FDA-SOL-1146560.pdf

RFQ – Requisition 1146560 Multi-Color Jetted 3D Printer System

(Subject to Availability of Funds)

1. Background/Scope:

Food and Drug Administration (FDA) requires an additive manufacturing printing system capable of depositing various materials, including conductive materials, polymers, and biological materials for professional engineering and research and development purposes.

2. Deliverables/ Salient Characteristics:

(QTY 1) 3D Printer Suggested Solution: Objet260 Connex3 Series

• Print multiple materials from soft/rubbery to hard

• Be able to combine materials in the printer so that their properties smoothly transition from one to another (for example a part may begin as pliable and become gradually harder along the part’s length)

• Print in multiple colors and combinations of colors simultaneously

• Primary / principle colors must be able to be combined as they are printed to allow more than combinations than simple alternation of the primary colors.

• Be able to vary color and material properties simultaneously

• Be able to print with biocompatible polymers

• Be able to change raw materials from one type to another with minimal loss of material remaining in the system and minimal contamination of subsequent materials

• Have a minimum layer thickness of less than 20 microns

• Have a build volume of more than 250 x 250 x 200 mm

• Have an x-y (in plane) resolution of at least 500 dpi

• Run on standard commercial power (120V and <= 20A)

• Include cleaning equipment to remove support material (e.g. water jets, dissolution bath, bead blasting cabinet, etc)

• Include starting material, operator’s manual, and required software (e.g. machine interface software, slicing)

• Include at least one day, preferably two days of user training

• Include a consumables subscription plan if consumables expire.

(QTY 1) Parametric Modeling Software Suggested Solution: SolidWorks

• Allow computed aided design of parametric parts

• Accommodate large assemblies

• Import other CAD package formats such as Creo/ProE, Catia, parasolids

• Be compatible with existing laboratory software

• Provide a floating /network node license

• Statement of Work February 17, 2015 Page 2

• Export to 3D printable formats

• Be able to create molds

• Be able to modify parts through tools such as warping and wrapping

• Have an established history of use in medical product design

• Contain design comparison tools (e.g. identify changes)

(QTY 1) Non-Parametric (NURBS) Software Package with Haptic Input Device Suggested Solution: Freeform Plus with Touch X (by Geomagic)

The software must:

• Use NURBS modeling techniques

• Import many file formats such as IGES, STP, SLDPRT, & STL

• Have a lineage of use in medicine and medical device R&D

• Provide tools to add and remove material in an “organic” fashion – ie: physical sculpting - to facilitate patient matching

• Be able to create inverse molds

• Integrate natively with a haptic force feedback system

The haptic hardware must:

• Provide at least 1.5 lb. of force feedback

• Have six degrees of freedom in movement

• Utilize stylus or other intuitive input

• Not require special eyewear or glasses

• Have low inherent inertia / resistance to movement

• Be useable in a desktop environment

• Must include at least one day of in-person training

(QTY 1) Digital Model Preparation Software Suggested Solution: Magics 19 (by Materialise)

• Intelligently and automatically repair errors in STL meshes with minimal user intervention.

• Create support structures with both automated algorithms and manual intervention

• Automatically pack the build platform

• Be able to divide parts to fit a build platform

• Automatically integrate assembly connectors (e.g. locking pins, tongue and grove, etc.) into parts that must be divided

• Allow adding and subtracting multiple STL files

• Have a history of being used with production additive manufacturing solutions in the medical devices or other industries.

• Offer a floating/node-based license

• Include one year of maintenance and 1 day of in-person training

(QTY 1) Onsite Installation/Configuration

• Set-up hardware/software to be fully functional at delivery location

• Quoter shall dispose of any and all trash, boxes, plastic, etc. present during/after installation

(QTY 1) Maintenance – Hardware

• Onsite Maintenance (1-2 Business Days after service request)

• Travel/Parts/Labor included

• Email Support

• Phone support -at least (10AM – 2 PM Eastern Time)

(QTY 1) Maintenance – Software

(QTY 1) Maintenance – Hardware (Option 1)

• Travel/Parts/Labor included

(QTY 1) Maintenance – Software (Option 1)

(QTY 1) Maintenance – Hardware (Option 2)

• Travel/Parts/Labor included

(QTY 1) Maintenance – Software (Option 2)

*All delivery costs will be included in the quote pricing.* *Standard Manufacturer Warranty shall be applied to all components*

3. Delivery & Point of Contact:

Delivery shall be made no later than 30 days after award to the following address:

Attn: TBD

FDA

10903 New Hampshire Ave Bldg 62 Silver Spring, MD 20903

**All contract questions and concerns shall be directed to the Contract Specialist as designated below:

Kyle Smith Contract Specialist – FDA – OAGS Kyle.smith@fda.hhs.gov

(240) 402-7553

4. Period of Performance:

Base: July 2015- July 2016 Option 1: July 2016- July 2017 Option 2: July 2017- July 2018

-Delivery shall be made no later than 30 days after award.

