NHLBI awards $1.76M for advanced cardiovascular device engineering and technical support

Contract Overview

Contract Amount: $175,718 ($175.7K)

Contractor: Guidehouse Digital LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2026-05-18

End Date: 2027-05-17

Contract Duration: 364 days

Daily Burn Rate: $483/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: NHLBI REQUIRES ENGINEERING AND TECHNICAL SUPPORT SERVICES TO DESIGN, PROTOTYPE, AND VALIDATE NEXT-GENERATION CATHETER-BASED CARDIOVASCULAR DEVICES, INCLUDING INTEGRATION OF SENSORS, DEVELOPMENT OF TESTING PROTOCOLS, AND DOCUMENTATION SUPPORTING REGUL

Place of Performance

Location: MCLEAN, FAIRFAX County, VIRGINIA, 22102

State: Virginia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $175,717.6 to GUIDEHOUSE DIGITAL LLC for work described as: NHLBI REQUIRES ENGINEERING AND TECHNICAL SUPPORT SERVICES TO DESIGN, PROTOTYPE, AND VALIDATE NEXT-GENERATION CATHETER-BASED CARDIOVASCULAR DEVICES, INCLUDING INTEGRATION OF SENSORS, DEVELOPMENT OF TESTING PROTOCOLS, AND DOCUMENTATION SUPPORTING REGUL Key points: 1. Contract focuses on critical R&D for next-generation medical devices. 2. High-value support for innovation in cardiovascular technology. 3. Potential for significant public health impact through improved devices. 4. Firm-fixed-price contract type suggests clear cost expectations. 5. Long-term contract duration indicates sustained need for expertise. 6. Small business participation not explicitly detailed, requiring further review.

Value Assessment

Rating: good

The contract value of $1.76 million for a 364-day period appears reasonable for specialized engineering and technical support in the medical device sector. Benchmarking against similar R&D contracts for device prototyping and validation would provide a more precise assessment of value for money. The firm-fixed-price structure is generally favorable for controlling costs on well-defined projects.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This competitive process is expected to yield a fair market price and ensure the selection of a qualified contractor. The specific number of bidders is not provided, which would offer further insight into the intensity of the competition.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that drives down costs and encourages innovation among contractors.

Public Impact

Patients with cardiovascular conditions stand to benefit from the development of advanced, potentially life-saving devices. The National Heart, Lung, and Blood Institute (NHLBI) will receive critical engineering and technical support for its research initiatives. The project supports the advancement of medical technology within the United States. Potential for highly skilled engineering and technical jobs in the medical device sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of explicit small business subcontracting goals requires monitoring to ensure broad economic participation.
The specific technical challenges and potential for unforeseen issues in novel device development could pose risks.

Positive Signals

Awarded under full and open competition, suggesting a robust selection process.
Firm-fixed-price contract type provides cost certainty.
Focus on critical, next-generation medical devices aligns with public health priorities.

Sector Analysis

This contract falls within the broader Health and Medical sector, specifically focusing on the research and development of medical devices. The market for cardiovascular devices is substantial and highly competitive, driven by continuous innovation and an aging population. This contract supports a niche but critical area of R&D, aiming to advance catheter-based technologies, which are a significant segment of the interventional cardiology market.

Small Business Impact

While the contract was awarded under full and open competition and does not indicate a small business set-aside, the prime contractor, GUIDEHOUSE DIGITAL LLC, is a large business. It will be important to monitor subcontracting opportunities to ensure that small businesses have a chance to participate in this project and contribute their specialized expertise to the development of these advanced medical devices.

Oversight & Accountability

The contract is managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. Oversight will likely involve program managers monitoring technical progress, adherence to milestones, and financial expenditures. The firm-fixed-price nature of the contract provides a degree of financial oversight. Transparency will depend on NIH's reporting practices and public availability of project updates.

Related Government Programs

NHLBI Research and Development Programs
NIH Medical Device Innovation Initiatives
Cardiovascular Disease Research Funding
Biomedical Engineering Services Contracts

Risk Flags

Novel technology development carries inherent technical risks.
Potential for scope creep if R&D requirements are not tightly managed.
Dependence on contractor's specialized expertise.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $175,717.6 to GUIDEHOUSE DIGITAL LLC. NHLBI REQUIRES ENGINEERING AND TECHNICAL SUPPORT SERVICES TO DESIGN, PROTOTYPE, AND VALIDATE NEXT-GENERATION CATHETER-BASED CARDIOVASCULAR DEVICES, INCLUDING INTEGRATION OF SENSORS, DEVELOPMENT OF TESTING PROTOCOLS, AND DOCUMENTATION SUPPORTING REGUL

Who is the contractor on this award?

