Signed- Medical JandA for Depuy Synthes Mitek Surgical_Redacted.pdf
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- Solicitation number
- SPE2DE21R0004
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This document is a justification for other than full and open competition regarding a solicitation from the Defense Logistics Agency Troop Support Medical for orthopedic procedural packages from DePuy Synthes Mitek Surgical. The justification cites 10 U.S.C. 2304(c)(1) as the authority to award this sole-source contract without full competition due to DePuy Synthes Mitek being the only responsible source that can meet the agency's requirements. As the current orthopedic marketplace consists of manufacturers that produce proprietary product lines requiring specialized physician training, the physicians will consistently use the products they are most familiar with from previous training. DePuy Synthes Mitek's orthopedic implants and instruments are provided in complete procedural packages including all necessary items for surgical procedures, and no other manufacturers can provide all requirements in a ready-to-use package. DePuy Synthes Mitek representatives also provide on-site technical support before, during, and after surgeries as requested by medical facilities.
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JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION
DePuy Synthes Mitek Surgical and Early Intervention “Procedural Packages”
Electronic Catalog (ECAT) Manufacturer Direct Program
SOURCE SELECTION INFORMATION – SEE FAR 2.101 AND 3.104
4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented by FAR 6.302-1.
5. The use of this authority is necessary because the current orthopedic marketplace consists of orthopedic manufacturers that produce their own line of orthopedic products. 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 training with a particular manufacturer’s product increases their aptitude and familiarity with 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. DePuy Synthes Mitek 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 consistently thereafter.
In addition, the DePuy Synthes Mitek representatives are experts on the vendor’s products and are a vital part of helping to ensure that the patient is getting the necessary treatment. At the request of MTFs, DePuy Synthes Mitek 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 noted above, DePuy Synthes Mitek’s orthopedic products are provided in procedural packages that include the proprietary DePuy Synthes Mitek orthopedic products, instrumentation sets and ancillary accessories that are essential for the surgical procedures involving the implant products. The instruments and ancillary accessories are available individually from sources other than DePuy Synthes Mitek, but the overall requirement for a complete surgical package ready for immediate use makes separate competitive buys of these instruments and ancillary accessories impractical and such buys would not satisfy the requirement.
There are no known manufacturers or distributors other than DePuy Synthes Mitek that can provide requiring medical facilities with the complete procedural package under all three
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