Keeping the Faith: Staying Motivated During Medical Device Commercialisation. Unknown Commercial Roadmaps, Ticking Patent Clocks and Uncertain Royalties

In my previous article, I discussed why an NHS medical device inventor’s expertise can become just as valuable as their intellectual property. Years of clinical experience pre-ceded by hard earned qualifications, usability knowhow and an understanding of why a medical device exists, may or may not be essential, as each inventor has their own personal unique perspective.

However, recognising your worth is only one part of the journey when entering a partnership to commercialise your medical device. Another challenge emerges throughout this process which often receives far less attention. How do you stay motivated once the initial burst of excitement of inventing has passed and the innovation enters the long and unpredictable world of commercialisation?

It seems for many clinician inventors the journey can play out in a familiar way, as in a patient problem is spotted,  which leads to a niggling feeling that over time leads to a solution.  However in my case with LEAFix it was very different.  I saw the patient problem of random single patient us e tape being use to secure a patients et tube and Boom, I felt a physical sensation enter through the top of my head, down through my body. I felt a knowing that what I was seeing was wrong, the taping of the airway with transpore tape

Whichever way the inventor identifies the patient problem the process is the same.  You begin writing things down, talking to trusted friends, family and colleagues, sketching ideas, building prototypes, inviting people onto your project.  Depending on the person and personality, this stage can massivly vary from, “I’m convinced I’ve got a good idea here to solve this problem, but who am I to solve it?” to, “I’m an absolute genius and I’m going to take on the world with this solution!”

When you get going, those early years are so exciting. It’s a mixture of optimism intertwined with sporadic absolute fear of it all ending at any point. You have absolutely nothing to gauge it against because the concept of what you are doing in the moment is so exciting whilst simultaneously being absolutely insane! But you believe you have something and try to balance the insanity with logic. Some clinician innovators may be motivated by the possibility of financial reward at this stage, but for others it’s ambition,  the thought that one day their idea could potentially become a product that makes patient care safer for all patients globally or easier for staff across, perhaps even changing an archaic current culture, forever.

If everything goes to plan a commercial organisation may well recognise the potential of your invention and a licensing agreement is agreed. Bingo, a major milestone moment, we’ve done it!  As the inventor of a medical device you’ll definitely feel a massive sigh of relief, the sigh of recognition.    You’re medical device invention has now entered a commercial partnership.

Although the commercial partner now leads the business, you remain the person who understands the device better than anyone else. You know why certain materials were selected and already tested, why previous designs failed, which compromises are acceptable and how the product will actually be used under real clinical pressures. That’s expert knowledge, forged in years of grafting the device concept from nothing to everything. This knowledge has been developed through years of clinical experience and countless design decisions and can’t be replaced by paying an external consultant.

Because of that, many inventors continue supporting the project long after the licensing agreement has been signed. They review prototypes, attend meetings, produce educational material, train clinicians, speak at conferences and help solve unexpected clinical challenges. They do these things willingly because they absolutely remain emotionally invested in the success of the innovation. It’s their baby. Helping the commercial partner feels like helping the device, and helping the device ultimately means helping maximise unit device sales, hopefully creating net profit and royalties.

However, this is where the journey can become psychologically challenging.

Whilst the inventor continues contributing their expertise, they may have very little knowledge of the commercial strategy itself.  The business plan. The Marketing plan.  Updates may arrive in the form of encouraging news. Another international exhibition has been attended, a distributor has shown interest in a new country, regulatory approval has been achieved in another market, territory or new conversations are taking place overseas, encouraging conversations. Individually these all sound positive, and they may represent genuine progress, but they don’t necessarily answer the questions that increasingly matter to the inventor.

Where is the business actually heading? What are the priorities over the next few years? How is success being measured? What obstacles remain? What timeframes are in place for the project, costs, revenue, net profit?

Without understanding at least some of that bigger picture, the inventor can find themselves grafting away, sacrificing family time and doing everything they can, whilst having very little sense of how their efforts fit into the overall strategy or structure of the business. You can be incredibly busy supporting a medical device whilst simultaneously having little idea where the commercial journey is actually taking you.

Commercial organisations are perfectly entitled to protect confidential business information. Every company has commercially sensitive plans, financial forecasts and strategic decisions that can’t always be shared with every party involved. This isn’t suggesting that inventors should have unrestricted access to every discussion or financial projection.

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However, if an inventor is expected to remain actively involved throughout the commercialisation of their medical device innovation, they should also understand enough of the overall direction of the project to ensure their expertise is being used where it creates the greatest value, and be financially rewarded for their time and expertise?

Maintaining motivation by the clinical inventor over the course of commercialising their medical device is a conundrum.  Often by the time they enter a commercial partnership they’re motivational can be waning, having gone through the initial baptism of fire of taking on and grasping the challenge of identifying and committing to producing the solution to the patient problem they’d originally identified.  Next comes the prototype, where does that come from, but it comes.  Next the tweaking & creating, all the while working and family and potentially colleague ridicule & jealousy.  Then comes reliance on agencies, funding.  All before meeting the commercial partner .  Something out of absolutely nothing.

A commercial partner sharing the trajectory of the medical device isn’t simply about satisfying curiosity for the inventor of their medical device innovation. It can strengthen collaboration, improve decision making and massively help maintain motivation over what is often a journey measured in many years rather than months. Relationships are built on certain factors, in any walk of life.

