RFI_Vitrectomy_USAMMA.pdf

REQUEST FOR INFORMATION (RFI)

Vitrectomy System

THIS IS NOT A REQUEST FOR PROPOSALS, NOR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A

REQUEST FOR INFORMATION (RFI). NO CONTRACT WILL BE AWARDED PERSUANT TO THIS

ANNOUNCEMENT.

SUBJECT: The U.S. Army Medical Materiel Agency (USAMMA) is conducting market research for vitrectomy systems. Any vendor questions regarding this RFI are requested by 5:00 pm EST on 29 October 2018 to allow sufficient time for USAMMA to respond. Vendor responses to this RFI are due by 5:00 pm EST on 5 November 2018.

DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. USAMMA does not anticipate awarding or modifying a contract in response to this RFI. All information comments and suggestions determined to be beneficial to USAMMA may be incorporated into future acquisition documents or contracts, without identifying the source or obtaining prior approval from the source. The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI. All information received in response to this RFI marked as “proprietary” will be handled accordingly. Information provided in response to this RFI will not be returned. USAMMA does not guarantee that any resultant acquisition action will result from this RFI.

BACKGROUND: The U.S. Army has requirements to perform eye surgery in deployed military settings, primarily to treat service members injured in combat or non-combat accidents. The specialized equipment needed to conduct this type of surgery is a vitrectomy system. The currently fielded vitrectomy systems are no longer procurable due to manufacturer discontinuation. This RFI is an invitation to submit to USAMMA the following: Technical information and all related supporting documentation for vitrectomy systems and associated components and accessories.

Please provide detailed responses submitted on the Vendor Response excel spreadsheet (attached). These responses will be directly related to the current, and subject to change, characteristics as specified in the list of questions below along with any supporting technical literature. Responses must be straightforward, clear, concise, and specific to the information requested. Vendors must provide the applicable page numbers in the supporting technical literature and additional options/features/items.

Requested Essential Characteristics/Information

Please submit, on the attached Vendor Response Spreadsheet, detailed responses addressing the below listed characteristics/information concerning your vitrectomy systems as well as providing supporting technical literature and additional options/features/items. Responses must be clear, concise, and specific to the characteristic/information. To facilitate review, please reference applicable document and specific page/paragraph numbers for the specific characteristics/information. For a detailed explanation of the Integrated Product Support Essential Characteristics, vendors can go to the Defense Acquisition University website at https://www.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=c9b84a4f-b25b-4315-8a66-8bd6c37f6ddd.

1. Essential Characteristics (EC) These characteristics are essential and must be met in order for the device to be considered acceptable. They may be subdivided into a threshold (T) and an objective (O). The threshold (T) is the minimum acceptable value while the objective is a desired level of performance above the threshold.

Essential Characteristics Definition

FDA Clearance Shall have FDA 510k approval for use in ophthalmic surgery (T)

Aspiration Vacuum Range The aspiration vacuum shall have a minimum range encompassing 25 mmHg to 600 mmHg (T)

Vitrector Cutting Speed Shall include a high speed vitrector which utilizes speeds up to 5000 cuts per minute (cpm) (T) or utilize equivalent alternative technology such as hypersonic technology (O)

Trocar/Surgical Wound Diameter The trocar/surgical diameter shall have a minimum range encompassing 23-25 gauge (T)

Pressure Range

Shall operate on a range of pressures of approximately 70 to 120 PSI with no gases other than medical air or nitrogen

(T) or utilize alternative technologies that provide equivalent or superior clinical results with no gases required (O)

Light Source Shall have an integrated light source (T) to illuminate the eye during vitreoretinal procedures or LED is the preferred light source (O)

Fluid Transfer System Shall permit the replacement of vitreous fluid with filtered air (T)

2. Additional Performance Parameters (APP) These are additional desired performance parameters but not essential. They allow for technical trade space and assist in best value determination. If these areas of support are met, they will be rated as strengths and if unavailable as weaknesses.

