FDA-SOL-1119680
Solicitation Number: FDA-SOL-1119680
Subject:Volumetric Assessment of Wear and Corrosion of Conical Head/Stem Taper Junctions in Explanted Total Hip Replacements to Provide Regulatory Guidance and Better Predict Clinical Success
Part 1 – Description
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation(FAR)Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.
This solicitation is a Request for Quote (RFQ) using Federal Acquisition Regulation (FAR) Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66. This is a full and open competition requirement. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541711, Research and Development in Biotechnology, with its size standard of 500 employees.
Part 2 –Supplies or services and Prices/Costs
- Description of Supplies & Services
The U.S. Food and Drug Administration’s (FDA) Center for Device Radiological Health (CDRH),)has a requirement forservices to conduct a study on Volumetric Assessment of Wear and Corrosion of Conical Head/Stem Taper Junctions in Explanted Total Hip Replacements to Provide Regulatory Guidance and Better Predict Clinical Success.
2.1 Contract Type: Firm-Fixed-Price
2.2 Pricing Table
CLIN / Service Description / Price*0001 / Volumetric Assessment of Wear and Corrosion of Conical Head/Stem Taper Junctions in Explanted Total Hip Replacements to Provide Regulatory Guidance and Better Predict Clinical Success / $
PART 3
STATEMENT OF WORK
- SCOPE OF WORK
The contractor shall furnish all personnel, services, facilities, except as provided in the schedule, required for or incident to the performance of the work as described below.
3.1.Technical Requirements
3.1.1.Background
There is renewed concern of wear and corrosion of conical head/stem taper junctions in modern modulartotal hip replacements (Chana R, JBJS 2012, Gill IP, JBJS, 2012). Although taper wear and corrosion is not a new phenomenon in orthopedics (Black J, JBJS, 1988), recent design trends of contemporary metal-onmetal (MoM) hip bearings, large heads, and modular necks have recently reintroduced implant corrosion as a clinical issue. Therefore, the primary objective of this project is to investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted total hip replacements andclinical outcomes. Other factors to be investigated include: patient usage and implant design parameters,such as conical taper angles, head/neck offset, implant alloy variations and implant positioning. These data will help build an understanding of the controlling factors governing wear at hip implant modular connections. The results will aid development of standard test methodologies for pre-clinical evaluation of total hip implants.
Modular junctions have become common place in orthopedics and allow surgeons to better re-create the patient's anatomy. Total hip replacement systems can include a number of modular components and allow for various length and orientation of the femoral necks, size and type of femoral head, as well as size and type of acetabular articulating surface. They also facilitate replacement of a malfunctioning implant (revision) by permitting a surgeon to preserve properly functioning components while replacing others. This shortens the time of the revision procedure and can make it Jess stressful to the patient. From a business perspective, modular components simplify manufacturing and inventory control by using interchangeable parts to accommodate more situations than would be possible by manufacturing single piece (monoblock) components.
The mechanism of head/stem taper corrosion is believed by many to be mechanically assisted crevice corrosion (Gilbert JL, ASTM, 1997, Goldberg JR, CORR, 2002), where mechanical fretting and wear contribute by disrupting the atomically thin. protective oxide layers that border the crevice environment. Rapid repassivation of the metal surfaces then alters the voltage and acidifies the solution trapped in the taper crevice. Previous, single and multicenter implant retrieval studies have identified many potential factors in taper wear and corrosion, and include implantation time, lateral offset, femoral stem modularity, and dissimilar alloys. Unfortunately, many studies cannot refine these hypotheses further because they do not use measurement techniques with enough precision, cannot correlate experimental observations with patient data, or have enough implants to provide the statistical power. Until recently, such precise and robust techniques were not thought necessary to characterize head/stem taper corrosion and wear.
The American Society for Testing and Materials (ASTM) protocol F1875-98 (2009) "Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface" was first published in 1998 and was most recently reapproved in 2009. The described tests effectively characterized the amount and type of wear and corrosion that occurred at taper but they did not measure the individual components in great detail. In July of2012, the ASTM released a draft testing protocol: (WK34551) "Standard Guide for the Characterization of Material Loss from Conical Taper
Junction between Femoral Head and Stem in Retrieved Modular Hip Prostheses," indicating the importance of this topic given recent discoveries. New techniques available to measure wear and corrosion at the taper junction, and described in this standard, are very precise and can yield more information about possible mechanisms causing the corrosion and wear. However, to completely characterize the possible modes of failure, de-identified patient radiographs of the devices and de-identified patient data are required. They elucidate the final contributions of patient parameters that arc missing from the cited standards.
