36C25919Q0126-001.doc

VHAPM Part 813.106 Simplified Acquisition Procedures Attachment 1: Justification for SAP under $250K

DEPARTMENT OF VETERANS AFFAIRS

Brand Name Justification IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:

Title: SCI EQ01, Exoskeleton (Indego) Contracting Activity:

Department of Veterans Affairs

Network Contracting Office 19 (NCO19)

6162 S Willow Dr. Suite 300

Greenwood Village, CO 80111 Organizational Activity:

Department of Veterans Affairs

Rocky Mountain Regional VA Medical Center

1700 N. Wheeling Street

Aurora, CO 80045

1. Brief Description of Supplies/Services required and the intended use/Estimated Amount:

The Rocky Mountain Regional VA Medical Center needs to purchase two distinct types of Clinical Exoskeleton Gait Trainers for use in the Spinal Cord Injury (SCI) Unit. The impending action is a new requirement and is intended to be a firm-fixed-price purchase order of the supplies and services described below:

· Battery recharging station

· Hand held controllers

· Set of padding

· User manual

· Motion+ Software Suite

· Therapy+ Software Suite

· Indego Specialist training course

· Indego Trainer Clinic training course

The proposed action is to justify NCO19 conducting an open market, brand name only for the outfitting of the above items at the Spinal Cord Injury (SCI) Unit at Rocky Mountain Regional VA Medical Center in Aurora, Colorado.

2. Unique characteristics that limit availability to only one brand, with the reason no other manufacturer can be used:

The research, development and usage of exoskeleton systems is a very new and emerging market that directly contributes to individuals with spinal cord injuries and hemiplegia conditions to regain the ability to walk and have improved functionality in daily activities. The Indego shares many characteristics with the two other exoskeleton systems on the market to include the ReWalk Rehabilitation (Argo Medial Technologies Inc.) and the EksoGT (Ekso Bionics Inc.). Each of these two devices provide different capabilities at different phases of a patient’s rehabilitation goals. The Indego Therapy Device by Parker Hannifin Corporation has multiple unique features that set it apart from other systems on the market and align with the clinical requirements of the SCI unit as detailed below.

Indication of Use: The device must be capable of providing rehabilitative therapy for spinal cord injuries originating at C7 (AIS A-D) and below.

Weight/Ease of Transport: The system must be lightweight to and separate easily into separate pieces for ease of transportation and storage. The Indego system weighs approximately 26 lbs and its modular design allows for the device to separate into five pieces.

Variable Power Assist: Power assist or how much the device augments a patient’s own capabilities is needed at a range of 0-100% support for each lower extremity as well as the ability to separate out the hip and knee joints as needed for specific and unique therapy requirements.

Untethered Control: As a clinical requirement, the suit must be capable of being controlled wireless or untethered. This allows the patient a full range of motion without being restricted by cable length.

Wheelchair Wear: Since many patients starting treatment with an exoskeleton device are restricted to a wheelchair, it is critical that a patient be able to use a wheelchair while the suit is being worn. The intent of these types of devices to allow therapy to extend beyond a single location or training room and for the patient to engage new environments such as public spaces, outside venues, etc. In these cases, a place for the patient to sit and rest may not always be readily available. Having the ability for a patient to sit in a wheelchair while still wearing an exoskeleton eliminates the need for the suit to be removed and refitted once the patient is ready to resume the therapy session.

3. Description of market research conducted and results or statement why it was not conducted:

Besides the Indego Therapy Device, there were two other exoskeleton systems on the market; the ReWalk Rehabilitation, by Argo Medial Technologies Inc. (508-251-1154) and the EksoGT by Ekso Bionics (720-439-6669);

The ReWalk Rehab was reviewed with multiple conversations taking place with the local sales team. This system was found to not meet many of the clinical requirements detailed in the above Section 3. Specifically, for patient care and utilization, the ReWalk is intended for spinal cord injuries at the T4 level and below. Procurement of this device would reduce the number of patients that can be treated.

The Indego Therapy Device as well as the EksoGT system are compatible with patients that have spinal injuries at the C7 level and below; however the EksoGT does not meet the maximum weight requirements, have the ability to use a standard wheelchair while the device is being worn, and does not provide a variable power assist feature that separate out the hip and knee joints. The EksoGT and ReWalk are also tethered via a control cord. For the specific application the Indego Therapy Device is being procured for, the device must be untethered. The Indego Therapy Device being requested with this procurement action is the only product on the market that will meet clinical requirements described in Section 3.

VHAPM Part 813.106

Original Date: 04/23/18