Improving Medical Device Testing With Robotic Automation

By Stephen Prabu, senior technical program manager, Baxter

Medical devices are integral to modern healthcare, yet failures in these devices have led to thousands of preventable deaths. Studies show that between 2008 and 2017, more than 83,000 deaths and 1.7 million injuries were related to faulty medical devices in the U.S. alone.^1,2 These failures could have been prevented with rigorous verification testing during development.

In 2020, the famous medtech infusion system recall affected 774,000 units in the U.S. due to software and system errors, resulting in 55 injuries and one death. In 2024, another company’s infusion pumps were linked to six serious injuries and one death, prompting a Class I recall, the most severe kind issued by the FDA.

Even more recently (in 2023), incidents involving medical device failures have resulted in several injuries and deaths, prompting significant FDA recalls. Some notable examples include:

1. In July 2023, nearly 350,000 implantable cardiac devices were recalled due to their inability to deliver proper high-voltage shocks during life-threatening arrhythmias.
2. More than 19.7 million drug delivery devices were recalled after reports of two deaths and 25 injuries. The devices were found to have tubing blockages, leading to under-delivery of critical medications.
3. A defibrillator experienced electrical problems, preventing it from delivering lifesaving shocks during cardiac arrest, which could result in permanent damage or death if uncorrected.

These incidents highlight ongoing concerns about medical device safety, particularly with devices used in critical care. The FDA has responded with stringent recalls,^3–6 but the failures demonstrate the need for better testing, monitoring, and innovation in device safety.

The Growing Need For Efficient Testing

As healthcare technology advances, medical devices are becoming highly developed, featuring innovations such as smart technology, connectivity, and data analytics with artificial intelligence (AI). With healthcare technology advancements come stricter regulatory requirements for verification and validation to confirm the highest levels of safety and performance. While effective, traditional manual testing methods are often not cost-effective and are inclined to variability. Delays in device verification can delay time-to-market, impacting the availability of crucial medical devices.

Robotic automation addresses these challenges head-on by streamlining the verification process; delivering faster, more accurate results; and reducing human error.

The Role Of Robotic Automation In Medical Device Verification Testing

Robotic automation systems are designed to perform repetitive and precise tasks accurately and consistently. In the medical industry, robots can replicate various testing scenarios, certifying that devices operate as intended and reliably under various conditions.

Whether simulating different power levels, environmental factors, or patient conditions, robotic testing systems can provide detailed, consistent feedback on device performance. This enables manufacturers to make data-driven decisions during product development, ensuring that only the best products reach the market.

The integration of robotic systems into medical device verification offers numerous advantages, making it an indispensable tool for manufacturers and healthcare providers:

• Precision and Accuracy: Robots can execute tests with 100% accuracy to ensure that medical devices meet the exacting standards for patient safety and regulatory compliance. Reducing human error is significant in testing environments where even minor deviations can have serious consequences.
• Efficiency and Speed: Automating testing processes drastically reduces the time necessary to verify a medical device. Robots can run tests continuously, without breaking, fatigue, or the need to work in human shifts, allowing manufacturers to accelerate their time-to-market. This is particularly critical for high-demand devices like ventilators and infusion pumps, where rapid deployment can directly impact patient care.
• Cost-Effectiveness: While the initial cost of robotic systems may be more, the long-term savings are substantial. Automated testing reduces the need for sizeable manual testing teams, lowers the chances of costly product recalls due to testing errors, and cuts operational costs associated with extended testing cycles. Over time, robotic automation is a highly cost-effective solution.
• Scalability: Robotic testing systems are highly scalable and can be adapted to various medical devices. As new products and innovations emerge, robots can be reprogrammed to test new functionalities, making them versatile tools for the modern healthcare industry.
• Regulatory Compliance: Healthcare regulations, such as those from the FDA and international bodies, require rigorous and documented verification processes for medical devices. Robotic automation can efficiently capture data, generate reports, and confirm compliance with these regulations, reducing the risk of noncompliance penalties or delays.

Spotlight On Automation Of Medical Device Testing For Two Product Areas

Below, I highlight two medical device product areas, chosen due to the complexity, regulatory demands, and potential areas of improvement that can be achieved using robotic testing, as per my observation.

Infusion Devices

Robotic systems are transforming the testing process for infusion pumps, which deliver drugs and fluids to patients in controlled amounts. Automation ensures that these devices are thoroughly tested for dosage accuracy, flow rates, and alarm functions, decreasing the probability of faults that could hurt patients. Robots simulate real-world usage patterns to test how devices perform over extended periods, ensuring safety and reliability.

Medical Containers and Bags

Testing medical containers and bags, such as IV bags and blood storage units, is critical in avoiding contamination and ensuring proper drug administration. Robots can automate the testing of these containers by performing leak tests, pressure tests, and other checks, ensuring that the product meets rigid safety standards. This speeds up the testing process and improves accuracy, minimizing the risk of compromised medical supplies reaching patients.

A Future Driven By Robotics

The role of robotic automation in medical device verification testing will continue to expand. As technology advances, these systems will integrate AI-driven algorithms, allowing robots to learn from testing data, predict potential issues, and optimize testing protocols. This GenAI ability will reduce failures and improve overall device performance, creating a safer healthcare environment.

Additionally, the future of robotic automation will likely involve enhanced collaboration between human testers and robotic systems, where robots handle repetitive, precise tasks, and human engineers focus on more complex, critical thinking aspects of device development.

Robotic automation for medical device verification testing is a blessing to the healthcare industry, providing excellent accuracy, efficiency, and reliability in a world where medical device performance can mean the difference between life and death. Confirming that these devices are tested rigorously and without error is a must. With robotic systems, manufacturers can deliver safer, more effective devices to healthcare providers, enabling successful patient care. This advancement marks a new age in healthcare technology, where robotics and automation improve medical devices' safety standards and quality.

References

1. https://www.gao.gov/products/gao-24-106699#:~:text=More%20than%201.7%20million%20injuries,safety%20issues%20in%20such%20
   devices
2. https://www.icij.org/investigations/implant-files/patients-and-advocates-still-fighting-for-safer-medical-devices-five-years-after-implant-files/
3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-feb-4-2020-voluntary-recall-bd-alaristm-system-pc-units-and-modules
4. https://www.fda.gov/medical-devices/medical-device-recalls/infutronix-llc-recalls-nimbus-and-nimbus-ii-infusion-pump-systems-multiple-device-failures-may-cause
5. https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-implantable-cardioverter-defibrillators-icds-and-cardiac-resynchronization-therapy
6. https://www.beckershospitalreview.com/supply-chain/2-deaths-spur-recall-of-19-7m-drug-delivery-devices

About The Author:

Stephen Prabu is a PMP certified senior technical program manager who has worked in client locations worldwide: Japan, Denmark, Germany, U.S., and India. He has 20 years of experience in managing large-scale teams involving technology migrations, software development, and process improvements. He is pursuing an MBA from Jack Welch Management Institute (U.S.) and holds a bachelor’s degree in engineering from Government Engineering College in India. He can be contacted via email at stevenprabu@gmail.com.