Security from the beginning: Integration of security in the development process of mechatronic systems

The development of medical devices poses many challenges, especially concerning security. To guarantee control over sensitive health data and ensure patient safety, it is of utmost importance for medical device manufacturers and developers to consider cybersecurity as an integral part of development and to implement it properly during all phases of the product life cycle. This is the beginning of “Security by Design”.

Recognizing challenges and targeting security risks

Medical products that communicate with each other are important components of modern healthcare. Although networking offers undeniable advantages, there are often media reports about systems with major flaws and attacks from hackers. Vulnerabilities in IoT devices can have fatal consequences and, in the worst case, endanger the lives of patients. There are numerous challenges for secure, high-performance medical products during their entire life cycle:

• Regulatory requirements: It can be difficult to keep track of and correctly apply all the regulatory requirements and standards. Currently, the medtech industry only has a bit of experience in this area. This presents a major challenge, especially for companies that are new to the industry. One possibility for these companies is early collaboration with industry experts who have experience in medical product development and understand the relevant regulatory requirements.
• Correct balance and assessment: Security measures in medical product development are essential for ensuring patient safety and the integrity of patient data. However, too many security measures can affect the user-friendliness of the product. Therefore, a comprehensive risk assessment and careful tuning of security measures versus usability are vital for a correctly balanced relationship.
• Developers: It is also important to ensure that the developers have the knowledge and skills required to integrate security-related functions into the product. This is solved through training programs and coaching for the developers.
• System architecture: Conscious decisions about technology, design, and third-party components must be made and properly documented for a holistic and secure architecture. There must be a focus of attention on “Security by Design” using proven methods and algorithms. The organization and structure also have an influence on the system architecture and must be considered.

Furthermore, an important part of the development process for medical products is the security risk analysis. The analysis identifies and evaluates potential threats and vulnerabilities in the system which allows defining and implementing key security controls to minimize these risks. Conducting the risk analysis at an early stage makes it possible to promptly identify security problems and respond accordingly. Afterwards, the design verification ensures that the product fulfills the previously defined requirements. A thorough, well-documented design is essential and supports product security during the entire life cycle.

Continuous monitoring of the product life cycle is essential

In conclusion, compliance with regulations and standards as well as the consideration of security risks and the determined requirements are essential when developing medical products. An early impact analysis and threat modeling enables a targeted security architecture and helps minimize security risks from the beginning which promotes user confidence in the product. Since threats can change over time, it is important to continuously monitor the market and adjust security measures through the entire product life cycle. Therefore, the distributor and the operator are ultimately responsible for maintaining a sufficient level of security to protect patients and medical staff as well as ensure product safety. Security requirements must be an integral part of the development process for mechatronic systems.

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Authors:

Ivo Locher, Program Manager (in collaboration with Manuela Scavelli, Copywriter)

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