HHS awards $2.2M for advanced medical product manufacturing system, focusing on R&D

Contract Overview

Contract Amount: $2,236,097 ($2.2M)

Contractor: Advanced Regenerative Manufacturing Institute Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-19

End Date: 2027-09-29

Contract Duration: 1,105 days

Daily Burn Rate: $2.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: R&D

Official Description: BIOFAB FOUNDRY: A SCALABLE, CLOSED, AUTOMATED, MEDICAL PRODUCT MANUFACTURING SYSTEM

Place of Performance

Location: MANCHESTER, HILLSBOROUGH County, NEW HAMPSHIRE, 03101

State: New Hampshire Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.2 million to ADVANCED REGENERATIVE MANUFACTURING INSTITUTE INC for work described as: BIOFAB FOUNDRY: A SCALABLE, CLOSED, AUTOMATED, MEDICAL PRODUCT MANUFACTURING SYSTEM Key points: 1. Contract awarded through full and open competition, suggesting a robust market. 2. The contract type is 'Cost No Fee', indicating risk is primarily on the contractor. 3. Performance period spans over three years, allowing for substantial development. 4. The awardee, Advanced Regenerative Manufacturing Institute Inc., is positioned to lead this R&D effort. 5. Focus on a 'scalable, closed, automated' system points to future manufacturing efficiencies. 6. The project falls under Research and Development in the Social Sciences and Humanities, though its application is medical.

Value Assessment

Rating: good

The contract value of $2.2 million for a three-year R&D project in advanced medical manufacturing appears reasonable, especially given the 'Cost No Fee' structure which places financial risk on the contractor. Benchmarking this specific type of R&D contract is challenging due to its specialized nature. However, the focus on developing a scalable, automated system suggests potential for significant long-term cost savings and efficiency gains in medical product manufacturing, which could represent good value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'Full and Open Competition,' indicating that all responsible sources were permitted to submit a bid. While the number of bidders is not specified, this procurement method generally fosters a competitive environment, which is expected to drive innovation and potentially lead to more favorable pricing for the government. The open nature of the competition suggests a healthy market for this type of advanced manufacturing R&D.

Taxpayer Impact: A full and open competition process is beneficial for taxpayers as it maximizes the pool of potential offerors, increasing the likelihood of receiving competitive proposals and achieving the best possible value for the government's investment.

Public Impact

The primary beneficiaries are expected to be patients and the healthcare system through the development of more efficient and potentially lower-cost medical products. The project aims to deliver a 'scalable, closed, automated, medical product manufacturing system,' representing a significant advancement in manufacturing technology. The geographic impact is not specified but is likely to be national, given the nature of medical product development and FDA oversight. Workforce implications could include the need for highly skilled personnel in advanced manufacturing, automation, and biomedical engineering.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'Cost No Fee' contract type, while beneficial for the government in terms of cost control, places all financial risk on the contractor, which could potentially limit the scope or pace of innovation if the contractor faces unforeseen cost overruns.
The specific R&D area, while medical, is categorized under 'Social Sciences and Humanities,' which might indicate a novel or interdisciplinary approach that requires careful monitoring for alignment with tangible medical product outcomes.

Positive Signals

Awarded through 'Full and Open Competition,' suggesting a competitive market and potential for innovation.
The 'Cost No Fee' structure incentivizes the contractor to manage costs effectively and deliver the project within budget.
The three-year duration provides ample time for the contractor to develop and refine the advanced manufacturing system.
The focus on automation and scalability in medical product manufacturing aligns with national priorities for healthcare efficiency and advanced manufacturing.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on advanced manufacturing technologies for medical products. The market for such systems is driven by the need for increased efficiency, precision, and cost-effectiveness in healthcare. Comparable spending benchmarks are difficult to establish due to the specialized nature of automated, closed-loop medical manufacturing systems, but investments in advanced manufacturing R&D are generally increasing across various industries.

Small Business Impact

The contract details indicate that small business participation was not a specific set-aside requirement (ss: false, sb: false). The primary contractor is Advanced Regenerative Manufacturing Institute Inc. Further analysis would be needed to determine if subcontracting opportunities exist for small businesses within the scope of this R&D project, particularly in specialized areas of automation or materials science.

Oversight & Accountability

Oversight for this contract will likely be managed by the Food and Drug Administration (FDA), given their role in regulating medical products and manufacturing processes. The 'Cost No Fee' structure implies that financial oversight will focus on ensuring the contractor meets milestones and deliverables without incurring costs beyond the agreed-upon scope. Transparency will depend on the FDA's reporting practices for R&D contracts and the public availability of project outcomes.

