before launch, and you discover an issue. Then what? Unless you’re willing to risk releasing an insecure product to market, you have no choice but to go back and correct the issue, which means significant delays and added expenses.
True security starts on the first day of development and ends years after the product’s end of life or end of support. It is imperative that you incorporate cybersecurity early in the medical device product development lifecycle process. By evaluating risk across each phase and addressing issues as they arise, you ensure smoother design, manufacturing, testing, and post-market monitoring processes.
More specifically, when you embed cybersecurity into your medical device product development lifecycle, you will be poised to:
How to improve cybersecurity in medical devices:
As you incorporate cybersecurity practices across your medical device product development lifecycle, think through the following core security elements, as outlined by the International Medical Device Regulatory Forum:
Embedding appropriate security activities into each step of the product development lifecycle process is not a nice-to-have; it’s essential. But recognizing the need for cybersecurity in your medical device product development lifecycle and knowing how to do it are not one and the same. Sterling PLM can help.
Backed by Polarion ALM, a browser-based regulatory-compliant project management software, we’ll help you manage your product development lifecycle, ensure the appropriate cybersecurity practices are incorporated, and overcome any project management challenges you encounter along the way.
For help navigating the complex world of cybersecurity for your medical device, contact us here.
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