Co-authored by Erin McKenna, B-BIC Deputy Director & Ron Blackman, B-BIC Sr. Project Manager.
When considering a development path needed to move technology to the clinic and beyond, it’s essential to address two questions: Who will support the development of your technology, and what will they want to see to believe it can be commercialized?
Who Will Support The Development of Your Technology?
The initial target audience for finding support is the potential investors. This group includes government funders (for example B-BIC, SBIR, DoD or NIH), institutional grants, licensees, venture capital, angel investors and friends/ family; anyone who would be willing to provide funds for developing the product. Potential investors may or may not include potential users of the product, such as clinicians or patients, but any product concepts you are presenting for investors will need to focus on addressing user needs and identifying key design elements their products require, as described earlier in our Specialist Series.
At first, the de-risking bar will be set low (for example: providing proof of concept in animal studies, building a prototype device, or identifying a lead candidate therapeutic), but will rise quickly as development progresses (several millions of dollars will be needed to get the product to the clinic). For an early stage therapeutic or device, the target audience / de-risking needs can and will change as the product development continues downstream.
What will they want to see to believe it can be commercialized?
At a high level your supporters want to see a combination of data that shows the potential of your technology to address a clear unmet need, along with a picture of how the technology will be developed into a product and the resources necessary to make that possible. Each technology presents challenges, so in addition to understanding the big picture of what is needed your supporters will also have concerns that are specific to the product you intend to develop. You can learn about these concerns by asking potential investors and users what they would need to see to believe in your product concept. Answers to that question will likely require the completion of technical work, but may also require addressing other vital questions about how the product will be commercialized that are not technical and have been discussed in the other articles in our series. Completing the work to address these questions is often referred to as an “inflection point,” where teams can trigger additional investment from supporters.
In parallel to gathering input from potential investors, imagining your future product will also help clarify your project goals and increase confidence that your product can be commercialized. For drug candidates, teams can create a target product profile or TPP (see Developing a Target Product Profile). Medical device product concepts capture user needs and critical design elements required to address them, referred to as Design & Development Inputs or DDIs. DDIs include a range of features which end up being captured in several separate documents (see Project Management for Medical Device Development).
Once the project goal is more explicit, it is essential to identify milestones for measuring progress and supporting go-no-go decision points along the development path. These will allow you to monitor that progress is being made, as well as encourage assessment at pre-defined milestones to assure that it is on track for success. Creating benchmarks that are meaningful and based on quantifiable metrics is critical, as they will drive decisions that determine whether the work should continue according to the current project plan or if they should change course. Key milestones should also be aligned with the inflection points described earlier, to ensure you are focused on addressing the concerns of your supporters while also enabling additional resources.
Once you have identified your milestones alongside your decision points, the focus shifts towards understanding the work and resources necessary to accomplish your goals. Estimating the amount of time needed to complete work towards each milestone should include elements that your team can directly control (examples: experiment time, data analysis) along with those that are out of your control (examples: equipment scheduling variances, production yield variabilities). Work that is dependent on the completion of other work can impact the time needed to complete a project, and teams should evaluate how dependencies may affect the project timeline before it is finalized. Understanding best and worst case scenarios for achieving work will help increase confidence that the project plan is realistic.
For an academic, building an experimental plan is one of the most familiar parts of preparing a typical grant proposal. However, in developing a business plan, the project plan is typically more goal-oriented, and achievement is measured by meeting prescribed milestones. When applying for early-stage development funding, proposals will request an overview and justification for each benchmark in the project plan, along with the work that will be required to achieve success. Thus, to convince your supporters to invest it is critical to lay out a project plan that prioritizes milestones from a business planning perspective and ensures they are aligned with addressing the most significant areas of risk.