The Podfo Development Team (pictured from left to right): Scott Rader - General Manager-Healthcare Solutions, Steve Cook – Business Development Director at Podfo, and Chris Peacock – Owner of Peacocks Medical Group[/caption]
Do you suffer from aches and pains at the end of a day on your feet? Tens of millions of people worldwide benefit from custom foot orthoses to help with these issues of comfort and health. To address this demand for a better performing insole, the process to fit, purchase and customise them is undergoing a significant step-forward. The industry is moving ahead from a plaster cast based orthotics solution that take weeks to deliver to 3D printed custom-fit precision orthotics delivered in days. And the industry for orthotics is booming.
My name is Professor Jim Woodburn, and I am a podiatrist specialising in inflammatory arthritis as well as diabetic foot disease at Glasgow Caledonian University. I had a vision to develop a new kind of orthotic insert that would take some of the key podiatry paradigms for motion control, and re-design the features through manufacturing capabilities like regional stiffness and thickness of materials, which cannot be easily undertaken by conventional manufacturing. I envisioned that the new devices could be less bulky and lighter without losing stiffness and flexibility, and would also have excellent aesthetics and detailing which could improve the user experience and patient outcomes. I believed strongly that if we looked at the issue of enhancing orthotics in a new way, by utilising the technology of 3D printing, that we could achieve things that were not attainable or affordable by utilising conventional methods of manufacturing.
[caption id="attachment_146060" align="alignleft" width="305"]
Each Podfo is unique, tailored for the user’s individual bio-mechanical requirements.[/caption]
After the partnership with Peacocks Medical was established, we began work on the design and development of Podfo right away. It was a wonderful experience in that Peacocks Medical has had shared values that demanded quality and excellence in research and innovation and through that the development of potential high-value, knowledge-based foot orthotics products and services. As the venture continued through the development and validation stages, it quickly became clear that we would need to enlist additional help as demand was quickly outpacing the current levels of production capacity. At this point, we realised that we needed to partner with an organisation that could deliver large-scale production without sacrificing quality. Stratasys Direct Manufacturing was an excellent fit because they have extensive experience fabricating a variety of production parts with stringent quality requirements. With their mature finishing capabilities and process flows, they were able to streamline the labour intensive post-processing steps, thereby reducing per-part costs. Additionally, SDM’s proprietary manufacturing methods allowed them to easily provide serialized traceability and consistently meet durability requirements.
While these partnerships have indeed been a great fit, the project hasn’t been without challenges which have presented learning opportunities, some unique to the medical device industry, others are more general that translate through all facets of creation. Throughout the project we observed the emergence of multiple players into the 3D printing orthotic space. It would have been easy to jump ahead with manufacturing to get products ‘out there’. However, we stuck with the plan and developed new foot orthoses that are truly differentiated and knowledge-based. This development framework underpins the sustainability of the 3D printed Podfo orthotics and new devices and approaches in the pipeline.
As 3D printing and additive manufacturing processes continue to move medical innovations forward, I believe that there are still many opportunities to be explored. 3D printing technology will drive innovation but must be exploited to develop devices with functionality that could not be achieved with conventional manufacturing. That should include adaptive properties that respond to forces, temperature and humidity. Additive manufacturing should support integration of smart sensing that improves patient interaction and use of orthotic products. Nanoscale integration of biomaterials and medicinal products, in the long-term, could extend the functionality even further. I also believe we will move to functionally optimised devices in the mid-term integrating techniques such as finite element analysis into the design-chain. Finally, we may see orthotics being printed closer to or in the home or in challenging environments in low and middle income countries using local materials and portable printing technologies.
