Redacted_Sole_Source_Justification.pdf

Version – November 2015

JUSTIFICATION REVIEW DOCUMENT

FAR PART 13 SIMPLIFIED ACQUISITION JUSTIFICATION AND APPROVAL FOR

OTHER THAN

FULL AND OPEN COMPETITION

Supply/Service: The US Army Research Laboratory requires two (2) integrated wearable wireless electromyography (EMG) and 3-D motion capture systems.

Authority: Per 41 U.S.C. 1901(e)(2), implemented by FAR 13.501(a) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: Redacted

Prepared by: Redacted DSN: Redacted Mechanical Engineer Date: 23 June 2016 Email: Redacted

Contracting Officer: Redacted DSN: Redacted Contracting Officer Date: 16 August 2016

Technical: Redacted DSN: Redacted

Requirements: Redacted DSN: Redacted

Email: Redacted

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Redacted

Department of Army FAR Part 13 Simplified Acquisition Sole Source Justification and Approval for

Other than Full and Open Competition

1. Contracting Activity: Army Contracting Command, Adelphi Division, Adelphi, Md

2. Description of Action: The US Army Research Laboratory requests a firm-fixed price contract with Noraxon USA, Inc., 15770 N. Greenway-Hayden Loop, Suite 100, Scottsdale, AZ 85260. The Government projects award for September 2016 and fiscal year 2016, Mission funds will be used.

_X_ An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

__ An approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B).

__ The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting approval.

Sources:

Manufacturer:

Noraxan USA, Inc.

15770 N Greenway Hayden Loop, Suite 100 Scottsdale, AZ 85260

CAGE: 0XR96

3. Description of Supplies/Services:

The total estimated value of the proposed action for the purchase of two (2) integrated wearable wireless electromyography (EMG) and 3-D motion capture systems and required accessories is $165,922.00. The individual items and quantities included in this purchase are:

Item Description Quantity TELEmyo DTS EMG 16ch w/ myoMUSCLE Master software (Part No. 580-16M)

Desktop DTS receiver with analog output (Part No.

586)

DTS BioMonitor Cardio-respiratory Sensor (Part No.

552)

DTS Analog Input Probe (Part No. 511) 2 DTS Fine Wire Lead set (Part No. 542FW) 6 Analog Input System w/ BNC inputs (Part No. 222BNC) 1 myoSYNC, Master Sync Station (Part No. 262) 1 myoMOTION Research Pro System (16 sensors) (Part No. 680-16) myoMOTION High Speed Upgrade (up to 16 sensors) (Part No. 681B) myoMOTION Datalogger (Part No. 682) 2 Data Processing Station (Part No. STATION) 2

4. Authority Cited:

Per 41 U.S.C. 1901(e)(2), implemented by FAR 13.501(a) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

The Integrated Capability Enhancement Branch (RDRL-HRF-B), of the Human Research and Engineering Directorate (HRED), of the US Army Research Laboratory (ARL) requires two integrated wearable wireless electromyography (EMG) and 3-D motion capture systems to support research studies conducted within laboratory and field environments. The systems must be capable of simultaneous data capture from at least 16 EMG sensors at 1.5 kHz and 16 motion sensors at 200 Hz. The EMG sensors must be available with electrode leads in varying lengths, up to a minimum of six (6) inches in length, to accommodate placement under Soldier equipment. The system must also possess the ability to: (1) collect and view synchronized data from any combination of the included wireless EMG and motion sensors, compatible wireless biomechanical sensors, third-party biomechanical data collection systems, and other analog data sources; (2) apply filters to incoming raw signals and view filtered signals in real-time; (3) seamlessly switch between laboratory and field modes of data collection, so the subject can change from a laboratory environment to a field testing environment with no physical interaction with sensors required; (4) collect, view, and analyze data for any combination of standard biomechanical and novel configurations of the motion sensors; and (5) batch export raw and/or processed data in text and c3d file formats. Additionally, the time required to transfer data from the datalogger to desktop system must be on the order of minutes, and the time required to fully charge system components must be under 4 hours. Based on market research conducted included in Section 8 of this justification, Noraxon USA Inc. was determined to be the only source capable of meeting all of the Government’s requirements listed above.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. Because this is a sole source action, effective competition is not applicable. All items being purchased for this procurement are supply items only available from the manufacturer, with no subcontracting possibilities.

ARL Subject Matter Expert (SME) has performed market surveys to identify vendors capable of meeting ARL’s requirements, details of which are in the market research section of this document. The Requiring Activity’s research confirmed that Noraxon USA Inc. is the only source capable of meeting all of the Government’s minimum requirements listed in section 5.

Therefore, it is not possible to compete this procurement requirement. ARL will continue to pursue web searches and consultations with knowledgeable government and industry personnel to help locate alternative manufacturers capable of meeting the Government’s requirement, but until that is known ARL will use the only existing known source. If ARL discovers that another manufacturer could provide a reliable alternative, ARL will not hesitate to purchase the system competitively.

7. Actions to Increase Competition: ARL does not anticipate purchasing another integrated EMG and 3-D motion capture system for at least five (5) years. During this time, the marketplace should evolve to overcome some of the barriers to competition. In the event ARL does purchase another integrated EMG and 3-D motion capture system, a market survey will be conducted to identify all sources capable of meeting the Government’s requirement.

8. Market Research: Market research was conducted by Dr. Angela Boynton, PhD in Biomechanics and Movement Science, with 15 years of experience in Soldier performance and biomechanics research, with RDRL-HRF-B, from 5 May 2016 through 10 June 2016. Market research included internet searches (key words “wireless EMG” and “wearable motion capture”) to identify potential source, reviews of on-line documentation from identified potential sources, and live system demonstrations for those sources determined to be most relevant.

