When the chasm becomes a canyon and how to cross it

MOORE’S OTHER LAW

Geoffrey Moore’s seminal 1991 book, Crossing the Chasm, has been a go-to source for technology entrepreneurs looking to take a product to the mass market.  2021 marks the 30^th anniversary of the original publication of the book and it remains as relevant today as it was on first publication.

In it, Moore argues that technology products do not follow a gentle path from the early adopters to the early majority but must cross a chasm between the two.  One of the universal truths I have experienced time and again during my 25-year commercial career has been the chasm is challenging to cross.  Never has that been truer than in bringing a medical device to market.

MEDICAL TECHNOLOGY – A MARKET WORTH EXPLORING

Innovation in medical technology is uniquely important to the future of healthcare.  As populations age, we will need breakthrough medical technology to bridge the gap between delivering an affordable healthcare system and maintaining high levels of care that patients expect. Particularly important are ‘platform’ innovations: those technologies that solve more than one medical issue.

OnPulse™ is one such platform technology.  The technology is used to stimulate the common peroneal nerve and activate calf and foot muscle pumps, resulting in muscle contraction in the lower leg.  This has around 60 percent of the impact on blood flow increase in the deep veins as walking would have, but without raising someone’s pulse or blood pressure.

This capability is important for anyone that is unable to move around for long periods of time, since immobilisation can increase the risk of blood clots forming.  For people in a hospital bed, wheelchair bound or unable to leave the home, OnPulse™ technology offered a way to reduce those risks.

At Sky Medical we spent some time turning this promising technology into a medical device, where that capability to move blood around a person could be reliably productised.  By 2015 we had incorporated OnPulse™ technology into a working medical device – the geko™ device – that could offer positive patient outcomes to a number of medical conditions.

CREATING FOCUS

Moving blood around the body of otherwise immobile people is a positive medical intervention for multiple potential ailments.  Initially we counted almost 50 potential medical applications for the geko™ device.  The first critical part of the journey to commercialisation was to focus on the most important potential markets for the device.  Having agreed a process through which we could prioritise the most important applications and largest markets, we were able to focus on three key medical issues: the prevention of venous thrombosis (VTEs); the prevention and treatment of oedema (swelling); and wound therapy applications (hard-to-heal leg ulcers). The total addressable market opportunity for the geko™ device in each of these areas is £202 million, £282 million, and £603 million respectively in 2020.

Creating this focus did not come without its challenges.  Investors, board members and employees all had their own thoughts on application areas and it was important to demonstrate these three application areas offered the best route to commercial success from the outset, based not only on the size of market but also how our product stacked up – financially, clinically and technically – against other forms of treatment for these medical conditions.  By creating an objective commercial analysis, everyone was able to support the conclusions.

THE CONSUMER MARKET?

Perhaps one of the biggest decisions we made at this stage was whether the geko™ device would be a medical device or a consumer product.  The consequences were significant: medical devices require reams of clinical evidence before they are adopted.  However, the compelling argument for the medical market was based around the evidence already gathered on the success of the device in circulating blood.  We wanted to demonstrate the impact the geko™ device could have on positive medical outcomes against threatening illnesses.  It was the right decision, but one that would generate additional hurdles to be overcome on the journey to mass adoption.

FINDING THE INNOVATORS

Partly because medicine is a cautious practice, those willing to embrace innovation are usually easy to identify: they are typically well published individuals or those that have been at the forefront of bringing innovation to healthcare in the past.  These champions were critical to Sky Medical generating the earliest data sets around the performance of our medical device.  These innovators are the most open individuals to innovation and are often at the forefront of medical technology adoption.  In our case, we were fortunate the identify and work with several innovators at an early stage who helped us generate our first clinical data.  This, in turn, helps garner the interest of early adopters.

For us, the support of early adopters was possibly the most critical part of the journey to mass commercialisation.   Early adopters in the medical industry are open to change but also pragmatic.  They are also visionary, believing that patient outcomes can be improved by challenging the status quo.

One such individual was Dr Indira Natarajan, from Royal Stoke University Hospital.  The early data from our innovators convinced Dr Natarajan to look at what the geko™ device could do for patient outcomes.  Crucially he had access to a large number (approximately 100 per month) of stroke patients, some of which needed an alternative to intermittent pneumatic compression devices (IPC) – a cumbersome, full or half leg plastic sleeve that repeatedly inflates and deflates to move blood through the veins.  He was able to deploy the geko™ device in the 30 percent of patients that were either unable to tolerate or should not receive IPC treatment.

