An essential factor for the design of a medical device is practicality, whilst giving it user appeal. To achieve this, designers and manufacturers must focus on communication and cooperation to make the best use of new technologies.
There are many issues to consider before a product design on paper can be brought to life as a usable, effective and cost-efficient medical device. Many stakeholders, each with different sets of skills and priorities, make up the value chain and any failure to integrate their efforts can result in costly delays to product release.
Unfortunately, it seems that such failures are all too common – often resulting from a breakdown in communications between the consultants designing new devices and the manufacturers charged with making the products a reality.
The ultimate aim of the medical device production process should be to better the needs of the end-user and provide a marketable product. It seems, however, that the skills of designers and manufacturers are not always organised effectively around these objectives. Furthermore, the problems are found along the entire value chain, starting with the design phase.
"In my experience, design consultants do not always understand the importance of designing a product that can be easily manufactured and that uses state-of-the-art technology," says Brian Barney, an expert in product development at Cambridge Consultants. "Nor do they always grasp the importance of deadlines. A pharmaceutical company can make a big loss if its products are delayed for even a week."
Cambridge Consultants has seen these problems first hand, and therefore focuses its resources around solving them. Its approach favours practical solutions to drug delivery issues, which means not only being creative at the design stage, but also recognising the needs of manufacturers.
Its internal policy is to break down some of the barriers between design and manufacturing by ensuring that its designers have a broader grounding in the process of bringing their ideas to market as practical, usable devices.
"Not enough focus is put on apprenticeships before designers move onto consultancies," observes Barney. "So you end up with designs that look fantastic but do not take into account the practicalities of manufacturing. Designers need a broader set of skills and also to understand where their skill sets stop. They need to take into account the needs of manufacturers, to look at what injection moulding companies, for example, can do."
BLURRING THE LINES
Consultants working on product development must increasingly overcome a disruptive trend in the other direction, as the debate continues over where the design process ends and manufacturing begins. A growing number of device manufacturers are stepping into the designer’s role, some claiming to offer turnkey product development.
"By and large, it is simply not true," says Barney. "Furthermore, it makes consultants uncomfortable. As manufacturers end up being seen as competitors rather than partners. If they take that attitude, it doesn’t move products to market more quickly. It doesn’t help anyone if developers feel threatened by manufacturers."
Ultimately, there is a growing need for designers and manufacturing companies to work more closely, bringing benefit to both. While this depends on a greater mutual understanding of each other’s capabilities, it can be impeded if designers and manufacturers try to move too far out of their respective areas of competency.
Designers need to improve their understanding of what manufacturers can produce in a cost-effective manner, and those manufacturers need to recognise that design consultants can contribute most through their creative product design. "The process could be so much smoother, more efficient and cost-effective if we worked better together," adds Barney. "Increasing speed to market is in everyone’s best interests."
This need to improve collaboration is thrown into sharper relief when taking into account the need to compete with rapidly developing manufacturing bases abroad. China and India, for instance, are well known for their ability to produce products more cheaply, but they are also increasingly capable of improving the speed of production.
LEVERAGING NEW TECHNOLOGY
In an environment where there was greater collaboration between designers and manufacturers, there would be many opportunities to exploit the capabilities of sophisticated manufacturing technologies, many of which are more often associated with wider consumer technology markets.
The mobile phone market, for instance, could inform medical device design and production in many ways. Customers are keen to use mobile phones, partly because of how they look and how much attention has been paid to the user interfaces. The technology to incorporate more sophisticated and user-friendly interfaces is out there, but the medical device industry is not yet embracing it as readily as it could.
"There is a lot of nervousness in the industry about taking on some new processes, such as two-shop or even three-shop moulding, laser moulding and in-mould decoration," notes Barney. "These can be quick and produce attractive products,
and could easily be based around the kind of user interfaces we see in phones or iPods, for instance."
Drawing on manufacturing technology from such markets could be key to the kind of smart thinking that will drive designers, manufacturers and pharmaceutical companies to take a new approach to medical devices. These markets are increasingly gadget-led, while medical devices often have an old-fashioned appearance. The future may well call for good-looking devices with advanced user interfaces.
Manufacturing tools and processes from other technology markets could aid the development and efficient production of medical devices that appeal more to end-users. There is an argument that if patients feel they are using high-tech devices, which appeal to them as gadgets, they will be more willing to use them and to engage more with their conditions and their courses of treatment.
THE BENEFITS OF BUY-IN
There is certainly an opportunity to do something different in the medical device industry, particularly in key markets such as inhalation. In 2006, this market was worth around $18bn and saw around 700 million devices prescribed, so the pickings could be rich for the companies willing to try something new by exploring new manufacturing technologies and improving the integration of the design and production phases.
While few companies as yet are taking such a leap of faith, the opportunity remains there for the taking. Better collaboration between consultants and sophisticated moulding businesses could steer pharmaceutical companies towards innovation in their manufacturing processes by showing how easy it is to embrace new manufacturing technologies. For now, however, most pharmaceutical companies devote their attention almost exclusively to formulating the drugs that go into their delivery devices.
"The device element is a fraction of the cost of the drug that goes into it, so the focus is firmly on formulation, particularly when the goal is cost reduction," says Barney. "But there are some clever processes in injection moulding which, if embraced, could yield long-term benefits."
Focusing on an area that accounts for a relatively small proportion of costs, but which could yield significant value, would represent good leverage in the improvement of final products. A device may only be as good as the drug it delivers, but if the capabilities of a device can affect prescription rates and usability, then the companies formulating the drugs can exploit what might amount to a significant advantage.
This advantage could be made even greater if pharmaceutical companies recognise that adding more advanced user interfaces, for instance, or exploiting more advanced manufacturing technologies might not produce the upward pressure on costs that might be initially assumed. Communication is the answer to embracing these new technologies, if all employees of a company can be encouraged to work together in harmony.