I have spent about 30 years turning ideas into businesses, most of them in medical technology, and I have worked on more than 20 medical products along the way, from software to cardiovascular and neurological devices. If I had to sum up what those years taught me about healthcare business development in one sentence, it would be a line I wrote on my own website: I have seen excellent technologies fail commercially, and relatively ordinary products become successful businesses, and the difference often has very little to do with the technology itself.
That is a hard thing to say to an inventor who has given years of their life to a device, and I say it gently. But I think it is the most useful place to begin this series, because almost every other lesson about business development and marketing in our industry follows from it.
A great product is where the work starts
Founders usually come to business development after years of engineering, clinical work and regulatory effort, and it is natural for them to believe that the product will speak for itself once it is ready. In most industries a better product does have a good chance of winning. In healthcare it is only the entry ticket. A clinician may love your device and still be unable to use it, because the hospital has no budget line for it, because nobody will pay for the procedure, or because it does not fit into a working day that is already full.
The people who decide whether a medical device succeeds are many, and they rarely sit in the same room. There is the physician or therapist who uses it, the administrator who controls the budget, the payer who decides whether the treatment is covered, the regulator in each country, and in most international markets a distributor who decides whether your product deserves attention next to everything else they carry. Healthcare business development is the work of understanding each of those people, what they need to hear and what they are risking by saying yes, and then building a path that makes sense for all of them at once.
What I learned from selling without a code
My clearest lesson in this came early in my career, when I established and led the US subsidiary of a medical device company I worked for. We built it into a solid business within three years, despite the fact that there was no CPT code for the procedure, which meant that clinicians had no simple way to be paid for using the device. These products had over 50 peer reviewed publications but no direct code. The AMA was against us, the Societies were against us, the leading physicians were against us, because we would cut their income by up to 80%. No one would support us, but we went forward and in the end succeeded and today, these technologies have overtaken the traditional ones.
People sometimes assume there must have been a clever trick behind that. There was no trick. When the payment system has not caught up with your technology, you are selling clinical value and economics directly to the people who live with the problem every day, one site at a time, and every satisfied clinician becomes the reason the next one agrees to listen. Because of having no code, we could not sell to the traditional market, and had to find alternative markets. Not easy, but we did it and we reached sales in the millions of dollars.
What that experience taught me was humility about the product. The device was good, but it was the work around it that made the business: understanding how each clinic was run, what it cost them to adopt something new, and which arguments mattered to the person who signed the order. Since then, the first questions I ask about any medical technology are about the world around the device, who will pay for it and what evidence that payer will need to see, because the answers usually shape the clinical study, the price and often the product itself.
Healthcare business development is built on relationships
The second thing a great product cannot do on its own is build trust. In my experience, healthcare is one of the most relationship driven industries in the world, because the people buying are responsible for patients, and they are understandably careful about who they let into that responsibility. A hospital department will often prefer a supplier it has known for years over a better product from a company it has never met, and a distributor will think very carefully before putting its own reputation behind a newcomer.
That means business development in healthcare is slow in a way that can frustrate founders who come from faster industries. Relationships with distributors, hospitals and regulators take years to build, and they have to be started well before you need an order. The companies I have seen do this well begin talking to the people who will eventually buy and sell their product long before the design is frozen, and they keep showing up in person, even when there is nothing new to announce.
Development and entrepreneurship together
Some years ago I coined a word for the combination of skills this requires: Developeneurship, a fusion of development and entrepreneurship. Entrepreneurship is the moment of seeing an opportunity, and development is everything that has to happen afterwards for that opportunity to become real. Can you develop the product to the point where it is safe and manufacturable? Can you find customers in markets you have never worked in? And can you survive long enough to build a sustainable business while all of that is happening?
Very few founding teams are strong at both, and that is no criticism of anyone. Most medical technology companies are started by brilliant engineers and clinicians, and what they usually lack is someone who has already taken a product through clearance and into distribution in several countries. Recognizing that gap early is one of the most valuable things a founder can do, because it changes who you hire, who you ask for advice and how you plan your first years.
What a business development plan should answer
In practice, I encourage founders to treat business development as a discipline from the very beginning rather than an activity that starts after launch. A good plan answers a small number of honest questions. Who will pay for this, in each market where you want to sell? What evidence will they need to see? Which markets come first, and why those? Who will sell the product there, and what will they need from you to do it with confidence? And who in your company has the time and experience to build those relationships over several years?
None of these questions has a quick answer, and most young companies cannot answer all of them on the day they start. That is perfectly normal. What matters is that they are asked early, while there is still time to shape the product, the study and the budget around the answers. Has it always worked for me? Absolutely not. I have had successes and failures, and more unexpected challenges than I care to remember, but almost every failure I have seen, my own included, began with a belief that the product would be enough.
Over the next articles in this series I want to follow that path step by step, from deciding where to start internationally, through choosing markets, partners and commercial models, to building the relationships and the launch that turn a good device into a business.
At Synergen MedTech Consultants, this is the work I do every day with medical technology companies. If your product is ready but the business around it is not yet clear, I would be glad to talk. Write to me at gary@synergenmedtech.com and tell me about your commercialization or international business development challenges. In the next article, I look at where international business development should actually start.
All names of people and partners have been removed for privacy reasons.
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