Developing Technology Solutions for a Procedure—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief

Orthopedic device development is a complex process that pulls inspiration and ideas from a variety of sources. The goal is to create a product that can be used within an existing procedure without disrupting the established routine while adding value through its use. However, when designing a complete system for a procedure, a different approach is required.

When creating instruments, implants, and other related products for a surgical procedure, the entire environment and actual surgery must be considered. This increases the complexity but can generate synergies not realized from using disparate tools and technologies that were created in more of a silo. Ultimately, a holistic offering can be provided.

To help further explain why a procedural solution may be a better approach, David Hannah, Chief Technology Officer at EXALTA, participated in this interview. In the following Q&A, he speaks to the difference in development approach, the benefit of input from surgeons and healthcare professionals, and how related aspects such as packaging are best handled.

Sean Fenske: Most projects involve the development of a single instrument or implant. Today, we’re discussing the development of a solution for a procedure. How does this alter the design/development phase?

David Hannah: It fundamentally changes the starting point. Instead of optimizing an individual instrument or implant, we start with the procedure and the entire surgical workflow. That means understanding how the surgeon, scrub tech, OR staff, instruments, implants, enabling technologies, and logistics all interact. We can then design the system around the procedure rather than trying to make individual components work together after the fact. Our clinical expertise across spine, trauma, extremities, and other specialties is particularly valuable here because we understand the procedure—not just the product.

Fenske: Does the procedure dictate the number of elements/parts in the solution, or does that need to be predetermined? How do you know if there are too many elements/aspects to the solution?

Hannah: The procedure should drive the solution—not a predetermined number of components. The goal is to provide everything necessary to perform the procedure efficiently without adding unnecessary complexity. We evaluate the entire workflow to determine where each instrument, implant, technology, or other element adds value. This includes considering the surgeon’s technique, OR workflow, instrumentation, logistics, manufacturing complexity, and even what the scrub tech needs to manage. A holistic approach often reveals opportunities to eliminate, consolidate, or simplify components that might otherwise be developed independently.

Fenske: How much input is needed from the surgical team/healthcare professional who ultimately would use the device? How is their input captured?

Hannah: Their input is critical, particularly early in development. The most valuable insight often comes from understanding how the procedure is actually performed, including workflow, technique, challenges, preferences, and unmet needs that may not be apparent from a product specification.

We capture this through direct surgeon engagement, procedural observation, interviews, design reviews, cadaveric or simulated evaluations, prototype feedback, and structured usability assessments. The goal isn’t simply to ask surgeons what product they want. It’s to understand what they’re trying to accomplish and why, then translate that insight into the system design.

Fenske: Is the surgeon/clinician involved in initial design ideas, do they provide feedback on prototypes, or is their insight provided in another way?

Hannah: Ideally, all of the above. Clinical input should begin with defining the unmet need and understanding the procedure, continue through concept development and design decisions, and then be validated through prototypes and simulated or cadaveric use.

Their role evolves throughout development—from helping define the problem to evaluating concepts to providing hands-on feedback on prototypes and ultimately validating the solution. This continuous clinical feedback loop helps ensure we’re not simply designing something that can be manufactured, but something that works in the real surgical environment.

Fenske: Are the individual elements in the solution manufactured as a set or is each manufactured as a separate product?

Hannah: Both approaches are possible, but the important distinction is that they are designed as a system even if they are manufactured as individual components. Each instrument, implant, or component may have its own manufacturing process, specifications, inspections, and quality requirements. However, we design the interfaces, tolerances, materials, manufacturing processes, and assembly considerations with the entire system in mind. This creates significant efficiencies compared with developing each component independently because we can optimize the relationships between components, not just the components themselves.

Fenske: How are later aspects handled, such as sterilization and packaging? Should these be brought up early? Should the packaging or sterilization selection be universal for all elements of the solution, or can these components be addressed separately? Can the packaging further enhance the solution?

Hannah: These considerations should be brought into the development process much earlier than many teams realize. Sterilization, packaging, storage, transportation, assembly, and OR presentation can all influence the design of the system. They shouldn’t be treated as downstream activities once the product is already designed.

Not every element necessarily requires the same sterilization or packaging approach. The right solution depends on the materials, intended use, configuration, regulatory requirements, and logistics. Packaging can also be part of the overall solution. For a complex surgical system, thoughtful packaging can improve OR organization, instrument identification, setup time, inventory management, and workflow. This is another advantage of taking a system-level approach: we can optimize the product and everything required to successfully deliver and use 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 orthopedic device manufacturers?

Hannah: The biggest opportunity is to stop thinking about complex surgical products as collections of individual instruments and implants and start thinking about them as complete procedural solutions. That requires expertise well beyond traditional product development. You need clinical and procedural knowledge, engineering and design, manufacturing, regulatory, quality, enabling technologies such as navigation and robotics, coatings and materials, sterilization, packaging, and the ability to scale the solution.

That’s where we differentiate ourselves. We don’t just have the capability to make the individual parts. We understand how the entire system needs to work—from the clinical need and surgical workflow through development, regulatory approval, manufacturing, packaging, and use in the OR. That holistic perspective can ultimately mean fewer iterations, better integration, less complexity, and a faster path to a commercially viable solution.

Lastly, it’s important not to leave out post-market surveillance and setting up registry studies for regional expansion so we can empower our customers to be global players.

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