NIH awards $2.2M for advanced electrosurgery guidewires, focusing on R&D for medical devices

Contract Overview

Contract Amount: $2,199,922 ($2.2M)

Contractor: Transmural Systems LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2018-09-21

End Date: 2022-06-30

Contract Duration: 1,378 days

Daily Burn Rate: $1.6K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: SBIR TOPIC 104, FAST-TRACK, TAPERED GUIDEWIRES FOR TRANSCATHETER ELECTROSURGERY

Place of Performance

Location: ANDOVER, ESSEX County, MASSACHUSETTS, 01810

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.2 million to TRANSMURAL SYSTEMS LLC for work described as: SBIR TOPIC 104, FAST-TRACK, TAPERED GUIDEWIRES FOR TRANSCATHETER ELECTROSURGERY Key points: 1. Contract supports critical research and development in medical device technology. 2. Focus on innovation in transcatheter electrosurgery aims to improve patient outcomes. 3. The award represents a strategic investment in a specialized area of healthcare technology. 4. Performance period spans nearly four years, indicating a substantial development cycle. 5. The contract type suggests a clear scope and pricing structure for the R&D effort.

Value Assessment

Rating: good

The contract value of $2.2 million for a definitive contract focused on R&D appears reasonable given the specialized nature of the work. Benchmarking against similar NIH R&D grants or contracts for medical device development would provide further context, but the amount aligns with typical funding for early-stage technological advancements. The firm fixed-price structure suggests that the contractor bears the risk of cost overruns, which is a positive indicator for value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'Full and Open Competition After Exclusion of Sources,' indicating that while specific sources might have been initially considered, the opportunity was ultimately opened to all eligible offerors. This suggests a competitive process was intended, though the specific details of the exclusion and subsequent opening are not fully elaborated. The number of bidders is not provided, which limits a precise assessment of the competition's intensity.

Taxpayer Impact: A competitive process, even with initial exclusions, generally benefits taxpayers by encouraging multiple firms to offer their best solutions and pricing, leading to potentially better value.

Public Impact

Patients undergoing transcatheter procedures may benefit from improved surgical tools. The development of advanced electrosurgery guidewires could lead to less invasive treatments. This contract supports innovation within the medical device sector, potentially creating high-skilled jobs. The research conducted could advance the field of cardiovascular and other minimally invasive surgeries.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited public information on the specific technical milestones and deliverables.
The 'after exclusion of sources' clause warrants further scrutiny regarding the initial competitive landscape.

Positive Signals

Focus on a critical area of medical technology development.
Firm fixed-price contract provides cost certainty.
Long performance period suggests a commitment to thorough R&D.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on medical devices and engineering. The market for transcatheter electrosurgery devices is a growing segment within the broader medical technology industry, driven by the demand for less invasive procedures. Comparable spending benchmarks would involve looking at other NIH grants and contracts awarded for similar medical device R&D, as well as private sector investment in this specialized area.

Small Business Impact

The data indicates that small business participation (SB) was not a factor in this award (ss: false, sb: false). There is no explicit mention of small business set-asides or subcontracting requirements. Therefore, the direct impact on the small business ecosystem for this specific contract appears minimal, though the innovation it fosters could indirectly benefit small businesses in the supply chain or through future licensing opportunities.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a definitive contract, it likely involves regular reporting and milestone reviews. The firm fixed-price nature provides a degree of accountability for the contractor to deliver within the agreed budget. Transparency is generally maintained through federal contract databases, though specific technical progress reports may be proprietary.

Related Government Programs

SBIR Program
Medical Device Development Grants
Transcatheter Procedure Research
Electrosurgery Technology

Risk Flags

Procurement method requires further clarification on initial source exclusion.
Limited public detail on specific technical milestones and deliverables.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.2 million to TRANSMURAL SYSTEMS LLC. SBIR TOPIC 104, FAST-TRACK, TAPERED GUIDEWIRES FOR TRANSCATHETER ELECTROSURGERY

Who is the contractor on this award?

The obligated recipient is TRANSMURAL SYSTEMS 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 $2.2 million.

What is the period of performance?

Start: 2018-09-21. End: 2022-06-30.

What is the specific innovation or technological advancement expected from these tapered guidewires?

The primary goal of this research and development effort is to create tapered guidewires specifically designed for transcatheter electrosurgery. These guidewires are intended to improve the precision, safety, and efficacy of electrosurgical procedures performed through catheters. Tapered designs can offer better maneuverability within complex vascular or anatomical structures, potentially reducing tissue trauma and improving the delivery of energy for cutting or ablation. The innovation lies in optimizing the physical characteristics of the guidewire to enhance its performance in the demanding environment of minimally invasive, energy-based interventions.

How does the $2.2 million award compare to typical R&D funding for similar medical device projects at NIH?

The $2.2 million award for a definitive contract over approximately 3.8 years is within a reasonable range for significant R&D projects funded by the National Institutes of Health. NIH often supports early-stage research and development through various mechanisms, including grants and contracts. While specific project costs vary widely based on complexity, phase (e.g., feasibility, prototype development, preclinical testing), and the specific institute's priorities, this amount suggests a substantial commitment to developing a novel medical device. For context, NIH's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which also fund medical device innovation, often award Phase II contracts in the range of $1 million to $1.5 million over two years, with opportunities for follow-on funding. This definitive contract likely represents a more advanced or targeted development effort.

What are the key performance indicators or milestones expected under this contract?

While the specific performance indicators and milestones are not detailed in the provided summary data, typical R&D contracts of this nature would include objectives related to the successful design, fabrication, and testing of the tapered guidewires. Key milestones might involve achieving specific performance metrics in laboratory settings (e.g., electrical conductivity, mechanical flexibility, durability), demonstrating compatibility with existing electrosurgical generators and catheter systems, and potentially progressing towards preclinical or animal studies to evaluate safety and efficacy. The firm fixed-price nature implies that the contractor is responsible for defining and meeting these milestones within the budget and schedule, with deliverables likely including technical reports, prototypes, and test data.

What is the track record of Transmural Systems LLC in securing and executing similar federal R&D contracts?

Information regarding Transmural Systems LLC's specific track record with federal R&D contracts is not provided in the summary data. To assess their capabilities, one would typically examine their past performance on similar contracts, including their ability to meet technical requirements, stay within budget, and adhere to schedules. Reviewing contract databases for previous awards to this entity, particularly those related to medical device development or electrosurgery, would be necessary. Their success in obtaining this NIH contract suggests they possess relevant expertise and capabilities, but a comprehensive assessment would require a deeper dive into their contract history and client feedback.

How does the 'Full and Open Competition After Exclusion of Sources' procurement method impact potential value for taxpayers?

The 'Full and Open Competition After Exclusion of Sources' (FCAES) method is a less common but permissible procurement approach. It typically involves initially excluding certain sources (e.g., for reasons of national security, proprietary data, or specific technical requirements) but then opening the competition to all eligible sources. While it aims to ensure competition, the initial exclusion might limit the pool of potential offerors. If the exclusion was narrowly justified and the subsequent open competition was robust with multiple bidders, it could still yield good value. However, if the exclusion was overly broad or the subsequent competition was weak, it could potentially lead to higher prices or less innovative solutions compared to a purely full and open competition from the outset. The specific justification for the initial exclusion is critical to understanding its impact on taxpayer value.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: PHS20181

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 4 DUNDEE PARK DR STE 101, ANDOVER, MA, 01810

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

Financial Breakdown

Contract Ceiling: $2,199,922

Exercised Options: $2,199,922

Current Obligation: $2,199,922

Actual Outlays: $148,136

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline