Ascend Custom Fabricated Smart Orthosis

Employer: Roam Robotics

Role: Team Lead, Sr. Director of Engineering

Arthirits is the leading cause of disability globally. Millions of inidividuals face difficulty walking and climbing stairs which can be very lifestyle limiting. For these reasons, Roam designed Ascend, a custom fabricated, pneumatically powered knee orthosis.

Key Design Features:

• Custom fabrication ensured rotational control of the limb, comfortable fit of interfacing components, device suspension, and alignment of orthosis joint and anatomical joint of user

• Pneumatic power reduced distal mass on the user which reduces the metabolic cost of wearing the device. 90% of the device mass is located in the SmartPack worn on the user's trunk.

• Intent recognition controllers were able to detect user's movement and appropriately adapt to changing terrian and movement. This reduced the cognitive load on the user to change modes when changing gait patterns such as moving from flat ground to a flight of stairs.

• High stregnth plastic and fabric construction made the design cheap to manufacture (injection molded and reinforced plastics) and contributed to keeping the over mass of the system at a minimum

• Compliant pneumatic actuation made the force application to the user feel comfortable and natural. Depending on the force setting, with some effort the user was able to back drive the actuator which provided extension torque and flexion damping.

We completed a 80 person pilot study where participants used a prototype version of the system (not custom fabricated) in a controlled lab setting. Participants were asked to perform functional outcome measures both with and without (baseline) the system and rate their perceived pain on a scale from 1-10 for each activity. 70% of users experienced improved outcomes and on average a 50% reduction in pain. This study was repeated by 3rd party investigators at the San Francisco VA and the University of Pittsburgh Medical Center.

The Ascend product was paused in February, 2021 when the company failed to meet it's fundraising goals. The product was on track for limited launch of ~100 units in the Spring of 2021.

As the lead for the Health product vertical, this project was my primary focus for the majority of my tenure at Roam Robotics. As is common in start-up environments, I wore many hats and contributed to all aspects of the product develpment cycle.

Some of my main contributions as the Health Team Lead are:

• Built the Health product team from the ground up as the lead for design, clinical evaluation, quality and new product introduction teams (8 direct reports, 20 total reports).

• Led the hardware team (8 direct reports) from ideation through production for all assemblies on the Ascend system by creating a culture of collaboration, design reviews, and brain storming.

• Key contributor to Health product strategy and original author of the product and engineering requirements documents.

• Generated evidence for knee osteoarthritis use case and presented to the Center for Medicare and Medicaid (CMS) and the Pricing, Data Analysis, and Coding (PDAC) for the designation of the Roam Health product in the Healthcare Common Procedure Coding System (HCPCS) as L1844.

• Authored and managed the hardware development roadmap, engineering requirements document (ERD), design FMEA, risk management documentation and design history file for ski and health products through several limited product launches (>100’s quantities).

• Designed, coordinated, and implemented a pilot study for early user feedback and validation for Health orthosis which collected user data from 81 participants (50% pain reduction from participants with 70% of users improving outcomes)

• Led Health product from early prototype to pilot studies, product development, DFM, verification/validation, and IEC/EMC (60601-1) testing. Health product was 4 months away from limited product launch of 100+ units before the program was shuttered due to failure to fundraise.

• Worked with regulatory agencies (FDA) to get health product Class I listed for sales in the U.S.

• Established a quality management system (QMS) and implemented design and document control.