Since TTi Founder & CEO, Dr. April Zambelli-Weiner, PhD, MPH was featured on an episode of the MedTech Gurus podcast late last year, we’ve received an outpouring of questions on how to be a signal among the noise – especially pertaining to due diligence and planning, SMART and cost-effective evidence generation strategies, and early health economics. Here, we’ve answered your top 5 questions.
What should I be doing pre-revenue to maximize my market access?
First and foremost, you should prioritize an investment in a market access roadmap. This assessment illuminates the critical steps your technology must take to ensure success, identifies gaps in your current strategy, and serves as a tool for budgetary planning and monitoring milestones.
Development of your market access roadmap should take place prior to evidence generation – and ideally as early as possible in order to capture and influence evidence generation strategies. An incomplete or ill-defined roadmap can stunt your market access growth, delaying commercialization and revenue, however. It’s important to develop your market access roadmap with an understanding of the market landscape as well as what’s been done before (by competitors) – and what has previously been successful.
A full understanding of the current market landscape – as well as what has succeeded and failed in the past – will make or break your commercialization. An incomplete or ill-defined roadmap will stunt your growth, delaying both market access and revenue.
What are the components of a successful market access roadmap?
A clearly defined, effective market access roadmap should include:
- 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; and
- Supportive activities (e.g., health economic models and support from different societies and foundations).
My regulatory studies are done. How can they still help maximize my technology’s market access?
Building on your regulatory studies is a smart evidence generation strategy, when appropriate. While the majority of our clients seek our help years before FDA approval to maximize investments in development to support market access, there are still many opportunities to leverage the existing studies and data you already have to accelerate adoption and reimbursement. Existing regulatory studies can be expanded to serve a dual-market purpose by adding comparator groups and buyer-focused endpoints, including medical resource utilization and other economic endpoints. Any remaining data gaps should be filled with smaller, focused pilot and quality improvement studies to bolster your value proposition.
A word of caution: not all studies are created equal. A deep understanding of the market landscape and health technology assessment is required to know what type of studies and evidence will move the needle for you.
How do I find key opinion leaders (KOLs) and orchestrate KOL engagement?
You want to engage with KOLs who will provide insights into your technology’s value from the medical community perspective. Payer Advisory Boards (PABs) are key to gaining insights into your technology’s value from the medical community perspective as well as buy-in to inform study and health economic modeling design to optimize market access. They can provide an enhanced understanding of evidence requirements specific to your product.
These information exchanges should be comprised of questions carefully crafted to capture the first-hand opinion of members comprising the PAB. The insights gained from these engagements should be used to inform/refine future business decisions in areas such as R&D, regulatory strategy, and market access strategy.
How can I demonstrate my technology’s economic value if my ongoing studies don’t already include economic data?
While there are several possible strategies – all associated with some level of additional expense and time – one of the most under-utilized and cost-effective methods is collection of enrolled patient billing data from facilities participating in your studies. Medical resource utilization and charge data gleaned from patient bills can be used to build highly impactful facility-focused and payer-focused value propositions.
How can I leverage early adopters?
While innovators (the first 2.5% to adopt your project) differ from early adopters (the next 13.5%) and early adopters differ from the early majority (the following 24%), your early adopters are an opportunity to collect data that will influence the early majority.
Strong HECON Studies Lead to HUGE ROIs
While money may be tight in the beginning of your launch strategy, it’s important to invest in HECON studies as early as possible to maximize your growth potential. In our experience, companies investing in these studies accelerate time to market by 2 years and save hundreds of thousands of dollars in overall study expenses. Some companies mistakenly assume they can get by with a budget impact model, however, this analysis may not cover all your bases with stakeholders requiring additional information – resulting in costly study expenses later on.
The payer and provider adoption rates for technologies with strong HECON studies is significantly higher than for those without – and these devices also tend to command a higher price.
Make the Most of Your Data
For flexible, high-ROI health economics studies and market access consulting, contact the team at TTi Health Research & Economics for solutions that fit your budget.