Creating a Technical and Business Assistance request

Developing a clear story of what your company needs in written format, steps 1,2, and 3, can be a new activity for some entrepreneurs. SEED's Scope of Work consultation brings together business and product development experts from NIH to help CEOs define and communicate their business needs in a templated solicitation document.

Step 1 – Identify your need

Identify a business need which is eligible for TABA funding. If you have (or had) a Phase I Small Business award from NIH you may request a Needs Assessment Report.  Areas of emergent focus for your business or technology identified in these reports are generally an excellent use of TABA Funding. 

Alternatively, your leadership team may be experienced and able to self-identify a need aligned with use of TABA funds.  

Step 2 – Define your deliverables 

Use this approach to maximize the value of your vendor engagement:

• Clearly articulate your need to potential vendors. Pay close attention to the required outputs, what information do you need, without (initial) regard for the budget.  
• Categorize deliverables as “needed” and “nice-to-have” 

Step 3 - Draft a clear Statement of Work (SOW)

 A clear SOW for a project includes:

• Background and Introduction - What is important about your product or service?
• Company Overview - Why did you start your company; what is your passion? 
• Context of Service Request - How will this work contribute to your company’s vision and mission?
• Requested Deliverables (Step 2) and Reporting Requirements - including a timeline to complete the work
• Existing Project Information - include the data you already have (avoid duplication!) and the gaps in data you are looking to fill.  
• Required Vendor Qualifications - What evidence should they provide to demonstrate their fit for the project? 

See below for NIH-developed sample Scope Of Work documents describing potential Technical and Business Assistance requests for vendors in the areas of intellectual property, market analysis, regulatory, and reimbursement planning.

Reimbursement Sample SOW
Intellectual Property Sample SOW
Market Analysis Sample SOW
IND Regulatory Services Sample SOW
Pre-IND Regulatory Services Sample SOW 

Step 3 – Identify potential vendors and evaluate proposals 

Applicants are required to include a proposed vendor (or vendors) and a budget in their application.Not all vendors are equal.  Some will have extensive experience in a field unrelated to your product/service, others will have experience that is relevant but very dated.  Maybe your product/service is very niche, or maybe it targets an atypical population.  You want to know how your potential vendors will address the unique aspects of your company and its product(s). Tell them  When identifying and requesting a quote from a vendor, consider the following criteria:

• Subject Matter Expertise: does the vendor have the appropriate expertise to perform the work you require?
• Past Performance: can/will the vendor provide references from current or former clients about the quality of their work and their customer service approach?
• Value: how much work will you get for the $6,500 or $50,000 you are requesting in TABA funding?  When you engage your own vendor you have the flexibility to supplement TABA funding with other sources of funding, for example, your fee, external investor funds, or prizes from business competitions.  What are the minimum and the maximum costs you can support for the service(s) you are seeking?

Be clear about what you expect the vendor to do and when. Vendors know their capabilities.  Some will say you are asking for too much or too fast.  Recognize that you may modify the Deliverables after talking with potential vendors. For vendors to create a proposal, it is important for them to know what information you already have related to the requested service you are asking them to complete.  This is an important topic to cover when talking with a vendor before they submit a proposal.  

Identifying vendors who are willing to develop a proposal within the limits of the TABA funding may be challenging.  Talking to local incubators, state economic development agencies, other small business CEOs in your network, and your board members can be effective approaches to finding vendor options.   

Step 4 – Review proposals and select a vendor

Once you have identified several vendors from whom you will request proposals, you should meet with them to refine their understanding of your need and of the information you already have (if any) about the work to be performed.  Most companies will not sign a non-disclosure agreement during the proposal development process, so keep these conversations specific enough to get a good response, yet general enough that you are not revealing information you would not want made public.  Pre-proposal calls are highly encouraged, however, at times, a series of email exchanges may be sufficient.  Once you have received proposals, you will need to compare their responses and evaluate which proposal you want to pursue to a contract. Some common items to consider include:

• Cost – This is always important however should not be the only evaluation factor.  Sometimes the lowest cost proposal is low for a good reason.  Ideally payment to the vendor will be milestone driven, where you are only responsible for the cost of work you deem acceptable.  Including acceptance criteria in your final contract will be important with this approach.
• Approach – Does the vendors approach align with your company philosophy? Do they appear to have all the relevant tools (databases, programs, processes) to accomplish the goals of your service request.
• Experience of the service team – Some vendors are one person consultancies, and some are multi-national organizations.  Regardless of the size of the service provider you will want to ensure the experience of all members of your support team are appropriate for the work you are requesting.  You can request copies of resumes, or a short description of similar work performed by each team member (at least for key personnel).
• Timeline – Do you have a drop-dead date for needing your deliverables? Will your next round of fundraising require the market or pricing analysis you are requesting? Do you need FDA feedback to inform the contract requirements for your IND-enabling studies? How long will each milestone take to complete and what happens if there are delays?  For example, during the COVID public health emergency, several groups within FDA declined or delayed meeting requests due to extremely heavy workloads. Once a contract is signed it can be hard to modify deliverables or timelines so if interacting with an external party is a required part of your request (the FDA, or USPTO for example), you may want to build in a time range for your deliverables.

NIH SEED has developed white papers to help you understand how to evaluate vendor responses.  To find the resource most relevant to your TABA funded activity, please review the resources posted at the bottom of 

https://seed.nih.gov/support-for-small-businesses/commercialization-enhancement-programs/entrepreneurial-development/scope-of-work-consultation 

Step 5 – Describe your proposed use of funds in a TABA funding request

NIH has provided examples of how a TABA funding justification statement could be developed following the grant application instructions. These sample TABA funding justification statements are provided for educational purposes to assist applicants with developing justification statement but are not intended to be used as templates and their use does not guarantee approval by NIH.

• Fake Hats Co. is requesting $50,000 in TABA funding to support the engagement of The Best Regulatory Consultancy to assist in the preparation for, conduct of, and debriefing from a pre-IND meeting with the US FDA.  We provide as an attachment a letter of interest from The Best Regulatory Consultancy indicating their ability and intent to provide this service for this amount. 
• Blue Eye Blind is requesting $48,750 in TABA funding to support the development of a reimbursement strategy as we launch our neural implant/contact lens system.  We will engage the consulting firm of Payor Professionals to develop a pricing strategy, structure our reimbursement dossier, and connect us with a minimum of three major insurers.  We have included a Letter of Intent indicating their ability to provide these deliverables for this price.
• Plum Surgical is requesting $49,750 in TABA funding to engage the market research firm Market Monitoring Maniacs (M3) to conduct customer discovery interviews with a minimum of 10 wound healing experts and identify and connect the company with a minimum of 5 influencers in the wound healing space who will help drive early adoption of our PostOp DxTM technology.  M3 has provided the attached Letter of Intent confirming their ability to provide these services for this price.