Commercializing medical devices and precision medicine technology is not a straightforward process, and with the ever-changing regulatory & reimbursement landscapes as well as evolving policies surrounding precision medicine & AI, the path to reimbursement and adoption is becoming even more difficult to navigate.
Know Your Stakeholders
Within the US payer system there are many different stakeholders and high variability amongst them and the evidence they require for adoption. The key to widespread adoption is understanding these requirements as well as how decisions are made within stakeholder subgroups. These subgroups include:
Each of these stakeholders plays a pivotal role in the adoption of new medical technologies.
Evidence is the Flywheel
While no one can dispute the complexity associated with gaining FDA approval, too many companies underestimate the barriers associated with securing reimbursement. Evidence is the flywheel that accelerates successful commercialization and it should be generated across the product lifecycle, not just for regulatory approval. Although there needs to be ample data presented to each stakeholder group, it doesn’t necessarily mean that robust RCTs and costly studies are required. Experts in health economics and market access can often find cost-effective ways to supplement existing clinical trial data to satisfy the needs of your targeted stakeholders.
Create Your Flywheel
At TTi, we pride ourselves on providing support for medical technology across the product lifecycle. We can help you generate the right evidence at the right time, in the right populations, to the right people bringing your technology to market faster and more cost-effectively.
Let’s start 2022 off strong! Click below to schedule and appointment with one of our experts to see how we can build your flywheel.