DoD's $23.3M sepsis treatment device contract awarded to Battelle Memorial Institute for R&D

Contract Overview

Contract Amount: $23,316,842 ($23.3M)

Contractor: Battelle Memorial Institute

Awarding Agency: Department of Defense

Start Date: 2013-03-12

End Date: 2019-12-31

Contract Duration: 2,485 days

Daily Burn Rate: $9.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 4

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF THE GOAL OF THIS DLT INTEGRATION PROGRAM IS TO DEVELOP A PORTABLE DEVICE THAT CAN EFFECTIVELY TREAT SEPSIS ACROSS THE MILITARY HEALTH SYSTEM; CAPABLE OF REMOVING DIRTY BLOOD FROM THE BODY, SEPARATES HARMFUL AGENTS, AND RETURNS CLEAN BLOOD TO THE BODY IN A MANNER SIMILAR TO DIALYSIS TREATMENT OF KIDNEY FAILURE.

Place of Performance

Location: COLUMBUS, FRANKLIN County, OHIO, 43201

State: Ohio Government Spending

Plain-Language Summary

Department of Defense obligated $23.3 million to BATTELLE MEMORIAL INSTITUTE for work described as: IGF::OT::IGF THE GOAL OF THIS DLT INTEGRATION PROGRAM IS TO DEVELOP A PORTABLE DEVICE THAT CAN EFFECTIVELY TREAT SEPSIS ACROSS THE MILITARY HEALTH SYSTEM; CAPABLE OF REMOVING DIRTY BLOOD FROM THE BODY, SEPARATES HARMFUL AGENTS, AND RETURNS CLEAN BLOOD TO THE BODY IN A MANNER … Key points: 1. Contract focuses on developing a portable device for sepsis treatment, akin to dialysis. 2. The technology aims to remove harmful agents from blood, improving military health system capabilities. 3. Awarded via full and open competition, suggesting a broad search for qualified vendors. 4. The contract duration of over 2000 days indicates a long-term research and development effort. 5. This initiative falls under the biotechnology R&D sector, a critical area for defense health. 6. The cost-plus-fixed-fee structure allows for flexibility in R&D while managing contractor profit.

Value Assessment

Rating: fair

Benchmarking the value of this R&D contract is challenging due to its specialized nature and the absence of direct commercial comparables. The $23.3 million allocated over its multi-year duration reflects the significant investment required for developing novel medical technology. While the cost-plus-fixed-fee (CPFF) structure can lead to cost overruns in some R&D projects, it also provides flexibility for unforeseen technical challenges inherent in developing a first-of-its-kind device. Without specific performance metrics or a deployed product, a definitive value assessment is pending.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that the Defense Advanced Research Projects Agency (DARPA) sought proposals from all responsible sources. The number of bids received is not specified, but this procurement method generally fosters a competitive environment, encouraging multiple companies to offer their best technical solutions and pricing. This approach aims to ensure the government receives the most advantageous offer.

Taxpayer Impact: A full and open competition process is generally favorable for taxpayers as it increases the likelihood of obtaining competitive pricing and innovative solutions, potentially reducing overall program costs.

Public Impact

Military personnel suffering from sepsis will be the primary beneficiaries of this advanced treatment technology. The contract aims to deliver a portable device capable of treating sepsis, enhancing battlefield medical capabilities. The geographic impact is primarily within the military health system, potentially deployable across various global operational theaters. Development of this technology could lead to specialized jobs in biotechnology research and medical device engineering.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The long development timeline (over 6 years) for a single R&D project could indicate potential for delays or technical hurdles.
Cost-plus-fixed-fee contracts can sometimes incentivize cost escalation if not closely monitored.
The novelty of the technology means there's inherent risk in achieving the desired performance and efficacy.
Dependence on a single contractor for such a critical R&D effort could pose a risk if the contractor faces financial or technical difficulties.

Positive Signals

The contract is for cutting-edge research and development in a critical medical area (sepsis treatment).
Awarded through full and open competition, suggesting a robust selection process.
The project addresses a significant unmet need within the military health system.
Battelle Memorial Institute has a strong track record in research and development, particularly in defense-related technologies.

Sector Analysis

This contract falls within the Research and Development (R&D) sector, specifically focusing on biotechnology and medical devices. The market for advanced medical technologies, particularly those with military applications, is characterized by significant investment, long development cycles, and stringent regulatory requirements. Comparable spending in this area often involves substantial government funding for innovation in areas like diagnostics, therapeutics, and medical equipment designed for extreme environments or specialized operational needs.

Small Business Impact

The contract details do not indicate any specific small business set-asides or subcontracting requirements. Given the specialized nature of the R&D and the prime contractor (Battelle Memorial Institute), it is possible that subcontracting opportunities for small businesses might be limited unless specific expertise is required. Further analysis would be needed to determine if small businesses are involved in supporting roles.

Oversight & Accountability

Oversight for this contract would typically be managed by the contracting officer and the program office within DARPA. The cost-plus-fixed-fee structure necessitates close monitoring of costs and progress to ensure adherence to the contract's objectives and budget. Transparency is generally maintained through regular reporting requirements from the contractor. Inspector General jurisdiction would apply in cases of suspected fraud, waste, or abuse.