The current study will employ novel techniques based on the ASTM standards, protocols from literature (Gilbert JBMR 20 II, Rodrigues JBMR 2009), and findings from computational simulations performed at the FDA during previously funded research (CPOSEL22). The study will investigate a cohort of at least250 explanted MoM total hip replacements of mixed gender and sizes. The majority ofthe devices mustshow varying degrees of visible wear and corrosion from extensive to minimal. De-identified patient data and radiographs must be available or obtainable for all devices. The contractor will create surface profiles (to an accuracy below 0.5 Jim) for all components and determine the taper angle mismatch and wear volume. Preferably, these 3D scans will be measured using a roundness machine, which is currently thought to yield a higher accuracy compared to that achieved via coordinate measuring machines. These profiles along with patient data and radiographs will be analyzed to determine the most important factors leading to a greater chance of taper failure in this cohort. The final measurement protocols will be
determined by FDA in consultation with the contractor.These studies will be presented at ASTM, scientificmeetings, and published in peer reviewed journals to advance testing standards for modular connections and aid development of special controls for hard on hard (the more general class of MoM) hip implants.
3.1.2. Specification and other minimum requirements:
The contractor shall have the following qualifications in order to participate in this project:
- Contractor shall already own at least n=250 explanted total hip replacements with mating femoral heads and femoral neck components, either in the form of a femoral stem or modular taper component. The majority of these total joints should be metal-on-metal articulations and show visible evidence of either corrosion or wear of the taper connection. In addition, these ex plants shall beaccompanied with relevant clinical data, and can be destructively tested if necessary. A large sample size of250 explants is necessary to achieve a desired statistical power.
- Contractor shall have immediate access to an analytical facility that includes, 1) a coordinate measuring machine (CMM) with an accuracy of approximately I micron, 2) a roundness machine with an accuracy of approximately 0.1 microns, 3) an alloy identifier, 4) 3D modeling software package, 5) surface roughness interferometer, 6) a reflective-light microscope (RLM), and 7) a scanning electron microscope/EDS combination (SEM).
- Contractor shall be considered an expert in explant analysis. The contractor shall have a demonstrated publication record (a significant number of peer reviewed journals) related to tribological and biomaterial studies of total joint replacements.
- Contractor shall collaborations with orthopedic surgeons with experience in total hip replacement surgery.
- Contractor shall be actively involved with standards groups, such as American Society for Testing and Materials(ASTM) on topics relating to MoM hip bearings.
- Contractor shall abide by Good Laboratory Practices (GLP) when conducting all
applicable testing and analyses and is conversant with standard guidelines (ISO 17025).
Quantities:
As stated in the requirements above, FDA will work with a contractor that has at least n=250explanted total hip replacements with mating femoral heads and femoral neck components, either in the form of a femoral stem or modular taper component.
PART 4
4.1. Deliverables Table
Performance dates, including a deliverable schedule:
Task / Time Frame1.)Explant Analysis Study - To investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in ex planted total hip replacements and clinical outcomes. / Total
12 months
1a / Protocol Design - Contractor shall collaborate with CDRH to identify
1) appropriate methods for estimating volumetric wear of conical taper components using 3D scans measured via a roundness machine or coordinate measuring machine, and 2) identify appropriate cohort of MoM total hip ex-plants to be studied. / I month
1b / Explant Analysis - Development of Volumetric Analysis Methods
Contractor shall develop computational methods for estimating volumetric wear of conical taper components using measured 3D scans. This method should possess a high accuracy in predicting volumetric wear. / 3 month
1c / Explant Analysis - Volumetric Wear Measurement of Explant Tapers
Contractor shall select a number of MoM total hip ex-plants from their own collection that possess notable taper wear/corrosion in varying degrees of severity. Contractor will then conduct full volumetric analysis of the taper components, including the assessment of taper angles, scoring of corrosion and quantification of wear/damage. / 4 months
1d / Explant Analysis – Investigation Correlations - Contractor shall investigate possible correlations between volumetric taper wear and
corrosion and relevant clinical parameters, such as implantation time, lateral offset, head size, femoral stem modularity, and dissimilar alloys. / 3 months
le / Peer Reviewed Journal Submission
Contractor shall collaborate with CDRH to combine all test results into a journal article submission(s) for peer review. / 3 month
4.2 Reports (i.e., quarterly progress reports, annual reports and final report), containing
the description of experiments and data analysis, will be provided to the FDA in both
paper and electronic format. In addition, all of the raw data from the experiments will be
provided to the FDA in both paper and electronic format, along with these reports.
4.3No information furnished to or generated by the contractor in the performance of this
contract will be released to the public until it has been reviewed by the Government
Contracting OfficerRepresentative for accuracy of factual data and interpretation. The
Government will have sixty (60) calendar days after receipt of the manuscript or other
written draft of the material to be released, to review, comment, andreturn to the contractor.
The contractor and the Government will mutually agree on theauthorship of any scientific
paper(s) resulting from this contract.
4.4The contractor shall submit a quarterly invoice once every three months after the
Government’s receipt and acceptance of the quarterly process report, annual reports and
final report as delineated in Section 4.1.