Internet searches revealed a total of eight (8) commercially available wireless EMG and/or wearable motion capture systems. Of those eight (8) companies, five (5) do not offer an integrated EMG/motion tracking capability. Myon and BTS Bioengineering offer EMG capabilities only. Xsens, Motion Workshop, and APDM offer motion capabilities only. The three (3) remaining companies; Delsys, Inc., Noraxon USA, Inc., Cometa offer systems including both EMG and motion tracking capabilities. Each of the vendors provided a live on-site demonstration of their systems under realistic data collection conditions to evaluate their system capabilities against the requirements for this purchase.

An on-site demonstration of the Delsys Trigno system was provided by Nicholas Ducey, Jr. Applications Engineer, with Deslys Inc. Although the Delsys Trigno system offers both desktop and data logging capabilities, the process for switching between modes is extremely time consuming and requires physical interaction with each body worn sensor.

This is unacceptable for studies conducted with Soldiers wearing military clothing and equipment, since the clothing and equipment would have to be removed each time the sensors are adjusted. Additionally, the Trigno system is primarily intended for the measurement of EMG signals and although motion tracking is possible, the capability is limited. The primary limitation comes from the fact that the EMG and motion tracking are integrated into a single sensor, requiring that motion be tracked at the muscle site rather than close to bony landmarks. This increases the likelihood of introducing soft tissue artifacts into the resulting motion data. Separate motion tracking sensors are not available. Additionally, the sampling rate for the incorporated motion tracking does not meet our requirement of 200 Hz. Delsys offers analog input, biofeedback and spring contact auxiliary sensors, however, since the Trigno system can only accept a total of sixteen (16) sensors, the use of any auxiliary sensor will reduce the total number of EMG sensors that can be used. Finally, the Delsys software does not offer the option of exporting data in the .c3d format, which is required for streamlined incorporation with existing data processing software.

An on-site demonstration of the Cometa Wave wireless EMG and WaveTrack inertial measurement systems was provided by Matteo Dellacorna, Sales Manager, with Cometa Srl and Michael Rowling, Chief Operating Officer, at ProtoKinetics. The Cometa systems offer both desktop and data logging capabilities, and although physical interaction with the sensors is not required to switch between modes, it is necessary to observe lights on each sensor to ensure proper operation during the data logging mode. Also, the amount of time required to transfer logged data from the sensors to a computer is equivalent to the duration of the data collection, and the time required to recharge the sensors is equivalent to the duration of usage, both of which exceed the limits specified for this purchase. While the Cometa system includes the ability to output signals via a BNC patch cable, it does not offer any options for bringing external signals into the Cometa data collection software. A fine wire EMG probe is available for the Cometa system, however, as with the Delsys system the connection type is a spring connector rather than the desired screw terminal. A biomonitor sensor is not available for the Cometa system. The Cometa software does not include the ability to apply filters to streamed data in real-time and does not include a biomechanical model for motion or the ability to calculate and/or visualize relative angles between motion sensors.

An on-site demonstration of the Noraxon telemyo DTS and myoMotion systems was provided by Zachary Scarano, a Biomedical Applications Engineer, with Noraxon USA.

The telemyo DTS EMG system and myoMotion 3-D motion tracking system can be used independently or together in both desktop streaming and data logging modes. Switching between modes requires a simple changes in the software without any physical interaction with the sensors. Signals from the telemyo and myoMotion systems can be viewed synchronously within Noraxon’s software, along with signals from external analog systems connected via optional wireless analog input sensors, desktop analog input systems through BNC or bare wire connections, and/or a standard National Instruments data acquisition board similar to the one currently used within our laboratory. The technical specifications for the wireless EMG and motion sensors meet all of our requirements. Additionally, auxiliary input, biosignal, and screw terminal fine wire EMG sensors are available for use with the telemyo system. The Noraxon software provides the ability to apply filters and event markers to signals in real time, as well as the ability to batch export raw and processed signals in all desired file formats. A 3-D biomechanical model within the software permits real-time viewing of subject and external object motion.

Based on the conducted market research and observations made during the on-site demonstrations, it was determined that only the Noraxon telemyo and myoMotion systems will meet the Government’s requirements for an integrated wearable wireless EMG and 3-d motion capture system. These systems are only available for purchase from Noraxon. Based on the aforementioned, this acquisition will be pursued on a sole source basis with Noraxon.

9. Interested Sources: A synopsis was posted to Federal Business Opportunities (www.fbo.gov) in accordance with the requirements at FAR 5.202, for fifteen (15) days, on 18-AUG-2016 through 02-SEP-2016, in an effort to identify interested sources. No responses were received.

10. Other Facts: N/A

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signer’s Title: Angela Boynton, Mechanical Engineer

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signer’s Title: Angela Boynton, Mechanical Engineer

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

__ Cost analysis _X_ Price analysis __ Should-cost

__ IGCE

__ Audit:

__ Other:

As a part of this basis, certified cost or pricing data:

__ will be required.

_X_ will not be required and the following exception applies (FAR 15.403):

__ Prices that will be agreed upon are based on adequate price competition.

__ Prices that will be agreed upon are based on prices set by law or regulation.

_X_ A commercial item is being acquired.

__ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

__ The contract action is a modification to a contract or subcontract for commercial item(s).

__ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

Based on the foregoing justification, I hereby approve the procurement of two (2) integrated wearable wireless electromyography (EMG) and 3-D motion capture systems on an other than full and open competition basis pursuant to the authority of 41 U.S.C.

1901(e)(2), subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

(End of Justification)