Every person is different, and when we get sick we all get a custom solution. A physician sees each patient, orders specific tests and defines a treatment plan. But the medical devices we use are standard, there are usually several different sizes of each device to fit the majority of the population, putting it in other words, we face a situation similar to what happens in the fashion industry, people go to the store and try on different size and designs and end up buying the garment that better fits them this provides a good look. When people want/need to look absolutely perfect they go to a tailor and have their garments custom made. Obviously the price is higher but the results are likely to be much better. 3D printing has allowed this in the medical industry, where imaging data from a CT or MRI can be used to create a 3D model of any desired anatomical structure. CAD software can be used to take 3D data generated from these images and design, not only specially matched medical devices, but also to simulate their behavior using mechanical simulations. A 3D printer can then be used to manufacture custom devices like implants, surgical templates and the like. This workflow offers not only better results for patients allowing the optimal surgical treatment to be used but it also allows for treatment of patients where no standard solution is available. These benefits are worth it in themselves, and as the cost of 3D printing drops and the speed increases more and more people will be able to benefit from custom solutions. These are what I call the first order benefits of 3D printing in healthcare. But are there any other benefits? If we look deeper the way 3D printing affects the economics of medical device design and manufacture we can expect a surge in health innovation driven by 3D printing.
On the surface, medical device design is all about risk mitigation, everything is tested and standardized to make sure the devices that are going to market have a demonstrated efficacy, which in quality jargon means the devices work the way they should and the benefits of the treatment outweigh the risks associated with its use. This is extremely important, but there is another driver in medical device design and it is what I call innovation economics. Usually devices are manufactured in series, and in relatively high volumes. This means that once a suggestion or innovative idea arises that may improve the device or the procedure, the costs of implementation can be very high due to the existing inventory levels and the outsourcing supply chain, and if the market or patient benefits are not significant enough to justify the innovation, small incremental improvements are likely to be included in big releases that upgrade devices periodically. This all means that improvements take longer to reach the market, competitors take longer to react and the innovation speed of the industry as a whole is reduced.
The above images show some applications where we have used 3D printing and custom design to solve complex medical cases where traditional devices generate significant compromises in patient outcome.
With 3D printed custom devices though, the economics are completely different because of two major aspects. First, with 3D printing the price of added complexity is zero. In terms of a 3D printer, the cost of making a cube is practically equal to the cost of making the most complex shape imaginable with the same volume of material. This means that concepts like DFM (Design for manufacture) become obsolete and design engineers will now be limited by their creativity and their skill using design software rather than the specific constraints posed by the manufacture of a given component. The added complexity that is made possible by these technologies will most definitely make for some very interesting device geometries to be adopted, particularly in terms of structures that interact with tissue. Surface engineering for implants that should integrate with bone comes to mind as an initial application, but the sheer number of opportunities to innovate becomes massive. The other and I believe greater opportunity for innovation is the economic aspect of it. Custom 3D printed medical devices are manufactured on a per patient basis, this means that though a specific design envelope is respected and certain parameters are kept constant, each patient is a new design. This gives the design team a new opportunity to iterate the design one more step for every patient that uses it. In my articleDarwinian Innovation Spaces: Does nature hold the key to growth? I explain how better designs are often the ones that have the most design iterations under their belt. In the particular case of custom medical devices, the number of “generations” and improvement steps can increase at a much faster pace as there are no economic constraints. If a given maxillofacial implant is designed for a patient with a facial tumor, the list of lessons learnt from how to make the surgery easier can be implemented in the next patient operated of a maxillofacial tumor and so forth. Additionally, changing the design specs is now just a matter of doing the engineering, there is no need for a recall and reprocess or write-off of the existing inventory. This for sure will allow the industry to take greater design risks and will serve as a catalyzer for greater innovation where definitely the sum of 2 and 2 will be more than 4.
In conclusion, we are facing a very exciting age, where medical devices will, to a very large extent be patient-specific and 3D printing will likely play a role in the manufacture of the device. This is great news for patients because they will receive treatments that involve increasingly smaller levels of compromise. But the 3D printing revolution will also become a great catalyst for the medical device industry which with the increased capability to manufacture more and more complex devices and the significant reduction in the costs of iteration will usher what can be a golden age of medical innovation.
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