Interview about Bracesys Customizable Rigid Orthotic Brace, winner of the A' Medical Devices and Medical Equipment Design Award 2025
Bracesys offers a modular orthopedic brace that adapts to the patient’s body throughout the healing process. Designed for onsite fitting and easy adjustment, it replaces traditional casting with a more practical, hygienic, and comfortable alternative. Its reusable structure helps reduce medical waste, while standardized sizing makes it more accessible across diverse patient groups. Bracesys brings flexibility, sustainability, and user centered thinking to orthopedic care.
View detailed images, specifications, and award details on A' Design Award & Competition website.
View Design DetailsThe anatomical dataset derived from over 600 anonymized CT scans served as a foundational reference in developing the Bracesys brace’s structural language. Our objective wasn’t merely to capture anatomical averages, but to identify the patterns and variabilities across a wide range of patients—differences in bone contour, soft tissue volume, and skeletal asymmetry that influence brace comfort and clinical performance.This data was cross-referenced with anthropometric data from external sources such as the U.S. Army’s hand and limb measurements. The result was a statistically optimized sizing system that doesn’t rely on full customization for each patient but still provides a highly personalized fit. This allowed us to develop a modular brace framework where pre-configured segments can be fine-tuned on-site without sacrificing anatomical compatibility.What emerged from this process was not just a set of brace sizes, but a rethinking of how modular medical devices can reflect real-world anatomical diversity. Instead of designing for the "average," we designed for the range. This not only improved comfort and efficacy but also aligned with our goal to democratize access—by reducing dependency on expensive, time-consuming, fully custom fabrication.Furthermore, these insights directly influenced the geometry of key connection points within the brace—where motion, swelling, and therapeutic alignment are most critical. In that sense, the anatomical research didn’t just inform the shape; it informed how the brace behaves during healing.
The integration of timepiece mechanics and sailing rigging systems into the Bracesys design emerged from a desire to create something that was both mechanically precise and intuitively adjustable—an orthopedic brace that feels engineered yet organic. Both disciplines—watchmaking and sailing—deal with complex tension systems, compact mechanical relationships, and modularity in motion. These were exactly the qualities we needed in a brace that must adjust around a healing, changing body.Timepieces inspired the way we approached controlled movement and fine-tuned locking mechanisms. Just as a watch functions through interconnected, compact components, Bracesys uses internal ratchets and mechanical joints to allow micro-adjustments that are reliable and repeatable. This kind of precision is vital in orthopedic applications, where even minor misalignments can affect comfort or recovery outcomes.Sailing rigging systems, on the other hand, offered a metaphor and mechanism for load-bearing under dynamic conditions. In sailing, rigging allows sails to be tensioned and released smoothly under changing wind conditions. We saw healing as a similarly dynamic state—the anatomy swells, contracts, and reshapes. This inspired the use of axial tethering systems and anchor points that maintain structural integrity while allowing flexibility.For healthcare providers, these systems translate into faster application times, easier on-site adjustments, and reduced reliance on technician-specific customization. For patients, the result is a brace that adapts to their body in a way that feels supportive without being restrictive—something that moves with them, rather than holding them still. The end goal was to create a system that treats the patient as a participant in their recovery, not just a recipient of treatment.
Medical bracing has long relied on single-use solutions—plaster casts, thermoplastics, and prefabricated braces that are discarded after a short treatment window. The Bracesys modular framework was developed to challenge this cycle by introducing a reusable, reconfigurable alternative that supports both environmental and clinical goals. Its structure allows healthcare professionals to adjust the brace directly on-site without having to fabricate a new one for each patient or stage of recovery.This approach reduces material waste at multiple levels: fewer discarded devices, fewer remakes due to improper fit, and less packaging and transport required for fabrication and delivery. Modular components can be disinfected, replaced individually, or refitted for different patients, depending on regulatory and institutional protocols. The system also facilitates inventory management for clinics, reducing the need to stock multiple rigid SKUs for different body types.Crucially, this sustainability-driven architecture does not compromise clinical efficacy or patient comfort. On the contrary, the ability to adapt the brace over time—tightening it as swelling reduces or re-aligning it to changing anatomy—enhances both therapeutic performance and user experience. Patients are more likely to comply with treatment when the device is breathable, adjustable, and less invasive than traditional alternatives.Recognition by the A’ Design Award highlights not only the innovation in form and engineering, but also Bracesys' role in shaping a more responsible model for orthopedic care—one where ecological and clinical priorities are addressed in the same system, not traded off.
