Leveraging Microbiology to Accelerate an Orthopedic Program Launch—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief

The medical device development phase is a complicated stage, involving multiple aspects that need to be ascertained to achieve the best outcome. Unfortunately, several of these may be done in silos or later in the process, creating delays in moving to production. Waiting on certain teams to complete their portion can needlessly stall development.

As an alternative, tackling the multitude of tasks in tandem can keep the schedule on time, reducing unnecessary delays and expenses. One aspect of this that can be challenging is aligning the development, testing, and regulatory needs to result in a timely outcome that moves the project into production on schedule. One tactic to help ensure a smooth transition is integrating microbiology into the process early.

With this in mind, Dan Hickey, Ph.D., Lab Director and Lead Research Scientist at EXALTA, took time to share insights on how to optimize this process and offer best practices. In the following Q&A, Dr. Hickey identifies the biggest bottlenecks, the impact microbiology can play in the process, and how best to incorporate it to gain the greatest benefit from its early inclusion.

Sean Fenske: Orthopedic programs often face delays between development, testing, and regulatory readiness. Where do you see the biggest bottlenecks, and how does microbiology factor into them?

Dr. Dan Hickey: The biggest bottlenecks tend to occur at the handoff from development to testing, then in the interpretation of test results for regulatory readiness. These phases are often managed across different teams or partners, with limited real-time feedback between them. That’s where complications and delays start to compound.

Microbiology is frequently a part of that disconnect. It’s typically introduced late and handled externally, so when results don’t align with design or manufacturing assumptions, programs are forced into re-testing cycles.

What we see is that when development, manufacturing, and testing are structured to move forward together rather than sequentially, those bottlenecks are significantly reduced. Microbiology becomes part of the feedback loop instead of a late-stage gate.

Fenske: Microbiology is often treated as a downstream validation step. How does bringing these capabilities in-house change the way programs are developed and advanced?

Dr. Hickey: Bringing microbiology in-house changes both timing and visibility. Instead of being a final checkpoint, it becomes part of the development process. Teams can discuss challenges earlier, conduct iterative testing as needed, and align decisions across engineering, manufacturing, and regulatory. Removing dependency on external lab queues also eliminates a common source of delay.

In a more connected model, microbiology supports parallel progression rather than sequential validation. That alignment across functions improves predictability and allows programs to move forward with fewer disruptions.

Fenske: Can you explain the key microbiological tests most critical for orthopedic implants and instruments, and where they typically create friction in the timeline?

Dr. Hickey: The most critical areas include bioburden determinations, sterilization validation, bacterial endotoxin testing, cleaning validation, and environmental monitoring.

For orthopedic implants and instruments, the friction usually comes from timing, coordination, and interpretation of results. When testing is disconnected from development and manufacturing, teams often have limited visibility into protocols, scheduling, and turnaround times. That lack of visibility can create misalignment between design assumptions, cleaning processes, sterilization strategy, and validation outcomes. When microbiology is connected earlier to engineering, regulatory, and manufacturing, those issues can be identified and addressed before they become late-stage delays.

Fenske: EXALTA recently established an in-house ISO 17025-accredited microbiology lab. What does that enable in practical terms for customers moving toward 510(k) clearance or EU MDR readiness?

Dr. Hickey: ISO 17025 accreditation confirms that testing is performed using validated methods and meets recognized standards of competence, which is critical for supporting 510(k) submissions and EU MDR documentation.

In practice, it allows testing to be performed within the same environment as development and manufacturing. That proximity reduces delays and enables faster iteration when adjustments are needed.

It also strengthens continuity in how data is generated and used across the program, which becomes increasingly important as teams move toward regulatory milestones.

Fenske: How does integrating microbiology with development, regulatory, and manufacturing teams improve continuity and reduce risk compared to more fragmented models?

Dr. Hickey: Integration aligns development, regulatory, microbiology, and manufacturing around a shared plan. That reduces the risk of misalignment between design intent and validation outcomes. When these functions operate within a connected structure, issues can be identified and addressed earlier, which limits rework and late-stage surprises.

It also simplifies execution. Instead of managing multiple handoffs, programs move forward through a more consistent pathway, which improves both speed and reliability.

Fenske: From your perspective, how early should microbiology considerations be brought into the product development process, and what changes when that happens?

Dr. Hickey: Microbiology should be considered from the earliest stages of development. Decisions around materials, design, and manufacturing processes all influence cleaning, sterilization, and validation outcomes. When those considerations are built in early, teams can design with downstream requirements in mind. That reduces the likelihood of late-stage issues that require redesign or revalidation. In practice, this shifts programs from a reactive model to a more structured, forward-looking approach, in which development and validation are aligned from the start.

Fenske: Looking ahead, how do you see microbiology evolving as a strategic lever in accelerating orthopedic innovation?

Dr. Hickey: Microbiology is increasingly moving beyond a compliance role and becoming part of how programs are accelerated and de-risked. As expectations around regulatory readiness and data integrity continue to increase, the ability to integrate testing into the broader development process will become more important. Organizations that bring these capabilities closer to engineering and manufacturing will be better positioned to support innovation while reducing variability and maintaining project momentum.

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 orthopedic device manufacturers?

Dr. Hickey: One of the biggest opportunities today is reducing fragmentation across the development lifecycle. Many delays are not driven by technical complexity, but by how programs are structured across multiple partners. Bringing critical capabilities into a more connected model improves coordination, shortens feedback loops, and reduces reliance on external dependencies. For manufacturers, the focus should be on building continuity from development through launch. That’s where meaningful gains in both speed and predictability can be achieved.

Click here to learn more about EXALTA >>>>>