Not just for Biomeds . . .
Fluke Biomedical products are used by medical device companies in more ways than you might think.
Introduction -- Some other title here?
Multifaceted machines
Watch this video with Joe West from Spacelabs Healthcare, a patient monitor manufacturer in Snoqualmie, WA, to see how they use the Fluke Biomedical ProSim 8 in their manufacturing quality assurance, field service teams and in the classroom during product training.
Applications
Training & Education
Fluke Biomedical products allow for testing to be done more quickly since they have built-in autosequences (semi-automated procedures), which, for many products, can be customized. When in the field, this minimizes raises efficiency, but in the classroom this allows students to focus on learning how to maintain medical equipment vs. learning how to push buttons. Nurse Supervisors have also used Fluke Biomedical patient simulators to train their nursing staff.
Watch this video to see how Spacelabs leverages the ProSim 8 autosequences in their training center.
Go through video footage to see if we can edit a second video
Production
Manufacturing is focused on getting products out of the factory that are 1) properly assembled and 2) meet their design specifications. Fluke Biomedical simulators and analyzers allow for original equipment manufacturers (OEMs) to perform final assembly testing as part of their quality assurance processes without having to design their own test equipment. By taking a device “off the shelf”, manufacturers are able to build test systems easily and quickly with reliable test and measurement equipment, as well as minimize downtime through stocking spare devices and/or taking advantage of quick service turnaround time.
Physio-Control test system? Try again? OPEN
Steal Physio-posted image showing test room
Verification & Validation
V&V are processes that are used together to check that products meet their requirements and specifications and that it fulfills its intended purpose. These are critical to any OEM’s quality management system (QMS) such as ISO 9000.
Validation: “The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders.“
Verification: “The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition.”
In the field, Fluke Biomedical products are used to simulate a product’s use case to a customer or end-user to show that it is fulfilling its intended purpose in lieu of hooking the medical device up to a patient. In terms of verification, Fluke Biomedical products comply with international standards and provide adequate parameters, ranges and accuracies for OEMs to conduct most or all of their testing.
See how Virgin Orbit used the VT900A to perform V&V on their ventilator (emailed)
Bench Testing
Some research and development (R&D) engineers focus only on a single parameter and nothing else. Fluke Biomedical provides not only multi-parameter devices, but also single-parameter devices for those applications. Many Fluke Biomedical products have versions with improved accuracies to help engineers conduct their testing, verify their design concept and to iterate more quickly. This decreases time to market and allows for development teams to be much more agile.
See how Mindray uses single- and multi-parameter simulators in China (emailed - wants actual questions and content use cases to make pitch)
Interested in learning more?
Follow-up with a product expert to learn more about our product line.
Remote Commands / Streaming
OEMs need to document their testing results in order to gain market clearance and many choose to use Fluke Biomedical products for their remote command sets / communication interfaces. This allows Fluke Biomedical test equipment to interface with many software packages (MATLAB, LabVIEW, etc.) to automatically pull test data (and in some cases even stream data) to document results.
Check out the available communications interfaces under the product families.
See how Virgin Orbit worked with Fluke Biomedical to implement streaming into the VT900A (emailed @ review)
Focused on the OEMs
ProSim 8P – multi parameter simulator higher NIBP accuracy
Acculung – customizable compliance and resistance for the OEM application
BPPump 2M – single parameter simulator with higher NIBP accuracy
Index 2XLFE – single parameter simulator for pulse oximetry including electrical simulation
Trusted By
Philips – OneQA – ask pending for OneQA
Spacelabs – PS8 - should be easy
Siemens
Draeger
Breas
Physio-Control
GE
Vyaire
Virgin Orbit – emailed, not talked about brand use yet, only testimonial
Mindray (emailed)
Fun Facts
R&D spend as a % of revenue for OEMs – public
38% of the R&D spend contribution is from the top 5 OEMs https://zinnov.com/medical-devices-industry-r-and-d-spend-and-talent-trends/ link also shows geo trends, etc.
Who spends the most on R&D?
Alcon, J&J, Siemens, GE, Toshiba, Abbott, Philips https://www.massdevice.com/medical-device-companies-who-spends-most-rd/
Largest medical device manufacturers by revenue – public
Medtronic, J&J, Abbott Labs, GE, Fresenius, BD, Siemens, Cardinal Health, Philips, Stryker Corp. https://www.mddionline.com/business/top-40-medical-device-companies-0