The Bracesys brace is built around a reconfigurable mechanical system that allows the device to fit to the patient’s anatomy. The decision to engineer it using segmented units was driven by the need to move away from rigid, one-size-fits-all orthotic devices and toward a structure that could be customized in both shape and function—on-site, without fabrication delays.Each segment acts as a modular unit within a connected framework, allowing clinicians to configure the brace to match a specific anatomical region or therapeutic goal. This segmentation supports not only initial fitting but also realignment and selective pressure distribution during the healing process. Instead of requiring full replacement as conditions evolve, individual modules can be repositioned or swapped, offering a more efficient and sustainable clinical workflow.The tension dial system plays a key role in this reconfigurable architecture. In its loose state, the brace remains flexible and open—this is when major adjustments should be made, such as aligning segments or accommodating anatomical swelling. Once the configuration is finalized, tightening the dial brings the system into a solid state, securing the brace into a stable, weight-bearing structure. This dual-state functionality allows for both precision and responsiveness, ensuring that the brace can be both adaptable and supportive as needed.Together, these mechanical features make Bracesys not just adjustable, but truly reconfigurable—a system that evolves with the patient’s needs while reducing the reliance on single-use materials and technician-intensive procedures.
Navigating the regulatory landscape while developing Bracesys’ reusable architecture required a careful balance between innovation and compliance. While the brace in its single-use format qualifies as a Class I medical device under both EU MDR and FDA guidelines, the moment reusability is introduced—particularly with shared use across multiple patients—it elevates the product into Class II territory. This shift comes with significantly more stringent documentation, testing, and risk mitigation requirements.From an early stage, we designed Bracesys to accommodate both classifications, with modular pathways depending on market and use case. For instance, the EU regulatory framework under MDR is comparatively more accommodating to reusable orthotic devices, provided traceability, hygiene, and performance criteria are met. This made the EU a strategic starting point for our clinical pilots and regulatory filings. In contrast, achieving reusable Class II clearance under the FDA pathway in the U.S. poses a more complex regulatory challenge due to stricter interpretations of reusability, cleaning validation, and device tracking.To address these differences, we developed Bracesys with a split-architecture approach: reusable core components paired with optional single-use patient interface elements. Materials were selected based on compliance with ISO 10993-5, 10993-10, and 22523, and mechanical durability was validated under simulated clinical re-use cycles.By integrating regulatory foresight into our design process, we were able to reduce redesign risks, meet diverse regional expectations, and retain the clinical and environmental advantages of reusability. Rather than treating compliance as a constraint, we used it as a framework to ensure Bracesys could be deployed responsibly and adaptively across healthcare systems with differing rulesets.
Bracesys integrates AI-driven segmentation and implicit skinning algorithms to transform raw anatomical data into functional, patient-compatible brace designs. These technologies were developed to overcome one of the most common barriers in orthotic customization: the gap between high-resolution imaging and real-world anatomical fit.Using AI-driven segmentation, the system rapidly interprets CT or 3D scan data by isolating key skeletal and soft tissue structures. This automation dramatically reduces the time and expertise required to prepare patient-specific models. More importantly, it improves consistency, minimizing errors that can occur during manual modeling.The implicit skinning algorithm plays a different role—it bridges the geometric data of the scan with the modular architecture of Bracesys. Instead of treating the patient’s anatomy as a rigid surface, it interprets it as a volumetric influence field, allowing the modular segments of the brace to align themselves with anatomical curves and varying contours. This method ensures that Bracesys is not just shaped around the body, but tuned to its dimensional subtleties, even in areas with asymmetry, swelling, or structural variation.Together, these computational methods allow us to move beyond binary scanning workflows (full custom or generic prefabrication) and into a hybrid model that enables mass customization. The brace framework generated by this process is highly compatible with real anatomical diversity but still manufacturable using standardized, reusable modules. It also enables rapid fitting in clinical settings, giving practitioners the ability to offer personalized care without long delays or expensive fabrication processes.By embedding this layer of computational intelligence into the Bracesys workflow, we ensure that the system is both anatomically precise and operationally scalable—a key innovation that helps bring personalization into routine orthopedic care.
While sizing optimization in Bracesys was largely addressed through computational methods—including AI-based anthropometric analysis and modular segment scaling—fitting emerged as one of the most critical areas shaped by clinical feedback. Because the framework is reconfigurable, sizing was rarely a challenge in trials. The challenge, however, lay in translating digital precision into physical comfort for patients already in pain or distress.In early iterations, the transition from semi-rigid to rigid states occasionally caused discomfort—specifically, patients experienced pinching or pressure points where skin became momentarily caught between adjacent brace segments during tensioning. This feedback was consistent across different clinical settings and patient profiles, highlighting that mechanical performance alone was not enough; the system needed to be sensitive to how patients physically and emotionally experience brace application.In response, we revised the segment edge geometries to introduce micro-contouring and increased inter-segment spacing at identified pressure-prone zones. This reduced shear during tensioning and prevented soft tissue entrapment. We also modified the angle of articulation in transitional joints to maintain uniform closure under variable surface tension. Beyond geometry, we collaborated with clinicians to develop standardized fitting protocols, including a staged tightening procedure and pre-alignment steps that minimize stress on sensitive areas.These changes, though subtle in terms of form, had a significant impact on patient comfort and clinical usability. The insights gained from real-world fitting sessions became a central part of our design criteria, reinforcing the idea that the brace is not just a technical device—it is a human interface. Bracesys’ final form reflects this convergence of mechanical intelligence and compassionate clinical design.
