Medical product developement at LifeTec Medical product developement at LifeTec | HBM

LifeTec uses the PMX platform by HBM to test medical devices

LifeTec in Eindhoven specializes in independent contract-based research for businesses and institutions that introduce medical devices, implants, surgical instruments or new medical techniques onto the market. The research involves testing and evaluating the functionalities of the devices, often under highly realistic conditions. For acquisition and processing of all of the critical test data, LifeTec purchased the PMX measurement amplifier platform by HBM.

“The idea for LifeTec came about at the faculty of Biomedical Technology at the Eindhoven University of Technology. It appeared that the business community was regularly posing research questions to the university, but no one was doing anything with them. The reasons for this were lack of capacity, lack of publications, or the issue was not ‘scientific’ enough for students,” begins Marco Stijnen, Cardiovascular Group Manager at LifeTec Group. “A predecessor to today's LifeTec was set up at that time. It was a group for researchers with an academic background dedicated to projects and applications for industry.

LifeTec's first project was a study on the functioning of a new type of heart valve, which lasted one year. We are currently conducting subsidized research projects under contract from clients such as the Netherlands Institute for Science and Technology (the "STW") and we perform contract-based research for businesses seeking to introduce new medical devices or techniques. A considerable portion of our work involves the testing of cardiovascular and orthopedic devices, for which we have developed our own methods. In addition to this, we also have access to a wide array of scientific expertise on campus, as well as equipment such as electron microscopes and micro and nano CT scanners.

Mismatch between laboratory, animal and clinical testing

LifeTec has an unusual philosophy. “We believe that in the process from product development through the approval of a medical device, there is a mismatch between laboratory, animal and clinical testing,” explains Stijnen. “If you need to test the functioning of medical devices or implants in the human body, then we don't think it makes much sense to do so in an artificial environment with no resemblance to a human body. Unlike with a technical component used in a car engine, it is much more difficult to predict how medical devices will behave later on in a living human body.

Not to mention the fact that different people can have completely different reactions to interventions. As a manufacturer, if you invest in the best possible design for a product, but then the first animal study produces disappointing results, you have to start all over again. That means additional costs and delays in market introduction. That's why we work with test environments that provide true-to-life simulations of the human body.”

Test environment 'Physioheart'

LifeTec also developed the "Physioheart" platform, a test environment with a beating pig's heart, a complete vessel system and flowing blood, which can be used to test the functioning of devices such as stents and heart valves or new surgical techniques. The system makes it possible to measure key parameters such as blood pressure, blood flow and expansion of the heart. Another benefit is that instead of real blood, a transparent fluid is used in order to film the functioning of the heart and the condition of the tissue.

In addition to this, LifeTec also develops bioreactor systems where cells or tissues are kept in culture. This kind of bioreactor can be used for tests with living blood vessels or bone growth, for instance. Its main benefit is the ability to examine the condition of the tissue several weeks after the intervention. The findings from realistic tests of this kind are much more reliable, which accelerates product development. They also result in fewer animal studies.

Discussions on realistic tests

Stijnen: “We are ISO-certified and accredited, and we can demonstrate that our methods are reliable, our test stations are calibrated and our data are collected and documented properly. Nevertheless, we still have to hold frequent discussion on the importance and benefits of the kind of realistic testing that we conduct. Another option would be to use standardized tests in artificial environments, which are necessary for certification, for instance. We believe that our approach to testing devices and techniques in the preclinical phase is more efficient and offers more certainty in terms of the future progress of product development and approval. Whatever approach you choose, the test findings will, in fact, ultimately have to be verified in clinical studies.

Quality of test data is critical

It should be clear that the quality of test data acquisition, processing and recording is critical in the medical sector. “In principle, we monitor everything that could have an influence on a bioreactor of this kind,” notes Stijnen. “We measure just about anything you could possibly imagine: temperature, blood pressure, flow, blood gas values and acidity, even electrical activity in the muscles. In addition, we also measure mechanical forces: such as when testing the tensile stress on screws for the attachment of prostheses. And we must be able to synchronizing test data precisely with other equipment, such as MRI and CT scanners in hospitals. That is why we use advanced equipment to collect and process all of the various test data.

PMX measurement amplifier monitors bioreactor systems

For monitoring of bioreactor systems, LifeTec has purchased the PMX measurement amplifier system by HBM Benelux. This system won out over other name brands on the market thanks to its attractive price/performance ratio. “The system is flexible and can read in all possible measurement signals and integrate them into test reports,” touts Stijnen. “The PMX hardware is portable and, in combination with a notebook computer, it quickly becomes a complete testing station. The measurement stations are quick and easy to set up, configure, store and visualize using a normal PC. Moreover, thanks to the web interface, our researchers can monitor the bioreactor system continuously from any location. HBM has also developed a LabVIEW driver for the PMX system, which enables complete integration with LabVIEW, a software solution for monitoring complex tests.

LifeTec has purchased a number of basic modules, featuring a variety of plug-in cards, such as the PX878 (digital inputs and outputs), the PX455 (Wheatstone bridges, inductive, piezo-resistive and potentiometric sensors) and the PX401 (voltage and current signals). “Another benefit of the PMX is that the system also lets you control devices. Right now it's just a nifty gadget,” admits Stijnen, “but we are already thinking about actively controlling a servomotor, which activates a piston to artificially open and close a heart valve. This offers possibilities in applications such as demonstrations or temporary test setups during training sessions.”

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