What Is System Test Engineering in the Medical Device Industry?

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This article about medical device system engineering is an overview of test and measurement system development for the medical device sector. You’ll find a description of important pieces, and tools as well as a summary of the knowledge and techniques required for effective testing.—Paweł Zieliński, Marketing Manager Consonance

What is test system engineering?

To ensure that a medical device system works as intended, doesn’t produce inaccurate information, and is suitable for use in daily life, it must undergo medical device testing, which entails a complete analysis, assessment, and evaluation of the device. A medical gadget that has undergone the necessary testing satisfies all legal and regulatory requirements. 

It takes a mix of planning and evaluating to create test systems for R&D. To verify the quality of their products, many makers of medical devices utilize automated test and measuring systems. Success depends on developers and clients having a solid working relationship. More businesses are connecting their corporate databases with test systems. Test system developers are progressively using more effective techniques for creating software and overseeing projects. Test applications are routinely transferred to common office programs like Microsoft Word and Excel. Standardizing test system development tools and instrumentation is another cost-cutting strategy that is gaining popularity.

What is a medical device system?

Medical Device Data Systems (MDDS) are pieces of hardware or software used to move, store, format, and display information about medical devices. A MDDS does not alter the data itself or how it is displayed, nor does it alter how any other medical device’s parameters or functionalities are set. That’s why it makes them an inevitable part of medical device engineering

What is the purpose of testing medical devices?

Test and measurement systems are employed in the development of medical devices for a variety of reasons. Among few examples are those created to:

  • Showcase proof-of-concept prototypes of innovative cardiac tissue cauterization equipment.
  • Examine how much new dental filling materials shrink as they harden.
  • Check that implanted gadgets like neurostimulators and pacemakers operate as intended.
  • For implanted devices, maintain and test the batteries.
  • Monitoring and recording a blood-treatment machine’s performance involves simulating the pushing of buttons, twisting of knobs, gathering of patient data, and other tasks.

Medical device testing types

Cutting production expenses is possible however sooner modifications are implemented, the better. There is no such thing as a perfect product from the very beginning. You can modify design, materials, or manufacturing processes because the prototyping stage is for.  On the other hand you minimize the risk of product recalls which usually lead to legal or financial problems.

Lifecycle Verification and Validation

Implementing the preceding phase involves doing verification testing in relation to providing the processes that can identify each stage of the growth process. The goal is for the system to catch all potential faults.

A type of medical device testing called validation can assist you assess a system component at the conclusion of the development phase to see if it meets the required requirements.

GUI testing

The use of GUI testing ensures that the medical equipment reacts appropriately to user interface-based inputs. With the use of GUI testing for medical devices, problems like UI complexity creating user confusion, usage lag, data entry mistakes, false inputs, and others may be avoided before they cause a life-threatening situation in the application phase.

Reliability testing 

When medical equipment is put through reliability testing, its capacity to function well over a wide range of time and even under stressful circumstances is evaluated. In essence, it evaluates the medical device’s dependability in each given circumstance.

Interoperability testing

The capacity to communicate and use information across one or more devices, goods, technologies, or systems is known as medical device interoperability. In order to enhance patient care, lower mistakes and adverse events, and improve patient care, interoperability testing assesses a medical device’s capacity to communicate information across systems and platforms.

Compliance testing

To guarantee that a medical device in use is secure and efficient, several federal and regulatory standards are established by various healthcare organizations. By carrying out a compliance test, it is verified that the medical equipment complies with all quality and safety standards by using the best design and manufacturing techniques.

Performance testing or Bench testing

This kind of testing is intended to obviate any mechanical or design problems that might affect how well the medical gadget performs. Medical equipment are subjected to performance bench testing to assess their durability and capacity to function as efficiently under various types of stress.

Medical device system testing summary

Testing of medical devices is a broad concept to think about. Deft project management is necessary to meet regulatory standards in the complex field of medical devices. This task may be challenging and intricate. While maintaining under budget and meeting deadlines, you must balance the requirements of many different stakeholders. It is essential to show that the equipment is safe and meets clinical demands. At this point you’ve learned about the importance of medical testing methods. To fulfill your goals, all testing methods are distinctive and worth consideration and I advise you to discuss this with an experienced partner in this field.