Motivation During Medical Device Commercialisation: Limited Commercial Visibility, Ticking Patent Clocks and Uncertain Returns

In my previous blog post, I discussed why an NHS medical device inventor’s expertise can become just as valuable as their intellectual property. Clinical inventors often bring years of frontline experience, preceded by hard-earned qualifications, alongside an understanding of the clinical problem their device was created to solve. That expert knowledge holds real value, as does the inventor’s time. With a device moving from an idea towards commercialisation, it's important that clinical inventors recognise the value of both, particularly when years of their time and expertise will likely be invested long before any financial return is seen.

However, recognising your worth as an inventor 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?

Whichever way the inventor identifies the patient problem, whether it be a flash of inspiration or years of mulling the problem & solution over the next process of development 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 massively 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!”

The Honeymoon Period

Once you get going on the inventor runway 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 feeling absolutely terrifying. But you believe you are producing something truly beneficial for patients and therefore try to balance these emotions 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, perhaps even changing a current archaic culture, forever.

If everything goes to plan a commercial organisation may well recognise the potential of your invention and a licensing agreement is reached. Bingo, a major milestone moment, you'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 phase.

Reality Kicks In

Although the commercial partner now leads the business, you will 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 over years of grafting the device concept from nothing to everything. This knowledge has been developed through years of clinical experience and countless design decisions, which 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'. After all Helping the commercial partner feels like helping the device, and helping the device ultimately means helping to try and maximise product success & patient benefit, leading to increased 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, when are royalties likely to appear?

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. The inventor can be incredibly busy supporting a medical device whilst often simultaneously performing their daily clinical duties and having little idea where the commercial journey is actually taking both them and their invention.

Obviously commercial organisations are perfectly entitled to protect their 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 blog post isn’t suggesting that inventors should have unrestricted access to every discussion or financial projection.

However, if an inventor is expected to remain actively involved throughout the commercialisation of their own medical device innovation, then they should also be made aware 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

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 their motivation 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's produced.  Next the tweaking & creating. All the while the inventor is often performing very responsible clinical duties, whilst balancing family time and potentially colleague ridicule & jealousy relating to their innovation endeavours.  Then comes the reliance on agencies, funding issues.  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, trust, 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.

Lessons To Learn

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, the training session, overseas conferences, prototype discussions. The inventor needs to ask themselves whether their expertise, knowledge and time are being appropriately recognised within the commercial relationship. Continuing to contribute significant amounts of specialist expertise without financial reward is something an inventor may eventually need to consider.

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 will also include an expert identification of clinical patient problems related to the device, and 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 for inventors to recognise when their continuing contribution may have evolved beyond simply supporting their invention and into providing ongoing specialist expertise to a commercial partner.

Money, Money, Money

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 etc.  They should receive payment for their time & services, as other professionals rightfully do receive in the commercialisation process.  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. An inventor can therefore find themselves in the strange position of seeing their invention manufactured, promoted and potentially entering different markets, while still having little certainty about when, or indeed whether, meaningful royalties will eventually arise, 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 for the inventor because so much of what determines them may now sit outside the inventor’s control.

You simply can’t motivate yourself with money that doesn’t yet exist, however the inventor shouldn't ignore commercial performance or pretend 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 matt doodles and absolutely no idea where any of it is going to lead. But those years disappear quickly, gone forever.

The Hard Yards

This can be difficult once a commercial partner has taken control of the commercialisation process. An inventor may not necessarily have visibility of the wider commercial roadmap, however the patent clock continues to 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.

This is the process and medical device commercialisation is a difficult business. 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.

But nobody can recover years of lost patent protection. Once that time has passed, it has gone forever.  This is where the inventor’s motivation has to evolve again.

How Is Commercialisation Success Measured?

Ultimately, through profitability. That's simply how a successful commercial business is measured. Not through exhibition attendance or another encouraging conversation overseas, not even through regulatory approval in a new territory, however genuinely positive that news might be. All of that matters, but none of it is the measure of success, net profit is the measure as net profit is what royalties are so often built on, and royalties are the whole point of a commercialisation deal in the first place. That's not a criticism of the process, it's simply what successful business looks like.

Sales turnover sounds impressive when it's announced, but turnover isn't profit, and a device can be selling steadily in more countries every year without the bottom line having moved anywhere remotely close to breaking even, where royalties actually begin. Historical and ongoing accumulated annual costs need to be recovered before profit exists, and profit needs to exist before anyone, inventor included sees any return on many forms of investment. But the underlying measure of whether commercialisation has genuinely succeeded doesn't change. The new distributor, the exhibitions, the good news, the market expansion, only really means something once it all eventually turns into that one measure of commercial success, net profit. Anything other than net profit simply cannot be viewed as successful commercialisation of a medical device.

Final Thoughts

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 to evolve 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 to provide, and hopefully receive some financial reward for what you've created. The patent clock will keep ticking regardless.

As a medical device inventor, you start with nothing more than a patient problem that you 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!

Disclaimer: The views expressed in this article are my own and are intended as general observations on the medical device innovation and commercialisation journey. They are informed by my experience as a clinician inventor but are not intended to refer to, criticise or make allegations about any specific individual, company, commercial partner or organisation. Any examples or scenarios discussed are illustrative and should not be interpreted as representing the circumstances, conduct or financial position of any particular organisation. Nothing in this article is intended to disclose confidential or commercially sensitive information, or to constitute legal, financial or commercial advice. Any similarities between the general scenarios discussed and any particular commercial arrangement are incidental, and readers should not infer that hypothetical examples describe any specific commercial relationship.