Additional Performance Parameters Definition

Console Shall have a console for powering and controlling the device functions.

https://www.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=c9b84a4f-b25b-4315-8a66-8bd6c37f6ddd

Ophthalmic Diathermy Unit shall include an embedded diathermy unit

Foot Switch Shall have a multifunction foot switch to operate the functions of the system

System Weight The total system in its cases shall not exceed 200 lbs

Shipping Cube The total system in its cases shall not exceed approximately

1.36 cu m (48 cu ft)

Trocar/Surgical Diameter Shall include 27 gauge surgical/wound diameter

Laser Shall include an integrated laser capability

Fragmatome Shall include an integrated fragmatome

Integrated Expansile Gas Shall include integrated expansile gas capability (C3F8/SF6) delivery

Fluid Delivery Shall include an integrated viscous fluid delivery/removal capability

3. Integrated Logistics Support (ILS) Elements These are areas of desired support including logistics, maintenance, training, parts, and others which allow for the sustainment of the device during storage, transport, and use. They allow for technical trade space and assist in best value determination. If these areas of support are met, they will be rated as strengths and if unavailable as weaknesses.

ILS Element- Supply Support Definition

Accessories and Consumables Support

Vendor shall provide a full listing of consumables, accessories, and optional items. This listing shall include a description, part number, and pricing. It is desirable for these items to be placed on a procurement contract allowing for rapid purchase. These items must be available for procurement throughout the useful life of the system.

Repair Parts Support

Vendors shall provide a full listing of repair parts. The list must provide the country of origin and identify any high failure rate parts. This listing shall include a description, part number, and pricing. It is desirable for these items to be placed on a procurement contract allowing for rapid purchase. These items must be available for procurement throughout the useful life of the system.

Obsolescence

The vendor shall notify the USAMMA and DLA that their system and/or parts are coming to the end of useful life, or that they are no longer available for procurement within 12 months of such date. System shall be supportable for a minimum of 8 years.

Parts and Supplies Request

Vendor shall allow DoD personnel, including maintenance and logistics, to contact manufacturer to request information, verify data, and order accessories, consumables, and spare parts as required to support the system throughout the useful life of the system.

ILS Element - Maintenance Planning Definition

Maintenance Concept

Vendor shall work with the USAMMA to develop a maintenance plan that allows the device to be maintained during storage, transport, and use. The maintenance plan should include areas such as inspection, lubrication, cleaning, preventative maintenance, calibration, troubleshooting, diagnostics, software upgrade, security, safety, parts replacement, and repair. System shall be supportable by a combination of Army Biomedical Equipment Specialists (MOS 68A), the Army depot sustainment enterprise, and the manufacturer.

Warranty

Vendor shall provide a minimum 12 month warranty from time of delivery that includes all parts, software updates, labor, technical support, shipping, and repair during the warranty period. Extended warranty options are desirable.

Maintenance Agreement, Optional

Vendor shall provide a maintenance agreement option after the warranty expires. The maintenance agreement shall include a variety of levels of support from parts only to full maintenance support. The agreement shall provide specifics as to each level of support, time frames, and costs.

Software/Firmware Obsolescence

Vendor shall provide a software obsolescence plan for addressing the maintenance of any software that reaches end of life whether company produced or produced by a third party vendor. i.e. Windows XP or WIN7.

Software/Firmware Support

Vendor shall make available support and upgrades to system software/firmware throughout the life of the system.

It is desired that system software upgrades be able to be performed in the field by Biomedical Equipment Specialists (MOS 68A) or remotely over the network.

Operator and Maintainer Technical Support Vendor shall provide operator/maintainer telephone technical support during vendor's normal business hours for the useful life of the system.

Alerts, Recalls and Field Change Order Notifications

Vendor shall notify the government, including DLA and the Services of all field change orders, alerts, recalls and equipment notices affecting the system's effectiveness and/or safety for the useful life of the system.

ILS Element - Package, Handling, Storage, Transportation Definition

Transport

Components of the system shall be able to be disassembled for storage and to facilitate transport. The system shall be able to be removed from the case, assembled, and made ready for use by the operator using only the instruction manual.

System Packaging The transport cases shall meet the appropriate handle and lifting requirements for the weight and cube of the proposed system, IAW MIL-STD-1472G.

Transport Case Labeling

Each case shall have a permanent marked data plate with the following information: National Stock Number, Item Unique Identification (IUID), IAW DFARS 252.211-7003, Item Unique Identification and Valuation (MAR 2016), System Nomenclature, and Manufacturer Name.

