CuffLink

• CuffLink provides a solution for the 529,689 annual surgical shoulder patients that often exhaust their insurance-allotted outpatient physical therapy visits.
• Cufflink pairs a patented mechanical device that has been prescribed for over 5,000 post-operative patients with sensors, a mobile app, and a clinician portal to quantify movement into clinically meaningful motion metrics with real-time biofeedback for an improved patient experience.
• Safely moves early rehabilitation home, saving outpatient PT visits for later in the recovery when hands-on functional rehab is the most valuable.
• Enables remote monitoring of patient progress and helps identify patients that are in need of added intervention.
• Exists as an established and safe mechanical device with an Alpha-prototype of the CuffLink platform suite with clearly defined development needs to begin Beta launch.

Over 500,000 shoulder surgeries are performed each year and rotator cuff repairs have increased by approximately 10% each year over the last decade. Rotator cuff tears alone generate $3-$12 billion in healthcare costs annually. The goals of shoulder post-op rehabilitation are to protect the repair, promote healing, and safely progress the restoration of motion to prevent stiffness. Post-operative shoulder patients require 4 to 6 months of rehabilitation, but variability in insurance coverage can leave patients unable to return to work or engage in other activities of daily living.

Patients typically attend outpatient physical therapy (PT) twice per week for 18 to 24 weeks, or for 36-48 visits. With this patient population’s extended rehabilitation time frame, patients can exhaust their limited insurance allotted visits, incurring additional financial burden or electing to cut treatment short rather than pay out of pocket. Only 12 to 20 covered visits per diagnosis is common practice. Outpatient PT also requires patients to travel to the clinic several times a week, which can be difficult for patients who are unable to drive or have limited access to healthcare providers.

Together, the University of Pittsburgh and elizur, a local medical equipment provider, propose to develop CuffLink, a novel approach to rehabilitation and patient monitoring. In addition to safely moving early post-operative rehabilitation to the patients home, CuffLink minimizes variables and provides consistent and reproducible protocols. It combines a patented home rehabilitation device, with real-time biofeedback, and a clinician portal for remote monitoring.

The mechanical device guides and limits motion for the safety of outpatient physical therapy with the convenience and compliance of an in-home device. Sensors quantify motion/compliance, and CuffLink synthesizes the data for real-time biofeedback and remote monitoring of patient progress. Cufflink will be prescribed, the rented device delivered to the patient’s home, and the mobile application downloaded to the patient’s device for guided sessions. Compliance/range-of-motion data will be available in the CuffLink clinician portal for remote monitoring by the prescribing physician and other care team members.

CuffLink thereby shifts often limited physical therapy visits for later in the recovery continuum, increases the accessibility to care for patients with limited mobility and/or healthcare access, and increases communication and supervision by physicians through the clinician portal.

• Kevin Bell, PhD, Associate Professor, Department of Bioengineering; role: Co-PI.
• Michael McClincy, MD, Assistant Professor, Department of Orthopaedic Surgery; role: Co-PI, expert clinician.
• Bambang Parmanto, PhD, Professor and Chair, Department of Health Information Management; role: app development.
• Andi Saptano, PhD, Assistant Professor, Department of Health Information Management; role: app development.
• Adam Popchak, DPT, PhD, Department of Physical Therapy; role: expert clinician.
• Jim Grant, Founder and President, elizur, role: business expert.
• Jennifer Lambiase, Product Development Manager, elizur; role: mechanical device refinement.
• Swanson School of Engineering IDEA Lab (Makerspace), role: hardware refinement.

Current STTR Phase I research activities developed an Alpha version of CuffLink, and clearly defined development needs for Beta release. PInCh funding will be able to get CuffLink ready for a Beta launch: a usable production ready platform compatible with popular external operating systems.

Once available, elizur will perform a Beta release with current surgeon customers rapidly and effectively. Many of the surgeons utilizing the Shoulder SSS mechanical device for their patients are eager to begin using CuffLink’s remote monitoring capabilities. Furthermore, a Beta ready version will prepare us for a STTR Phase II application. An awarded Phase II will then focus on refinement, scaled manufacturing, and nationwide implementation.

• What is the implementation strategy, especially for rural regions with limited access to care? For beta release, CuffLink will be driven to the patient’s home. Once a standard carrier shipping model is established as safe and effective, national access will be available and implemented. In these scenarios, virtual set up guidance will be scheduled pre-operatively, when a friend is available to help.
• What is the expected reimbursement model? CuffLink will provide diverse cost-savings: reducing burden to limited healthcare resources, getting patients further with the same amount of PT visits, and reducing follow-up visits for on track patients. We plan to explore the precedent of bundled payments per incident with payors during STTR Phase II research activities.
• Could this replace formal outpatient Physical Therapy? CuffLink is designed to be complimentary to hands-on physical therapy – not a replacement. The goal of CuffLink is to prime patients for formal PT by reducing post-operative stiffness and pain, and thus setting them up for success during each PT visit.
• Are there additional applications and opportunities for growth? While initially focusing research efforts on Rotator Cuff Repairs, we are designing to accommodate the specific needs of a variety of shoulder pathologies and diagnoses -including surgical and non-surgical patients. Additionally, we are laying the groundwork for the seamless expansion to other joints such as the hip and knee.