SPECIAL NOTICE
65 -- Products forClinical Study 05-CC-0091
- Notice Date
- 9/19/2012
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P12-012834
- Archive Date
- 10/11/2012
- Point of Contact
- Gail Akinbinu, Phone: 301-496-0692
- E-Mail Address
-
gakinbinu@cc.nih.gov
(gakinbinu@cc.nih.gov)
- Small Business Set-Aside
- Woman Owned Small Business
- Description
- NOTICE OF INTENT TO NEGOTIATE ON A SOLE SOURCE BASIS NOTICE FOR SOLICITATION NO.12-012834,Vitaldyne Products for Clinical Study 05-CC-0091. National Institutes of Health, Clinical Center Office of Purchasing and Contracts, intends to negotiate on a sole source basis with Vitaldyne, Inc. 400 Cokato St.E Cokato,MN 55321-4454 pursuant to 41 U.S.C.253(c)(1)--Only one responsible source and no other supplies or services will satisfy agency requirements. This procurement is for Vitaldyne products for use in Clinical Study 05-CC-0091. Radiology & Imaging Sciences intends to procure custom designed scientific equipement and supplies to be used in a Clinical Study. A purchase order for supplies will be processed for the required products. BACKGROUND The Center for Interventional Oncology is a collaboration involving the Clinical Center (CC), NIH's clinical research hospital in Bethesda, Md., the National Cancer Institute (NCI), and the National Heart, Lung, and Blood Institute (NHLBI). The Center offers new and expanded opportunities to investigate cancer therapies that use imaging technology to diagnose and treat localized cancers in ways that are precisely targeted and minimally or non-invasive. By use of advanced imaging technologies located at the Clinical Center, including cutting-edge magnetic resonance imaging (MRI), positron emission tomography (PET), computed tomography (CT) and ultrasound (US) - combined with the capability to use all four technologies simultaneously to navigate a therapeutic device through the body, the center's goal is localized treatment and drug delivery. The Center for Interventional Oncology operating under the Department of Radiology and Imaging Sciences, requires the procurement of the following items with the below mandatory requirements to be procured in order to support mission critical research in translational medicine and imaging technologies. • Conductive Basket Device • Guidewire with embedded electromagnetic [EM] sensor coil in tip • Ultrasound transducer Guide with embedded EM sensor • Surgical Instruments with EM sensors • Product development removable bronchial stent • Conductive catheter with power supply These devices and sensors will extend research to develop and advance the practice of translating image-guided technologies for localized cancer diagnosis and treatment. The guidewire with embedded electromagnetic sensor coil in tip and ultrasound transducer guide with embedded EM sensor will be used in support of the protocol 05-CC-0091 with deals with multimodality fusion and electromagnetic navigation. The rest will be in support of treatments performed in the Interventional Radiology Lab. PURPOSE/JUSTIFICATION • Conductive Basket Device This device will be used as an endovascular electrode for delivery of cauterizing radiofrequency energy to the vascular smooth muscle and vessel wall to promote large vessel occlusion, as an alternative to embolization or other method for vessel sclerosis. There is an NIH patent that was issued on this in 2005, and ASTHMATX (now Boston Scientific) took out a non-exclusive license for the use in pulmonary airways for the treatment of drug-recalcitrant asthma. The device requires conductive elements or wires on the edge of a basket (or balloon), such that the basket coapts the wall of the vessel when expanded, for the delivery of radiofrequency energy when the electrode is connected to a radiofrequency generator. This is not otherwise available on the commercial market. Vitaldyne has specific electrical engineering and biomedical device prototyping expertise in the manufacture and design of similar vascular devices, and has designed, prototyped, and delivered custom vascular devices with conductive elements to the NIH in the past. They are capable of custom fabrication of a device with such a requirement. • Guidewire with embedded electromagnetic [EM] sensor coil in tip This endovascular guidewire must be hydrophilic (slippery when wet) and have an angled tip at ~45 degrees. The guidewire will have an embedded EM sensor coil (like that made by Northern Digital, or Ascension Technologies), that will be embedded (within the polymer of the wire, like a mandrill) in the wire tip, and an internal electrical connection will communicate from the tip of the wire to an EM programming interface, which can communicate with a navigation system, like the one developed by NIH for EM navigation and image fusion. In this way, vascular procedures can be monitored by xray, as well as by fusion multimodality imaging, where a pre-operative image is referenced to the procedural image. This is not otherwise available on the commercial market. Vitaldyne has specific electrical engineering and biomedical device prototyping expertise in the manufacture and design of similar vascular devices, and has designed, prototyped, and delivered custom vascular devices with EM sensor coild embedded to the NIH in the past. They are capable of custom fabrication of a device with such a