So, you are a MedTech company that just completed Series A funding from a local VC. Congratulations!
You are ready to conquer the world with your new innovative MedTech product. You probably conducted initial market research, and know in which part of the world you will start your journey in. Most likely, the US.
You have tested your new technology with one, maybe two, local sites, and have promising clinical outcomes that you would like to publish worldwide.
You probably have improved your technology, based on the feedback you received from your local KOL along the way.
So, what’s next? Well, if you are an Israeli start-up, typically, you’ll follow the regulatory pathway: FDA, MDR, and the ROW. You’ll participate in trade shows, showcasing your technology. You’ll sign exclusive distribution agreements with local and well-connected partners that will convince you that they are the best fit for you and your product.
In parallel, you’ll work intensively to achieve your FDA clearance, arm yourself with regulatory experts, statistics masters, and CROs, and, in case of a clinical trial, engage with prestigious hospitals. After a year or two, if all goes well, you’ll find The Holy Grail!
What’s next?
Find a national distributor? Or maybe regional ones?
Open your own subsidiary and sell direct?
Find and recruit local KOLs / Thought Leaders?
Reference sites? Must have those.
Is there a Reimbursement Code?
In the end, it’s all trial and error, and may take years until you’ll find the winning formula and achieve substantial sales after your product launch.
On the other hand, you may not be so lucky and be stopped along the way by your investors.
But what if you could do things slightly differently? Things like:
– Understanding where your technology has the most unmet need?
– Conducting thorough market research?
– Knowing how big the market really is?
– Knowing who the customers are that you need to target? Your ICP?
– Knowing what the best business model is?
– Knowing your competitors, direct and indirect?
– Knowing about pricing?
– Knowing what is required by the local Regulations of each territory?
– Knowing what parts are reimbursable or out-of-pocket?
– Knowing if you’re dealing with the public or private sector?
– Knowing about distribution channels, customer support and service?
– Knowing about margins?
– Knowing how you create brand awareness and generate demand?
– Knowing if your technology be embraced/adopted by local culture/users?
– Knowing what adaptations will be required to meet local market needs?
– Knowing what your short- and long-term goals are?
– Knowing what infrastructure you are missing to allow successful growth?
It may look like a long list, but pre-planning and executing each one of the line items above, will help to reach better decisions, and may shorten the pathway to your success.
There are no shortcuts and, yes, planning takes time and resources and is always prone to alteration. But if your road map and your intent are solid, and if you are resilient, and persevere, you’ll get there.
Good luck!
