When any new product is developed, time to market is a key factor in its success. For consumer products, this is all about speed. But for medical devices, there are also factors like patient safety and regulatory approval to navigate. On average, it takes three to seven years for a device to make it from concept stage to market – all while the demand for accessible and effective devices continues to rise.
It’s no wonder, then, that manufacturers are under increasing pressure to cut costs and get their products to market as soon as possible. That’s why rapid prototyping is of such interest to CMOs and their clients. It offers a way to quickly and efficiently build products that meet clinical needs.
Richard Bibb, associate dean of research at Nottingham School of Art and Design, whose published works include a book on the subject of rapid prototyping, says there is sometimes an absolute speed element driving the pressure to get a device to market quicker, but that it’s also often to do with bottlenecks within the process. Such bottlenecks often arise due to the need for evidence-based efficacy and safety validation. Here, it helps to be able to go through product iterations quickly to create a final product that can be certified as market-ready.
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 predeveloped 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, userengaged 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 small details, such as materials stiffness and surface detail. “There you move into a professional service style of prototyping, using 3D printers that are producing devices to much higher standards, including finishing and polishing to make them more representative of the final product,” notes Bibb. “With consumer products, you could stop there and commit to manufacture, but with medical devices very small details start to matter, so you have to move to an ‘as-manufactured’ item.”
A typical approach to product development would be to get as much information as you can as quickly as possible, so that you stack up the effort in the early stages, says Gibson, who is also co-editor of the Rapid Prototyping Journal and is best known for his work in the area of additive manufacturing, having worked in this field for more than 25 years.
“This lies behind the Japanese principle of kaizen – a lot of effort is put in at the start to minimise the expense of efforts later on,” he adds. “Digital models are becoming more effective and are good for minor changes and very quick iterations. Then additive manufacturing makes prototyping a more manageable process in terms of time management.” For example, he explains, if significant changes to a design were required, you would have to go back through multiple stages and make corrections. Yet if you used 3D printing, you could prevent that from happening by unearthing flaws early on.
The democratisation of 3D printing
Back in the early 1990s, a decent 3D printer would set you back around £250,000. Anyone working in the field knew where most of the machines were, as there were only a few thousand worldwide. But so much has changed in the past 30 years.
“I paid that much for one of the first machines I bought for my research lab in 1997, and I can now achieve the same things with a machine that costs £2,000,” says Gibson. “There are now millions of machines. This has put innovation in the hands of many more people. Around 50% of my students now have their own 3D printers. One benefit is personalisation. In the medical sector, you are not constrained by volume, so you can design personalised or highly customised products.”
“3D printing gets you to the final stage with more confidence – you can’t feel a CAD model,” says Bibb. “Virtual reality can do some great things, but it has its limitations and the same is true with 3D printing.” This technology can only take you so far, he explains. You can identify design issues early with 3D printing, but you still have to prove to regulators that it works. “When you put the logo on the packaging, you make the promise that the product will do what you say it does.”
The mass availability of inexpensive 3D printing has revolutionised rapid prototyping. Designers and manufacturers can iterate using cheap and fast 3D-printed devices from an early stage to get the fundamentals right. That model can go into CAD to refine functionality, then high-quality 3D printing using specialist service providers can prepare the devices for the validation stages before a commitment is made to pre-production.
“It is partly about speed to market, but it is more about increasing flexibility in the prototyping process,” says Bibb. “Make more mistakes early, rather than making them just before you are getting the tools ready for injection-moulding.”
“Improvement in 3D printing certainly has an upper limit, as there are limits to what materials can go through a polyjet process,” he continues. “That is simply physics and it won’t change. The cost has come down, and you can use cheap machines in-house early on and knock out a few versions to your heart’s content. The tech is so accessible.”
But while the tools and processes for rapid prototyping are easy to access, the key factor is knowing how to use them and what they can deliver. “There is still a need to understand what you are trying to achieve,” says Gibson. “The technology is plug-and-play, but there is still a learning curve. You still need the artisans, the creativity and the innovative understanding.”
“Know what you are looking for from additive manufacturing, which offers the ‘fail fast’ mechanism,” he adds. “You can quickly turn ideas into physical products, but you have to ask why you are doing it, what you are seeking to learn, and why you are building each specific model.”
