SOURCES SOUGHT
A -- Insole Research Development
- Notice Date
- 7/30/2019
- Notice Type
- Synopsis
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 20;8524 N Wall St;Spokane WA 99208
- ZIP Code
- 99208
- Solicitation Number
- 36C26019Q0659
- Response Due
- 8/2/2019
- Archive Date
- 8/12/2019
- Point of Contact
- 509-321-3969
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCE SOUGHT NOTICE in support of the Puget Sound VA Healthcare System in Seattle, WA, for market research purposes only to determine the availability of potential businesses with capabilities to provide the services described below. Potential offerors are invited to provide feedback via e-mail to Joshua Anderson at JOSHUA.ANDERSON2@VA.GOV. Responses will be used to determine the appropriate acquisition strategy for a potential future acquisition. All responses due by 08/02/2019, at 3:00 PM PST. Potential contractors shall provide, at a minimum, the following information: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Is your firm eligible for participation in one of the following small business programs? If so, please indicate the program. Anticipated North American Industry Classification System (NAICS) code is 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology). The largest a firm can be and still qualify as a small business for Federal Government programs is no larger than 1000 employees. [ ] yes [ ] no Small Business (SB) [ ] yes [ ] no HUBZone [ ] yes [ ] no Small Business 8(a) [ ] yes [ ] no Small Disadvantaged Business (SDB) [ ] yes [ ] no Women-Owned (WO) Small Business [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Other (please specify) 3) What types of information is needed to submit accurate offers? 4) Provide a brief capability statement (Max 2 pages) with enough information to determine if your company can meet the requirement. The Capabilities Statement for this sources sought is not expected to be a Request for Quotations, Request for Proposals or Invitation for Bids, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company s ability to provide the services outlined in the draft SOW below. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. Submission of capabilities statement will assist our office in tailoring the requirement to be consistent with industry standards. The capabilities will be evaluated solely for the purpose of determining to Set-Aside for the Small Business (SB) Community or to conduct as an Unrestricted Procurement. Other than small businesses may respond to this notice in the event the market does not indicate SB interest. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation. Note: Do not include Proprietary, classified, confidential, or sensitive information in responses. Not responding to this Sources Sought does not preclude participation in any future or potential solicitation, or Request for Quotation. It is the intent of the Mann-Grandstaff VA Medical Center to use the information gathered for market research purposes only. If a formal solicitation is released, it will be posted via the Federal Business Opportunity (http://www.fbo.gov). DESCRIPTION OF THE REQUIREMENT: STATEMENT OF WORK Introduction Through an extensive research program, the CLiMB at VA Puget Sound Health Care System is developing additive manufacturing designs for patient specific orthotics to relieve pressures on ulcerations and other complications of diabetes on the foot. Currently patients in the at-risk category for further complication leading to amputation are required to be provided with custom insoles several times a year involving several visits to a VA medical Center annually. The VAPS staff believe that their additive manufacturing design will improve patient care by reducing the time from prescription to fulfillment and extending the durability of the insole. Significant cost savings are to be expected as a result of these improvements. VA CLiMB seeks contract services in additive manufacturing to provide a local and system-wide solutions for the timely mass production of the novel CLiMB insoles. Based on early analysis of the VAPS insole design, the expectation is that patients will be able to use a single pair of insoles for up to a year, versus currently 3-4 months. The manufacturing turn around is targeting one day, rather than the 3-4 weeks for the current process, which places a multiple visit burden especially on veterans living more than a few hours away from their nearest VAMC. VA Puget Sound Health Care System provide insoles to approximately 2000 at-risk patients. We expect to perform a cost analysis that will project costs and savings to locally manufacture in order to gain the benefits above. This forecast will be tested using the prototype facilities co-developed and assessed in order to inform any future deployments. The business goal is not only to provide better care, but to do it at less cost to the VA in a mutually beneficial partnership. To achieve these objectives, we seek contract services from third parties with the following capabilities: Prior experience developing and designing workflows for 3D printed orthotics. Own and have on site access to a variety of different 3D printers that are applicable to manufacturing accommodating foot orthotics, including but not limited to Fused Deposition Modeling (FDM), Stereolithography (SLA), Select-Laser Sintering (SLS), and PolyJet. Evidence of prior experience working with a variety of different 3D printer materials including Acrylonitrile butadiene styrene (ABS), Polylactic acid (PLA), PLA, elastomers, photosensitive resin, nylon, and other materials. Evidence and examples of cost analysis and production optimization tools for components and/or finished goods produced using additive manufacturing Evidence of prior experience scaling production using additive manufacturing in a medical environment and/or for medical devices Experience with software development that includes Design Engineering for Security that rises to the level of DoD RMF requirements Experience designing software that is HIPPA compliant, providing and working within a legal framework including Covered Entities as well as third parties Prior experience designing manufacturing and distributing products that meet ISO, CE, and FDA regulatory requirements. Prior experience with for national and international standards conformance, for example, GMP, ISO 22523:2006, ISO/FDS 22675, CG-DME 19/DMEPOS QA Standard Prior experience developing quality assurance programs for internal production as well as 3rd party supplier qualification and management Prior experience working with 3D printed orthotic startup companies Deep knowledge and experience with medical imaging clinical workflows in a multimodality environment, Prior