The obligated recipient is GUIDEHOUSE DIGITAL LLC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $175,717.6.

What is the period of performance?

Start: 2026-05-18. End: 2027-05-17.

What is GUIDEHOUSE DIGITAL LLC's track record with the NHLBI and NIH?

A review of federal procurement data indicates that GUIDEHOUSE DIGITAL LLC has a history of receiving contracts from various federal agencies, including the Department of Health and Human Services (HHS) and its components like the National Institutes of Health (NIH). While specific details on past performance with NHLBI for similar engineering and technical support services would require a deeper dive into contract databases and performance reports, GUIDEHOUSE DIGITAL LLC is a known entity within the federal contracting space, often providing consulting, digital transformation, and technical services. Their experience across HHS suggests familiarity with the agency's mission and operational environment. Further analysis would focus on the quality of past deliverables, adherence to schedules, and overall client satisfaction ratings on prior HHS contracts to fully assess their suitability for this specific requirement.

How does the $1.76 million value compare to similar R&D contracts for medical device engineering?

The $1.76 million contract value for 364 days of engineering and technical support for next-generation catheter-based cardiovascular devices appears to be within a reasonable range for specialized R&D services. Contracts in this domain often involve high levels of expertise, proprietary technology development, and rigorous testing protocols. Benchmarking requires comparing this contract's scope (design, prototyping, validation, sensor integration, testing protocols) against other federal or commercial contracts awarded for similar services. Factors like the novelty of the technology, the specific device complexity, and the required skill sets (e.g., biomedical engineering, materials science, sensor technology) significantly influence pricing. Without direct comparable contract data, it's challenging to definitively state if it's high or low, but the amount suggests a focused, high-impact project rather than a broad, long-term development effort.

What are the primary risks associated with developing next-generation cardiovascular devices under this contract?

The primary risks associated with developing next-generation cardiovascular devices under this contract are multifaceted. Technical risks include the inherent challenges in designing and prototyping novel technologies, particularly integrating sensors and ensuring device reliability and safety for human use. There's a risk of unforeseen technical hurdles during the design and validation phases, potentially leading to delays or increased costs, although the firm-fixed-price contract aims to mitigate cost overruns. Regulatory risks are also significant; the path to FDA approval for novel medical devices can be complex and lengthy, and the contract's success hinges on meeting documentation requirements that support regulatory submissions. Furthermore, market adoption risks exist, as the ultimate success of the device depends on its clinical efficacy, patient acceptance, and physician preference compared to existing solutions. Contractor performance risk, while mitigated by competition, remains a factor.

How effective is the firm-fixed-price contract type in managing costs for this type of R&D?

The firm-fixed-price (FFP) contract type is generally considered effective for managing costs when the scope of work is well-defined and the risks are understood. For this contract, which involves designing, prototyping, and validating next-generation devices, the FFP structure provides cost certainty to the NHLBI. It shifts the risk of cost overruns to the contractor, GUIDEHOUSE DIGITAL LLC. This incentivizes the contractor to manage resources efficiently and control expenses. However, for highly innovative R&D where the technical path may be uncertain, an FFP contract can sometimes lead contractors to be overly conservative in their approach or to build significant contingency into their pricing, potentially making the initial price higher than it might be under a cost-reimbursable contract. The success of FFP here depends on how accurately the scope and potential challenges were defined during the solicitation process.

What is the historical spending pattern for engineering and technical support services at NHLBI?

Analyzing historical spending patterns for engineering and technical support services at the National Heart, Lung, and Blood Institute (NHLBI) requires examining procurement data over several fiscal years. NHLBI, as part of the NIH, funds a wide range of research activities, many of which necessitate specialized technical and engineering support, particularly in areas like device development, data analysis, and laboratory operations. Spending in this category can fluctuate based on specific research priorities, the initiation of new large-scale projects, and the lifecycle of existing research grants and contracts. Contracts for device development, like the one awarded to GUIDEHOUSE DIGITAL LLC, represent a specific subset of this spending. A trend analysis would reveal if there's a consistent investment in such services or if spending is project-driven. Understanding these patterns helps contextualize the current $1.76 million award within NHLBI's broader R&D budget and strategic objectives.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Administrative Management and General Management Consulting Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 1676 INTERNATIONAL DR STE 800, MC LEAN, VA, 22102

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

Financial Breakdown

Contract Ceiling: $175,718

Exercised Options: $175,718

Current Obligation: $175,718

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Parent Contract

Parent Award PIID: 75N92025A00008

IDV Type: BPA

Timeline