An initial one-month trial was extended to three months, then a year and then to 2,500 patients.  We were beginning to see the positive impact that the geko™ device had in hard numbers!

REGULATORY CHALLENGES

Clearly one of the ways in which medical products differ from other technical products is they need to meet regulatory requirements of different health services around the world.  Building positive patient evidence is a critical part of the process of gaining regulatory approval.  Sky Medical was able to receive National Institute for Health and Care Excellence (NICE) based largely on early prototypes and the OnPulse™ technology’s performance in a laboratory.  The work of Dr Natarajan in Stoke helped the geko™ device gain approval from the US Food & Drug Administration (FDA).  Despite being the first bioelectronic device of its kind to receive both NICE and FDA clearance still does not guarantee the geko™ access to the global market.  One of the most important reasons to continue collecting data as adoption of the device grows, is to satisfy the varied requirements of healthcare systems globally.  Each wave of new positive patient data provides fresh evidence to support the product’s extended reach into new geographies and medical use cases.

THE ECONOMIC REALITIES

With global regulatory approval and real-world evidence to support positive patient outcomes, the geko™ device seemed ready for mass adoption.  The reality was that there was still a long way to go before we could reach the mass market; not least building a strong economic case for each healthcare system.

The economics needed to reach beyond simple cost vs. benefit.  Healthcare systems base decisions on multiple factors – for example the investment required and payback period.  There may be a clear financial benefit but if the cost of adoption comes before the financial upside, it may be difficult to realise within budgets. Even when the economic case is unarguable, other issues can limit the speed of adoption; in one case we were slowed by a hospital that had just reordered prescription chart stationery for an entire year which would need changing to incorporate our product.

It is essential that companies recognise multiple stakeholders are involved in the decision making, all of which may have their own responsibilities.  Companies can help speed adoption by providing support with collateral such as staff training, information manuals, product videos as well as better understanding the process through which innovation is adopted in healthcare services and being sympathetic to it.

We certainly relied heavily on the goodwill of clinicians to champion our cause, many of whom were doing so in their own time and outside of their day job. Bridging the chasm is tough in any technology business but in medical technology the bar to bringing innovation to the mass market is rightly extremely high.  Companies need to show patience.  Technology investors – perhaps more used to a five-to-seven-year runway before seeing a return on investment – need to remain patient and see that, while the timescales may be longer in medical technology, the rewards can also be more significant.

CHANGING TIMES

All of this means the chasm between early adopters and the early majority in medical technology can seem more like a canyon; medical innovation should require a high level of evidence to ensure technology that does get adopted has been through the most rigorous processes.  In our experience, technology adoption relies on the passion, expertise and determination of clinicians, who carry the torch of innovation through the system, driven only by the passion to improve patient outcomes and generally carrying out these roles outside of their normal working hours.

There is now growing evidence that things are changing.  The medical challenges of COVID-19 have forced faster evaluation of new medical innovation with some medical stakeholders reporting that as much innovation has taken place in the past 12 months as in the entire decade previously.

The launch of the MedTech Funding Mandate on 1^st April 2021 will further support devices, diagnostics or digital products that are:

• demonstrably effective, proven through positive NICE guidance
• delivering material savings to the NHS and cost saving within the year
• affordable to the NHS

The implementation of this mandate should help accelerate the deployment of proven, safe and cost effective medical technology in the NHS, reducing the burden on clinicians to be the out-of-hours champions for innovation.

A JOURNEY WORTH TAKING

Medical technology is critical to bridging the gap between today’s healthcare needs and tomorrow’s.  Innovation that can improve patient outcomes and reduce costs will be central to managing finite resources and keeping people well.  Despite this, the bar for mass global adoption remains – rightly – extremely high.  To cross the chasm between the early adopter and the early majority requires a combination of a proven technology that is safe and effective, global regulatory approval driven by evidence based positive patient outcomes, a cast iron economic case, alongside a clear understanding of the processes through which innovation adoption takes place.  It will still likely take a considerable amount of time to cross the chasm, but for those like Sky Medical that do so, the economic and societal benefits make the journey fully worthwhile.