Stryker_CMF_-_JA_Final__Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Stryker Craniomaxillofacial (CMF) Procedural Packages

Electronic Catalog (ECAT) Manufacturer Direct Program

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Operations ECAT Division, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an Other than Full and Open competition basis in accordance with FAR 6.302-1.

3. The supplies to be acquired are Stryker's CMF Procedural Packages that will be delivered Just-in-Time (ITT) for surgery, Direct Vendor Delivery (DVD), or Consignment. These procedural packages include the implant, instrumentation and ancillary products (such as drill bits, saw blades, bone cement, etc.) that are necessary for the maxillofacial, craniofacial, and neurosurgical procedures and surgeries.

The proposed contract will be a Fixed Price Indefinite Delivery/Indefinite Quantity contract with a one year base period and four one-year option periods. The estimated dollar value for DLA's requirements is approximately $23 million over the five-year life of the contract.

The total estimated dollar value is $29,881,589.00.

the maximum dollar value of the proposed procurement is

$89,644,767.00.

4. The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(l), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented by FAR 6.302-1.

5. The current orthopedic marketplace consists ofCMF manufacturers that produce their own line of maxillofacial, craniofacial, and neurosurgical products. Unlike many other industries, product selection in the CMF industry is not based solely on price which is overshadowed by physician preference/experience and highly specialized training on use of specific surgical items. A physician's training with a pmticular manufacturer's product increases their aptitude and fmniliarity with the technical characteristics of the implantable products used, producing a higher quality of life for their patients or achieving certain therapeutic results. The industry standard is for implantable products and the surgical procedures used to be unique and proprietary and to require highly specialized training on the part of the physician. Stryker CMF implantable products follow this industry standard. Once trained and comfortable with a particular manufacturer's products and the surgical procedure, the physician will likely use that manufacturer's products for the duration of their career.

Stryker has made the decision to sell their CMF products direct to the Government. Currently, Stryker CMF products are distributed through two third-party distributors (Beacon Point and American Medical Depot (AMO)) under the MedSurg ECAT Program; however, they m·e only offered through DVD. DLA Troop Support is establishing ECAT contracts to be able to support all of the various delivery methods (DVD, JIT, and Consigrunent). Under the DVD method, MTF's may order products in advance of a scheduled surgery or purchase replacement inventory on an as needed basis. Under the JIT method, the Medical Treatment Facility (MTF) calls the manufacturer sales representative when a surgery is scheduled to discuss the case, makes a product selection and informs him or her of the surgery date and time. The manufacturer sales representative will either "carry-in" or "ship" the CMF products necessary for implantation to the designated site at the scheduled time. Under the consignment delivery method, the