Decentralized digital Prosthetics - CALCE

CALCE uses web platforms and 3D scanning points so anyone with a 3DPrinter can print a final health product

In Southamerica there is an important prosthetic deficit, this is because there is lack of professionals (Certified Prosthetist/Orthotist, CPO for short) who are the ones that can manufacture it. Additionally, the process is a very handcraft one, specially the one related to the socket, the most important piece of any prosthetic, as it is the one that connects the residual limb of the patient with his prosthetic. This process usually takes 1 or 2 weeks for any CPO. Just in Chile a patient has to wait 1 1/2 years in order to get their prosthetic and this reality is a latent one in South america, In Chile there are 4500 amputees per year, and in Mexico this numbers ups to 32.000, just because of Diabetes. The "socket market" moves around US$35MM just in these two countries, while in the entire word this market moves US$1200MM.

CALCE aims to solve this problem, using Software as a Service (SaaS) that integrates web platforms, 3D scanners and 3D printers in order to obtain a lower limb prosthetic. This kind of focus can easily double or triple the productive capacity of the CPO's, reducing at the same time 50% of the costs that involves manufacturing the socket and other devices. The new process uses non-industrial 3D Printers and available market 3D filaments such as PLA. This technological aim is fundamental in order to obtain a decentralized network of 3D Printers that can print with a healthcare purpose and not just for hobby-like interests, this also increases prosthetic coverage, lowers down the investment of any healthcare institution and powers up the local 3D printing environment.  

Right now, the socket printing service (and other healthcare devices) is provided entirely by CALCE SaaS, with more than 70 patients in the most prestigious rehabilitation institutions of the Chilean Ministry of Health , like the Instituto Nacional de Rehabilitación Pedro Aguirre Cerda  (INRPAC), and also on the private work insurance institutions like MUTUAL de Seguridad, doubling the productivity and increasing important metrics in all of them.

The innovation consists on using existing technologies (3D scanners/printers) in order to increase the prosthetics production. Traditionally, in order to make a socket, the CPO uses cast molds positives, rectifying them with manual tools to get the correct model. In our focus, CPOs only indicates the design of the socket and the technologies does the rest. For patients, this reduces rehabilitation time, because they don’t need to move at CPO’s workshop, instead the 3DScan and the final assembly can be done in the same place where the patient lives, this is especially important in remote places.

The innovation includes the CPO's knowledge about the correct form the socket must have. This is done on a web-platform specially designed for them, where they can give indications on the 3D model trough color marks and comments, and then anyone else can print their model. 3D Scanning and web interface consumes about 20 min (in contrast with the 3 hrs on traditional method) allowing the CPO to do more patients.

The solution also empowers the local 3D printing community such as users/fablabs/universities/companies letting them know there is a final medical device ready to be printed.

• Web Platform: Digitally acquire the CPO knowledge on the 3D models of different patients is a must. This is important in order to start using others tools associated with big data and machine learning.

• Manufacture: Using Desktop 3D-Printers is a blessing because of their availability, but keeping the resistance of their print is crucial in order to keep using them. 3D Printing parameters for different machines should be established.

• Devices: ISO 22523:2006 Certified in socket resistance. Incorporate  new medical devices to enrich the network like 3D facial compression mask for burn injuries. Look for more products is crucial.

CALCE aims to effectively use and coordinate the current manufacture resources with the needs of the medical industry.

This vision implies having different types of medical devices with their requirements and different types of manufacture devices asides from 3D Printing in order to comply those requirements. The final goal is to get manufacture users aware that they can contribute with the medical industry.

For the prosthetic sockets however, in south america there a lack of CPO’s so their productivity should be maximized, incorporing kinesiologist to the scanning network and let the CPO’s do the rest of the assembling is crucial.

3D Scanning kit is deployed into the CPO institution, along with a 2 hour capacitation on how to use the scanner and the web platform. After that, they start scanning patients and 3D Printed sockets arrive 3 works days later, so they can assemble it with the rest of the prosthetic (tube, foot, adaptors, etc.)

Healthcare Institutions targeted are often from government, non-profit or from work insurance. So any user in need of a prosthetic can access to the new technology if they are registered in the corresponding healthcare insurances (public and private).

Right now, there are 70 users who are using one of our prosthetic sockets with the new innovation process. The principal benefit for them (asides of a prosthetic) is the speed at what they are getting it.

In institutions where the innovation has been deployed, typical wait time is about 3 weeks, and that is after they have been waiting for a year and a half in order to get their prosthetic (lack of CPO’s in Chile). So, with the innovation process the wait lists are severely being diminished thanks to the 18 Hrs printing time of a prosthetic Socket.

In 12 month, the innovation aims to have impacted in 250 users that are using a prosthetic with a 3D printed socket, they we’re all have been served from a healthcare institution who have adopted the innovation with supervision of the physiatrist and CPO. Also, at that time it is expected to have a network of 6 3D printer institutions that can print the final socket asides from CALCE (who is doing it right now)

In 3 years, the impact should be in all South America, covering more than 10.000 patients annually.

The team has a strong component on technology, it is composed from electrical, mechanical and software engineers, which aims is to solve the different needs from healthcare manufacturing with technology-like solutions.

CALCE also has industrial designers so they can land a ready to-use solution achieved in a pre-stage by the engineering team.

Finally, we have different health related advisors such as  the University of Chile through their incubator and accelerator comercial programs; Open Beauchef and Beauchef Acelera and the Ministry of Health for deploying the solutions in our country.  

The current revenue model includes a final payment that includes the whole service, that is:

• 3D Scanning (done by the client with CALCE scanners)

• Web Platform

• 3D Design

• 3D Print

• Delivery

This is the same for the 3 Product that CALCE has (3D Cosmetic covers and 3D compression masks).

But for the future, the revenue model should be more like a Service as a Software one, where the web platform performs all the coordination between the institution that needs the manufacture of a medical device and a institution that can print it or manufacture it.  Also it is desirable that the 3D Scanners are rented or buyed by the Healthcare institution.

So CALCE should receive a fee for each transaction, estimated in 30%,  where the medical institution pays and the manufacturer and they gets the other 70%.

In this way, the cost of expanding and increasing the manufacturing capacity are minimal and it just related to adding more 3D Printing Partners.

We believe that validating your innovation day at  day is the angular stone in order to get it successful at the end. This validation not only consist on consulting our clients, but to be always interacting with the innovation global network so we can learn much of the community.

We are applying to SOLVE in order to know more about the innovation global community, get to know successful innovations and how to apply that experience to CALCE.

Particularly we are very interested in professor Hugh Herr from the biomechatronics MIT Lab in order to know his vision about the innovation.

Every medical device has certain requirements to get manufactured,  from just design to physical and heat resistance they all have to be completely satisfied in order to contribute to healthcare. And in order to keep the low-cost of all the products CALCE must work with desktop printers so keeping the quality at the top will definitely a hard endeavor.

MIT has a great reputation on technology, so landing their solutions into the low-cost manufacturing is pretty desirable. In particularly we would like to meet Professor Hugh Herr form Biomechatronics Labs and their work.