Cybersecurity and the Medical Device Product Development Lifecycle

Author: John Campbell | October 8, 2021

medical device product development lifecycleWhile 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:

  • Get FDA premarket approval sooner, without being required to rework your product to address security issues
  • Reduce time-to-market and costs
  • More accurately assess medical device development progress
  • Protect your brand image
  • Easily produce the appropriate compliance artifacts at each stage of the product development lifecycle process to support traceability

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:

  • Secure communications: Determine how your device will communicate with other devices and networks—and even less secure devices
  • Data protection: Identify the appropriate level of protection (e.g., encryption) required for data that’s stored on or transferred to or from your device, as well as necessary confidentiality risk control measures
  • Data integrity: Evaluate the system-level architecture to determine the need for specific design features that ensure data non-repudiation and anti-malware controls
  • User Authentication: Determine who is authorized to use the device and the associated access controls and granting of privileges
  • Software Maintenance: Define how the software will be securely updated and maintained to ensure it is protected against emerging vulnerabilities
  • Physical Access: Consider necessary controls to prevent an unauthorized person from accessing the device
  • Reliability and availability: Think through any design features that will enable the device to detect, respond to, and recover from cybersecurity attacks

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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    Dan Sterling Photo of Dan Sterling President
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 dan@sterlingmedicaldevices.com
    John Campbell Photo of John Campbell VP of Operations
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jc@sterlingplm.com
    John Fargo Photo of DanJohn Fargo PLM Manager
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jf@sterlingplm.com