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More about our Business Model:
-How do you subsidize for those from developing countries. Will the devices be provided at no cost?
LegWorks has a social business model that uses tiered pricing to ensure all amputees get access to high-quality prosthetics. We design high-performing products that enable amputees to walk with confidence and make sure we can manufacture these products affordably. We then sell these products at appropriate prices that allows us to be financially sustainable as a company while ensuring the highest level of distribution possible.
In countries where health insurance systems are in place, we make sure our products are covered by insurance. In countries where there are no health insurance systems in place, we make sure our product can fit into the budget of an NGO. We never price our product to the “highest willingness to pay” – providing access to our products to as many amputees as possible trumps our bottom line (hence why we are a social business).
Because our products are so high quality, we can sell in the highest income markets (e.g. USA & Germany) and also serve amputees living in harsh developing world conditions (e.g. Cambodia, Haiti, Tanzania). Overall, our blended margin allows us to be financially sustainable in the long-term which means we have the product, funds and team to tackle distribution in hard to reach developing world countries. We have now sold our first product in over 20 countries. Last year, 25% of our volume was sold in the United States, from which we made over 40% of our revenues for the year. Over 40% of our volume was sold to partners in the developing world, the majority of which fit low-income patients for free. This volume made up 25% of our revenues. (The remainder of our volume and revenues came from Europe and Australia). We do charge our humanitarian provider partners for our product ($200 per knee). These providers then fit patients – some charge a small fee for the fitting, but many fit patients at no cost.

More about Fit and Training:
-How would a child with very limited resource get the device serviced/repaired? How will implementation of your device address challenges around fitting, training by physical therapists, durability over time, etc.?
Durability and usability are certainly of top-most importance when providing assistive technology (1). Our approach is 1) to engineer and test our knee technology to the highest standards, for the most demanding users, including extremely active kids and adults. In particular, while most prostheses intended for developing countries are not tested or pass at even low loading levels, the All-Terrain Knee has successful passed at the highest loading level (based on the independently conducted ISO 10328 structural tests for prostheses conducted in 2016). As such, in high-income countries we are able to successfully market the All-Terrain Knee to the most demanding and physically active users for use in water, salt water, and dirty environments with minimal requirements for maintenance.
Over the past 10 years, we have tested the All-Terrain Knee technology in long-term clinical trials in both low and high-income countries (covering a broad range of environments, mobility conditions etc), so we have assessed the knee joint technology as both highly durable and reliable, and this will similarly be translated to the pediatric knee. Also, the All-Terrain Knee is FDA and CE approved.
While even the most durable devices can ultimately break down and need servicing, our number 2) way to ensure that a device can be serviced and repaired is to keep the design as simple as possible. The knee was designed to be able to be assembled, repaired, and replaced with only the use of simple, easily accessible hand tools. To prove the point, a couple of years back we asked our bright (but not technically trained) CEO Emily to fully dissemble and assemble the All-Terrain Knee. She was able to do so in about 30 minutes on her first try with minimal instructions. For a trained person, this process takes about 10 minutes.
To facilitate repairs and servicing, LegWorks has worked to develop a highly refined instruction manual and videos for our customers. These resources and the simple design of the knee also help to ensure usability. The robust mechanics mean that the knee is not fussy in how it is setup and how it operates, making it possible to achieve satisfactory fittings and get people walking well quickly, even in areas of the world where technical and clinical training is limited. Finally, the stability of the knee helps to prevent falls, thereby decreasing the likelihood of damage to the prosthesis due to fall, and increasing the expected lifetime of the device.

-What type of expertise is needed to appropriately fit these products and service them? And will that expertise be available in the target regions? How often will a child need to replace their prosthesis to ensure that they are not doing damage to their bodies due to poor fit that results from normal growth over time?
The All-Terrain Knee and the paediatric version in development are very simple devices to install and adjust. The adult All-Terrain Knee has been fit successfully by both trained and certified individuals (Class 1 – Prosthetists, Class II – Orthopaedic Technicians, and Class III – Technicians) and untrained individuals. The more complicated aspect of a complete prosthesis delivery is the prosthetic socket, which is often made and provided by a Class 1 or 2 professional or under the guidance of one, the traditional path in most lower resourced settings.
As the child grows, the paediatric All-Terrain Knee will continue to meet their needs due to its high-functionality and high weight rating. The two parts of the prosthesis that will need to be most frequently modified/replaced as the user grows is the socket and the pylon. It depends on the growth rate of the individual, but this may occur approximately every two years with the knee being able to perform well into the user being a young adult.

