VA awards $34M contract for custom surgical implants to Edwards Lifesciences LLC

Contract Overview

Contract Amount: $34,000 ($34.0K)

Contractor: Edwards Lifesciences LLC

Awarding Agency: Department of Veterans Affairs

Start Date: 2026-04-06

End Date: 2027-04-05

Contract Duration: 364 days

Daily Burn Rate: $93/day

Competition Type: NOT COMPETED UNDER SAP

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: CUSTOM SURGICAL IMPLANT

Place of Performance

Location: IRVINE, ORANGE County, CALIFORNIA, 92614

State: California Government Spending

Plain-Language Summary

Department of Veterans Affairs obligated $34,000 to EDWARDS LIFESCIENCES LLC for work described as: CUSTOM SURGICAL IMPLANT Key points: 1. Contract awarded to a single, established supplier. 2. Focus on specialized surgical implants indicates a niche market. 3. Potential for higher costs due to limited competition. 4. Long-term contract suggests ongoing need for these specific devices.

Value Assessment

Rating: fair

The contract value of $34 million over one year for custom surgical implants appears to be within a reasonable range for specialized medical devices. However, without specific per-unit cost data or benchmarks for similar custom implants, a precise pricing assessment is difficult.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

The contract was not competed under SAP, indicating a limited competition approach. This likely means the VA identified a specific need that could only be met by a particular supplier, or the procurement process favored a sole source. Limited competition can lead to higher prices than a fully competed contract.

Taxpayer Impact: Taxpayers may bear a higher cost due to the lack of competitive bidding, as the price is not driven down by multiple offers.

Public Impact

Ensures availability of critical custom surgical implants for veterans. Supports patients requiring specialized medical devices for treatment. Maintains supply chain for essential healthcare services within the VA.

Waste & Efficiency Indicators

Waste Risk Score: 93 / 10

Warning Flags

Limited competition may result in inflated pricing.
Lack of transparency in price discovery.
Potential for vendor lock-in.

Positive Signals

Ensures access to specialized medical devices.
Long-term contract provides supply stability.
High contract value indicates significant demand.

Sector Analysis

The healthcare sector, particularly medical devices, often involves specialized manufacturing and high research and development costs. Spending benchmarks for custom surgical implants can vary widely based on complexity and material, but $34 million for a year's supply suggests a significant volume or high-value items.

Small Business Impact

This contract does not appear to involve small businesses, as it was awarded to a large corporation (Edwards Lifesciences LLC) and was not competed under SAP, which often includes provisions for small business set-asides. There is no indication of subcontracting opportunities for small businesses.

Oversight & Accountability

The Department of Veterans Affairs is responsible for overseeing this contract. Accountability would involve ensuring the quality and timely delivery of the custom surgical implants, as well as managing the vendor relationship and contract terms. The 'NOT COMPETED UNDER SAP' status warrants scrutiny to ensure the limited competition was justified.

Related Government Programs

Surgical Appliance and Supplies Manufacturing
Department of Veterans Affairs Contracting
Department of Veterans Affairs Programs

Risk Flags

Lack of full and open competition.
Potential for overpricing due to limited vendor options.
Absence of small business participation.
Reliance on a single supplier for critical medical devices.

Frequently Asked Questions

What is this federal contract paying for?

Department of Veterans Affairs awarded $34,000 to EDWARDS LIFESCIENCES LLC. CUSTOM SURGICAL IMPLANT

Who is the contractor on this award?

The obligated recipient is EDWARDS LIFESCIENCES LLC.

Which agency awarded this contract?

Awarding agency: Department of Veterans Affairs (Department of Veterans Affairs).

What is the total obligated amount?

The obligated amount is $34,000.

What is the period of performance?

Start: 2026-04-06. End: 2027-04-05.

What specific factors justified the limited competition for these custom surgical implants, and how were these factors verified?

The justification for limited competition typically involves demonstrating that only one source can provide the required supplies or services due to unique capabilities, proprietary technology, or urgent needs. Verification would involve reviewing documentation submitted by the vendor and the contracting officer's assessment, ensuring it meets federal acquisition regulations for sole-source or limited-source procurements. This process aims to prevent unnecessary sole-sourcing while acknowledging situations where it is genuinely required.

How does the per-unit cost of these custom surgical implants compare to industry benchmarks for similar devices, considering the limited competition?

Without specific per-unit cost data and detailed specifications of the custom implants, a direct comparison to industry benchmarks is challenging. However, limited competition generally leads to higher per-unit costs compared to fully competed contracts. The VA should have internal benchmarks or market research data to assess if the negotiated price is reasonable given the lack of competitive pressure. Further analysis would require access to the contract's pricing details and comparable market data.

What is the long-term strategy for ensuring cost-effectiveness and innovation in the supply of these custom surgical implants beyond the current contract period?

The long-term strategy should involve exploring options for future procurements, potentially including market research to identify new vendors or technologies that could foster competition. If the need remains highly specialized, the VA might consider performance-based contracts that incentivize innovation and efficiency. Periodic reviews of the market and technology landscape are crucial to avoid long-term reliance on a single source without exploring avenues for improved value and reduced costs.

Industry Classification

NAICS: Manufacturing › Medical Equipment and Supplies Manufacturing › Surgical Appliance and Supplies Manufacturing

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: NOT COMPETED UNDER SAP

Solicitation Procedures: SIMPLIFIED ACQUISITION

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 1 EDWARDS WAY, IRVINE, CA, 92614

Business Categories: Category Business, Limited Liability Corporation, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $34,000

Exercised Options: $34,000

Current Obligation: $34,000

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Timeline