requirement, and have delivered similar devices to collaborators in the past. • Ultrasound transducer Guide with embedded EM sensor Ultrasound transducers help to guide needles with ultrasound image feedback. Adding a single 6 degree-of-freedom sensor (or 2 orthogonal sensors if 5 degrees-of-freedom sensors) epoxied onto the transducer, allows for fusion or multi-modality imaging. Such sensors must be made with biocompatible epoxy and materials, and the sensor coil must connect to an internal electrical connection or wire that will communicate from the ultrasound guide (fixed to the ultrasound transducer) to an EM programming interface, which can communicate with a navigation system, like the one developed by NIH for EM navigation and image fusion with ultrasound. This will allow for commercial ultrasound transducers being used for NIH research and clinical trials to have a non-commercial solution for image fusion, that is not otherwise available on the commercial market. In this way, ultrasound procedures can be monitored by xray, as well as by fusion multimodality imaging, where a pre-operative image is referenced to the procedural image using ultrasound data as the frame of reference. Each different ultrasound needle guide would need a different sensor coil glued to it, with an advanced programming interface plug connecting to an NDI API, to enable this. Vitaldyne has specific electrical engineering and biomedical device prototyping expertise in the manufacture and design of similar EM tracking devices, and has designed, prototyped, and delivered custom medical devices with EM sensor coils embedded to the NIH in the past. They are capable of custom fabrication of a device with such a requirement, and have delivered similar devices to collaborators in the past. • Surgical Instruments with EM sensors Surgical instruments will be retrofitted with EM sensor coils with biocompatible NAMSI tested epoxy and resins to attach embedded EM sensor coilS (like that made by Northern Digital, or Ascension Technologies), to be attached to the shaft of a scalpel, bovie, clamp, or cauterization device, for use in a IRB approved clinical trial at NIH for surgical instrument navigation. The device internal electrical connection will communicate from the tip of the wire to an EM programming interface, which can communicate with a navigation system, like the one developed by NIH for EM navigation and image fusion. In this way, surgical procedures can be monitored by multimodality imaging or referenced to pre-operative images, where a pre-operative image is referenced to the procedural image. This is not otherwise available on the commercial market, and is the subject of an IRB approved NIH clinical trial. Vitaldyne has specific electrical engineering and biomedical device prototyping expertise in the manufacture and design of similar surgical devices, and has designed, prototyped, and delivered custom surgical devices with EM sensor coils embedded to the NIH in the past. They are capable of custom fabrication of a devices with such a requirement, and have delivered similar devices to collaborators in the past. • Product development removable bronchial stent Metallic stents are often placed in the body but cannot be removed without major trauma to the natural anatomy or organ. Custom design of a stent device that is designed to be removed when its job is complete, or when its position is not ideal or when it causes problems, would be ideal in some settings. Removal mechanisms for bronchial stents could be custom fabricated by altering standard nitinol stents to allow for removal mechanisms welded to the stent. Vitaldyne has specific materials science engineering and biomedical device prototyping expertise in the manufacture and design of similar ando-cavitary devices such as stents and IVC filters, and has designed, prototyped, and delivered similar custom endocavitary devices that are removable by various means (like the NIH patented removable inferior vena cava filter) to the NIH in the past. They are capable of custom fabrication of devices with such requirements, and have delivered similar devices to collaborators in the past. • Conductive catheter with power supply A vascular access device should be custom fabricated with conductive elements and the power source internalized and miniaturized as a requisite step to in vivo testing prior to clinical translation. The catheter should have a small camera-type battery embedded in a battery chamber residing inside the plastic of the catheter hub, such that in vivo testing can occur without requiring attachment to a large stationary power source. The current and voltage settings will be specified, as well as the expected duration of activity prior to battery replacement. Vitaldyne has specific materials science and electrical engineering and biomedical device prototyping expertise in the manufacture and design of identical devices such as electrically conductive catheters, and has designed, prototyped, and delivered similar custom endovascular devices to the NIH in the past. They are capable of custom fabrication of devices with such requirements. CONTRACT REQUIREMENTS Provide the devices and sensors with the following requirements: A. Conductive Basket Device 1. Must possess conductive elements or wires on the edge of a basket (or balloon) such that the basket coapts the wall of the vessel when expanded to provide coagulation. 