NIH invests $3.4M in bioresorbable stent development for neonates, aiming to improve cardiovascular treatment

Contract Overview

Contract Amount: $3,399,279 ($3.4M)

Contractor: Pediastent LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-26

End Date: 2022-03-22

Contract Duration: 2,003 days

Daily Burn Rate: $1.7K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 4

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: IGF::OT::IGF THE DEVELOPMENT LEADING TO THE COMMERCIALIZATION OF A BIORESORBABLE STENTS (BRS) FOR THE TREATMENT OF COARCTATION OF THE AORTA (COA) IN NEONATES.

Place of Performance

Location: CLEVELAND, CUYAHOGA County, OHIO, 44106

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $3.4 million to PEDIASTENT LLC for work described as: IGF::OT::IGF THE DEVELOPMENT LEADING TO THE COMMERCIALIZATION OF A BIORESORBABLE STENTS (BRS) FOR THE TREATMENT OF COARCTATION OF THE AORTA (COA) IN NEONATES. Key points: 1. Significant investment in a novel medical device for a critical pediatric condition. 2. Focus on research and development suggests a long-term innovation strategy. 3. Contract awarded through full and open competition, indicating a broad search for qualified vendors. 4. The definitive contract structure allows for flexibility in project scope and duration. 5. Potential for significant public health impact by addressing a serious congenital heart defect. 6. The relatively small contract value for R&D may indicate an early-stage or focused project.

Value Assessment

Rating: fair

The contract value of $3.4 million for research and development appears moderate for a medical device innovation project. Benchmarking against similar R&D contracts for novel medical devices would provide better context. The fixed-price nature of the definitive contract suggests that the government has a clear understanding of the scope, but the duration of over 2000 days indicates potential for evolving requirements or challenges in development. Without specific cost breakdowns or comparable project expenditures, a precise value-for-money assessment is difficult, but the investment is directed towards a high-need area.

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,' which implies that while the competition was open, certain sources were initially excluded, possibly due to specific technical requirements or prior relationships. The presence of 4 bidders suggests a reasonable level of competition for this specialized R&D effort. This level of competition is generally positive for price discovery, though the unique nature of medical device R&D can sometimes limit the pool of qualified bidders.

Taxpayer Impact: A competitive process, even with initial exclusions, helps ensure that taxpayer funds are used efficiently by encouraging multiple vendors to offer their best proposals and pricing.

Public Impact

Neonates and infants suffering from coarctation of the aorta will benefit from potential new treatment options. The development of a bioresorbable stent could lead to improved patient outcomes and reduced long-term complications compared to traditional metal stents. The research is being conducted in Ohio, potentially creating or supporting high-skilled jobs in the region. Advancements in medical technology could position the US as a leader in pediatric cardiovascular device innovation.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for delays in development given the complexity of medical device R&D and the contract duration.
Uncertainty in the commercialization success of the bioresorbable stent technology.
The 'after exclusion of sources' clause warrants further scrutiny to understand the rationale and impact on competition.
Dependence on a single contractor (PediaStent LLC) for this specific development phase could pose a risk if performance falters.

Positive Signals

Investment in a critical unmet medical need for neonates.
Awarded through a competitive process, suggesting a vetted solution.
Focus on innovative, potentially less invasive, medical technology.
Contract duration allows for thorough research and development.

Sector Analysis

This contract falls within the broader Health and Medical sector, specifically focusing on the research and development of innovative medical devices. The market for cardiovascular devices, particularly those for pediatric use, is specialized and highly regulated. Investments in R&D by agencies like NIH are crucial for driving innovation in this space. Comparable spending benchmarks would typically involve looking at other NIH grants or contracts for early-stage medical device development, which can range from hundreds of thousands to millions of dollars depending on the technology's maturity and scope.

Small Business Impact

This contract does not appear to have a small business set-aside component (ss: false, sb: false). The focus on specialized R&D for a novel medical device likely means the primary contractor, PediaStent LLC, is selected based on specific technical expertise rather than size. There is no explicit information regarding subcontracting plans with small businesses, which could be an area for future consideration to foster broader economic impact.

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, NIH program officials would monitor progress against milestones and deliverables. The contract's fixed-price nature provides some cost control. Transparency is generally maintained through federal contract databases, but detailed project progress reports may not be publicly available. The Inspector General for HHS would have jurisdiction over potential fraud, waste, or abuse.