Related Government Programs

Military Medical Research
Biotechnology Development Programs
Advanced Medical Device Innovation
Sepsis Treatment Research
Defense Health Agency Initiatives

Risk Flags

Long-term R&D project
Novel medical technology development
Potential for cost overruns
Dependence on contractor expertise

Frequently Asked Questions

What is this federal contract paying for?

Department of Defense awarded $23.3 million to BATTELLE MEMORIAL INSTITUTE. IGF::OT::IGF THE GOAL OF THIS DLT INTEGRATION PROGRAM IS TO DEVELOP A PORTABLE DEVICE THAT CAN EFFECTIVELY TREAT SEPSIS ACROSS THE MILITARY HEALTH SYSTEM; CAPABLE OF REMOVING DIRTY BLOOD FROM THE BODY, SEPARATES HARMFUL AGENTS, AND RETURNS CLEAN BLOOD TO THE BODY IN A MANNER SIMILAR TO DIALYSIS TREATMENT OF KIDNEY FAILURE.

Who is the contractor on this award?

The obligated recipient is BATTELLE MEMORIAL INSTITUTE.

Which agency awarded this contract?

Awarding agency: Department of Defense (Defense Advanced Research Projects Agency).

What is the total obligated amount?

The obligated amount is $23.3 million.

What is the period of performance?

Start: 2013-03-12. End: 2019-12-31.

What is Battelle Memorial Institute's track record with similar large-scale R&D contracts for the Department of Defense?

Battelle Memorial Institute has a substantial history of performing complex research and development contracts for the Department of Defense and other federal agencies. They are known for their work in areas such as materials science, chemical and biological defense, and advanced manufacturing. While specific details on sepsis-related R&D contracts are not immediately available, their broad expertise in scientific research and engineering suggests a strong capability to undertake such a project. Their past performance would likely be evaluated based on successful delivery of technical milestones, adherence to budget, and innovation demonstrated in previous DoD engagements. A review of their contract history would reveal the scale and complexity of projects they have managed, providing context for their suitability for this sepsis treatment device initiative.

How does the $23.3 million cost compare to the development of similar advanced medical devices for military use?

The $23.3 million allocated for this sepsis treatment device development is a significant investment, but it is not unusual for advanced medical technology R&D, especially for military applications. Developing novel devices that must function reliably in diverse and potentially harsh environments, meet stringent military specifications, and undergo rigorous testing can incur substantial costs. Comparable projects, such as advanced diagnostic tools, portable surgical equipment, or specialized life support systems for military use, often require tens of millions of dollars over several years. The cost is influenced by factors like the complexity of the technology, the need for specialized materials, the extensive testing and validation required, and the long development timelines inherent in bringing such innovations from concept to a deployable product. Without specific benchmarks for portable sepsis treatment devices, direct comparison is difficult, but the funding level aligns with the high-risk, high-reward nature of defense medical R&D.

What are the primary risks associated with developing a portable sepsis treatment device as described in this contract?

The primary risks associated with developing a portable sepsis treatment device are multifaceted. Technical risks include the inherent difficulty in designing a device that can effectively and safely remove harmful agents from blood while being portable and user-friendly for military medical personnel. Achieving the required efficacy and safety standards for a medical device, especially one involving extracorporeal blood treatment, presents significant biological and engineering challenges. Furthermore, the device must be robust enough to withstand military operational conditions. Programmatic risks involve potential cost overruns due to the complexity of R&D, schedule delays stemming from unforeseen technical hurdles or regulatory approval processes, and the possibility that the final technology may not meet all performance objectives. There's also a risk related to the long-term sustainment and maintenance of such a device in military settings.

What is the expected impact of this technology on military healthcare readiness and patient outcomes?

The expected impact of this portable sepsis treatment device on military healthcare readiness and patient outcomes could be substantial. Sepsis is a life-threatening condition, and rapid, effective treatment is crucial. A portable device would allow for immediate intervention closer to the point of injury or illness, potentially in austere environments where traditional hospital facilities are unavailable. This could significantly improve survival rates and reduce long-term morbidity among service members suffering from sepsis. Enhanced readiness stems from the ability to treat critically ill patients effectively in the field, reducing the need for immediate evacuation to distant medical centers and allowing personnel to return to duty sooner. The technology aims to provide a 'dialysis-like' treatment, which, if successful, represents a major advancement in battlefield medicine.

How does this contract fit into the broader landscape of DoD investments in medical R&D and biotechnology?

This contract fits squarely within the Department of Defense's broader strategic investments in medical R&D and biotechnology, particularly those aimed at enhancing the health and survivability of service members. The DoD consistently funds research into critical areas such as infectious diseases, trauma care, and advanced medical technologies that can be deployed in operational settings. Sepsis is a significant concern in both military and civilian populations, and developing innovative treatments aligns with national security interests by preserving the fighting force. This specific project, focusing on a portable device, reflects a trend towards developing ruggedized, field-deployable medical solutions. It complements other DoD R&D efforts in areas like regenerative medicine, advanced prosthetics, and rapid diagnostics, all contributing to a more resilient and capable military medical system.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › DEFENSE (OTHER) R&D

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: BASIC RESEARCH

Offers Received: 4

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 505 KING AVENUE, COLUMBUS, OH, 43201

Business Categories: Category Business, Corporate Entity Tax Exempt, Manufacturer of Goods, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $23,451,842

Exercised Options: $23,451,842

Current Obligation: $23,316,842

Subaward Activity

Number of Subawards: 7

Total Subaward Amount: $21,523,991

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline