In the fast-changing world of healthcare technology, HTM professionals are always looking for new ways to test and maintain equipment accurately. Here, industry experts Elliot Weldon, product application specialist at Fluke Biomedical; Greg Alkire, vice president of sales and marketing at Pronk Technologies; Tim Welby, vice president of sales and marketing at BC Group; Lewis Lennard, product manager at Rigel Medical; share insights on the current trends and strategies driving advancements in the biomedical test equipment sector.

Greg Alkire: Healthcare technology is in a constant state of evolution and advancement. We at Pronk are passionate about supporting biomedical engineers and others in HTM with products that solve issues raised by this dynamic landscape. This is very much true with our latest product, Pressure MAX Digital Pressure Meter. Designed to address a greater need for high accuracy, portability, and efficiency, it features multi-channel capabilities—i.e., two meters in one, to test fluid, gas, or air.

It includes automated testing and data collection capabilities, plus a new target feature for speed and ease of use. The Pressure MAX is both tiny and highly durable, passing our industry-leading 50-times drop testing without any failures and still operating within specifications. With a tool like this, biomeds save time and gain flexibility to get more accomplished.

Tim Welby: The field is looking for more automated processes that include auto-sequences based on OEM requirements. This allows more throughput and reduces missed steps. Additionally, having the opportunity to run tests via Bluetooth on an app is very inviting. This reduces transcription errors as the app captures the actual readings, eliminating the opportunity for keystroke errors or reading the wrong information due the information being illegible.

Lewis Lennard: There is a trend toward portability in biomedical test equipment to meet the demand for compact, lightweight, and handheld devices. Portable analyzers enable healthcare facility testing and field service applications, expanding access to testing capabilities in remote or resource-limited environments. Several of Rigel’s portable analyzers have been used in harsh, remote conditions, and the durability of the equipment has been recognized. 

Integration with IoT technology stands out as another prominent trend. We recently released an app that can generate PDFs and test reports, which helps facilitate real-time data capture and storage, simplifying the management of test results and documentation.

Elliot Weldon: As with many other areas in healthcare, workflow automation is becoming a focus in the biomed arena. Most biomedical test equipment companies are now offering some form of automation.

What distinguishes Fluke Biomedical is our OneQA workflow automation software. OneQA facilitates the standardization of test procedures and records test results for the technician, saving valuable time and reducing human error. Additional features include the ability to save notes and pictures in the procedure, allowing for the tech to easily follow the necessary test steps. Plus, OneQA has an open [application programming interface]that allows the solution to work with most major CMMS platforms.

24×7: What are some of the biggest challenges facing the biomedical test equipment sector today, and what strategies are being employed to overcome them? 

Weldon: Biomeds face multiple challenges daily. Some of these issues include:

  • An aging and rapidly retiring workforce.
  • The diminishing availability of colleges to train a new workforce.
  • Increased equipment counts that require maintenance.
  • Rapidly changing technology that blurs the line between IT and biomed.
  • Seemingly daily changes of rules and regulations.

Workflow automation offers a solution to manage testing processes, boosting compliance and enhancing patient safety amid multiple responsibilities.

Welby: Identifying the needs of current and future biomeds to create more efficient processes.  Fortunately, we have an in-house engineering department that allows us to respond to new requirements and demands from the field. BC Group is engaging with outside agencies to capture a much broader audience to gather information than we could on our own.  This will allow us to be more proactive and less reactive.

Alkire: We look at test equipment as more than just devices with features requiring biomeds to navigate through menus to find the needed test or feature, but rather as solutions-based products. Biomeds can utilize our products as standalone devices or, with our Mobilize Wireless solution, they can create testing protocols for a wide range of medical devices, set the test parameters, and run automated tests wirelessly to the test equipment via our Pronk Mobilize App on their smart device.

Automated test sequences are user-programmable, including the option to run detailed checklist-type procedures with both test and set-up instructions, as well as customizable pass/fail limits per the medical device manufacturer’s requirements. This allows biomeds to conduct necessary testing and address the challenge of performing services on the spot, completing all required tests, and electronically recording all data.

Lennard: Keeping pace with rapidly evolving technology is challenging. Test equipment manufacturers need to be innovative with the next generation of test equipment. Collaborating with biomeds, biomedical equipment technology colleges, and medical device manufacturers keeps us up-to-date on emerging technologies and ahead of the curve.

One of the biggest challenges is connected devices and IoT integration. If biomedical test equipment is on the same networks as patient data, the risk is clearly high.  To enhance cybersecurity measures, test equipment must implement encryption protocols and secure network processes in the same way that medical devices do. 

24×7: How does your company ensure efficient, flexible servicing of medical devices, especially in emergencies, amid the growing demand for portable solutions in biomedical testing?

Alkire: Biomedical engineers must be as mobile as possible to manage the high volume of demand for maintenance and repair from hospitals, clinics, and other remote sites. Having portable and highly reliable products in this environment is a must-have. At Pronk, product development is very focused on maximum portability, high reliability and durability, and great accuracy to support biomeds’ responsibilities in meeting the testing requirements of medical devices.