There’s another invaluable lesson first time inventors only discover through experience unfortunately. Their passion for the medical device can make them vulnerable and as a result undervalue their overall contribution once within a commercial partnership.

Because they desperately want their product to succeed, it becomes incredibly easy to keep saying yes. Yes to another design review, another evening spent solving a clinical problem, training session, overseas conference, prototype.  The inventor needs to ask themselves if their expertise and knowledge is being accounted for in the business plan. This work and ‘time’ may likely not be financially accounted for and rewarded?  Yet there comes a point where it’s worth asking yourself a simple question.

“Am I still simply supporting my invention, or have I become an expert consultant to a commercial business” as these are not the same thing.

The clinical inventor’s knowledge is highly specialised and should be recognised as such. Most clinicians have spent years developing their expertise through formal education, hard-earned professional qualifications and extensive clinical experience. That journey can also reflect dedication, ambition, perseverance and a commitment to continually improving patient care. It can also include an identification of clinical patient problems, an understanding of medical device usability, human factors, medical device material selection, design compromises and the subtle decisions that can determine whether a product is embraced or rejected by healthcare professionals. That knowledge has significant commercial value. It can help companies avoid mistakes, improve products and ultimately increase the chances of commercial success.

It’s important to recognise that likely in the commercialisation process the inventor may have become an ‘assistant’ for the commercial partner.  Although not being paid, Recognising this is vitally important.

Money, nobody wants to talk about it. Inventors should be financially rewarded for their patient benefiting innovation.  They should be included within negotiations of their invention between their hospital Trusts and commercial partners, relating to the percentage of royalties which they should receive.  They should receive payment for their time & services, as other professionals receive in the commercialisation process, when supporting commercial partners develop their own medical devices.  For an inventor who may have spent years developing an idea alongside their normal clinical career, providing years of ‘free’ expert clinical expertise to the commercial partner in the commercialisation process, the possibility of eventually receiving some financial reward is perfectly reasonable.

But royalties can remain somewhere over the horizon for a very long time.

Medical devices cost money to develop, manufacture, regulate, market and sell. Depending on the commercial agreement, royalties may be linked to sales, profit (net profit) or other financial milestones, and development costs or investment may need to be recovered before the inventor ever receives anything. You can therefore find yourself in the strange position of seeing your invention manufactured, promoted, taken to conferences all over the world and potentially sold into different markets whilst still having absolutely no idea whether meaningful royalties are two years away, ten years away or may never arrive at all, if ever due to the patent running out.

There is nothing wrong with wanting financial reward for something you’ve created. Inventors shouldn’t feel embarrassed about that. If intellectual property creates commercial value, wanting to share appropriately in that success is perfectly reasonable. But anticipated royalties are a difficult fuel to run on because so much of what determines them may now sit outside the inventor’s control.

But you simply can’t motivate yourself with money that doesn’t yet exist.  That doesn’t mean forgetting about commercial performance or pretending royalties don’t matter. Of course they matter, inventors should remain interested in whether the product is commercially viable, whether sales are growing and whether the partnership is delivering what everyone hoped it would. But psychologically, motivation eventually needs something else underneath it, particularly when the journey begins stretching into many years.

And all the while, the patent clock is ticking away, counting down in money lost.

Unlike almost everything else in medical device innovation, patents never pause. A twenty year patent can initially feel like an incredibly long time, especially when you’re standing at the beginning of the journey with an idea, a few beer mat doodles and absolutely no idea where any of it is going to lead. But those years disappear quick, gone.

This can be difficult once a commercial partner has taken control of the commercialisation process. The wider commercial roadmap may be unknown to you, however your watching the patent clock continue tick away. Another year passes, another chunk of patent protection disappears, and you naturally begin asking different questions about where the project is heading and what can realistically be achieved within the remaining time, P&L accounts analysed, net profit & royalties assessed.

This isn’t necessarily because anybody has done anything wrong. Medical device commercialisation is difficult. Regulation takes time, markets take time to develop, healthcare systems can be painfully slow to adopt new products and international expansion doesn’t happen overnight. But time itself is one of the few assets in innovation that can never be recovered. A prototype can be redesigned, a material can be changed, a distributor can be replaced and a marketing strategy can be reconsidered.

You can’t get 5 years, 7 , 8  of patent protection back.  This is where the inventor’s motivation has to evolve again.

So perhaps staying motivated as a medical device inventor isn’t about trying to recreate the excitement you had at the beginning, because that’s never going to happen. The motivation has evolved with the journey. The initial buzz at the start is a frightening mix of optimism, discovery and fear, which evolves into the prototype, the patent, the commercial partner and eventually hopefully seeing your device being used on patients. Through the business end commercialisation of the real world process, you hope to be valued for the expertise you continue provide and hopefully, receive some financial reward for what you created. The patent clock will keep ticking regardless.

As a medical device inventor, you start with nothing more than a patient problem that only you have identified, and an idea of how it might be solved.  Which then turns into intellectual property and a real medical device. Whatever happens next commercially, you’ve done something that most people will never experience, be capable of doing or be brave enough to do.  That is create something from absolutely nothing.  Keep going.