2. Device must function utilizing 500 kilohertz. B. Guidewire with embedded electromagnetic [EM] sensor coil in tip 1. Sensor coil measures.035 mm in diameter and 8 mm long. 2. Overall length of guidewire is approximately 80 cm. 3. Core tip must provide torque control. 4. Hydrophilic properties and have an angled tip at 45 degrees. 5. Embedded EM sensor coil. 6. Internal electrical connection to enable communication from the tip of the wire to an EM navigation and fusion system. C. Ultrasound transducer Guide with embedded EM sensor 1. Single 6 degree-of-freedom sensor (or 2 orthogonal sensors if 5 degrees-of-freedom sensors) epoxied onto the transducer. 2. Made with biocompatible epoxy and materials. 3. Sensor coil must have an internal electrical connection or wire that will communicate from the ultrasound guide (fixed to the ultrasound transducer) to an EM programming interface, which can communicate with a navigation system. 4. Must provide design file with CAD files. D. Surgical Instruments with EM sensors 1. EM sensor coils with biocompatible NAMSI tested epoxy and resins to attach embedded EM sensor coils. 2. Sensor coils will be magneto-resistive and have low frequency. E. Product development removable bronchial stent 1. 10 mm stent with reattachment arms. 2. Stent attachable to an IVC filter. F. Conductive catheter with power supply 1. Less than 10 microamps. 2. Power supply has sealing system. GOVERNMENT RESPONSIBILITIES N/A REPORTING REQUIREMENTS AND DELIVERABLES • 20 Conductive Basket Device • 10 concept prototypes of guidewire with embedded electromagnetic [EM] sensor coil in tip • 5 Ultrasound transducer Guide with embedded EM sensor • 10 Surgical Instruments with EM sensors • 1 Product development removable bronchial stent • 10 Conductive catheter with power supply PROGRAM MANAGEMENT AND CONTROL REQUIREMENTS N/A INSPECTION AND ACCEPTANCE REQUIREMENTS Receipt of the following as ordered to be acknowledged and verified by the user: • Conductive Basket Device • Guidewire with embedded electromagnetic [EM] sensor coil in tip • Ultrasound transducer Guide with embedded EM sensor • Surgical Instruments with EM sensors • Product development removable bronchial stent • Conductive catheter with power supply Interested parties may identify their interest and capability. Interested parties may respond to this requirement by submitting written capabilities/specifications to the Contract Specialist at the National Institutes of Health, Clinical Center, Office of Purchasing and Contracts,10 Center Drive, Room 1C541, Bethesda, MD 20892, Attention:Gail Akinbinu, or by email to gakinbinu@cc.nih.gov. Specific information the Government requires to make a determination of acceptability include the following: General Requirements Independently, and not as an agent of the Government, the Offeror shall furnish all necessary products and supplies specified. The Contracting Officer's Technical Representative will monitor evaluate offer using criteria as follows; I.The contractor supplying above items shall demonstrate the following: A. A minimum of five (5) years of experience in manufacturing and designing prototypes of advanced engineering and biomedical devices. B. Has capability to custom fabricate endocavitary devices and similar devices to be used with EM tracking and navigation protocol similar to or equivalent to the items listed above which are the subject of this procurement. C. Provide list of any recent customers the items listed above and the specifications and complexity of the devices and sensors which are the subject of this procurement. II. EVALUATION OF PROPOSALS The evaluation will be based upon the information provided in the Proposal, additional information requested by Project Officer for clarification, information obtained from references and independent sources, and oral presentation, if requested. Proposals will be evaluated strictly in accordance with the requirements set forth including any addenda that are issued. NIH, OPC will award the contract to the qualified and responsible Contractor whose Proposal is determined to be the most advantageous to the government, taking into consideration the evaluation criteria listed below: This notice of intent is not a request for competitive proposals; however, all responses received within 5 days from the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely with the discretion of the Government. Information received will normally be considered for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 5 days of this notice to determine whether a qualified source is more advantageous to the Government, the order will be issued to Vitaldyne. The NAICS Code/Size is 339112/500 employees. This procurement is to be processed using Simplified Acquisition Procedures-Commercial Item Acquisition in conjunction with FAR Part 12 Commercial Item Acquisition of Commercial Items. There is no solicitation package available. For any questions regarding this announcement, please contact Gail Akinbinu via email at gakinbinu@cc.@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P12-012834/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02890521-W 20120921/120920001933-e66d2a109a0ad0a895253a015048f3d4 (fbodaily.com)
- Source
-
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