The MedTech industry depends on software to power life-saving devices, manage patient data, and improve healthcare access and efficiency. From diagnostic tools to wearable health devices to telehealth platforms, medical software applications are central to the functioning of modern healthcare systems. However, as reliance on software grows, so do cybersecurity threats, regulatory challenges, and the risks associated with third-party components. Addressing these risks proactively is essential to maintaining compliance, safeguarding patient information, and ensuring the reliability of medical applications.

In this blog, we’ll explore the unique security challenges faced by MedTech companies, the importance of application security as part of a broader software security strategy, and how SOOS helps MedTech companies protect their business and their patients.

MedTech Software Security Challenges

MedTech companies create devices and applications that handle sensitive patient data, including personal health information (PHI) and medical records. Critical healthcare infrastructure also depends on MedTech software to run. A breach or software failure in the MedTech sector can have devastating consequences, both for patients and for the companies involved.

Key Risks in MedTech Software Security

1. Data Breaches: Medical applications store and transmit sensitive health information. A breach could lead to identity theft, fraud, or compromised patient care.
2. Device Malfunctions: Medical devices with unpatched software or known vulnerabilities can malfunction or be exploited, potentially putting patients’ lives at risk.
3. Regulatory Non-Compliance: The healthcare industry is heavily regulated. MedTech companies must adhere to strict regulations such as HIPAA, FDA regulations, and ISO 13485. Non-compliance can result in legal penalties and product recalls.
4. Loss of Trust: A security incident can damage a company’s reputation, leading to loss of customer confidence and business setbacks. This can be particularly devastating as trust is essential in the healthcare sector.

MedTech Software Security Best Practices

To mitigate the risks of cybersecurity incidents and avoid unmanageable or costly rework of software and/or hardware, MedTech companies must prioritize software security at every stage of the software development lifecycle (SDLC). Focus on these MedTech software security best practices first:

1. Secure Software Development Lifecycle (SDLC)

Embedding security in every stage of development helps prevent vulnerabilities before they reach production.

• Why it’s important: Addressing security early reduces the cost and complexity of fixing vulnerabilities later in development.
• Example: A team conducting regular threat modeling can identify potential attack vectors before code is written, reducing security gaps from the start.

2. Data Encryption and Protection

Sensitive patient data requires strong protection to prevent unauthorized access and ensure privacy. Protecting sensitive health data through encryption is essential, both when it is stored and when it is in transit. MedTech companies can ensure that all sensitive patient data is encrypted by following industry-standard protocols like AES-256 and TLS.

• Why it’s important: Encrypting data prevents attackers from accessing personal health information, even if they intercept it.
• Example: A MedTech application encrypting all stored and transmitted patient data using AES-256 ensures that even in the event of a breach, the data remains unreadable to unauthorized users.

3. Vulnerability and Patch Management

Due to the critical nature of MedTech applications, regularly scanning applications for vulnerabilities and implementing processes to quickly patch software helps MedTech companies prevent cyber incidents.

• Why it’s important: Unpatched software can be an easy entry point for attackers, leading to security breaches and system failures.
• Example: A MedTech company running weekly vulnerability scans and immediately patching known issues with a critical and high priority level reduces the risk of cyberattacks exploiting outdated software.

4. Third-Party Component Management

MedTech applications rely heavily on open source software and third-party libraries, which can introduce vulnerabilities if not monitored properly. Using tools to perform regular software composition analysis (SCA) can help MedTech companies identify risks in third-party dependencies and keep their code secure.

• Why it’s important: Unverified third-party components may contain security flaws or outdated code that can be exploited.
• Example: A team using software composition analysis (SCA) tools to scan dependencies ensures that their applications do not contain insecure or non-compliant open-source components.

5. Regulatory Compliance

Meeting regulatory standards ensures that MedTech companies can legally operate and provide safe products to the market. These standards require robust security practices to protect patient data and ensure the safety and effectiveness of medical devices.

• Why it’s important: Compliance protects both the company and its users by ensuring security best practices are followed.
• Example: A MedTech company maintaining comprehensive audit logs and automated compliance reports can quickly provide regulators with the necessary documentation during an audit.

The Role of Application Security in MedTech

Application security is a core component of MedTech cybersecurity. It ensures that the software applications used in medical devices and healthcare systems are secure from cyber threats. Here’s how application security helps MedTech companies reduce risk, protect their business, and keep patients safe:

1. Proactive Threat Prevention: Application security helps identify and mitigate risks during the development phase, before vulnerabilities can be exploited.
2. Securing Patient Data: Proper application security ensures that personal health data is encrypted, authenticated, and protected from unauthorized access.
3. Automated Vulnerability Detection: With automated security tools, vulnerabilities in code, dependencies, and third-party components can be detected and remediated quickly, minimizing the risk of a breach.
4. Compliance Enablement: Secure applications simplify the process of achieving compliance with industry standards by providing comprehensive security measures and detailed audit logs.

How SOOS Helps MedTech Companies

SOOS provides a comprehensive and easy-to-use application security platform that’s tailored for regulated industries like MedTech. Here’s how SOOS helps MedTech companies strengthen their software security:

1. Patented Software Composition Analysis (SCA)

SOOS scans third-party libraries and open source dependencies to detect vulnerabilities, misconfigurations, and licensing risks, ensuring MedTech applications remain secure and compliant. SOOS offers the only deep-tree dependency scanning, which catches issues other tools can’t deep in an application’s dependency tree.

2. CI/CD Pipeline Integration

Security testing can occur continuously and in real-time as software is being written, with SOOS’s seamless integration into CI/CD pipelines. This makes it easy for teams to see issues right away, while they can be easily fixed and before they can cause business damage.

3. Automated Vulnerability Management

Detailed security reports and configurable risk prioritization enable MedTech companies to proactively address the most critical threats without being distracted by less important issues. Companies can specify acceptable levels of risk and other parameters, from prioritization to ticket auto-creation and assignment in tools like JIRA, to ensure the right people see the most important issues that need to be addressed as quickly as possible. 

4. Regulatory Support and Compliance Assistance

SOOS simplifies compliance with HIPAA, FDA cybersecurity guidelines, and ISO 13485 by providing real-time security assessments, automated reporting for regulatory submissions, and compliance-ready audit logs, including historical point-in-time snapshots that show what actions were taken to secure applications at any given time.

5. Scalable and Cost-Effective Security

SOOS offers flat-rate pricing based on team size, with unlimited scanning at all levels, which allows MedTech companies to easily scan and secure their applications as often as needed without unexpected costs. With SOOS, security efforts can scale with business growth and there are no surprises.

Make MedTech Software Security Doable, Not Daunting

The MedTech industry’s reliance on software to power medical devices and applications makes robust software security practices a fundamental requirement, but implementing effective software security practices doesn’t have to be overwhelming. By adopting secure development practices, managing third-party components, and ensuring compliance with industry standards, MedTech companies can mitigate risks and protect patient data while staying focused on other business priorities like new product development and patient support.SOOS offers a comprehensive, easy-to-use, and cost-effective solution for MedTech software security, making it the ideal platform for MedTech organizations to enhance their cybersecurity without consuming significant team resources. SOOS helps MedTech companies protect the software they build, as well as third-party software, all from one centralized place, while allowing teams to run automated scans, see issue details, and more from within the tools they use today to develop and manage applications. To learn more about how easy it is to get started with and use SOOS, contact our team today.