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As the Vice Chair of ASTM International’s Arthroplasty Subcommittee (F04.22), Leah Guenther co-leads a global volunteer team of experts from industry, academia and regulatory bodies to advance standards for joint replacement devices.
She provides a valuable perspective on working with orthopedic companies to ensure the products they develop pass rigorous testing and regulatory requirements before they’re implanted into patients.
The ASTM F04.22 subcommittee brings together engineers, scientists, clinicians, testing experts and regulatory professionals to collaboratively develop and refine consensus standards for orthopedic devices. Each perspective plays a critical role: Engineers and scientists contribute technical depth and real-world design considerations; testing experts ensure methods are repeatable and meaningful; and regulatory professionals help align standards with global regulatory expectations.
Together, the group works to create practical, scientifically sound standards that support safety, performance and ultimately regulatory approval.
This dynamic leads to the first bit of advice that Guenther offers to product development and R&D engineers who are working hard to deliver safe and effective devices.
Break Down the Barriers
Engineering teams turn a surgeon’s concept into a commercialized device, but subsequent performance testing must make sense for the desired outcome and what surgeons are trying to accomplish in the O.R. However, organizational silos can make that end-to-end alignment difficult to sustain.
Functional teams — regulatory, product development, R&D and clinical research — may operate in parallel rather than in coordination. For example, engineering teams often focus solely on modeling, design and development, while regulatory teams solely manage submission strategy. As the industry continues to evolve, that siloed approach may result in misalignment, which can surface later in the product development cycle. This misalignment can result in additional testing, rework and, ultimately, slower time to market.
Guenther emphasizes the need for a more holistic view of the entire product development process across all teams — one that integrates regulatory and testing strategy early and intentionally.
Translating a surgeon’s idea into a viable product requires a clear understanding of risk across all teams, and a deliberate connection between device design, performance testing and the regulatory pathway that will ultimately support approval. Engaging in standards development, she suggested, is one practical way engineers (and other teams) can develop that systems-level perspective.
Get Involved
R&D and product development engineers who stay engaged in standards development are at the forefront of the latest technical developments and regulatory insight that can lead to effective and proactive risk mitigation.
While large OEMs typically have the resources, historical data and internal infrastructure to manage regulatory shifts, smaller and mid-sized companies face greater challenges. These companies often need to build their risk management approach from the ground up, which is difficult to do.
However, Guenther is quick to point out that meaningful participation in standards development does not require deep technical mastery.
“We’re not asking everyone to be well versed in every standard,” she said.
Instead, it’s an invitation to bring diverse perspectives and stay engaged with what’s happening in the industry.
Guenther believes product development engineers and clinical researchers can bring an essential perspective to standards developments because of their direct access to clinical data and insight into what surgeons use and want in real-world practice. She has watched with interest as orthopedics companies adapt technologies from other industries to address patient-specific concerns.
For example, challenges such as nickel sensitivity are prompting companies to apply advanced coatings to materials, which were originally developed for aerospace and other highly regulated industries. That adaptation creates new challenges for standards development in the orthopedics space.
“Now that these technologies are being applied in new ways, we need to make sure our standards are robust enough to evaluate them, while still providing meaningful guidance,” Guenther said. “The difficulty lies in the data gap. The reality is that it’s hard to write a standard that is inclusive of new technologies when you don’t yet have supportive clinical data.”
As a result, standards development can appear to trail technological advancement.
That’s why bringing multiple viewpoints into the conversation strengthens standards so that they guide safe, effective and patient-focused use.
Stay Current
The Arthroplasty subcommittee is one of the largest and most dynamic within ASTM. “We’re incredibly active in developing new standards to address emerging technologies or revising existing standards to make sure they’re still relevant,” she said.
Every standard undergoes a formal review at least once every five years to determine if it’s being withdrawn, reapproved or significantly revised. What many in industry don’t realize is how long that process can take. “These aren’t just words on paper,” Guenther said. “They’re consensus standards, which means everyone has to agree on the approach and content — and that can take years to attain.”
Many OEMs want to bring new products to market through the FDA 510(k) pathway because of its relative speed and predictability. Challenges arise when a differentiating design pushes beyond the features of comparable reference devices. How do engineers demonstrate substantial equivalence while also highlighting meaningful innovation?
Guenther’s advice is to address these realities well before submitting products for FDA review. Risk analyses can often fail to account for the fact that standards and regulatory requirements aren’t static.
“Standards development is an ongoing, dynamic process,” Guenther said.
Engaging in these conversations early and consistently not only keeps you aligned with evolving expectations, it also builds institutional knowledge and influence — a clear return on investment when the time comes to submit your devices for regulatory review.
Grasp the ROI
Contributing to standards development is often overlooked as a strategic advantage. Guenther believes early and active involvement gives companies insight into emerging requirements, a voice in shaping consensus and practical guidance that can pay off when navigating regulatory pathways.
“This involvement can effectively turn participation into a tangible return on investment, and allows you to plan your next product development project more strategically,” she said.
Regulatory insight is another major advantage of being involved in standards discussions. “Regulatory bodies contribute significantly to standards development, which provides a greater understanding as to what regulators are really looking for and how to navigate those requirements,” Guenther said.
Simply being in the room, Guenther adds, provides invaluable context. “The information and history shared in our meetings is incredibly rich,” she said. “You begin to understand where standards came from and why they’re structured the way they are.”
That understanding informs an effective regulatory strategy. Engineers with intimate knowledge of standards can determine how to design products so they’re tested in ways that support a 510(k) pathway instead of being forced into the lengthier regulatory pathways.
Having a more holistic understanding of consensus standards sets the stage for thinking more strategically about the next generation of products.
Think Bigger
Orthopedic OEMs must allocate resources to quality testing one way or another. “Whether you’re putting in the effort internally or partnering with organizations that have that expertise, it’s not optional,” Guenther said.
OEMs can invest in having in-house engineers understand the regulatory process or they can pay outside experts to tell them what’s going on. To Guenther, the choice is obvious.
She emphasizes that product development and R&D engineers benefit most when they understand how their work fits into the larger regulatory and standards landscape. Focusing only on the immediate task can create bottlenecks later, whereas a broader perspective allows teams to anticipate requirements and avoid delays.
In her view, companies that encourage broader, cross-functional awareness, especially around standards and regulatory dynamics, are better positioned to streamline the product development process.
“Systems-level thinking is what keeps you from getting stuck late in the game,” Guenther said. “It’s ultimately what helps you get to market faster.”
Getting involved in standards development isn’t just a checkbox – it’s a strategic move that can shape how products are designed, tested, and brought to market. Engineers who engage early and embrace a more systems-level approach are the ones who will bring the next generation of safe, effective, and patience-centered solutions to life.
