Is Your Roadmap Complete?
Even in the midst of a pandemic, the medtech industry needs to remain focused on bringing innovative technologies to market – improving patient health and access to care. We strongly encourage companies to prioritize strategic roadmap planning in order to avoid delaying commercialization and revenue.
Developing a clearly defined roadmap can give you – and your stakeholders – clarity and confidence in the steps you will take to maximize revenue and rapidly increase your technology’s adoption.
A comprehensive roadmap can help you develop a robust and clear understanding of:
- Traditional and non-traditional revenue opportunities across multiple markets.
- Available coding options for reimbursement of your technology.
- Critical near-term activities versus short-term activities.
- The requirements for success, including estimated evidence generation.
- A plan for meeting all requirements, including protocol synopses for clinical studies necessary for success
- Supportive activities needed (e.g. HE models) and societal/foundation support
An effective market access roadmap is vital to minimizing your time to market and maximizing your ROI and revenue, while an incomplete roadmap will stunt your market access growth – during the pandemic and for the life of your product. Take time now to ensure yours is robust.
Case Study: Clinical Evidence Generation Strategy and Implementation & Revenue Generation Roadmap Development
A start-up software-as-a-service (SaaS) provider needed clinical data to support its FDA application and early evidence of clinical utility in multiple respiratory indications to support market access. Additionally, the client required an understanding of all possible revenue-generating strategies for their entire suite of services, inclusive of pre-clinical animal scanners and pre-clinical SaaS products.
To meet FDA and market access data requirements, we designed and implemented a 3-phased clinical evidence generation program to: 1) Establish “proof of concept”; 2) Demonstrate performance “as good as” current pulmonary function tests (PFTs); and 3) Establish the technology as “better than” current PFTs for managing patients with severe respiratory disease.