By Sean Fenske, Editor-in-Chief

Additive manufacturing (AM) is growing rapidly—in interest, in appropriate applications, in acceptable materials, and in the range of capabilities. Gone are the days when this technology was only used for fabricating prototypes. However, with such advancement and growth comes new complexities with which not all companies are familiar or even aware of.

With this in mind, it’s important to find a partner with which to work to ensure the best collection of capabilities, technologies, materials, and post-processing techniques are combined for the greatest outcome possible. To that end, early involvement with that partner is also critical. The sooner they can be included in early development, the less likely costly redesigns will be required.

To help further explain the role additive manufacturing plays in orthopedic device development, two representatives from Paragon Medical responded to a series of questions about it. In the following Q&A, Scott Anderson, Sr. Manufacturing Engineer, and Byran Rogers, Sr. Additive Quality Engineer, spoke on a variety of related topics to help ensure your next AM project is successful.

Sean Fenske: Where are you primarily seeing interest in additive manufacturing from customers? Do they request the process, or do they bring a challenge and, when appropriate, you suggest that direction?

Scott Anderson: We’re seeing the greatest interest from design teams focused on developing cementless and porous implants that enhance osseointegration, or the bone’s ability to fixate with the implant. Additive manufacturing uniquely enables this type of complex surface structure, which would otherwise require post-processing steps like plasma spraying or coating applications that can drive up cost and waste.

While some customers approach us with additive in mind from the start, many come to us with a design challenge and we help determine whether additive is the right fit. Often, we’ll prototype parts that were originally designed for traditional machining and demonstrate features like lattices, internal channels, or integrated porous surfaces.

Our additive team works closely with customers throughout this discovery phase, using printing technologies like DMLS, binder jet, and resin printing to develop samples. It’s an iterative, collaborative process that allows us to align design intent with the realities of manufacturability.

Fenske: How are you ensuring quality with this process? What aspects of your quality controls are most important?

Byran Rogers: Quality control in additive manufacturing is multi-layered and begins long before a part ever comes off the build plate. Every build incorporates process monitoring and data tracking, including sacrificial test coupons that measure mechanical strength, density, and surface integrity. This gives us a quantitative understanding of each build’s performance and helps us identify even subtle process trends over time.

The most critical inputs happen during the printing operation, and the quality controls are influenced by man, machine, and material.

• Man: Proper cleaning, machine preparation, and adherence to validated work instructions directly affect printer health and consistency.
• Machine: Routine calibration, maintenance, and verification of performance are essential to ensure dimensional accuracy and surface quality.
• Material: We carefully control powder reuse, sieving, and chemistry validation to maintain compliance with stringent specifications.

Once printing is complete, additional inspection, hot isostatic pressing (HIP), and mechanical testing verify that every component meets both customer and regulatory expectations. Quality, for us, isn’t a final check. It’s a continuous process embedded throughout design, build, and post-processing.

Fenske: Are you performing all quality control processes in-house or do you work with a partner on any of them (for example, for testing)?

Rogers: We leverage a hybrid approach. The majority of our process control, inspection, and mechanical testing is performed in-house to maintain full visibility and speed. However, for specialized or regulatory-driven testing, such as advanced fatigue analysis or biocompatibility validation, we partner with certified external labs. This approach combines the speed and control of internal testing while allowing us to offer any testing needed to the customer, even if it’s outside of our in-house capabilities.

Fenske: Where do you encounter the greatest challenge(s) with additive manufacturing for medical devices?

Anderson: The greatest challenge lies in design iteration, and it’s where the success of a program is often made or lost. Additive allows incredible freedom, but it also demands a new mindset. Designs optimized for machining don’t automatically translate to success in additive. Iterating prototypes based on surgeon feedback, refining lattice structures, and validating mechanical performance through functional testing can take several rounds before finalization.

These steps are necessary to balance clinical intent with manufacturability and long-term device performance. It’s not uncommon for a single iteration loop—including redesign, build, post-processing, and testing—to span multiple weeks. That’s why having an experienced partner with in-house prototyping, printing, finishing, and HIP capabilities can dramatically accelerate the process while maintaining quality and regulatory compliance.

Fenske: What complementary technologies are you using alongside additive manufacturing? What technologies are best utilized pre- or post-manufacturing?

Anderson: HIP is one of the most critical post-processing steps, and one that Paragon Medical offers in-house, which is quite unique in this industry. HIP applies high pressure and temperature to eliminate internal porosity, improve density, and enhance fatigue performance, which is a must for load-bearing implants.

Having HIP integrated under the same roof as printing allows us to reduce lead times, minimize part handling, and maintain full process control. Our HIP system—the Quintus QIH 60 URC®—is fully validated for 3D-printed titanium and integrates high-pressure heat treatment (HPHT™), combining densification and heat treatment in one cycle. This not only streamlines production but also improves consistency and surface quality.

Pre-manufacturing, we rely heavily on design for additive manufacturing simulation tools to optimize print orientation, minimize support structures, and validate dimensional stability. Post-manufacturing, our teams employ machining, finishing, and inspection operations as needed.

Fenske: What is an often overlooked or not considered aspect of additively manufacturing parts for medical devices? What should designers keep in mind?

Rogers: One of the most overlooked factors is design intent alignment with additive capability. Many designers underestimate how build orientation, tolerances, and inspection requirements can impact both cost and lead time. For instance, if a design calls for extremely tight tolerances on non-critical features, it can drive unnecessary machining and inspection, offsetting the efficiencies that additive offers.

Designers should focus on what’s truly critical to quality and increase tolerances where possible. They should also understand the dimensional capabilities of their chosen AM process and how post-processing will affect geometry. The goal isn’t just to print a good part, but rather to print a part that meets functional requirements, can be reproduced reliably, and doesn’t require excessive downstream intervention.

Ultimately, success in additive comes from balancing innovation with practicality: designing smartly for the process, not just within it.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Anderson: Additive manufacturing has opened a new frontier in medical device design and manufacturing, but realizing its full potential requires a shift in how we think about manufacturing collaboration. It’s not just about having the capability; it’s about having an ecosystem that supports it from concept to commercialization.

Rogers: At Paragon Medical, we’ve built that ecosystem. By combining additive design expertise, in-house HIP, machining, finishing, and regulatory support, we help OEMs move from prototype to production faster and more confidently. Additive is evolving rapidly, and the manufacturers who succeed will be those who see it not as a standalone technology, but as part of a fully integrated, quality-driven manufacturing strategy.

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