experience integrating imaging and/or medical device solutions in a mobile or otherwise tightly packaged configuration including national and international distribution, installation and acceptance trial management Experience integrating subsystems from diverse sources and validating a robust systematized solution against internal and external performance criteria. Experience packaging and hardening products to withstand multiple modes of delivery and diverse operating environments. Experience planning for and coordinating service and replacement parts support for complex end-user products Experience and a global mechanism to create and deliver training materials for service and manufacturing deployments Tasks Broad Goals Facilitate the design, manufacturing scaleup and in general the commercialization of 3D printed custom foot orthotics. Assist with the setup of 3D orthotic manufacturing factory in a special purpose dedicated room design specifically for mass production of the local, regional, and national VA demand for custom foot orthotics. Insole Development Work Characterize the internal 3D shape of existing footwear that is worn by the patient population. Create library. This would inform on limits of insole outer shape. Create partnership with existing diabetic shoe companies. Figure out how we can get the custom insole to fit in the customer shoe. Explore and improve 3D foot geometry acquisition methods (see appendix B) and create market report and evaluate systems for both direct foot scan and scan of crush box. Deliverable is a report on the different 3D acquisition methods, their performance, cost, and relevant commentary Physical testing of characterize current standard of care metamaterial stiffness and durability. Physical tests to characterize metamaterial stiffness and durability across lattice patterns and material options (see Appendix A). Measure and shear (on subset) stiffness, durability) across lattice patterns and materials (see appendix B). Characterize metamaterial properties and shore hardness. Manufacturing Scaleup Estimate current and future mass production unit cost based on fixed durable goods (3D printers), consumable goods (3D printer material), clinician and technician time. Contractor will not have access to Protected Health Information. Line Item Summary of Scope of Work Line Quantity Description 1 1 Explore and improve 3D foot imaging methods (pg 3), create market report and evaluate systems for both 1) direct foot scan and 2) scan of crush box. Deliver a report on 3D acquisition methods, their performance, cost, and relevant commentary. 2 1 Physical tests to characterize metamaterial stiffness and durability across lattice patterns and material options (see App. A). 3 1 Perform physical testing to characterize both standard of care and designed insole for stiffness, durability, Shore hardness and shear (on subset) across lattice patterns and materials (App. B). 4 1 Apps training for products, other 3rd party provided services such as data migration, calibration, refurbishment. Summary of Project: The RR&D Center is requesting contractor work to assist with the design and development of 3D printed insoles. SERVICES The services specified may be changed by additional written modification to this contract. The modification will be prepared by the VA Contracting Officer and, prior to becoming effective, shall be approved by the VA Under Secretary for Health or his/her designee. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the VA at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming. The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility. The services to be performed by the contractor will be under the direction of the VA PSHCS Research and Development. WORK HOURS The services covered by this contract shall be furnished by the contractor. The contractor will not be required, except in case of emergency, to furnish such services on a national holiday or during off-duty hours as described below. The following terms have the following meanings: National Holidays: the 10 holidays observed by the Federal Government are New Years Day Martin Luther King s Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas And any other day specifically declared by the President of the United States to be a national holiday Off Duty hours: those hours not covered by the established tour of duty including call coverage. PERSONNEL POLICY The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel: Workers compensation Professional liability insurance Health examinations Income tax withholding, and Social security payments The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose. RECORD KEEPING The contractor shall establish and maintain accurate record keeping system. SUPERVISION Services will be delivered to Patrick Aubin, Ph.D. at VA Puget Sound Health Care System. Appendix A Characterize metamaterial stiffness and durability across lattice patterns and materials Characterize bulk normal and shear stiffness and durability of different lattice patterns for a given material. Gyroid lattice Vary unit cell size and percent infill Measure bulk normal and shear stiffness as a function of frequency Measure durability (uniaxial compression cycles to failure) Node and strut lattice Vary strut diameter and node density Measure bulk normal and shear stiffness as a function of frequency Measure durability (uniaxial compression cycles to failure) Characterize bulk normal and shear stiffness and durability of different materials for a given lattice. Material A Measure bulk stiffness and shear as a function of frequency Measure durability Material B Measure bulk stiffness and shear as a function of frequency Measure durability Lattice Material Gyroid Node & Strut A Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? B Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? C Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? D Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? E Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Normal Stiffness = ?? Shear Stiffness = ?? Durability = ?? Explore and Improve 3D Foot Geometry Acquisition Method Test and review these methods of getting 3D scans of feet under various body weight loading conditions. Evaluate 1) performance/accuracy of system, 2) easy of passing scan output data into downstream software packages, 3) ability to scan foot under preferred body weight loading, 4) cost 5) other. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (30-JUL-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/SpVAMC/VAMCCO80220/36C26019Q0659/listing.html)
- Record
- SN05385839-F 20190801/190730230027 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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