Outline – Part II

• Requirements and Qualifications

• Phase I Components

• Subcontractors

• Phase II Overview

• Tips and Resources

SBIR Requirements

• Small U.S. Businesses– U.S. owned & controlled (>51%)– <500 employees– PI works for company– Subcontractors

• Universities, Federal Labs… • Up to 1/3 budget in Phase I• Up to 1/2 budget in Phase II

• Almost All AT Companies

Ownership ChangeSABIR Act 2005

http://www.theorator.com/bills109/hr2943.html

• Principal Investigator– Work for small business (SB) OR non-profit research institution

(RI)– Minimum 10% time & effort

• SB & RI Requirements– Formal agreement between SBC and RI– Research Institution at least 30% of budget– Small Business at least 40% of budget

• Subcontractors– Other Small Businesses, Federal Lab…– Up to 30%

STTR Requirements

Other Considerations

• Expertise – Research, Design, Fabrication, Development, Testing, Market

Research, Clinical Trials, Analysis..– Administrative, Contractual, Legal, …

• Infrastructure– Office, Shop, Lab, Equipment, Software…

• Grantsmanship

• Opportunity Cost – 100 to 200 hours– $10,000 to $20,000 @ $100 / hr

Sub-Contractors

• Why Bother?– Save Time & Money– Fill Gaps in Expertise– Fill Gaps in Infrastructure– Access To Consumers

• Elders, People w Disabilities, Clinicians…

– Cultivate Path to Market • OEM, Suppliers, Marketing & Distribution, Licensee

• Write the Proposal!

Market Research in SBIR/STTR

• Best Practice: Customer Centered Design

• 37% of AT companies NEVER used consumers in product design (DOC, 2003)

• Applications– Design Requirements– Prototype Validation– Price Point– Purchase Intent

Phase I Proposal

• Registration• Significance• Background• Research• Work Plan• Sub-Contractors• Letters of Participation• Other Stuff

Phase I is the Gateway to Phase II and the Presentation Focus

Generally, we won’t focus on the STTR Program but

similar considerations apply.

• Small Business Must Obtain:– DUNS number– Entity Identification Number (EIN)

• Register EARLY: – Grants.gov (Ed, NIH, etc.)– Fastlane (NSF)

Registration

Significance

• Market – Description, Demographics, Trends, Drivers, Legislation,

Reimbursement, Competition

• UNMET NEEDS – Description, Impact, Importance

• Agency Mission, Long Range Plan– Relevance to Your Proposal

• Opportunity– Why Your Company Is Interested

Significance (Market/Needs)

• Trade Publications• Academic Journals• Online Databases• Legislation• Agency Websites (mission, long range plan)• Advocacy Organizations• Market Research (public, free)• Market Research (private, contracted)

– Contracted ($): e.g. Forrester Research

• Demographics– US Census Bureau – Disability Statistics Center

• Product Information– Abledata– US Patent and Trademark Office

Significance (Market)

Significance (Legislation)

• Section 504 of the Rehabilitation Act• Section 508 of the Rehabilitation Act• Americans with Disabilities Act• Section 255 of the Telecommunications Act• Hearing Aid Compatibility Act• Goals 2000: Educate America Act• New Freedom Initiative• Olmstead Decision & Executive Order• Individuals with Disabilities Education Improvement Act

– National Instructional Materials Accessibility Standards• No Child Left Behind Act• Assistive Technologies Act

Significance (Legislation)

• National Conference of State Legislatures

• National Collaborative on Workforce and Disability

Background

• State of the Art – Research (Yours and Others)– Products and Technology (Yours and Others)

• GAPS – In Products and Technology– Failure to Address UNMET NEEDS

• History of Accomplishment– Company’s Ability to Carry Out Research– Prior Research, Research Infrastructure, Expertise,

Successful Product Development, Publications

Research (Overview)

• What will be Done– General Description– GAP (s) to be Addressed– Innovation

• Novelty• Challenge

– Expected Result (s)• “Consumer Validated Prototype”• “Bench Tested Prototype”

Research (Objectives)

• OBJECTIVES (1,2,3…)– Detailed Description (s)– Relate to GAP (s) being filled– Specific Challenge (s)– How Challenge (s) will be Overcome– Method (s)– Evaluation (s) (Progress, Successful Completion)

• Subcontractors– Specific Role (s)

Research (Scope)

• Phase I– Limited time and budget– Proof-of-concept prototype– Bench testing, validation with focus groups…– Small or large scale clinical trials…

• Phase II– Still limited time and budget– Pre-commercial prototype– Bench testing, validation with focus groups…– Small scale clinical trials…

Yes!

