The medical device sector is a cautious place. Work within the framework of ISO 13485 is subject to many constraints that have been designed to ensure that patient safety comes first. The requirement for continuous product improvement (present in ISO 9000) is removed, sending a strong message that if a medical device is good enough to get a CE mark, it is good enough, full stop. If it functions, there is no requirement to make it better, despite plenty of evidence that good design improves patient compliance.
Form and Function
Much has been written on the relative importance of ‘form’ and ‘function’ in the design process. Indeed, the issue is used to pigeonhole people into one of two opposing tribes, with some taking the view that practical ‘engineers’ don’t care what a product looks like and that creative ‘designers’ don’t care whether it actually works.
In many market sectors, there is considerable freedom to create and manufacture products that look fantastic, but don’t necessarily do their job particularly well. The occasional user may complain, but many will love the product for what it is. Form and function trade-off against one another, with either one being the primary objective of a given design. Let us illustrate this with a simple tale of two lemon juicers.
On the one hand, we have the beautiful ‘Juicy Salif’. It is a work of art, a "stunning addition to any contemporary kitchen,” the creation of Philippe Starck who describes it as a "conversation starter.” Full marks for good looks, but in all honesty it scores rather less well on usability. On the right we have an un-named lemon juicer complying perfectly with its description – it juices lemons. It works beautifully to gather the juice, it separates out the pips, is easy to hold onto and there is no chance of it corroding. However, you are unlikely to leave it casually on the worktop to excite visitors. It won’t start conversations, not positive ones, anyway.
I must confess to loving Starck’s design – the fabulously retro space-rocket lines, the unashamed shininess of it. But I own the other because when I need to juice a lemon, I need to juice a lemon. It was a low-risk purchase, I knew it would work.
Obviously, unless you are a prolific maker of homemade lemonade, your choice of juicer will make little difference to your life. Lemons get juiced, no one gets hurt. And that is the critical bit. No one gets hurt.
Medical devices are different from most other products because when something goes wrong people most certainly do get hurt. They quite simply have to function, must do whatever it is claimed that they will do, and looking great or being ergonomic is no consolation if they fail. Great form has to be created in addition to, rather than instead of, great functionality.
So while comparisons between consumer products such as mobile phones, cars or lemon juicers can illustrate the common trade-off between aesthetic form and function, between beauty and usability, medical devices cannot afford the luxury of this compromise. They have to comply with the claims that are made of them as well as the needs of the many stakeholders. This is a tough place from which to start, and tough problems need more creativity to solve them, not less.
Creating Risks
Being creative is fun. It is part of the human condition and something that all of us do to varying extents, whether it is planting the flower beds, cooking something new or humming our own tune. And yet all creativity involves risk, a word that sends shivers down many a medical industry spine.
Whenever we do anything that hasn’t been done before, every time that we create something new or make a change to something that is well understood, we are also creating risks, no matter how slight they may be. Perhaps risk is actually part of the pleasure of doing something creative - when a risk pays off, we feel good and if it doesn’t we can feel wretched. I even suggest that the bigger the risk, the bigger the impact, for good or bad, emotional or financial. Creativity and risk are two sides of the same coin.
Designing something is no different. On the development path of a new medical device, every innovative stroke of the pen and each brilliant concept will provoke more questions than they answer, initially increasing the risk that something will go wrong, not decreasing it.
I hope it not too contentious to suggest that the medical device sector is risk averse. Those of us active in the field are all too aware that we are designing not lemon juicers but products that can change, save or indeed prematurely end people’s lives. There are many checks and balances to minimise the chances of dangerous products and treatments being unleashed on a vulnerable, trusting public: standards, quality systems, regulatory bodies, clinical trials. These corral us towards compliance, providing us with principles to guide us at every stage. As we design medical products, we can be very aware of the weight of regulation and what is often seen as the burden of regulatory compliance.
But where is the fun in that? How can we be creative when at every turn there is a reason not to do something? How can we find the space to innovate amidst the restrictive constraints of a quality system? Can the creativity within us be herded into compliance?
The answer, of course, is a resounding yes. Without innovation and creativity there are no risks, but there is also no progress. Yet without checks and balances, mistakes are made, something that the medical sector especially has to avoid. We need creativity at every stage in the process, but it has to result in compliant products.
The Bounds of Creativity
I define creativity as doing something new, something that has not been done before. A creative thought may not be an obvious one, although it will often seem so afterwards. It is a fundamental part of solving problems and I firmly believe that it is possible to be creative in almost everything that we do. Yes, creativity is more visible in the context of a brainstorm or a design competition, but it can be brought to bear in much less openly exciting ways than those.
