Locking the Front Door Before the Thief Knocks: Why Penetration Testing Matters in Medical Device Development

Imagine you’ve built a dream house. It’s beautiful, high-tech, and has a state-of-the-art alarm system. But before you move in, wouldn’t you want someone to try picking the locks, jimmying the windows, and testing every possible entry point? That’s penetration testing for medical devices: your “friendly neighborhood burglar” checking your defenses before the real criminals show up.

Penetration testing for medical devices is more than just a “good idea.” It’s a vital step in protecting patients, data, and the device’s reputation. Medical devices are increasingly connected to other devices, to hospital networks, to cloud platforms, and sometimes directly to the internet. That connectivity brings incredible benefits but also opens the door to potential cyber threats. Penetration testing helps manufacturers see exactly where attackers might slip in, long before the product reaches a patient’s bedside.      

Why pen testing matters:

• Understanding real-world risks: Lab testing, baseline controls, and checklists are useful, but they can’t replace the insights gained from a skilled tester actively trying to break into your device. Pen testing reveals vulnerabilities you didn’t know existed.

• Identify gaps early: Do you ever leave your house wondering if you locked the door or shut the garage? Pen testing is a secondary check that you locked the door by checking for any gaps in your security controls, weak controls, or implementation errors before regulators, customers, or attackers find them.

• Proving your security works: It’s one thing to design security controls — it’s another to watch them stand up against an actual attack scenario. Pen testing is a key Validation Testing activity to confirm that your safeguards are as strong in practice as they are on paper.

• Regulatory confidence: Global regulators are raising the bar on cybersecurity for medical devices. Demonstrating robust, independent penetration testing results reassures them that your device meets not only functional and safety requirements but also stands resilient against malicious interference.

Why the right penetration testing vendor matters: Not all penetration testing is created equal. Working with vendors like MedSec, who are experienced in the medical device field, ensures your test is scoped to meet regulatory expectations and      reflects the unique clinical environments where your device will operate. Our experts understand the technical requirements regulators look for and can tailor testing to demonstrate that your security measures will meet — and ideally exceed — industry standards. It’s the difference between hiring a locksmith who knows houses in general and one who knows how to secure a hospital operating room door.

Skipping penetration testing is like installing a vault door but never checking if the hinges are loose. By proactively seeking out weak spots — with the help of experts who know your industry inside and out — you give your device the best shot at surviving in the wild, keeping patients safe and trust intact.

In short — don’t just lock the front door. Try to kick it in yourself. Because when it comes to medical devices, the stakes are far too high for surprises.

To find out more about FDA requirements around penetration testing, take a look at their guidance, which was recently released in June 2025: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA

About Michelle

Michelle Jump, MedSec CEO

Michelle Jump is at the helm of MedSec’s growth, expansion, and overall success strategies. She is an active participant in the development of U.S. and international standards and regulations surrounding medical device cybersecurity. Recognized for her deep industry knowledge, she frequently serves as a panel member, session leader, and presenter at events focused on cybersecurity in healthcare.

Most recently, she testified before congress with other industry leaders about cybersecurity risks posed to our healthcare critical infrastructure by aging medical devices. 

Michelle is the co-chair for the Software working group and the Health Software Quality working group, both part of the Association of the Advancement of Medical Instrumentation (AAMI). She has served on the AAMI Standards Board and has participated as the primary U.S. representative for the International Medical Device Regulators Forum (IMDRF) where she was part of the “Software as a Medical Device” working group.