Traditional methods are ineffective for testing additively manufactured devices. The AM team at Cretex Medical | rms is pioneering new methods that more accurately test materials, saving time and money for customers.
November 20, 2025
AM experts from Cretex Medical | rms take the lead in making testing more accurate and efficient
BONEZONE, a leading magazine for the orthopaedic manufacturing industry, featured an article titled “Additive Manufacturing and the Evolution of Testing Methods.” The article featured the role of Cretex Medical | rms in working with the Food & Drug Administration (FDA) and other industry members to improve verification testing for AM-manufactured devices and components.
The FDA and the medical device industry have long relied on traditional verification coupons such as E8 tensile bars and validation methods designed to evaluate the outcomes of established production processes like casting and machining. While these approaches work well for conventional manufacturing, they fail to capture the complexities of additive manufacturing, where factors like laser power, scan strategy, and build orientation can significantly influence material behavior. Improved testing is a critical step for ensuring reliable, high-quality devices as additive manufacturing becomes standard in orthopedics.
Cretex Medical | rms, a leader in the field of additively-manufactured medical devices, has worked closely with the FDA, customers, and other industry members to develop better testing strategies and methods. Collaboratively, we’ve designed systems that allow companies to leverage coupons that more accurately represent their additively-manufactured products. These coupons follow defined guidelines but are tailored for each design.
Gravimetric Testing
In additive manufacturing, gravimetric relative density testing coupons are extremely sensitive to small process changes that cannot be detected by conventional coupons.
By measuring the mass of a representative coupon, we can evaluate its porosity. Small variations in porosity can indicate changes in factors such as laser power, beam quality, calibration, or scanner settings. Gravimetric testing helps verify that the device meets its intended specifications, including osseointegration and predicted mechanical properties.
Compression Testing
Additively-manufactured devices can include lattice structures, gradient densities, or internal cavities designed to mimic natural bone or tissue. These functionally porous designs enable controlled mechanical properties and biological integration but also present new challenges for testing.
Compression coupons can be designed to replicate the lattice or functionally porous architecture of customer parts, accurately capturing how complex 3D-printed forms respond to force. By adapting compression testing protocols to the unique characteristics of additively-manufactured parts, manufacturers can generate more reliable data about strength, elasticity, and failure points.
PIP Testing
Profilometry-based Indention Plastometry (PIP) is an emerging test method used to evaluate the mechanical properties of metallic components produced through additive manufacturing. By offering nondestructive, microscale evaluation of additively manufactured materials, PIP testing supports improved process validation, part qualification, and greater confidence in the mechanical reliability of 3D-printed metal components without the need for destructive tensile specimens. The size, preparation, and non-destructive nature of PIP testing also combine to significantly reduce testing costs.
The adoption of these new standards and processes has led to less time-consuming testing cycles for manufacturers and has reduced wasted material. Recent submissions to the FDA have also seen significantly shorter review times using this approach.
Applying advanced testing methods to advanced manufacturing processes saves customers time and money and increases confidence in the accuracy and utility of the testing results.
Cretex Medical | rms was one of the first medical device manufacturers to offer validated laser powder bed fusion (LPBF) products. Our years of experience and investment in industry-leading additive manufacturing technology allow us to design and produce components and devices of remarkable complexity.
Our experts are leaders in the field, working closely with regulators and industry partners to shape the AM standards of today and tomorrow.
When looking for a contract MDM to meet your additive manufacturing needs, you need a company with state-of-the-art technology and the capacity to scale with you as you grow. With Cretex Medical | rms, you also have a partner with the additive manufacturing expertise that’s needed to maximize efficiency, minimize costs, and guide your products safely to market.
To read the full article, visit BONEZONE Magazine.
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