1. Wyss D, Lindsay S, Cleghorn WL, Andrysek J. Priorities in lower limb prosthetic service delivery based on an international survey of prosthetists in low- and high-income countries. Prosthet Orthot Int. 2015 Apr;39(2):102-11.

Thank you for your comments and questions! We are happy to provide more information. We are going to focus on technical questions and product development in our first response, and then will focus on fit and business model questions.

-More about our research and testing:
The research we refer to was conducted in an academic setting and independent of the company. For the past 10+ years Jan has led a research program at a University-affiliated research hospital specializing in pediatric disability. As part of the development of the novel technologies used in the All-Terrain Knee (to also be used in the pediatric knee), he and his team have conducted and published in high-impact peer-reviewed journal a number of clinical studies.
One of our first clinical pilot studies involving children, published in an IEEE journal in 2005 (well before the establishment of LegWorks in 2014) demonstrated a statistically significant decrease in falls from 1 per day with high-end polycentric (4 and 6 bar linkage knees) to once per month (on average) with our knee locking technology (1).
These results have been reaffirmed in young adults using the All-Terrain Knee in a study conducted between 2012 and 2014 (2) that demonstrated improved stability and safety over weight-activated knee technologies, which themselves are considered to be highly stable and safe within the prosthetics industry.

-More about the locking mechanism of the knee for children:
The locking mechanism in the knee is automatically activated and deactivated based on the loading of the lower limb. Hence, upper extremity use is not needed for the main function of the knee. Additionally, it should be noted that the knee was successfully tested with children having both traumatic and congenital amputations (3).

-Involvement of end users, prosthetists, and physical therapists in the R&D:
An integrated and multidisciplinary approach is at the core of all our research and development activities. Practitioners and end-users are involved in all of our work, in one way or another. At the onset of our work with the All-Terrain Knee, we solicited the input from children via interviews (1). We continue this approach, using surveys and interviews to inform not just our work, but the work of others in pediatric rehab and developing countries (4, 5, 6). Furthermore, the bulk of our studies and development activities have included clinicians (prosthetists and physical therapists) as co-investigators and co-authors.
For the development of the pediatric knee, the work will continue to be conducted in close collaboration with clinicians at Holland Bloorview, Canada’s largest pediatric rehab hospital and also where Jan’s research lab is located. We will also continue to work closely with clinicians from our other partners organizations including Exceed International (providing prosthetic services and education in 5 countries in Southeast Asia) and MOI in Tanzania where we have ongoing monitoring and evaluation studies with the All-Terrain Knee. On the development team, we also have an above-the-knee amputee who is a daily user of the All-Terrain Knee, who provides a unique perspective of being able to experience the product’s functionality and know the design/technical specifications. Finally, and most importantly, the prosthetic user will be involved in all stages of the design and testing process, to ensure the knee can be designed and refined to meet expectations.

Full Citations:
1. Andrysek J1, Naumann S, Cleghorn WL. Design and quantitative evaluation of a stance-phase controlled prosthetic knee joint for children. IEEE Trans Neural Syst Rehabil Eng. 2005 Dec;13(4):437-43.
2. Andrysek J1,2, Wright FV1,3, Rotter K4, Garcia D4, Valdebenito R4, Mitchell CA4, Rozbaczylo C4, Cubillos R4. Long-term clinical evaluation of the automatic stance-phase lock-controlled prosthetic knee joint in young adults with unilateral above-knee amputation. Disabil Rehabil Assist Technol. 2017 May;12(4):378-384.
3. Andrysek J, Redekop S, Naumann S. Preliminary evaluation of an automatically stance-phase controlled pediatric prosthetic knee joint using quantitative gait analysis. Arch Phys Med Rehabil. 2007 Apr;88(4):464-70.
4. Kam S, Kent M, Khodaverdian A, Daiter L, Njelesani J, Cameron D, Andrysek J. The influence of environmental and personal factors on participation of lower-limb prosthetic users in low-income countries: prosthetists' perspectives. Disabil Rehabil Assist Technol. 2015 May;10(3):245-51.
5. Wyss D, Lindsay S, Cleghorn WL, Andrysek J. Priorities in lower limb prosthetic service delivery based on an international survey of prosthetists in low- and high-income countries.
Prosthet Orthot Int. 2015 Apr;39(2):102-11. Epub 2013 Dec 13.
6. Sayed Ahmed B, Lamy M, Cameron D, Artero L, Ramdial S, Leineweber M, Andrysek J. Factors impacting participation in sports for children with limb absence: a qualitative study.
Disabil Rehabil. 2017 Mar 12:1-8.