***UPON COMPLETION OF THIS PROJECT, **ALL DELIVERABLES SHALL BE SUBMITTED TO FDA**
PART 5
INSPECTION AND ACCEPTANCE
5.1 This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:
FAR ClauseDescriptionDate
52.246-4Inspection of Services—Fixed-Price(AUG 1996)
52.246-6Inspection—Time-and-Material and Labor-Hour(MAY 2001)
PART 6
DELIVERIES OF PERFORMANCE
6.1Deliveries
6.1.1Satisfactory performance of this contract shall be deemed to occur upon
performance of the work described in the Statement of Work in PART 3 of this
contract and upon delivery and acceptance by the Contracting Officer, or the
COR, of the services, plans and reports required at the dates specified within
PART 3 of this contract.
6.1.2Deliveries of the reports are to be sent via email to the COR address:
TBD
6.2PERIOD OF PERFORMANCE
September 1, 2013 – August 31, 2014
6.3PLACE OF PERFORMANCE
The place of performance for this contract shall be at the contractor's site.
PART 7
CONTRACT ADMINISTRATION DATA
7.1 CONTRACTING OFFICER REPRESENTATIVE (COR)
The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award)
7.1.1.The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
TBD
7.2 CONTRACT ADMINISTRATION
7.2.1The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
Linda Troutman
Contract Specialist
404-253-1258
PART 8
SPECIAL CONTRACT REQUIREMENTS
8.1. HHSAR Clauses Incorporated by Reference
This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:
HHSAR ClauseDescriptionDate
352.202-1Definitions (Jan 2006)
352.203-70 Anti-lobbying (Jan 2006)
352.215-70Late proposals and revisions (Jan 2006)
352.223-70Safety and health (Jan 2006)
352.224-70Privacy Act(Jan 2006)
352.228-7Insurance--Liability to third persons (Dec 1991)
352.233-71Litigation and claims(Jan 2006)
352.242-73Withholding of contract payments (Jan 2006)
352.242-71Tobacco-free Facilities(Jan 2006)
352.242-74Final decisions on audit findings (Apr 1984)
352.270-1Accessibility of meetings, conferences, (Jan 2001)
and seminars to persons with disabilities
352.270-4Protection of human subjects(Jan 2006)
352.270-6Restriction on the use of human subjects(Jan 2006)
8.2 INVOICING INSTRUCTIONS
The Contractor shall submit invoices to the Contract Specialist and the COR concurrently, via email (ref. Part 7). To constitute a proper invoice, the invoice must be submitted on company letterhead and include:
1. Name and address of the Contractor
2. Invoice date and invoice number
3. Contract number
4. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of supplies
delivered
5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading
6. Terms of any discount for prompt payment offered
7. Name and address of official to whom payment is to be sent (Must be the same as that in the delivery order or in a proper notice of assignment)
8. Name, title, and phone number of person to notify in event of defective invoice
9. Taxpayer identification number
10. Electronic Funds Transfer (EFT) banking information
11. Name and telephone number of the FDA COR referenced on the delivery order
12. Any other information or documentation required by the delivery order
An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in 1-12 of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.
Questions relating to when payment will be received should be directed to the FDA payment office at 301.827-3742.
PART 9
CONTRACT CLAUSES
9.1 52.252-2 Clauses Incorporated by Reference (FEB 1998)
This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at
FAR ClauseDescriptionDate
52.212-3Offers Representations and
Certification-Commercial Items (APR 2011)
52.203-5 Covenant Against Contingent Fees (Apr 1984)
52.203-7Anti-Kickback Procedures (Jul 1995)
52.216-24Limitation of Government Liability (Apr 1984)
52.233-2Service of Protest (Sep 2006)
52.247-35 F.O.B. Destination within
Consignees Premises (April 1984)
52.227-14 Rights in Data—General. (JUN 1987)Alternate I
Alternate II
Alternate III
Alternate IV
Alternate V
52.227-15 Representation of Limited Rights Data and Restricted Computer Software. (MAY 1999)
52.227-16 Additional Data Requirements. (JUN 1987)
52.227-17 Rights in Data—Special Works. (JUN 1987)
52.227-18 Rights in Data—Existing Works. (JUN 1987)
52.227-19 Commercial Computer Software License. (JUN 1987)
52.227-20 Rights in Data—SBIR Program. (MAR 1994)
52.227-21 Technical Data Declaration, Revision, and Withholding of Payment—Major Systems. (JAN 1997)
52.227-22 Major System—Minimum Rights. (JUN 1987)
52.227-23 Rights to Proposal Data (Technical). (JUN 1987)
PART 10 – INSTRUCTIONS TO OFFERORS
Cover Page
Offerors shall include a cover page which shall include pricing information, a point of contact (name, telephone number, and email address), business size, and payment terms. Offerors shall ensure the RFQ number is visible in the header of the email transmission of their quote. Offerors must be registered in Systems of Award Management (SAM). Faxed quotes will not beaccepted.