What is Pen Testing and Why Do You Need It for Your Medical Device?

The healthcare sector is one of the most-targeted industries by cybercriminals – it ranked #1 for cyberattacks in early 2023. This is alarming because modern medical devices are increasingly connected, and a cyber breach could put patient lives at risk or expose sensitive health data. Regulators have taken notice, too. Starting in late 2023, the  FDA can even reject new medical devices that don’t meet cybersecurity requirements. 

So, what can MedTech organisations do to safeguard their products and comply with regulations? One crucial practice is penetration testing.

In this blog, we'll explain what pen testing is, and explore why it's essential for MedTech companies from a business and compliance perspective.

What is Penetration Testing?

Penetration testing (or pen testing) is essentially an ethical hacking exercise. It involves security experts simulating cyberattacks on your software, device, or IT system to identify vulnerabilities before malicious hackers do. Pen testers use the same tools and techniques as cybercriminals, but in a controlled and authorised manner. The goal is to find and safely exploit any weaknesses in the product’s defences, then report them so you can fix the issues. In the context of medical technology, pen testing has an added significance: it helps ensure that medical devices can withstand cyber threats that might compromise patient safety or sensitive patient data. Pen testing validates that your device’s security controls actually work as intended and that there are no hidden backdoors, weak passwords, unpatched software, or other flaws that could be exploited.

Key point: Pen testing is not a one-time checkbox activity. It can be integrated throughout the product lifecycle – from development (premarket) to deployment (postmarket) – to continually harden security as new features are added and new threats emerge. However, even a single round of thorough pen testing by a qualified team can reveal critical issues that developers might have overlooked.

Why Do MedTech Organisations Need Pen Testing?

Cybersecurity isn’t just an IT problem; it’s a patient safety and business risk problem. Here are some of the major reasons penetration testing is vital for medical device and health tech companies:

1. Protect Patient Safety: Many medical devices perform life-sustaining or critical functions, so a security breach can be life-threatening. For example, if a hacker were to maliciously reprogram a connected insulin pump or pacemaker, it could deliver dangerous doses or disruptions, with potentially deadly consequences. Pen testing helps uncover any such vulnerabilities in device software or wireless interfaces, so you can patch them before they put patients in harm’s way. This proactive approach is part of ensuring your device remains safe and effective under all conditions.

2. Safeguard Sensitive Data (Privacy Compliance): Medical devices and health tech systems often collect or transmit personal health information. A breach could expose patients’ medical data, leading to privacy violations. Frameworks like HIPAA in the US and GDPR in Europe mandate strong protections for patient information. Penetration testing can identify weaknesses that might lead to data leaks or unauthorised access. By fixing those issues, your organisation not only protects patient privacy but also stays in compliance with healthcare data regulations (avoiding hefty fines for non-compliance).

3. Meet Regulatory & Standards Requirements: Regulatory compliance is a huge driver for pen testing, particularly in MedTech. Healthcare product regulators now expect robust cybersecurity risk management as part of device approval. The FDA has issued clear cybersecurity guidance and will not approve devices that lack sufficient protection. In the EU, the Medical Device Regulation (MDR) requires that devices are designed and manufactured in a way that addresses cybersecurity risks. Standards like IEC 81001-5-1 and FDA-recognised UL 2900 series provide benchmarks for medical device security testing. Conducting penetration tests helps ensure your product conforms to these guidelines and standards. In fact, pen testing results can serve as evidence in your regulatory submissions to demonstrate that you’ve assessed and mitigated risks.  For example, one FDA-recognised consensus report, IEC TR 60601-4-5, explicitly covers security testing for networked medical devices, which pen testing can fulfill.

4. Preserve Trust and Reputation: Trust is paramount in healthcare. Hospitals, clinicians, and patients need confidence that the devices they use are secure and reliable. A high-profile hack of a medical device or health platform can erode that trust overnight. Beyond the immediate safety issues, a breach can bring reputational damage and loss of market credibility. Patients might fear using the device, and healthcare providers might think twice about adopting your technology. By regularly pen testing and strengthening your product’s security, you demonstrate due diligence. It’s a strong signal to customers and partners that you prioritise safety and data security. This can be a competitive advantage. Nobody wants their product to be in the news for a security failure; penetration testing helps you avoid that scenario by fixing problems proactively.

5. Avoid Financial Loss and Downtime: Security incidents carry significant financial risks. The cost of a data breach in healthcare is one of the highest among industries, factoring in incident response, notifications, legal liabilities, and lost business.  Breaches have cost the healthcare sector nearly $7.8 billion in losses since 2016. For a MedTech company, a serious vulnerability might force a product recall or firmware update campaign, which is extremely costly and disruptive. There could also be regulatory fines (for non-compliance), lawsuits from affected patients or providers, and even an impact on stock value. Penetration testing is a smart investment to prevent such costly incidents. It’s far cheaper to find and fix a weakness than to deal with a public breach. Additionally, maintaining robust cybersecurity via pen testing can smooth the path for certifications like ISO 27001, which in turn can open up more business opportunities (e.g., partnerships with larger healthcare networks that require proof of strong security controls).

In summary, penetration testing assures that your product’s security holds up under real-world attack scenarios. It’s a preventive measure that supports both safety compliance and business continuity. 

Pen Testing for FDA Compliance (iCare Case Study)

One example is iCare, a manufacturer of ophthalmic medical devices. When iCare was preparing to launch a new retinal imaging device, they needed to prove to the FDA that the device was cyber-secure as part of the approval process. You can read the full iCare penetration testing case study on how it benefited their FDA approval process here.

“The report they provided was incredibly thorough... Their findings were instrumental in our FDA submission, giving us solid, trusted evidence to support our application.”

The test covered both the hardware and software aspects of the device, evaluating it against FDA-recognized standards. As a result, the detailed pen test report became critical evidence for the FDA submission, helping iCare navigate regulatory requirements with confidence.

In the rapidly evolving world of digital health, penetration testing is a must-have for MedTech organisations. It answers the critical question: “Are our devices and systems truly secure against real threats?” By uncovering weaknesses before bad actors do, pen testing helps protect patients, ensures your innovations meet regulatory expectations, and guards your company’s hard-earned reputation. 

In business terms, penetration testing is an investment in quality and trust – one that can prevent devastating cybersecurity incidents down the line and even speed up regulatory approvals by demonstrating robust risk management. As threats continue to grow, proactive testing and remediation will help your organisation stay one step ahead. In short, pen testing keeps your MedTech innovations safe, compliant, and primed for success in a security-conscious market.

Book a Discovery Call to find out more...