Contributed by Erin McKenna, Deputy Director of B-BIC & Paul Tessier, B-BIC Coach
Once you understand the unmet clinical need your technology can address and have connected that need with a solid business opportunity, the next thing to be considered is to understand the development path for the product you want to create. Outlining the potential path (or likely paths) forward is a necessary step for attracting funding, whether it be through grants or investors. Anyone interested in contributing resources towards developing your concept into a product will want to understand two general things. The first is understanding the resource requirements for developing your product and bringing it to the market. Second is outlining the critical steps along the way where you can gauge that you have reduced the most significant risks and that the development work will lead to a successful product. Those points are typically referred to as inflection points or milestones, and grant reviewers and savvy investors will want to know what they are and agree that they are the correct ones before they invest in developing your technology.
In many cases, inflection points can be true for several different types of technologies. Some common ones include:
- Technology development milestones including lead compound identification, or functional prototype development
- Pre-clinical testing milestones such as pharmacokinetics study completion, toxicity studies, or completion of efficacy studies in animals (where that is possible)
- Intellectual property milestones such as obtaining a license to patents and/or filing your patents
- Clinical milestones such as approval of an Investigational New Drug (IND) or Investigational Device Exemption (IDE), and the completion of key clinical studies such as Phase 1, 2, and 3 studies for pharmaceuticals and biologics or safety and pivotal studies for devices
- Regulatory milestones such as submission or acceptance of a pre-market submission, for instance, a New Drug Application (NDA) for pharmaceuticals and biologics or Pre-Market Approval (PMA) or 510k clearance for devices
- Making the product available commercially for use, often referred to as the product launch
However, assembling a plan for developing your technology must be customized to fit the needs of the product you want to develop. So, in addition to carefully understanding which of the above milestones are the most important for your product, you also need to determine where the biggest risks are for failure along the development pathway. Potential funders will be assessing risks in a range of areas, including technology, regulatory, market/business, and clinical. You can learn what the biggest risks are by gathering input from clinical users and from experts in the technology, in the market space your product will enter, in regulatory and reimbursement strategy, in market analysis, and from potential investors. The key to having productive discussions that will help you identify the most impactful inflection points will be to ask questions about the ways the development of your product could fail, and which of those ways has the highest likelihood of occurring. These things will lead you to understand the work you will need to do to convince others, especially investors, that the product you are asking for support in developing can succeed.
Your development plan should be broken down into phases, each phase having milestones that further reduce risks. Potential funders will want to know what their investment will be used to accomplish and how accomplishing those goals will create the next inflection point allowing you to obtain the next round of funding. The goal is to create inflection points that show both significant risk reduction and progress toward commercialization. Balancing these can sometimes be challenging. For example, you may hear a concern from potential clinical users or investors that may not be directly connected to the most critical studies needed to gain regulatory approval. To obtain the necessary support from funders, you may need to consider front-loading plans for completing the work required to address their concerns. At B-BIC, we typically work with teams to make sure they understand how potential funders think and use that input to build plans designed to address their most significant concerns as quickly as possible.