Source Sought .pdf

General Information:

Document Type: Sources Sought (FDA-SSN-1278933) Release Date: July 5, 2024

Response Date: July 15, 2024 at 3.00 P.M. EST via e-mail to Hilda.Aryeh@fda.hhs.gov

Contract Information: Hilda M. Aryeh

Contract Specialist Office of Acquisition and Grants Services U.S. Food and Drug Administration Email: Hilda.Aryeh@fda.hhs.gov

Description: Pelvis with Proximal Femurs (L3/L4)- Intact This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), (1000 employees).

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**

Background

This procurement is to support regulatory science tool development for novel sacroiliac joint fusion devices in the Orthopedics program area. The Office of Health Technologies

– 6 (Orthopedic Devices) has noticed a substantial increase in submissions of in-line sacroiliac joint devices, which provide a minimally invasive posterior approach for implantation. However, this is an emerging technology with only five such devices cleared till date. The unique design approach of each of these devices has required applying non-standardized special controls during regulatory review (biomechanical evaluation via cadaver testing). However, lack of standardization of such techniques has resulted in lengthy regulatory reviews. Further, it remains unclear whether female SIJ biomechanics are considered during device design. The novel study design and methodologies employed in this study will provide an invaluable set of data which will substantially reduce the burden on innovators, manufacturers, and regulatory reviewers.

mailto:Hilda.Aryeh@fda.hhs.gov mailto:Hilda.Aryeh@fda.hhs.gov

To satisfactorily solve these unknown regulatory review challenges, the Division of Applied Mechanics Orthopedics program area has proposed a study that will address these knowledge gaps investigating the biomechanical response of the female and male sacroiliac joints under a variety of physiologically relevant loading and boundary conditions to develop a female-specific cadaver testing protocol.

To develop a reliable cadaver testing protocol, we need to procure 9 female pelvic cadaver specimens. This will allow us to publish a validated cadaver testing protocol for novel sacroiliac joint devices. The regulatory science tools stemming from this work with directly support the Center of Devices and Radiological Health mission of protecting and promoting public health by using applied mechanics to investigate interactions between medical devices and the human body.

Objectives The overall objective of the requirement is to develop optimized female-specific cadaver testing protocols that can be used by medical device manufacturers to assess bone-implant interface integrity of sacroiliac joint fusion devices.

The expected goal is to identify the ideal mechanical protocol to thoroughly investigate any sacroiliac joint fusion device requesting marketing approval.

If the contract is successful, we will receive 9 female pelvic cadavers per the requirements.

Period of Performance

It is requested that the specimens be delivered 3 at a time over a period of 4 months after award of contract. This will result in a total of 3 shipments and 9 specimens (9 female).

The work is expected to be completed in the 1st year after receiving of last shipment.

Capabilities and Technical Experience:

Provide a capability statement describing how your company would be able to meet the requirements.

Business Status:

Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and DUNS number.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses to the sources sought shall be no longer than 10 pages.