Our latest product, Pressure MAX Digital Pressure Meter, reflects this philosophy. It is the smallest multichannel pressure meter with tremendous accuracy and range for both positive and negative pressure measurements, eliminating the need to purchase multiple meters.

Welby: BC Group offers both onsite and depot calibrations with our team of technicians. If urgent, we have a Quick-Fire process to quickly address the customer needs.

Weldon: Fluke Biomedical offers advanced portable solutions in the biomedical test equipment industry. Our products are designed for multiple functional testing in one single unit—aka: carry less and do more. With our enhanced automation and CMMS integrations, our products help ensure quick diagnostics and effective reporting during maintenance and emergency repair. This streamlined approach helps ensure biomeds can depend on fast and accurate equipment when it matters most.

Lennard: Rigel has seen a growth in testing requirements for smaller, remoter healthcare facilities. The design of portable test equipment is important so that it can be easily transported to healthcare facilities, clinics, or remote locations during emergencies. These devices are lightweight, compact, and often battery-powered, enabling rapid deployment and onsite testing without the need for a specialized infrastructure. Test equipment solutions need to be diverse, catering to a range of settings, from large metropolitan hospitals to remote communities in Alaska.

24×7: What measures does your company take to ensure the precision and dependability of test equipment calibration and servicing, particularly in environments where accuracy is critical for patient safety?

Lennard: A test equipment manufacturer must have calibration to standards such as ISO 17025 for calibration laboratories, and at the very least ensure reference standards and calibrated equipment are traceable to national or international standards. This ensures the accuracy and traceability of measurements and minimizes uncertainties in calibration processes. Our service and calibration arm, Calibrationhouse, has [United Kingdom Accreditation Service] (IEC 17025) capabilities for biomedical test equipment and counts worldwide medical device manufacturers and healthcare organizations among its customers.

Weldon: We are ISO 9001 and ISO 13485 certified and provide ongoing service and support to ensure continuous customer satisfaction. We recommend annual calibration for all Fluke Biomedical tools. While third-party companies may be able to verify if the analyzer is in tolerance, the Fluke Biomedical service program will calibrate the device, update firmware, and complete any necessary repairs in a timeline under a single purchase order.

Welby: BC Group is ISO 13485:2016 certified, ISO 9001:2015 certified, ISO/IEC 17025:2017 accredited, National Institute of Standards and Technology traceable, American National Standards Institute Z540-1-compliant, and FDA Current Good Manufacturing Practices-compliant. 

Alkire: The key to ensuring accuracy and reliability starts with the product’s design. Products must be designed to withstand the rigors of the service environment—the wear and tear, such as test equipment accidentally falling to the ground—as well as to travel well in hot and cold environments, etc. Emphasizing these factors is a primary focus of every Pronk product.

Extensive field testing with customers ensures maximum accuracy and reliability for real-world applications. This, combined with our manufacturing and service quality standards that require a 100% inspection, test, and calibration of each product according to international standard ISO-17025, provides great confidence in the use of our products.

24×7: How does your company assist HTM officials in utilizing and maintaining test equipment through training and educational programs?

Lennard: We assist biomedical engineers by providing comprehensive training and education initiatives. These include online webinars, onsite training sessions, and video tutorials covering equipment operation, troubleshooting, and preventive maintenance. Rigel also offers certification programs, continuing education courses, and technical support to address topics, regulatory compliance, and any issues biomeds encounter.

We strongly believe in cultivating the next generation of biomeds. We have donated test equipment to colleges as this greatly benefits students by providing enhanced access to new learning experiences and preparing them for future careers in the field. Through hands-on experience with equipment, students develop crucial technical skills in equipment operation and maintenance. Additionally, networking opportunities with HTM professionals may arise, helping students’ educational experiences.

Weldon: Fluke Biomedical uses an assortment of tools and events to support training and education initiatives. Our Advantage Training program has over 13,000 users globally, providing education from the basics of biomed theory all the way to advanced technical training on our devices. We also host multiple live and on-demand educational webinars and have an in-depth product video library on the Fluke Biomedical website. Our global channel partner network assists with technical training, sales, and local biomed events.

Alkire: We’re proud to support our customers who purchase our products. This includes offering training videos and interactive online classes to help them make the most of our products, like our Pronk Mobilize™ Wireless Solution.

Our classes cover advanced features of our Mobilize App, such as creating your own test protocols and running manufacturer or AEM procedures while communicating wirelessly to Pronk test equipment, in addition to the defibrillator and ventilator analyzers available on the market. We provide training to help optimize automation for test equipment and electronic record-keeping within a CMMS.

Welby: BC Group holds periodic webinars—nationally, regionally, and locally. We have developed and continue to develop many how-to videos that are available on YouTube and our website. We design and manufacture under one roof; this allows the biomeds to talk directly with our support team as needed.