The advancement of science in the medical field has allowed human beings to expect a better prognosis of recovery after a serious illness, and a longer life span overall. Today, one of the most valuable resources healthcare professionals rely on is medical devices. These machines provide doctors with an accurate diagnosis and evaluation of a patient’s condition, which enables them to act fast in choosing the right treatment plan based on data analysis. Some of these devices, such as defibrillators, are replacing the human workforce in monitoring patients around the clock, and are powerful, reliable tools for accurate checking of critical health parameters. Some other devices, like external infusion pumps, are effective in delivering fluids, medication, or other necessary nutrients into a patient’s circulatory system in a controlled manner.

Regardless of the purpose these devices serve, physicians apply them to meet the goals of:

• Increasing medical practice safety
• Controlling those symptoms a patient has to coexist with
• Providing patients with confidence over their general health condition so they can enjoy life and keep up with their daily routine
• Lowering human workforce and health care cost
• Allowing physicians to upload patient medical reports on desktop computers and mobile handhelds

Medical devices that are embedded with a lightweight database designed by standards can be very beneficial for physicians in order to track a patient’s previous and present condition, as well as predicting the future path of some serious symptoms. An embedded database is a software library used by medical device applications to store data safely and efficiently. Embedded databases can be implemented in many different ways, but the choice of algorithms in a particular database product has a profound impact on performance characteristics and what features are available. Modern software-controlled devices allow healthcare providers to combine life-critical data and apply it to make better-informed decisions. A true relational embedded database serves medical devices for:

• Procedural data
• Reliable storing and setting
• Patient data management
• Medical device configuration
• Efficient queries
• Safe shared access

Storing, organizing, and sharing are important requirements for most medical applications, as they enable a combination of multiple tasks across devices and the monitors that control them. A medical device application can use an embedded database library to manage memory more effectively, by both imposing bounds on memory usage and analyzing worst-case behavior in a consistent way. The database library can handle all the details of reading, writing, indexing, and locking data within a predictable footprint, so that the application’s own memory requirements are greatly reduced. Simultaneously, the need to store health-sensitive data in a software library encourages developers of these embedded systems for the medical sector to take into consideration some critical areas when implementing a database, including:

• Frequency of costly disk or flash media I/O operations
• Time required to recover from a crash or power loss
• Ability to manage large amounts of data without severe performance degradation
• Performance impact of sharing data between tasks and other applications
• Relative performance of read and write operations
• Portability of the storage format and application code
• Effort required to integrate database technology into the application
• Making data management and connectivity secure

Medical devices are built with dedicated hardware that is tailored to the needs of the device. Compared to a desktop workstation, memory and storage space are limited, and the consequences of running out of memory are much more serious. A relational database software library is designed to function within such constraints. With cross-platform support and optimization for flash media storage, it is able to efficiently enhance the data management capabilities of the medical device. Some of major values of embedding such a database in critical medical devices are:

• Data protection (storage encryption)
• Security
• Shared access with row-level locking
• On-disk/In-memory
• Source code availability
• Assistance during development and deployment
• Assistance in obtaining various certifications
• Specific feature additions and customization
• Support for the Quality Assurance process

Another consideration for most medical devices relate to data loss and power management. Battery backup is often employed by certain medical devices to prevent sudden power failure, but even this cannot prevent full power loss in all situations. When a power failure occurs, the database protects data from both corruption and loss of critical data. On a medical device, data is often shared between concurrent tasks. While data is being continuously collected, it is also necessary to produce reports on that data. A database provides shared access capabilities that let several tasks safely work together on the same database. Among its many offerings, a relational database and connectivity framework empowers medical device applications with:

• Reliable data storage
• Linked drug library
• Cross-platform portability
• Fast search and sort on flash media
• Relational data functionality
• Scalable, reliable storage
• Small memory footprint
• Ease of maintenance
• Low cost per unit
• Shorter time to market
• Shorter sales cycle

As developers prepare their medical devices for global distribution, they look for more efficient ways to reduce cost, meet government safety requirements, respond to data needs beyond a single doctor’s office, reduce power consumption in portable medical devices, provide strong support for a broad range of authentication and encryption methods, and increase security and reliability. Every medical application that manipulates information must face at least one of the problems addressed by database such as reliable persistent storage, high-performance search, and safe data sharing.

ITTIA DB SQL is an out-of-the-box, true relational embedded database library that can bring a definite solution to all common data storage problems of medical device applications by enhancing them with features such as transaction logging, scalable index algorithms, and isolated concurrency. ITTIA empowers manufacturers of medical devices with:

• Support through all phases of product development
• Advice during planning and design that gets development started in the right direction from the very beginning
• Training programs that give medical application developers an edge up with a thorough introduction to the capabilities of embedded database and best development practices
• Customer support extending to the deployment of the device and application, ensuring a smooth delivery and market adoption

Securing data for management and connectivity purposes is the most important responsibility of any medical device manufacturer. When a bank account is hacked, we face financial damage; when a corporate computer system is accessed illegally, proprietary information may be revealed; but when a medical device data is attacked, the damage can be life-threatening.

To prevent theft and tampering, patient data must be protected through proven techniques such as encryption, authentication, and secure communications. Manufacturers also need to follow a design pattern that allows device software to scale without compromising security or performance. This is accomplished through a combination of compatible operating system, file system, and database technologies that provide safe and secured access to shared data.

By cutting out a large amount of software development work, a medical application using a true relational embedded database can be developed faster and at a lower cost compared to the same application without a database library. Software developers do not need to sacrifice performance in critical algorithms. And with the database supporting standard features like SQL, the application can offer features that would otherwise be impractical to develop.

Sasan Montaseri is the founder and president of ITTIA. He has more than 20 years of experience in the embedded database arena. He holds a BS in Electrical Engineering from the University of Kansas with a minor in Mathematics. He was a member of PI MU Epsilon National Honor Society of Mathematics.

Ryan Phillips is a senior lead database engineer at ITTIA. He has more than 15 years of software and database development experience. Ryan is a member of the ITTIA design and development team and holds a BS in Computer Science from the University of Washington.