J A_Anti-Gravity_Treadmill_Redacted.pdf

Log # 10194-14

Form 02.4G.AB / N6264514RCES073 / TDP 14-160 Page 1 of 3 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Navy and Air Force MTFs.

2. NATURE/DESCRIPTION OF CONTRACT ACTION: The proposed action is for a patient-lifting aerobic exercise treadmill. The Government intends on awarding a Firm Fixed Price

(FFP) IDIQ contract. The proposed source is AlterG, Inc., 48438 Milmont Dr. Fremont, CA

94538.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The requirement is for a patient-lifting aerobic, exerciser, treadmill for Navy and Air Force MTFs. The system shall be used for conditioning training for patients with musculoskeletal injuries and post-surgery patients to increase healing speed and decrease rehabilitation time. The system shall be able to reduce the patient’s effective body weight by at least 80%, controlled in at most 1% increments. The system shall increase in speed from 0 to at least 12 miles per hour (mph) in the forward direction and at least 3 mph in the reverse direction. The system shall be able to incline from 0% to a minimum of

10%. The treadmill shall have an interface to allow the user to control and set weight, speed, and incline. The treadmill shall use air pressure technology that will allow the patient to have unrestricted mobility and not influence their movement. There shall not be any liquid components.

The system shall at least be able to accommodate patients weighing between 100-400 pounds (lbs).

The weight of the system shall not exceed 1200lbs. The treadmill system shall include relevant accessories, such as a video monitoring system, a floor mat, and the shorts required to use the device. The treadmill electrical requirement shall be fulfilled by a standard NEMA 6-20 circuit.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United

States. The system shall be installed in compliance with OSHA requirements.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

4. IDENTIFICATION OF THE STATUTORY EXCEPTIONS PERMITTING OTHER

THAN FULL AND OPEN COMPETITION: The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Sole source

(including brand name) acquisitions.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF

THE AUTHORITY CITED: Only AlterG, Inc. can provide a patient-lifting aerobic exercising treadmill that is an air-based system for use in rehabilitation. The treadmills produced by AlterG, Inc. are the only treadmills available on the market that use air pressure based technology. The air-based system applies support uniformly in a way that patient-lifting pulley systems cannot. Only

AlterG, Inc. can provide a treadmill that uses air pressure technology that will allow the patient to have unrestricted mobility and all-around support without influence in their movement. No other vendor can provide this technology.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED

FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE: Market research was performed, the results of which are in paragraph 8. This requirement will be posted to

FedBizOpps in accordance with FAR 5.202. The government will evaluate any responses received.

7. DETERMINATION BY THE CONTRACTING OFFICER THAT THE ANTICIPATED

COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE: The Contracting

Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the commercial price list and will be determined fair and reasonable.

8. DESCRIPTION OF THE MARKET SURVEY CONDUCTED AND THE RESULTS, OR

STATEMENT OF THE REASONS A MARKET SURVEY WAS NOT CONDUCTED:

Market research was conducted by technical experts in March 2014. This research consisted of reviews of previous procurements for these types of patient-lifting aerobic, exerciser, treadmill and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, MedCompare, GSA advantage and ECRI sourcebook catalog. Three other vendors were identified that provide patient-lifting equipments, specifically PneuThera, Biodex, and h/p/cosmos. PneuThera, Biodex, and h/p/cosmos provide unweighting systems, which suspend patients over a general treadmill. This method creates pressure points on patients and constricts patients’ range of motion.

Only AlterG can provide a treadmill that uses air pressure technology that would allow the patient to have unrestricted mobility and not influence their movement in practice. No vendor other than AlterG meets the minimum requirements of the government.

9. OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN

COMPETITION: None

10. LISTING OF SOURCES, IF ANY, WHICH EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITION: To date, no other sources have written to express an interest.

This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. STATEMENT OF ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT

ACQUISITION FOR THE SUPPLIES OR SERVICES REQUIRED: Future requirements will be synopsized in accordance with FAR 5.203.

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.501

I certify that the facts and representations under my cognizance which are included in this justification, which form a basis for this justification, are complete and accurate.

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)