A typical medical device design project will start with a brief that is then developed into specification documentation. Specs can make for dry reading and they are sometimes seen as a roadblock that has to be cleared away before the real work can start. In fact, specifications are the foundations on which everything else will be built, setting the scene for what is to follow. This can be as true of the approach to the project as it is of the device itself.
Here’s another simple tale, this time from the garden shed. A user requirements specification (URS) for a new lawnmower is titled ‘New lawnmower specification.doc.’ It talks about a pleasing appearance, improved cutting performance, the required range from the nearest power socket, reduced noise and increased consumer safety. The design team that is given the spec starts to generate its concepts. The team investigates new motor technologies, lightweight cables, sound-muffling plastics and novel materials for the blades. They are being guided at every turn by the words of wisdom from the spec.
That all sounds very sensible and if you make lawnmowers, that is probably exactly how you do (and should) write your specs. But what do customers actually want from their new lawnmower? Is it to have a longer lead, quieter motor and plastic blades? Do they actually want a lawnmower at all, or do they want a way to keep the grass short?
What if the URS had been titled ‘A way to keep the grass short.doc’? That still provides plenty of scope to worry about motor selection, but would also open the field to much more interesting ideas, including the notions of astroturf or even keeping sheep, which may well be the best solution for some.
Describing the problem in a way that doesn’t direct the reader to a particular subset of preconceived solutions is a simple but surprisingly powerful tool. It is referred to as a ‘solution-neutral problem statement’ – a statement of the problem that is unprejudiced, a commitment to measure the effectiveness of the solution not by how well it conforms to our preconceptions, but by the efficiency with which it solves the real need. It doesn’t take long to generate, but forcing the author to distil the real essence of the problem also liberates the reader.
By approaching the initial brief and even the URS with a fresh mind, it is possible to encourage a creative outlook even within the constraints that are set by a very specific problem. The vast majority of the ideas that are generated during the course of a project will be discarded. But it is better to start with a really strong selection because this improves the chances of solving the problem at hand - and therefore achieving compliance.
Less is More
The brief has been signed off and it is time for the development process proper to begin. This is the home of creativity as viewed by most people – flipcharts, cardboard cut-outs, foam models and breadboards. The early stages of development can often be wonderfully chaotic, with wild ideas needing rapid evaluation to assess whether they are a hit, miss or maybe. As an aside, there is lots of scope for creativity in the assessment of these early ideas. Many a potential mechanism has been unashamedly tested with my schoolboy technical Lego, avoiding the time and expense of building costly test rigs that would quite possibly find themselves redundant within minutes of their first use. Our team of electronics engineers often find ways of testing concepts by modifying and combining existing items. Software too, even calculations, can be approached in a creative way to get a quicker indication of whether or not something might function.
This phase of a work programme can feel a long way away from the controlled development process that might be expected, but getting the best idea out of people requires a degree of freedom.
As outlined above, framing the questions posed at creative sessions is a key component of success. Which bits of information do the team really need to know? Do they need it all at the start of the session, or can it be drip-fed by the chair as the ideas flow? Do you intend to direct the thinking or merely to guide it? The more restrictive the brief, the fewer breakthrough ideas you are likely to get. By channelling the process, guiding it progressively through ideas sessions and more generally as the project progresses, it is possible to get really innovative ideas that are honed to meet the requirements. There will be diversions, deadends and u-turns – and these should be recorded - but the creative process starts to forge something that complies with the brief. A design starts to emerge, materials and components are chosen, form and function combine, order comes from disorder.
As you travel further into a medical device development project, you will find much more control being brought to bear. The breadboards and foam models have been tested with user groups and the most appropriate concepts have been selected. These in turn are replaced with documented test rigs and prototypes that are used to uncover every possible sign of failure. Designs are finalised, manufacturers are selected, tooling is ordered.
There is room for creative spark even at these late stages. The approach to tooling design, in some cases even the way in which a design will be validated, can offer many opportunities to do innovative things to save both time and money without damaging the efficacy of the overall process.
Creative Compliance
Stakeholders in the medical sector are understandably risk averse. The regulatory framework that has been set up over the years to protect patients can be viewed as a heavy weight that crushes any creativity from the product development process.
In fact, the exacting requirements of medical devices require more, not less creativity than other sectors. It is, therefore, not a question of creativity instead of compliance, but rather one of effectively managing creativity at all stages of the development process, enabling innovative products to be created and brought safely to market.
You can also read this article on the MedTech Innovation website here
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