Storage Temperature (low) The system shall be capable of low temperatures storage testing to -33°C (-27.4°F) IAW MIL-STD-810G-502.5:

Basic Cold (C1).

Storage Temperature (high) The system shall be capable of high temperatures storage testing to +71°C (159.8°F) IAW MIL-STD-810G-501.5:

Hot Dry (A1).

Operational Temperature (low) The system shall withstand low operating temperatures IAW the OEM technical literature without degradation of performance.

Operational Temperature (high) The system shall withstand high operating temperature IAW the OEM technical literature without degradation of performance.

Loose Cargo Transportation

The system shall be fully operational after being subjected to the shock and vibration encountered during military transport operation. This test will be conducted IAW MIL- STD-810G, Method 514.6 on the device in its packaged shipping container.

Settling Dust

The system while in its case shall withstand a settling dust environment without degradation of performance. This procedure is performed to ascertain the ability of the test item to resist the effects of dust particles which may penetrate the test item.

Altitude

The system shall be able to function properly at altitudes of at least 4,572 meters above sea level. Upon test completion, the device is removed from the test chamber, and the post-test validation procedure performed.

ILS Element - Technical Data Definition

Technical Data Support

Vendor shall provide all operator and maintainer technical literature, with copy-right release. The following shall be provided: One (1) hard copy and one (1) digital copy of the operator and maintenance manuals and one (1) digital copy of the operator and maintenance training materials.

Searchable PDF is the preferred format.

Technical Data Availability It is desired that the vendor provide access to all technical and training literature via their website. Vendor may create a portal for the DoD for technical support.

Service Manual and Operator Format

Vendor shall meet the intent of the DoD Performance Specification, MIL-PRF-32216A, Evaluation of Commercial Off-the-Shelf (COTS) Manuals and Preparation of Supplemental Data.

Technical Data Update

Vendor shall keep the technical literature and training materials up-to-date for the useful life of the system.

Updates to the manuals and other technical data shall be made available when released.

ILS Element - Support Equipment Definition

Specialized or Propriety Tools

The vendor shall identify any specialized or proprietary tool requirements. A list of these tools will be provided and include: description, part number, and cost. It is desired that the system be supportable with the standard tools found in a DoD Biomedical Equipment Specialist's tool set. A listing of this set will be provided.

Specialized or Proprietary Test Measurement Diagnostic Equipment (TMDE)

The vendor shall identify any specialized or proprietary TMDE requirements. A list of these items will be provided and include: description, part number, and cost. It is desired that the system be supportable with the TMDE found in a DoD Biomedical Equipment Specialist's TMDE set. A listing of this TMDE will be provided.

Specialized or Proprietary Support Equipment

The vendor shall identify any specialized or proprietary support equipment requirements. A list of these items will be provided and include: description, part number, and cost.

It is desired that the system be supportable with limited or no specialized support equipment.

Transit Drop

The system shall remain fully operational after being subjected to drops associated with transportation, in accordance to MIL-STD-810G Test Method 516.6 Procedure IV.

ILS Element - Training and Training Support Definition

Maintainer and Operator Training

Vendor shall provide an operator and maintainer training plan. Training topics will include: principles of operation, preparation for use, installation, software applications, startup/shutdown, operating instructions, emergency shutdown, maintenance, servicing instructions, cleaning and lubrication, performance verification, inspection, troubleshooting, software updates and security patch instructions, preparation for shipment and long term storage, safety hazard identification and mitigation, and required tools, test equipment, and consumables.

Clinical Training Support, Optional

The vendor shall provide the option for additional clinical training that can be procured on an as needed basis. It is desired that this training be on a contract vehicle that will allow for rapid purchase and execution.

Maintainer Training Support, Optional

The vendor shall provide the option for additional maintenance training that can be procured on an as needed basis. It is desired that this training be on a contract vehicle that will allow for rapid purchase and execution.

On-line Training Support

It is desired that operator and maintenance training be available on-line. This training can be the comprehensive or abbreviated. It must provide the basic knowledge required to setup, operate, and store the system as well as basic preventive and corrective maintenance procedures.

ILS Element –Computer Resources Definition

Cybersecurity Testing Requirement (Questionnaire) Vendor shall provide a completed Cybersecurity Questionnaire with their RFO/RFP response (Government will provide questionnaire).