Related Government Programs

NIH Research and Development Grants
Medical Device Innovation Programs
Pediatric Cardiovascular Research
Biomaterials Development Contracts

Risk Flags

Potential for technology obsolescence during long R&D cycle.
Uncertainty of successful clinical translation and regulatory approval.
Dependence on specific material science breakthroughs for bioresorbability.
Limited number of bidders despite open competition clause.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $3.4 million to PEDIASTENT LLC. IGF::OT::IGF THE DEVELOPMENT LEADING TO THE COMMERCIALIZATION OF A BIORESORBABLE STENTS (BRS) FOR THE TREATMENT OF COARCTATION OF THE AORTA (COA) IN NEONATES.

Who is the contractor on this award?

The obligated recipient is PEDIASTENT 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 $3.4 million.

What is the period of performance?

Start: 2016-09-26. End: 2022-03-22.

What is the specific technical innovation behind PediaStent LLC's bioresorbable stent for neonates?

The provided data does not detail the specific technical innovation of PediaStent LLC's bioresorbable stent. However, bioresorbable stents are designed to provide temporary support to a vessel and then gradually dissolve within the body, eliminating the need for a permanent implant and potentially reducing long-term complications such as restenosis or the need for re-intervention. For neonates with coarctation of the aorta, this could offer a less invasive and more adaptable solution compared to traditional metallic stents or surgical repair, especially given the rapid growth of infants. Further details would likely be found in the technical proposals submitted during the procurement or in the company's own research publications.

How does the $3.4 million investment compare to the total estimated cost for commercializing such a device?

The $3.4 million investment from NIH represents a significant, but likely early-stage, funding amount for the development and potential commercialization of a novel medical device like a bioresorbable stent for neonates. The total cost to bring a medical device from research through clinical trials, regulatory approval (e.g., FDA), and market launch can easily run into tens or hundreds of millions of dollars. This NIH contract appears to be focused on the research and development phase, aiming to prove the technology's feasibility and efficacy. Subsequent funding rounds, potentially from venture capital, strategic partnerships, or further government grants, would be necessary to cover the extensive costs associated with clinical validation and market entry.

What are the primary risks associated with developing and deploying bioresorbable stents in neonates?

Developing and deploying bioresorbable stents in neonates presents several significant risks. Firstly, the unique physiology of neonates, including rapid growth and smaller vessel sizes, poses challenges for stent design, deployment, and long-term stability. The material itself must be biocompatible, degrade predictably without adverse inflammatory responses, and maintain structural integrity during the critical healing period. Secondly, clinical risks include potential for malapposition, incomplete expansion, or fracture of the stent. For coarctation of the aorta, ensuring adequate flow and preventing re-stenosis or aneurysm formation is paramount. Finally, the regulatory pathway for such a novel device in a vulnerable population is complex and requires robust clinical evidence of safety and efficacy, which is inherently risky to obtain.

What is the expected timeline for this contract and what does it imply for the project's progress?

This definitive contract has a duration of 2003 days, spanning from September 26, 2016, to March 22, 2022. This extended timeline suggests a comprehensive research and development effort, likely involving multiple phases such as material science investigation, prototype development, preclinical testing (in vitro and in vivo), and potentially early-stage clinical feasibility studies. A longer duration is common for R&D contracts, especially in the medical field, as it allows for iterative design, testing, and refinement, and accommodates the complexities and potential setbacks inherent in developing novel technologies. It implies that the project is not expected to yield immediate commercial results but is focused on foundational development.

How does the 'Full and Open Competition After Exclusion of Sources' procurement method impact potential bidders and the final price?

The 'Full and Open Competition After Exclusion of Sources' method indicates that while the competition was broadly open, certain potential offerors were excluded from the outset. The rationale for exclusion is typically based on specific, justifiable criteria such as unique capabilities, proprietary technology, or prior essential involvement in developing related technology. This can narrow the competitive field, potentially reducing the number of bidders compared to a purely 'full and open' competition. While it aims to ensure the best-suited contractor is selected, it could theoretically limit price competition if the excluded sources represented significant competitive threats. The presence of 4 bidders suggests that despite exclusions, sufficient competition remained to foster some degree of price discovery and ensure a reasonable outcome for the government.

Industry Classification

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

Product/Service Code: RESEARCH AND DEVELOPMENT › Education, Training, Employment, and Social Services R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: PHS20161

Offers Received: 4

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 10000 CEDAR AVE, CLEVELAND, OH, 44106

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

Financial Breakdown

Contract Ceiling: $3,399,279

Exercised Options: $3,399,279

Current Obligation: $3,399,279

Actual Outlays: $222,170

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline