Johns Hopkins-trained epidemiologist, strategic healthcare leader and innovator, and CEO of TTi Health Research & Economics, Dr. April Zambelli-Weiner, is an expert in data creation at every level of the healthcare ecosystem and an advocate for early health economics (HECON). April answered a few questions for us around the significance of HECON, providing the following key HECON advice for MedTech leaders.
Why do MedTech leaders need to put HECON at the top of the list?
Delivering value and ROI has never been more important and the bar has never been higher. In the short term, the focus has got to be delivering not just value, but cost savings or revenue generation whenever possible and in a short period of time. COVID has forced all of us to shorten our planning windows. But the economic impact, the cost pressures on health systems, are only going to increase. So you need to be able to show in a concrete, concise, compelling and highly defensible way that your technology can have a meaningful financial impact.
Why do you advocate for early HECON?
Speeding time to market and decreasing the cost to commercialize really hinges upon maximizing opportunities throughout the development period. Early HECON allows you to build evidence and support your value story from very early on in your product development lifecycle. Early state value-analysis including outcome mapping and HECOn model mapping ensures clarity around key value drivers and what evidence needs to be developed to prove and communicate your value story. When companies wait they often miss key data acquisition opportunities that cause delays and slow time to market and adoption.
What advice do you have for MedTech developers working on their regulatory pathway?
Now is a great time to take a step back and understand how you can leverage existing studies and data assets. Don’t underestimate the importance of generating broader economic and outcomes evidence simultaneous with FDA approval; maximize your pre-approval clinical studies by collecting crucial payer- and provider-focused data. Conduct health economics and outcomes research (HEOR) within, or concurrent with, planned clinical protocols to provide evidence of the economic and patient-focused benefits as well as risks and results of a particular intervention.