Stryker Signed Medical JandA for Stryker Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Stryker Orthopedics’ Procedural Packages Electronic Catalog (ECAT) Manufacturer Direct Program

5. The current orthopedic marketplace consists of orthopedic manufacturers that produce their own unique line of orthopedic procedural packages. Unlike many other industries, product selection in the orthopedic industry is not based solely on price and is overshadowed by physician preference/experience and highly specialized training on use of specific surgical items.

A physician’s decision to use a particular manufacturer’s product is based on the technical characteristics of the implantable products that are expected to produce a higher quality of life for their patients or achieve certain therapeutic results. Stryker Orthopedic’s implantable products and the surgical procedures used are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. 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 Orthopedics is the only provider of their Hip, Knee, Spine, UER and Trauma procedural packages. There are no known manufacturers or distributors other than Stryker who can provide DoD hospitals with the complete procedural package under all three delivery methods and has direct control over a sales force that is knowledgeable in their products.

To facilitate the implantation process, there are auxiliary products (such as drill bits, saw blades, bone cement, etc.) and instrumentation sets that are part of the “procedural package” since they are necessary for orthopedic implant surgery. Stryker distributes these ancillary accessories and instruments since they are essential for implantation of their implantable products and needed at the scheduled time of surgery. These products are considered ancillary to the overall cost of the acquisition (less than 10%) but are an essential part of the procedural package.

At the request of a Medical Treatment Facility (MTF), Stryker will have a qualified representative on site at the MTF within the timeframe specified by the facility necessary to meet their requirements. The representative provides technical advice and guidance to the physician before, during and after implantation. Furthermore, technical support is available twenty-four

(24) hours a day, seven (7) days a week.

As technology advances or further product lines are required by the MTFs, additional orthopedic products determined to be sole source to Stryker may be added to the contract. All product lines added to the contract must be within the scope of the solicitation.

All items proposed for addition to the contract will be synopsized and the prices will be determined fair and reasonable prior to placement on the contract.

6. A Request for Information (RFI) was issued to ensure that offers are solicited from as many sources as is practicable. The RFI was issued on October 13, 2020 via the Beta.SAM.gov website seeking sources capable of providing Stryker Orthopedic Hip, Knee, UER and Trauma procedural packages. This RFI closed November 23, 2020. Stryker was the only company that expressed interested in the proposed acquisition.