Development of a bionic forearm prosthesis “Zeus” with a modular design, high impact resistance and intuitive movement control based on biosignal processing

Project title

Name of Beneficiary/Beneficiaries

Aether Biomedical

Name of programme

Operational Program “Smart Growth”

Competition

Fast Track – Accessibility Plus

Project value

PLN 4,047,356.00

Funding value

PLN 2,428,413.60

Project delivery period

01.11.2019 – 31.12.2022

Results of our work

Video

Issues addressed

Initially, the main problem that we tried to solve in this market was the lack of a prosthesis that would be functional enough to enable amputees or people with congenital absence of an upper limb to regain mobility, facilitate everyday life, and be affordable. Following this trail, we encountered many other, even more important, issues that needed to be resolved. This included a high “rejection” rate (the percentage of users who stop using their prostheses). Going further, it turned out that prostheses break down very often and this cannot be avoided because the devices currently available on the market send no sensory feedback (“feeling”) to the user. When the devices broke, they went back to the prosthetists first. The prosthetists sent them back to the makers. In the meantime, the patient, if lucky, received a replacement that had already been used by a number of other people before, and if not, had to wait from 3 to up to 8 weeks for the own prosthesis to be returned from the manufacturer after repair. Gradually delving into these problems and taking a very customer-centric approach, we decided to solve all these problems with “Zeus”, which was to become a cure for the harm done to patients by the existing system.

So, what did we do solve these problems? We invented a modular structure which allows each repair to be performed on-site in a prosthetic facility by a prosthetist within up to 15 minutes (of course, we train each of our clients for this purpose), so the patient does not leave the facility without his or her prosthesis.

Project beneficiaries

“Zeus” is a multifunctional bionic upper limb prosthesis featuring intuitive control, exquisite workmanship and functionality that allows the user to regain mobility. It is characterized by high grip strength, up to 152 N, which makes it the strongest prosthesis currently available on the market – it can hold a weight of up to 35 kg and is resistant to impacts. Thanks to these features, the user will have no problem with grabbing a shopping bag, holding a glass or mug in his hand, or even holding a pen, and will be able to do certain things (like riding a bike) for the first time in their life. The authors of the device wanted people who choose “Zeus” to continue living as much as possible like they did before the amputation, to be open to new activities and challenges and not to lose self-confidence.

“Zeus” is a class I medical device with the “CE” marking. It is sold in the USA, Canada, Mexico, 12 European countries and 4 countries in Asia. In the USA it is reimbursed by Medicare (the American equivalent of the Polish National Health Fund). In Poland, the purchase can be fully financed by the State Fund for the Rehabilitation of Disabled Persons (PFRON) as part of the “Active Self-Government” program.

The prosthesis can be used after three types of amputation: below the elbow, above the elbow and with exarticulation of the shoulder joint.

Even though we operate in a B2B model (i.e. we sell our products to clinics, centers and prosthetic workshops), our solutions are aimed at providing support not only to medical staff (prosthetists, physiotherapists, ergotherapists, rehabilitators, occupational therapists) but, above all, patients who are the target users of the “Zeus” prosthesis.

“Zeus” prostheses is already used by half a thousand people around the world, including over 50 soldiers and civilians who suffered as a result of the conflict in Ukraine.

Major implementation challenges

The most difficult aspect of the project were the epidemiological conditions in which Aether Biomedical had to carry it out. The unstable situation during the CoViD-19 pandemic in Poland was associated with repeated quarantines of R&D team members, which significantly delayed our work on the project and, consequently, the schedule of individual phases.

Moreover, the disruption of supply chains resulted in the extension of order fulfillment times for key components, which delayed the stages of R&D work planned in the pre-pandemic reality.