This case study offers valuable insights for orthopedic surgeons, rehabilitation specialists, and entrepreneurs interested in developing medical devices. By walking through RomBot’s evolution—from identifying the clinical need to refining prototypes and scaling production—you’ll discover practical lessons on innovation, patient-centered design, and navigating the complex path from concept to market.
The story of the RomBot product concept begins not in a hospital or research lab, but at a horse stable in China.
Two entrepreneurs, passionate about equestrian sports, had witnessed countless riding-related injuries and the subsequent rehabilitation journeys. They noticed a recurring challenge: there was no reliable way to track a patient’s joint mobility progress during recovery. Doctors and physical therapists relied largely on visual observation and manual measurements, making it difficult to optimize rehabilitation protocols.
This observation sparked a question: What if we could create a device that precisely measures joint movement during recovery?
The Clinical Need
Anyone who has worked in orthopedic rehabilitation knows the challenge. A patient comes in for their weekly check-up, and you ask them about their progress. “I think I can bend it more than last week,” they say.
But by how much? What’s the quality of that movement? Are they compensating with other joints?
These questions traditionally relied on subjective assessment and manual goniometer measurements.
From Concept to First Prototype
Our development team approached the challenge by first breaking down the essential measurements needed for meaningful rehabilitation tracking:
- Range of motion during natural movement
- Step length and gait patterns
- Movement quality and consistency
The first prototype was remarkably simple: a circular device that attached above and below the knee joint.
Inside, we packed an angle sensor, accelerometer, and gyroscope. The goal was to create something that patients would barely notice while wearing, yet would provide doctors with a wealth of data about their recovery.
Technical Challenges and Solutions
One of the biggest hurdles was accurately measuring step length. While the angle sensor could easily track joint flexion and extension, calculating actual step length required complex integration of data from multiple sensors. We found that combining gyroscope and accelerometer data with the angle measurements gave us the most reliable results.
The device evolved through several iterations:
- First version focused purely on angle measurement
- Added motion sensors to capture movement quality
- Integrated Bluetooth connectivity for real-time monitoring
- Developed internal storage for continuous data collection
- Refined the design for comfort and ease of use
The Human Element
Throughout development, we kept returning to our core users – both patients and clinicians. We learned that patients wanted something unobtrusive that wouldn’t draw attention during daily activities. Doctors needed clear, actionable data that could inform treatment decisions.
Working closely with rehabilitation specialists, we refined the data presentation to focus on key metrics:
- Daily range of motion trends
- Movement quality scores
- Activity level analysis
- Progress comparisons against recovery benchmarks
From Testing to Implementation
Early testing revealed unexpected insights. For instance, we discovered that patients tended to move differently when they knew they were being monitored during clinic visits versus at home.
This finding highlighted the value of continuous monitoring in understanding true recovery patterns.
Looking Forward
RomBot represents more than just a measurement tool – it’s a window into the rehabilitation process. For orthopedic surgeons considering their own device development journey, our experience offers several key lessons:
- Start with a clear clinical need you’ve personally observed
- Focus on gathering meaningful data that impacts treatment decisions
- Keep the user experience simple for both patients and clinicians
- Build in small iterations, testing each addition thoroughly
- Remember that the best medical devices often come from physicians who understand both the clinical need and the patient experience
Here’s a streamlined, step-by-step process highlighting how OVA Solutions helps surgeons bring their medical device ideas to life:
How OVA Solutions Helps Turn Your Clinical Idea into a Medical Device:
- Identify the Problem: It all starts with your clinical insight or observation. What is the unmet need or opportunity for improvement in patient care or clinical practice?
- Concept Discussion: Share your idea with OVA. We connect with your vision, assessing both the technical feasibility and clinical relevance of your concept.
- Feasibility Assessment: Our interdisciplinary team—mechanical engineers, firmware developers, and medical device experts—analyzes the technical challenges and regulatory requirements for your device.
- Design and Development: We create prototypes, focusing on robust, scalable designs that align with medical device standards from the start.
- Regulatory Pathway and Testing: We handle regulatory compliance, set up manufacturing protocols, and conduct rigorous testing to ensure the device meets safety and efficacy standards.
- Production and Scaling: With manufacturing processes in place, we move to scalable production, ensuring the device is ready for market launch.
- Support for Market Launch: We continue to support you through the final stages, including regulatory approval and market entry.
At OVA Solutions, we believe that the best innovations come from real clinical needs. We help transform your “What if?” into a reality that improves patient care and fits seamlessly into clinical practice.
For more information about how to turn your clinical idea into a medical device, contact OVA here – https://calendly.com/lisa-voronkova/45-minute-free-consultation