Written by Erin McKenna, B-BIC Deputy Director
There are multiple frameworks out there that outline the process for developing promising biomedical research into a range of innovative solutions – pharmaceuticals, biologics, medical devices, and diagnostics. Many of these processes leverage concepts that come from regulations developed by the FDA, the European Commission and others to evaluate the readiness of these technologies for clinical use or commercialization. Stanford Biodesign’s Innovation Process focuses on first ensuring that there is a thorough understanding of unmet health needs, which is a concept also described in the FDA design control guidance for medical device development. Once enough information has been gathered to clarify the unmet needs, you can then identify potential solutions that could address them and develop and refine these concepts with input from a range of stakeholders, including clinicians and patients (broadly referred to as “users”) along with providers (such as hospitals and clinics) and payers (including, public and private insurance) to ensure that these solutions address the unmet needs. From there you move on to evaluating other aspects such as market size, the range of potential indications and the likely regulatory path, the intellectual property landscape, competition, and the payment systems or reimbursement landscape. This broad space is evaluated in addition to building a plan for developing the core technology and is pulled together into a comprehensive business strategy that lays out the path and identifies the necessary resources to commercialize the solution.
In our last series we addressed all of the elements within a business plan for developing biotech and medtech products, which also mirrors what we request in our proposal. However, while we ask applicants to outline a path to commercialization that may seem straightforward, we recognize that they also need to be ready to pivot their ideas as they make the transition from research to development. All business plans are built on assumptions, and while you strive to ensure those assumptions are as solid as possible they are almost never absolute. The road to commercialization may be clear, but it is never linear.
Therefore, we have decided to introduce a new series, The Road to Commercialization: Challenges and Opportunities, on areas where our experts have observed the path is not as simple as it may appear from a distance. Each article will focus on an area within the idealized product development process and explore the ways that teams developing solutions encounter issues while sharing insight on how to move beyond them. We hope that this new series will complement our first series and serve as a valuable tool for helping innovators realize success.