ADMET works with medical device manufacturers, test laboratories, as well as consultants for medical device companies to provide mechanical testing solutions. This case study covers the testing system engineered by ADMET for a medical device consulting company to conduct a wide range of static and dynamic axial torsion tests on medical devices.
Medical Devices: Quality & Regulatory Processes
In the United States, medical device development is highly regulated by the Food and Drug Administration (FDA). Per FDA guidance documents, product development and commercialization requires verification and validation testing, which must be completed for multiple regulatory scenarios including; premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests. The tests selected should address the verification of the design inputs and ensure safety and efficacy. Testing can be performed by the device manufacturer or by an independent test lab. Companies may also choose to work with medical device consultants to aid in regulatory processes throughout the product development cycle.
Non-clinical bench testing includes but is not limited to: mechanical tests to determine properties such as fatigue lifecycle, tensile strength, compression strength, puncture resistance, and flexural strength.
Medical Device Consulting – How ADMET Can Help?
A medical device quality consulting firm reached out to our Sales Engineering team looking for a versatile testing system to account for the static and the dynamic testing requirements for various orthopedic devices. The system would be used to run non-clinical bench testing for medical device companies who don’t have in-house testing capabilities or who are looking for consulting services that cover the testing of devices.
Some of the mechanical properties our customer was interested in measuring included maximum tensile strength and strain, compressive strength, bending strength, bending stiffness as well as torsional properties such as maximum torque and axial pullout strength. Furthermore, since medical devices used in orthopedic applications stay in the body for an extended amount of time, fatigue testing with the same testing system was a supplemental request. Data compiled from dynamic fatigue tests would be used to determine how the device will perform over time and repeated use.
Our Solution
ADMET Sales and Engineering teams worked on a custom medical device testing system to run a wide range of orthopedic testing methods on metallic bone plates, bone screws, spinal implant interconnections, spinal constructs and more.
Engineered Solutions: Axial-Torsion Testing Machine for Orthopedic Device Testing
The system was designed with fixturing and software to run the following standardized test methods:
ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
The axial capacity of the system was 10kN. The system included tensile grips, compression platens, and bend fixtures to conduct these different types of tests. For standard test methods outlining the specifications of the test fixture, the fixture conforming to the ASTM standard was supplied.
ASTM F1717 Fixture
60Nm torque capacity at 900 rpm was found to be sufficient for orthopedic device testing. Specimens would be clamped using self centering vise and chuck grips to acquire torque data.
Metallic Bone Screws Torsion Test Setup per ASTM F543
The controller selected for the wide range of test applications is ADMET’s high-speed closed-loop multi channel MTESTQuattro(R) controller. MTESTQuattro produces sine, square and triangular waveforms based on force, displacement, torque or angle amplitude control. Users can manually adjust control gains and end point values on the fly or activate amplitude control so that the controller automatically adjusts the end point values to ensure waveform amplitudes stay within tolerance.
In addition, MTESTQuattro software helps to satisfy the requirements of FDA CFR 21 Part 11 by creating a documentation trail whenever there are changes to test procedures. These changes result in creation of a record which indicates what was changed, when, and by whom.
Conclusion
ADMET is a leading global manufacturer of universal testing systems, fixtures and accessories. We have the expertise to design, build, deliver, and implement custom mechanical test equipment based on your expectations. The engineered system specified above was built for a medical device consulting firm looking to expand their business by running in-house testing for medical device clients. The testing system is configured to run a variety of testing and includes all the applicable fixturing and a software with built-in test methods.
Manufacturers, researchers, and consultants choose to work with ADMET as we provide reliable solutions to meet the specified needs. Click here to fill out our Sales Inquiry form and a Sales Engineer will be in touch to discuss how we can help with your testing.
