Market authorization is not market adoption, yet many confuse them. Being able to legally sell your device (market authorization) is different from customers buying your device (market adoption).
Focusing on market authorization can seem rational. Investors and strategics see FDA clearance or approval as a major milestone, making it alluring to focus resources on reaching that goal. However, focusing on market authorization could leave you with a product to sell and no one to buy.
A focus on adoption will lower your total cost and time to value creation and patient impact.
The Market Adoption Challenge
Simply gaining market access doesn't guarantee adoption.
For example, if your device took the 510(k) pathway, there's already at least one alternative (your predicate device) that clinicians are comfortable using. How will you drive adoption if you’re “substantially equivalent?”
A focus on market adoption will have you asking key questions early in product concepting that drive R&D, regulatory, and commercial strategy decisions. Questions like;
Who are the Key Opinion Leaders (KOLs) in this specialty that influence adoption, and how can we engage them early in our development process?
Will our product interrupt clinical workflow, and if so, how can we minimize disruption?
Does our device have both strong clinical AND economic value propositions to appeal to different stakeholders?
What specific improvements will our device offer compared to existing solutions (quality of life, improved outcomes, increased efficiencies, cost savings, or time savings)?
What is the competitive landscape, and how does our device compare to existing solutions?
What regulatory pathways are appropriate for our device, and how will they impact our development timeline?
How will we design clinical studies to meet regulatory requirements and generate compelling evidence for payers and providers?
What coding, coverage, and payment procedures will govern how different insurance plans approach reimbursement for our product?
By addressing these questions early in your development process, you generate inputs that help build a medical device meeting regulatory requirements and is positioned for successful market adoption when launched.
The most successful medical device startups recognize that market authorization and adoption are essential parts of a single continuum. While regulatory approval is a necessary milestone, planning for adoption from the earliest stages of development will position your company for long-term success.
Startups are hard. We get it. Avio was born in the startup trenches. Founded by a medtech innovator, for medtech innovators, we understand the unique challenges you face. Let us leverage our firsthand experience to accelerate your journey to market.
It will never be easy or stressless, but it can be easier and less stressful.
P.S. - we've put together a presentation on the 10 most common mistakes medical device startups make. Reach out if you'd like a copy. frank@aviomedtech.com
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