No!

Yes!

Maybe?

“Reasonable Rigor” given the research objectives; and time and budgetary constraints...

Work Plan

• TASKS (related to OBJECTIVES)– What (1 or 2 Sentences, Details under Objectives)– Who (Lead, Staff)– How Much (% FTE lead, % FTE staff)– When (Start date, Stop date)– Where (Location, Facilities, Tools)– Subcontractors

• Who, How Much, When, Where…

• 1 TASK to 1 OBJECTIVE (Ideal)

• Bar Charts, Timelines

SBIR Outlines

• Education Solicitation (January 2007)

• NSF Solicitation (December 2006)

University Subcontractors

• Faculty consultants, research facilities, graduate students…

• Patent and Trademark Act (Bayh-Dole) of 1982

• University Owns New Intellectual Property– From Faculty, Staff, Graduate Students– During Work Hours, On Property, Using Equipment…

• Each University Establishes Policy for Working with Private Sector (or Not!)

University Subcontractors

• Technology Transfer Office– Manages intellectual property

• Market research, technology disclosures, patent applications, brokering, licensing, trains faculty…

– Implements university policy

• Avoiding Intellectual Property Issues– Negotiate ownership and licensing terms “up front. Often

“Challenging…!”

– Bring intellectual property to the university for refinement, fabrication, testing, trials… No NEW intellectual property! Generally a much better approach.

Work with University Tech Transfer Office

Up Front!!

Federal Lab Subcontractors

• Scientist consultants, research facilities, fabrication, production…

• Technology Innovation Act (Stevenson-Wydler) of 1982

• Agency Mission

• Transfer Mechanisms– Material Transfer Agreement– License Agreement– Cooperative Research and Development Agreements

Federal Lab Subcontractors

• Federal Laboratory Consortium– ~700 federal labs (maybe 250 BIG labs)– 6 regions (NE, MA, SE, MW, SW, FW)

• Federal Laboratory Locator Service– Match small business to laboratory capabilities and

expertise

Work with FLC Locator Service (s) First!!

Letters of Participation

• From Subcontractors, Consultants – For Completion Of R&D Tasks

• From (Potential) Commercialization Partners– To Support Business Opportunity (Path To Market)

• From Market Experts (E.g. Advocacy Groups)– To Support Market Need

Other Stuff

• Prior and Current Funding• Application to Other Agencies

• Key Staff Bio-Sketch • Key Staff CV / Resume (Appendix)

• Subcontractor Descriptions• Subcontractor Letter of Participation (Appendix)

Phase I Final Report

• Plan for Final Report from Day 1!

• Due Within 3 Months of Phase I Completion– Format Provided by Funding Agency Prior to Completing Phase I

• Progress on Each Objective/Task– How Progress Was EVALUATED– Percent Completion for Each Objective/Task– Problems Encountered– How Problems Were Overcome– Budget Report

• Agency-Specific Questions

Phase II Components

• Identification of Problem• Phase I Results • Technical Objectives and Work Plan• Commercialization Plan and History

– Outcomes and Impact– Company information– Finance and Production Plans

• Key Personnel and Available Resources

Phase II Components

• Products and services that will utilize your technology

• Customers and market size

• Money needed after Phase II to bring product to market– Source of these funds

• Competition

• Barriers to market entry and how these barriers will be overcome

Commercialization Plan

Budget

• Total budget = Direct costs + Indirect costs + Fee/Profit

• Indirect costs – “Negotiated Rate” preferred by some agencies,

although not required if rate is within guidelines– E.g. NIH requires a negotiated rate for indirect costs

exceeding 25% of total direct costs

• Fee/Profit- 7% of total budget is generally accepted

Tips

• Follow Solicitation Outline– Section Headings, Sections Contents...

• Follow Solicitation Instructions– Fonts, Referencing, Page Limits, Line Spacing, Margins…

• Eliminate Redundancy!

• Easy to Read– Short, Clear Sentences, Limit Jargon, Clearly Explain

Necessary Jargon, Proper Grammar, Spelling

• Check for Sample Awards

Tips

• Use the Program Manager– Send Proposal Abstract, Follow Up Call– Right Agency or Institute, Likely Interest in Proposal

• Don’t Propose Too Much– Technically Feasible, Enough Time, Enough Money– Key Staff MUST Have Enough Time on Project

• Do Your Homework!!!– Current Research, Competing Products– Cite these References in Your Proposal!

