When two medical professionals with 20+ years of operating room experience founded their company, they brought critical frontline knowledge to their mission: advancing embolic protection technology for lower extremity interventions. Re:Build partnered with these clinical veterans, leveraging their clinical insights throughout development. This collaboration of medical expertise and engineering excellence transformed their prototype into an FDA 510(k)-cleared Class II medical device that provides interventionalists with an innovative, quality care tool.
The Details
Industry
Medical
CAPABILITIES APPLIED
A common procedure to restore blood flow in the legs inadvertently creates a new problem: dislodged material that travels into the foot’s tiny blood vessels, where it can’t be retrieved. This trapped material can cause complications serious enough to require amputation.
The clients’ founders had developed an innovative idea—a rotational thrombectomy device combined with a technique that could capture emboli before it caused irreversible damage. Their prototype demonstrated the core concept effectively but transforming it into a market-ready device would require further refinement and a clear regulatory pathway to commercialization.
As a two-person startup, the client needed more than a traditional consultant, they needed a complete product development partner. Re:Build provided integrated research, human factors, product design, product engineering, branding expertise, and regulatory support, and together, we navigated the complexities of bringing a Class II medical device to market during the challenging COVID-19 era.
Re:Build enabled this client to transform from a two-person startup with a prototype into a company with an FDA-cleared, market-ready Class II medical device through a comprehensive, phased development approach.
We began by immersing ourselves in the clinical reality. Our team conducted observational research during actual procedures with the founder-interventionalist. When COVID-19 hit in March of 2020, we adapted by facilitating remote procedure observations via video conference, ensuring our research continued uninterrupted. These sessions provided critical insights into workflow, procedural context, and user needs. We documented our findings through detailed journey maps and validated our design direction through direct interventionalist feedback, establishing a foundation of clinical understanding that would inform every subsequent decision.
Our industrial design team explored multiple interaction paradigms, moving beyond the initial pistol-grip prototype to investigate pencil-grip configurations and other handheld options better suited to the clinical environment. Through extensive sketching, CAD development, and rapid prototyping using our in-house 3D printing capabilities, we refined both aesthetic and functional elements. The final design balanced precision and ergonomics, incorporating thoughtful details like surface texturing for secure handling during procedures. Every design decision was validated against clinical workflow requirements and interventionist feedback.
The core engineering challenge was clear: create a mechanism to reliably spin a catheter in a sterile environment while maintaining precise control, safety, and clinical ease of use. Our engineering team explored multiple mechanical approaches for the rotation mechanism, ultimately developing custom bonded assemblies that replaced off-the-shelf connectors and met specific performance requirements.
We developed sophisticated benchtop testing protocols that simulated the arterial geometry of the lower limb. Early validation of the concept included using coffee grounds and sand to simulate thrombus. The design incorporated the ability to control rotation, making the device more flexible for interventionists. Initially designed to provide three rotations per pull of the trigger, the components were updated so that the device provided only a single rotation on each trigger pull following clinical use.
We managed the client’s complete regulatory pathway to FDA 510(k) clearance for their Class II medical device. Our team executed a comprehensive validation program covering all necessary testing requirements, coordinated with specialized laboratories, and maintained ongoing FDA communication. We also helped them establish their Quality Management System and build their manufacturing infrastructure, including international molding partnerships and domestic assembly operations.
We developed Rovo’s complete brand identity in parallel with product development. Our branding team created a distinctive logo incorporating a visual representation of the catheter’s bent tip, with design elements showing the catheter path and thrombus capture action. Beyond the logo, we delivered a comprehensive brand package including all packaging graphics, product labeling, website design and content, and demonstration videos showcasing the device’s functionality through in-house testing with coffee grounds and gelatin-based emboli simulants.
The Rovo thrombectomy device successfully achieved 510(k) clearance on March 31, 2023, after navigating complex regulatory requirements including animal studies, a testament to the thoroughness of our integrated approach. Throughout the program, we adapted to challenges including COVID-19 restrictions, startup funding cycles that created natural pauses between development phases, and post-launch supply adjustments. Our continued engineering support post-launch, including design modifications based on clinical feedback, demonstrated our commitment to long-term partnership success.
