Business case development

What is the business case?

The business case is a justification for a proposed project or undertaking on the basis of its expected commercial benefit. Unlike classic research where you explore a problem to gain further understanding in product development you are expected to explain what you will make (output) and why, how this will modify a situation (outcome) and how this outcome will be beneficial for the stakeholders (realisation of benefits). These items are heavily intertwined so you will need to explain the causal link between output, outcome and realisation of benefits, the mistake is to assume the NHS or private healthcare company will want your product. The reality is that they want the realisation of benefits and that yours or other similar products will suffice depending on their own situation and a cost-benefit analysis.

The business case can take on various forms from an informal elevator pitch or a blisteringly complex commissioned report. Your best place to start is to begin answering some simple questions we pose below (Problem, Opportunity and Solution). Building on this, describe how you intend to develop, test, commercialise and eventually get adoption of your product in the market (Who, How, What, Where, When and Why). The business case looks at the overall picture of product development and the grant you apply for will be for funds that develop a sensible section of the overall development.

Is it necessary?

The bottom line: YES.

Both DPFS and i4i review panels contain a significant number of industry leads from a variety of backgrounds, they will test the soundness of your idea, feasibility, and commercialisation strategy during review. The NIHR i4i panel during interview will target your commercialisation/route to market strategy.
A sound strategy improves the likelihood that your product will reach its intended audience.
It is not expected that you develop your business case on your own (we recommend you don't!), the best course of action is to get help from experts whom are used to working with clinicians and academics and understand the challenges.

Who can help me?

See our list of business managers on the collaborator page. Make contact, give an overview of your project and plan a meeting.

To get the most out of your discussions with your business manager, prepare your answers in advance and discuss any past papers, abstracts, conference posters which contained relevant information

Do I need to have a complete business case in place before I apply for funding?

NO.

Many aspects of a business case are informed as the product is developed during the grant. Knowing that you need more information, a better prototype, more clinical data, large scale manufacturing process etc. so that you can inform the business plan is a legitimate project activity you can claim funds for.
Watch-Point: The more unknowns, the higher the risk that the product will not be successful during development. Planning for an NIHR i4i or MRC DPFS project may highlight your need to target bridging grant funding first (such as the MRC Confidence in Concept ).

Simple STEPS

Problem, Opportunity and Solution:

Problem: Why is this an important issue. "Why should people care?" ,"Is this an unmet need or a poorly serviced need?"

Opportunity: What unique property or process does your problem contain that could be exploited to provide a solution? "Why should anyone be interested in your product?", "If there are loads of products already on the market, what makes yours unique?"

Solution: What is it about your product that exploits the Opportunity and addresses the Problem above. "What that makes it attractive?" "Will it save money, improve peoples lives or create new commercial opportunities?", "What will compel customers and businesses to buy your product over existing or new and emerging technologies?"

Watch-Point: Re-purposing generic drugs can prove challenging as they are neither new, will make anyone money and could cost the NHS more money than currently available interventions. In this situation it would be good to highlight that the generic status improves the speed of the route to market compared to new treatments, will cost significantly less than a new drug and that the re-purposed drug is non-inferior to any existing therapies.

Who, How, What, Where, When and Why

Who: This is three-fold: the team, the competitor and the target population. Approaching potential project partners early on will allow you to get to know each other's strengths, gauge the commitment your partners are willing to make, and ultimately help you decide whether you have the best team on board. Knowing your competitor will ensure your hard work is not done in vain: who else is working in the same area, do you have Freedom To Operate (FTO)? Last but not least: who will benefit from your product? Involving stakeholders such as lay members of the public, patients or carers (PPI - Public & Patient Involvement) and healthcare professionals as co-Is ensures user/consumer representation on the application, a hot topic particularly with the NIHR!

How: Bringing a commercial partner on board at an early stage could facilitate your route to market later and may de-risk your project. Ideally, your commercial partner should be able to help you navigate the regulatory landscape

What: Outline clearly the unmet need and reassure reviewers that your product is a need to have rather than a nice to have. There are several types of innovation (Incremental, Disruptive, Architectural, Radical; see diagram below) and funders are unlikely to fund incremental innovation. By clearly demonstrating your Unique Selling Point (USP - what makes product stand out from others) and your Target Product Profile (TPP - the features of the intended commercial therapeutic product) it will help the panel assess your application

Where:

When:

Why: You may not have considered the importance of building a business case for your research project but in essence it demonstrates that you have considered all the requirements needed for your project to give it the highest chance of success. Together with your business manager, we can advice on how to build your business case. You may not have considered the importance of building a business case for your research project but in essence it demonstrates that you have considered all the requirements needed for your project to give it the highest chance of success. Together with your business manager, we can advice on how to build your business case

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