Tips

• Human Subjects (Especially People with Disabilities)– Privacy, Waivers, Fees, Transportation, Food, Accessibility– Reflect Costs in Budget

• Budgetary Instructions– Stay Within Budget!– Fees/Profit, Indirect Rate, Subcontractor Limits, Travel…

• Past Awards (Online Databases)– Abstracts, Types of Research Funded

• Tables, Graphs, Drawings – You May Be Asked for Alt-Text (blind reviewers)

Tips

• Break up the Proposal!– E.g. Hardware Development +– Software Development +– Accessory Development +– Training Materials Development +…

• Build Off of Prior Work– Much of an SBIR Proposal can be strengthened and

reused… – Its not “luck” that one small business won 18 Phase I

and 9 Phase II SBIR awards from DoED…

SBIR Solicitations

• Small Business Administration – Overview of SBIR, STTR Program

• SBIR Gateway – Upcoming Solicitations

• National Institutes of Health Apr Aug Dec

• National Science Foundation Jun Dec

• Education Jan

• Transportation May

• Agriculture Sept

Past Awards

• Small Business Administration• TECHNET (Database 1983+)

• Awards, Abstracts National Institutes of Health• CRISP (Database 1983+)• SILK (Text Files 1996+)

• National Science Foundation• AWARDS SEARCH (Database 1983+)

• Education• AWARDS HISTORY (Database 1983-2000) • AWARDS (Text 2001+)

• Agriculture; Topic 8.6 Rural and Community Development• AWARDS (Text 2002+)

• Transportation• VOLPE LIBRARY (Text 1999+)

Online Market Data

• U.S. Census Bureau (All)• T2RERC Industry Profiles (Vision, Education)• MarkeTrak (Hearing)• Disability Statistics Center (All)• National Organization on Disability (All)• Online Resource for Disability Statistics (All)• National Center on Education Statistics (Education)• DisabilityInfo.gov (All)• Microsoft Accessibility Part I, Part II (Trans-generational)• NSF Science and Engineering (Disability Statistics in)

Online Advocacy

• United Cerebral Palsy Association• The Alzheimer’s Association• National Federation of the Blind • Learning Disabilities Association of America• National Association of the Deaf• American Council of the Blind• World Institute on Disability• American Foundation for the Blind• Self Help for Hard of Hearing People

Legislation & Funding

• Industry Profile on Education Technology– Legislation, Funding related to Learning Disabilities

• Industry Profile on Visual Technology– Legislation, Funding related to Low Vision & Blindness

• Special Interest Group on Technology Transfer– Brief Descriptions, Links to Disability Legislation

• RESNA– Government Affairs Committee, Policy White Papers

• Department of Justice – Guide to Disability Rights Laws

• Americans with Disabilities Act Home Page– Many Useful Links

SectionAssessment of Needs

Legislation

Funding Sources

Appendix A. Manufacturers

Appendix B. Sources of Financial Aid for Eye Care

Appendix C. State and Provincial Services

Appendix D. Conferences and Tradeshows

Appendix E. Associations

Appendix F. Publications

References

SectionAcknowledgment

Introduction

Executive Summary

Anatomy and Physiology of the Eye

Vision Assessment

Eye Care Professionals

Visual Impairments, Causes and Treatments

Major Causes of Adult Blindness

Major Causes of Childhood Blindness

Demographics

Market Growth

Technologies

Industry Profiles (Visual Impairment)

Other Resources

• SBA SBIR Handbook

• NIH Grant Writing Tips Sheets• NIH Grant Application Guidelines

• NSF Grant Proposal Guide

• Agriculture SBIR Example Awards

T2RERC

• National Center, NIDRR Funded• 1 of about 20 RERC• 4 research projects

– Public Policy Project– Market Research Project– Efficacy Project

• 4 development (transfer projects)– Fortune 500 Project– Supply Push Project– Demand Pull Project

No cost for work that falls under a T2RERC project

• Fee-for-Service

• Solicitation Consultation• Secondary Market Research

– Demographics, Competition, Legislation and Funding…

• Primary Market Research– Focus Group, Panels, Surveys – Design Requirements, Prototype Validation, Price Point,

Purchase Intent…

• Grant Writing and Editing• AZtech Home

AZtech Services

General resource, also work that doesn’t fall under a

T2RERC project

Questions?

Thank You!

• Steve Bauer– smbauer@buffalo.edu– 716-829-3141 x117

• Jen Flagg– jlflagg@buffalo.edu– 716-829-3141 x144