The quick-release mechanism in Bracesys was developed to simplify the fitting and adjustment process, especially in time-sensitive clinical settings. Its primary goal is to allow clinicians to rapidly switch the brace between semi-rigid and rigid states during application or monitoring, without needing tools or complex training. For cooperative adult patients, this mechanism has proven highly effective—it provides reliable immobilization while significantly reducing brace application time and enabling small adjustments without full removal.However, clinical feedback from early trials revealed that ease of release can pose challenges in certain contexts—especially with pediatric patients or adults with cognitive impairments or limited cooperation. In these scenarios, there is a need for more restrictive or tamper-resistant locking systems to prevent unintentional disengagement or patient-initiated release.We selected the current quick-release mechanism specifically for clinical trial use, where trained professionals could fully control the adjustment process. This choice allowed us to validate the mechanical behavior and pressure distribution of the brace in a controlled environment. Moving forward, we are developing an alternate version of the release system with tiered access levels—essentially, a dual-mode interface where the mechanism remains simple for clinicians but more secure in unsupervised settings.Balancing these demands—clinical speed and patient safety—is central to the evolution of Bracesys. The mechanism is not just a technical component; it's a point of interface between the brace, the clinician, and the patient. Our goal is to ensure that its design can be adapted to the specific use case, while preserving the benefits of rapid deployment, anatomical conformity, and comfort during the healing process.
The standardized sizing system of Bracesys was the result of a data-driven approach combining clinical imaging, anthropometric databases, and iterative digital prototyping. Our methodology began with the collection and anonymized analysis of over 600 CT scans, which were used to map skeletal and soft tissue variations across a wide population. These scans were segmented using AI-powered tools, enabling us to extract key dimensional data—such as bone lengths, curvatures, and soft tissue envelopes—in a highly repeatable way.This internal dataset was then cross-referenced with large-scale public anthropometric datasets, including measurements from the U.S. Army’s Human Engineering Laboratory series. By layering statistical models over these data points, we were able to define a percentile range—from 5th to 95th—that could be accommodated without compromising either fit or mechanical performance. Our goal was not to create one-size-fits-all solutions, but to build a modular system of interchangeable units that, when configured properly, cover the vast majority of clinical needs.We validated the system using parametric design software, simulating hundreds of brace configurations across a range of limb geometries. This allowed us to test not just size compatibility, but also joint alignment, tension points, and pressure distribution. Crucially, we designed our modular segments to overlap slightly across sizes, so that edge cases could still be accommodated by minor reconfiguration rather than requiring full customization.By anchoring our sizing system in real-world anatomical diversity and computationally validated configuration logic, we were able to deliver a brace that adapts as well as it fits—without resorting to the time, cost, and waste associated with full custom fabrication.
Looking ahead, we see Bracesys not only as a product but as a modular platform capable of expanding into broader orthopedic and rehabilitative applications. The same principles that allow the brace to be reconfigured and adjusted in real time—modularity, localized tension control, and scalable manufacturing—can be applied to other anatomical regions and medical use cases.In the near term, we are exploring configurations for lower limb support, including applications for tibial fractures, ankle stabilization, and post-operative knee rehabilitation. Pediatric adaptations for complex developmental conditions such as scoliosis and clubfoot are also in development, requiring tailored geometry and growth-compatible modularity.Beyond orthopedics, the Bracesys architecture opens doors in therapeutic wearables. We are prototyping integrations for motion tracking sensors, EMS (electrical muscle stimulation), and LIPUS (low-intensity pulsed ultrasound) to support real-time healing feedback and non-invasive therapy. These would turn the brace from a passive support device into an active treatment platform.From a systems perspective, the platform’s parametric design and simplified sizing logic allow it to be adapted for mass production through injection molding or customized via on-demand 3D printing, depending on geography, clinical setting, or patient need. This versatility makes Bracesys a strong candidate for scalable public health deployments, especially in emerging markets where custom care is often limited by cost and infrastructure.In the longer term, we believe the Bracesys platform can serve as the foundation for intelligent orthotic systems—devices that learn from patient movement and healing patterns to dynamically adapt support, or even alert clinicians of complications. Ultimately, our goal is to make orthopedic care more responsive, data-driven, and accessible—without sacrificing design, sustainability, or clinical precision.
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