-Manufacturer’s warranty shall take effect beginning on date of installation

5. Inspection and Acceptance:

mailto:Kyle.smith@fda.hhs.gov

The COR or duly authorized representative shall perform inspection and acceptance of products. The performance criteria for these products shall be timely delivery and closure of all activities and requirements listed within Section 2 of this RFQ and within the established Period of Performance.

6. Security

It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that the contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the COR.

7. Invoicing Instructions

Two-Way Invoicing Instructions:

A. The Contractor shall submit all invoices to all addressees in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Attention: Kyle Smith 5630 Fishers Lane Room 2079 Rockville, MD 20857 Email: kyle.smith@fda.hhs.gov

(II) One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “Courtesy Copy Only.”

U.S. Food and Drug Administration Attn: TBD 10903 New Hampshire Ave Bldg 62 Silver Spring, MD 20903 Email: TBD@fda.hhs.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase order/award/number (IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

i. Period of performance for which costs are claimed;

ii. Itemized travel costs, including origin and destination;

iii. Any other supporting information necessary to clarify questionable expenditures;

mailto:kyle.smith@fda.hhs.gov

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer identification number (TIN);

(X) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award (XIII) Contractor __X__ is ____is not required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

i. List of all invoices submitted to date under the subject award, including the following:

1. invoice number, amount and date submitted

2. corresponding payment amount and date received

ii. total amount of all payments received to date under the subject contract or order

iii. for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

C. an electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA payment office at:

Office of Financial Services Food and Drug Administration

10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

8. Clauses:

The following clauses are applicable to this procurement:

52.217-8 Option to Extend Services (November 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months.

(End of Clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)] mailto:fdavendorpaymentsteam@fda.gov

(a) The Government may extend the term of this contract

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 3 years.

(End of clause)

52.252-2 Clauses Incorporated by Reference. (February 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The full text of a clause may be accessed electronically at this/these address(es):

Hhtp://www.acquisition.gov/far/ (End of clause)

52.211-6 Brand Name or Equal (Aug 1999)

52.232-99 Providing Accelerated Payment to Small Business Subcontractors (August 2012)

52.223-15 Energy Efficiency in Energy-Consuming Products (DEC 2007)

352.239-73 Electronic and Information Technology Accessibility (January 2010)

The following Section 508 Standards apply:

1194.24 Video and Multimedia products

1194.25 Self-contained, closed products

1194.31 Functional performance criteria

9. Instructions to Offerors:

9.1 Instructions

All selected vendors who can provide these items are strongly encouraged to submit a quote.

Quotes are due no later than 12:00 PM (Eastern Time) on June 12, 2015.

***PAT is required for the reviewing official to complete the technical evaluation of offers.

Please include this completed form as part of the submitted offer.***

The VPAT template can be found with the following link:

http://www.hhs.gov/web/508/contracting/technology/vpatinstructions.docx

9.2 Format

Offerors shall complete and submit the table below. Offerors may propose an alternative, provided that the proposed products satisfy all salient functional characteristics. Offerors who propose alternative products shall include manufacturer spec sheets for each product.

Part Description Brand Bulleted List of Salient Functional Unit Units Discounts Discounted Total

Number Name (Y/N)

Characteristics Listed in Solicitation and Narrative Description of How Proposed Product Satisfies Each Salient Functional Characteristics Notes: (1) Do not complete this column if proposing brand name product. (2) Attach manufacturer spec sheets for products proposed

Price Unit Price Price

9.3 Compatibility

FDA is purchasing this equipment on a “Brand Name or Equal” basis. In order to be considered an “equal” solution, any alternative solution proposed must be compatible with the equipment already possessed by FDA’s ORA. For the purposes of this RFQ, FDA defines compatible as meaning that there will be no communication, performance, maintainability issues in the interconnection of solutions with different configurations.

10 Evaluation

The Government shall award a contract resulting from this solicitation to the responsible offeror as a fixed-price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price (inclusive of options) meeting or exceeding the non-cost factor (technical conformance to the requirements of the solicitation). The Government intends to evaluate offers and award a contract without discussions. The offeror's initial offer should contain the offeror's best terms from a price standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the best interest of the Government; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

The following factors shall be used to evaluate offers:

1. Technical Features Meeting/Exceeding Salient Requirements (Brand Name or Equal)

2. Total Price (all CLINs shall be priced)

52.223-15 Energy Efficiency in Energy-Consuming Products (DEC 2007)