ILS Element - Manpower and Personnel Definition

System Start-Up The clinical user shall be able to unpack, setup, and prepare the system for operation using the operator’s manual.

Device Configuration The clinical user shall be able to configure the system (i.e.

foot control) using the operator’s manual.

System Preparation for Storage and Transport The clinical user shall be able to teardown, pack, and prepare the system for transport and storage using the operator’s manual.

Cybersecurity Testing Requirement (Testing)

The vendor shall pass cybersecurity testing prior to starting any performance and delivering any items to the Government. Testing will be based on DoD Instruction 8500.01, “Risk Management Framework (RMF)” (Government will provide all pertinent cybersecurity references).

Cybersecurity Testing Requirement (Testing Timeline) Vendor shall adhere to specified cybersecurity timeline and complete cybersecurity testing within 240 working days (Government will provide a timeline for testing).

Cybersecurity Testing Requirement (Operating System/ Application Software)

Vendor shall provide a system that has an approved operating system by the current RMF guidelines.

Cybersecurity Testing Requirement (Remote Diagnostic Access)

System shall have the remote diagnostic access capabilities to maintain, support and update software remotely.

Application Software Licensing

System shall include an enterprise software license that does not require an external device or key (such as a “dongle” or soft key) to operate, update, or maintain the system.

RFI Response:

Please complete the attached response spreadsheet with indicated information for Vitrectomy System, with specific, clear and concise answers, and provide a narrative response to the following:

Does the vendor have upgraded technology for this type of equipment that may be of interest to the Government? If so, provide detailed technical literature outlining this upgraded technology.

Have any current or prior vitrectomy systems been subject to recall(s)? If so, what corrective actions and/or product modifications have been made in response to the recall(s)?

Does the vendor currently have potential upgradeability of the system (as technology matures)? Include a discussion of upcoming new products and/or feature’s over the next 12 months.

What is the manufacturing lead time for the system, and how many systems can be produced and delivered yearly?

Discuss any considerations or trade-offs the Government should consider including issues with the draft requirement above or any additional information that the Government should be aware of.

Would your company be interested in responding to a future acquisition for the vitrectomy system outlined in this

RFI?

Include product brochures, operating, and service manuals, technical specifications, videos, and maintenance information for the vitrectomy system.

Include Reliability, Availability, and Maintainability (RAM) characteristics/life cycle data for the system (historical information on parameters such as mean-time-between-failures, mean-time-to-repair, etc.)

Include results of any environmental/durability testing performed and any experience with operating the system in an austere environment, including placing the unit in prolonged storage between uses. Vendors should address how their unit has or will be able to perform in a deployable environment which includes rough environmental conditions (heat, cold, moisture, dirt, etc.), rough handling (shipment by air including combat transportation (helicopter, air drop, etc.) and ground (over rough road or off road), and remote locations (limited access to electricity, no commercial shipping methods for parts/consumables, no online or phone access for tech support, etc.)

Address availability of spare parts from vendor including manufacturing sub-contractors and the company’s global distribution partners/centers. Address the willingness of vendor to provide spare parts, accessories and consumables under any procurement to include availability to purchase using a DLA automated ordering system (i.e. ECAT).

This should include discussion of the life of the product itself along with support after product is no longer sold in the commercial market.

The Government may request vendor presentation and product demonstrations as part of this RFI at no cost to the Government. Please describe the kind of product presentation or actual product demonstration that could be provided in conjunction with this RFI. Include whether there is an actual system available for possible product demo.

RESPONSE INFORMATION: Response to this RFI must be submitted via email or AMRDEC site to Erica Smith at Erica.k.smith5.civ@mail.mil. E-mail responses should be no larger than 5 megabytes (MB) in size.

Each RFI response will receive a confirmation e-mail. Please include a point of contact, phone number, e-mail address, and website information.

Vendor questions regarding this RFI are due by 5:00pm EST on 29 October 2018. Vendor responses to this RFI are due by 5:00pm EST on 5 November 2018.

If larger attachments are required, additional methods to submit responses include:

Sending documents separately due to size restrictions as long as each e-mail indicates how many total emails are being sent.

The following website can be used for file transfer: AMRDEC safe site file transfer: https://safe.amrdec.army.mil/safe/.

When using the upload site, please notify Erica Smith via email with list of documents being uploaded to ensure all submission documents are received.