Having recently retired from a career at 3M spanning more than thirty years in drug delivery systems R&D, it seemed a good time to pull together some key thoughts and impressions on the industry and its direction while they’re still fresh in my mind.
How the world has changed in thirty years. Back in the eighties, we had no cell phones, no internet nor email, no digital photography, no jet-pack commuting (OK, we still don’t have that, at least not where I live) and— perhaps most significantly—no real globalization. Instead, we had hand-written memos, faxes, and carbon copies. Yet somehow, we managed without it—perhaps because our drug delivery team was much smaller then, before we grew our capabilities so dramatically in the 90s and 2000s. Now, of course, instant communication is taken for granted and vital. Especially in organizations with a global presence and with customers all over the world, work— and innovation— goes on around the clock.
The pharmaceutical industry, of course, has also changed. When I joined it, fresh from an unrelated industry and clutching qualifications in a range of scientific disciplines, none of which particularly related to healthcare, Big Pharma was approaching the end of several lucrative decades in which high barriers to entry had preserved an era of relatively low competition. Tight regulation had made the development and manufacture of medicines for the West an almost exclusively Western privilege. Today, that is far from the case. Companies in India, China and elsewhere have largely caught up, and it would be a brave person who would now bet against their future successful expansion across Europe and the USA.
Many of the technologies with which I have worked over three decades in R&D have also changed enormously too. Early stage device design involved pen and paper and fairly crude machined plastic models when I started. We did have computer-aided design (CAD), but by today’s standards, it was very basic. Computer numerical control (CNC) machining was coming in for prototyping and was a major step forward in allowing us to try out concepts and design changes faster and cheaper than ever before, but additive technologies such as SLA (stereolithography) and 3D printing were still a long way off. Each of these technologies, once revolutionary but now on the cusp of becoming domestic household commodities, has allowed a step-change in medical device design productivity and creativity. It has truly been an exciting and fascinating era through which to have worked.
Like anyone, I have learned a great deal during my career. Much of it has been technical knowledge and the understanding of a complex commercial world, but more of it has been wisdom and experience. Coming from an educational background in the physical/material sciences proved to be a great enabler for me early in my career, in an organization staffed principally at the time by pharmacists and chemists. I was able to bring the occasional new perspective, and I was allowed to ask dumb questions as I sought to acquire some knowledge of this strange industry that I had joined. And yet, more times than not, I have found over the years that it is often the most basic and ‘left field’ questions that are the most thought-provoking, and which do most to advance a development project. The mantra of ‘challenge everything’ is not a bad one in science (or business), providing of course that it is always done respectfully and in good faith. And in turn, I have learned an enormous amount from thinking about the answers to other peoples’ own ‘dumb’ questions. Sometimes the learning was painful, but being challenged was often ultimately instrumental in the advancement of a project.
New paradigms from greater minds than mine have also been important spurs to progress. I can remember back perhaps fifteen years or so ago, to a period when for a while I started to believe that my personal creativity was beginning to plateau. I had been working in inhalation R&D for a decade and a half, on a wide range of interesting and challenging projects and products, and I recall wondering whether I’d perhaps already had every thought that I would ever have on inhalation. But then a senior manager started to argue strongly that a major future need would be innovation to remove cost, and not just innovation focussed purely on product feature and performance improvements. It was a new mindset, and revitalised my thinking. Lower costs were a much smaller driver of pharmaceutical industry thinking than they are today. But the new world was coming – companies from around the globe were starting to compete directly in established Western markets, and where they didn’t have the technical capabilities themselves they had the cash to access them from others. For a company such as 3M, this has been a two-edged sword. It has provided us with a whole realm of new customers and commercial partners, but at the same time, it has attracted a lot of new players into the inhalation device market. Is there a single technology consultancy or design house of any size, at least in the UK, that doesn’t seem to have inhalation in their sights and/or their glossy sales brochure?
I’ve been very lucky in the career area into which I happened to stumble back in the 80s. Inhalation drug delivery has remained a major focus for all sorts of technology innovators. I have had the privilege of working on such a wide variety of things, from early days in dry powder inhalers and mechanical breath actuated pressurised inhalers, to the successful development of reliable and robust dose counters and more recently to work on sophisticated electronic ‘smart’ inhalers. Interestingly, many of the broad concepts for adding electronics and ‘intelligence’ to inhalers were laid down by us and others back in the early 90s. Their development, to the requisite regulatory standards and to provide the functionality that patients desire, has taken much longer than we could have predicted back then.
So where do I see the future taking us? I would be foolish to attempt to predict where pharmaceutical technology might be in fifty years’ time, but over the next five or ten years, things are perhaps clearer. For drug delivery devices, the incorporation of electronics and software-based ‘intelligence’ is a trend picking up momentum. And although the regulators may be uncomfortable with it, diagnostics and drug delivery may converge with integrated devices before too long. The power of data, both on the condition of an individual patient during drug-based treatment, and to provide health authorities and insurers with ‘big data’ from across the entire patient population, is too compelling for it not to be so. The ability to ‘number crunch’ vast data sets from ‘real life’ patients will provide new insights into the effectiveness of treatments and the real-world factors affecting their success or otherwise. Coupling that with patient DNA-profiling could then allow truly personalised medicine.
The other big area that I think the industry needs to tackle, particularly for relatively complex and sophisticated drug delivery devices such as inhalers, is patient behaviour. Device designers can and should continue to improve the simplicity and foolproofness of their offerings, but with the best will in the world, and the best device, getting true patient engagement and compliance remains a significant obstacle. This is especially true for chronic conditions such as asthma, where patients taking maintenance medication on a long-term basis may not perceive an immediate response from taking, or missing, a single dose. In other words, taking your medication may not make the patient feel obviously better in the short run. And even with proactive patients— and there are many— motivation can still be an issue. With sceptical or unmotivated patients, the situation will be worse. Excess morbidity and mortality are not going to go away entirely while the patient and their behaviour remain the weak link. So when will pharmaceutical companies start to employ armies of psychologists in their product development labs? I think that this will become a future need if we drug delivery system developers are to truly get the most from our cleverly designed devices.
The next thirty years will remain an interesting time in which to work on the technology of drug delivery. The industry will continue to need plenty of industry-hardened experts with a deep understanding of pharmacy and chemistry, and of engineering and electronics and software and manufacturing. But it will also continue to need, I venture to suggest, a few of us jack-of-all-trades outsiders, with scientific backgrounds in other areas, who can bring fresh eyes and naïve questions to bear. I have always believed that the future lies at the intersection of fields, where the maverick thoughts lead to the next revolutionary idea.
If I’ve been blessed with one strength, I would like to think that it was the ability to both handle fine technical detail but also to be capable of standing back and clearly seeing ‘big picture’ context. The latter is key to identifying opportunities for ploughing new and important furrows – but the former is also vital if they are to be seen through into commercial reality. Being able to do both has been a real blessing, although I am not sure that I have always spent the optimum proportion of time in each mode over the years.
So now the dust has started to settle on my own very modest contributions to the field of drug delivery system development, and maybe I can start to look at things around me without always wondering whether they have some potential application to inhalation. Perhaps such thinking never wears off, though, even in retirement: I’m already estimating how big the particles of that dust might be so that I can plug them into the Stokes’s Law equation to work out when it will settle…