Contract manufacturing
In the early 1990s, a decent 3D printer would cost £250,000. Today, the same results can be achieved for £2,000.
An iterative approach
So, what exactly does rapid prototyping involve, and how does it help? For CMOs, it means using technologies and making changes that streamline their processes. This can include sourcing pre- developed components, but increasingly it means creating physical product prototypes, often using 3D printing, to identify and correct any flaws as quickly as possible.
“Prototyping is not all about making the perfect device,” says Bibb. “This is only partly true. It is more around ensuring that devices are safe. In product development and getting things to market, the iteration and refinement of design is one thing, but then there is the need for proof of efficacy and performance.” Producing a working model – or, to put it more accurately, a series of versions leading up to a fully working model – gives designers and manufacturers the opportunity to evaluate product feasibility and test its functionality. It can reveal flaws, either in device functionality or other areas such as ergonomics, and enable corrective measures to be incorporated into the design.
“The technology is there… to make design iterations shorter and make the development phase faster,” explains Ian Gibson, professor in design engineering at the University of Twente, where he is the scientific director of the Fraunhofer Project Centre in complex systems engineering. This is especially impactful for medical devices, which can be more difficult to get to market compared to other industries. For example, in automotive, the main focus would be on speed as you’d be wanting to get ahead of your competitors and avoid losing market share, Gibson says. “The
same is true with medical devices, though the trial process and regulatory aspects are what make time-to-market a little longer.”
Open the toolbox early
Prototyping plays a role in many different stages of design and manufacture, but the key is using the right prototyping tool at the right time. Nevertheless, one rule always holds true: start early. “A lot can be done in simulation, and virtual prototyping is useful in many ways, but less so in devices that have a user interface,” says Bibb. “With surgical instruments, where usability, dexterity, comfort and fit matter a lot, it pays to make a physical prototype as early as possible. It is about getting the product right first, then proving that it works later. Get into fast, iterative, user- engaged processes as early as possible.” Early physical prototypes are invaluable when usability is a key selling point, and this is where 3D printing comes into its own. It puts a version of the product into people’s hands fast while allowing for iteration on the design.
“3D printing can knock stuff out by the day, so there is no excuse for not doing it,” says Bibb. “It is so accessible and so cheap.” Early rapid prototyping can be particularly useful in persuading people who aren’t experts in your field and who can’t understand a virtual model, such as one created with CAD, he adds. “You can put something in people’s hands, which can be essential for a device used at home by a patient.” Later, at the product validation stage, the aim is to prove efficacy and validity with functional and laboratory tests of the device. That means that iterative testing is still important in refining the
Medical Device Developments /
www.medicaldevice-developments.com 23
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