Related Government Programs

Advanced Manufacturing Initiatives
Medical Device Development
Biotechnology Research
National Health Innovation

Risk Flags

Potential misalignment of NAICS code with project scope.
Financial risk concentration on contractor due to 'Cost No Fee' structure.
Technical complexity of developing a fully automated, scalable, closed medical manufacturing system.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.2 million to ADVANCED REGENERATIVE MANUFACTURING INSTITUTE INC. BIOFAB FOUNDRY: A SCALABLE, CLOSED, AUTOMATED, MEDICAL PRODUCT MANUFACTURING SYSTEM

Who is the contractor on this award?

The obligated recipient is ADVANCED REGENERATIVE MANUFACTURING INSTITUTE INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $2.2 million.

What is the period of performance?

Start: 2024-09-19. End: 2027-09-29.

What is the track record of Advanced Regenerative Manufacturing Institute Inc. in similar R&D projects?

Information regarding the specific track record of Advanced Regenerative Manufacturing Institute Inc. in similar R&D projects is not detailed in the provided data. However, their name suggests a focus on regenerative medicine and advanced manufacturing. A comprehensive assessment would require reviewing their past performance on government contracts, publications, and any prior development of automated manufacturing systems. The 'Cost No Fee' nature of this award implies a level of confidence from the awarding agency in the contractor's ability to manage the project effectively. Further due diligence would involve examining their financial stability and technical expertise relevant to creating a 'scalable, closed, automated, medical product manufacturing system.'

How does the $2.2 million award compare to typical R&D investments in advanced medical manufacturing systems?

The $2.2 million award for a three-year R&D project in advanced medical manufacturing is a moderate investment. R&D costs in this field can vary significantly based on the complexity, novelty, and scale of the technology being developed. Developing a 'scalable, closed, automated' system for medical products is a substantial undertaking. While specific benchmarks are hard to pinpoint without more granular data on comparable projects, this funding level suggests a focused effort on a specific technological advancement rather than a broad, multi-year foundational research program. It is likely sufficient for targeted development and prototyping, especially with the 'Cost No Fee' structure that incentivizes efficient resource allocation by the contractor.

What are the primary risks associated with developing a 'scalable, closed, automated, medical product manufacturing system' under a 'Cost No Fee' contract?

The primary risks associated with developing a 'scalable, closed, automated, medical product manufacturing system' under a 'Cost No Fee' contract are multifaceted. For the contractor, the main risk is financial: any cost overruns due to unforeseen technical challenges, material costs, or labor expenses will be borne entirely by them. This could lead to project delays or even abandonment if costs become unmanageable. For the government, the risk lies in the potential for the contractor to cut corners on quality or scope to manage costs, or to deprioritize the project if more profitable ventures arise. Ensuring the system meets scalability, closure, and automation requirements for medical products, which demand high precision and reliability, presents significant technical hurdles that could be exacerbated by cost-containment pressures.

What is the expected impact of this contract on the broader medical product manufacturing sector?

This contract is expected to have a positive impact on the broader medical product manufacturing sector by advancing the state-of-the-art in production technology. The development of a 'scalable, closed, automated' system could lead to significant improvements in manufacturing efficiency, product consistency, and potentially reduced production costs for medical devices and pharmaceuticals. If successful, this technology could serve as a model or precursor for future manufacturing paradigms, encouraging wider adoption of automation and closed-loop systems. This could enhance the competitiveness of domestic medical product manufacturers and contribute to more resilient supply chains, ultimately benefiting patient access to high-quality medical goods.

How does the 'Research and Development in the Social Sciences and Humanities' NAICS code align with a medical product manufacturing system?

The assignment of the NAICS code '541720 - Research and Development in the Social Sciences and Humanities' to a contract for a 'medical product manufacturing system' appears unconventional at first glance. Typically, medical product manufacturing R&D would fall under codes related to engineering, physical sciences, or life sciences (e.g., 541713 - Research and Development in Nanotechnology and Materials Science, or 541715 - Research and Development in the Physical, Engineering, and Life Sciences). It is possible that the 'Social Sciences and Humanities' classification is being used broadly to encompass the human factors, organizational aspects, or societal impacts related to the implementation and adoption of such advanced manufacturing systems, or perhaps it reflects an interdisciplinary approach that integrates human-centered design principles into the automation process. Clarification from the awarding agency would be necessary to fully understand this classification choice.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Social Sciences and Humanities

Product/Service Code: RESEARCH AND DEVELOPMENT › General Science and Technology R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 400 COMMERCIAL ST, MANCHESTER, NH, 03101

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

Financial Breakdown

Contract Ceiling: $2,236,097

Exercised Options: $2,236,097

Current Obligation: $2,236,097

Actual Outlays: $781,736

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline