STATEMENT-OF-WORK-Broncoscope_needle_trackers_and_software.docx

Statement of Work Bronchoscope Lung Biopsy Trackers and Software

Statement of Work: Bronchoscope Lung Biopsy Trackers and Software development for the Center for Interventional Oncology 03/12/2019

TABLE OF CONTENTS

1.0 INTRODUCTION/OVERVIEW

The objective of this project is to develop virtual bronchoscopy (video-scope of the lung’s airways) system that is affordable and universally integrated to any bronchoscope. The proposed system includes a compact clip that attaches miniature-tracking sensors to the bronchoscope or ultrasound and software that identifies tumor targets, maps airways, tracks the bronchoscope, and provides virtual navigation during the procedure. Also required are tracker needles, stabilizers and tools to support compatibility with multiple bronchoscopes and ultrasound machines. This system is for use in preclinical trials with the future intention to assist with lung cancer diagnosis via a commercial route.

1.1 BACKGROUND

Lung cancer deaths represent 25% of all cancer deaths in the United States. The overall rate fortunately has been declining in part to widespread anti-smoking campaigns. Some lung cancers not linked to smoking, called metastases that is, spread from a primary tumor due to tumors of the adrenal glands, colon, breast or liver. These latter cancers require biopsy diagnosis to determine their origin and genetic makeup. Biopsy can be challenging due to the tumors location and lung collapse can occur as the biopsy needle traverses to its target.

The Clinical Center, Interventional Radiology Department and Center for Interventional Oncology in partnership with the National Cancer Institute and National Heart Lung and Blood Institute diagnose and treat these cancers. Defining novel ways to obtain biopsy through the lung airways for diagnosis confirmation is this proposal’s aim. Imaging proposed allows the operator to navigate to the area of interest from multiple positional sensors directed by pre-procedure mapped coordinates fused with bronchoscopy images during the biopsy.

This device and software are investigational tools for preclinical trials.

1.2 SCOPE

Requirements for the incumbent include development of a tracking clip and software.

1.3 OBJECTIVES

1. Develop prototypes for preclinical studies for diagnosing solid tumors in the lung using the airways rather than percutaneous (through skin, and lung).

· prototype bronchoscope trackers QTY 20

· prototype needle stabilizers QTY 20

· prototype ultrasound camera-based trackers QTY 20

· prototype universal needle trackers for multiple-propose procedures QTY 20

· prototype universal tracking beacons for multiple-propose tracking QTY 20

· prototype ultrasound calibration kits QTY 20

2. A software prototype that will:

· segment the tumor and;

· facilitate airway path planning,

· display the predicted endoscope path in relation to the target, and;

· fuse at time of biopsy-bronchoscopy images with the pre-procedure developed virtual bronchoscopy map.

2.0 REQUIREMENTS

2.1 TASKS:

12 Month Period of Performance 12 Month deadline 3 and 6 month Progress report

2.2 DELIVERABLES

Expected 12 months following award:

Data on prototype testing and any user information should accompany the prototypes. Dr. Brad Wood or his designee will evaluate all prototypes and approve them. At time of first testing, the Vendor will be on site.

2.3 SCHEDULE

Period of performance: 12 months request a warranty for repair or replacement of any component originally developed or installed by the vendor for 12 months after the system is delivered.

Place of performance: vendors lab and NIH Clinical Center 1N314 preclinical lab Milestones: Develop prototypes as described above

2.4 ASSUMPTIONS

• Effort: Development of these prototypes requires expert level understanding of imaging techniques for biopsy. Must have experience developing and manufacturing prototype for preclinical applications. This may include using 3-D printing. Must have experience with computer software development and a knowledge of navigation software commercially available.

• Schedule: 12-month schedule, with progress reports at 3 and 6 months. On site evaluation of prototypes

• Resources: A PhD in computer engineering and an assistant.

• Budget: The estimated cost of the project $ 50,000 Table 1 Tasks, resources estimated to complete SOW

Manufacturing Costs

Materials

3.0 GOVERNMENT FURNISHED PROPERTY

The vendor for this project will not receive Government owned property.

4.0 SECURITY REQUIREMENTS

The contactor staff must follow all security rules and regulations to gain access to the NIH campus including but not limited to:

1) Required to show one (1) form of identification (a government-issued photo ID-driver's license, passport, green card, etc.) and to state the purpose of their visit

2) Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives with blades over 2½ inches, alcoholic beverages and open containers of alcohol.

3) Vendor owned or rented vehicle must go through the Gateway Vehicle Inspection Station (Building 66A), and the vendor must obtain a visitor badge

4) Vendor must contact a Wood Lab staff member for access to the IRL

Award

Hardware: prototypes delivered Software delivered