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Personalised prosthetic and orthotics in digitised world

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Engineering to provide solutions to needs.

As we, all know there are 7.5 billion of us living on this planet. Our shapes and forms are very close to each other, but we cannot find two that are identical. Under the skin, the functional anatomy and physiology differences are even greater. Loss of a limb or even small loss of function results in automatic compensation by body and mind resulting even greater differences between any two individuals with disability. The body machine of all aims at comfort and confidence and assistive technology is deployed in rehabilitation pathways to restore lost function to this aim.

This is the main reason personalised medical devices are tailor made to individuals and match their specification of disability. This will produce much better outcomes and in the long run provide good health economics and quality of life.

How many of us still remember the one shoe or one shirt that fitted our body so well that we search for that feeling and re-experience. The purpose of my talk at Arab Health is to discuss how to achieve this experience in prosthetic and orthotic. To get to provision of such an integrated product and service, we need to lay technological foundations and commercial demonstration of proof of concept as well validate and verify the vision before proceeding to larger investment.

Digital health acceptance plays a crucial role on the change of infrastructure. Fortunately, COVID-19 created the condition to accelerate this by user’s, payers and multi-disciplinary professionals.

To enable manufacturing of the Movement Assistive Devices (MADs) some key objectives need to be met. A Total Body Avatar will need to be created to store personalised information about the MAD’s user, gathered using state-of-the-art scanning tools. MovAiD will also advance engineering solutions to enable automatic generation of a personalised design of the MADs. To enable fabrication of morphologically- and kineto-dynamically tailored parts, advanced manufacturing solutions, including additive manufacturing will be developed. Since the design, production and assembly tasks will vary between consecutive MADs, an integration platform for their management will be formed to ensure that the production process is conducted in automated and timely manner.

The long-term vision of MovAiD is to promote development of smart, innovative and low-cost solutions and technologies, with a view on enabling emergence of new-generation Movement Assistive Devices as well as increasing the competitiveness of the European manufacturing industry. Such devices will bridge the gap between exoskeletons and classic orthotic devices, representing highly personalised solutions and featuring morphological and kinematic characteristics tailored the needs of the industry.

The Paralympic Games in London in 2012, and then in Rio later, have propelled more disabled athletes into the limelight than any games before. We have seen some astonishing success stories, resulting in the biggest medal haul of the Paralympic Games to date.

In recent decades, the most fascinating events featured lower limb amputees running on composite blades. The speed afforded by the prosthetics was amazing. The blades used in the Paralympic Games are designed with extreme sports in mind, but they are not ideal for the numerous challenging situations of daily life. Amputees must instead change between different prosthetic limbs for different purposes.

Today, our research focus lies in overcoming these everyday challenges. During the course of a typical day, a person takes a huge variety of different steps, makes numerous small movements and undertakes hundreds of complex tasks. When it comes to developing a device that can replace a missing lower limb, every motion must be considered.

The integrated prosthetic limb called ‘Linx’ is designed for people with amputations above the knee. The robotic limb has both a knee joint and a foot joint that are controlled by microcontrollers. The Linx limb is unique, mimicking natural Muscular skeletal control because both the knee and the foot can ‘talk’ to each other. In all previous prosthetics, knee and foot joints were developed separately and worked in isolation.

The need for a ‘translator’

The biggest challenge faced was developing a system that would allow the joints to communicate to each other. Let us imagine, for example, that one speaks English and the other speaks French. To make them work together, we needed to develop a ’translator’ that could understand both languages. One of my core tasks on this project was to develop the translator that holds the whole system together, and then develop additional limb functionalities.

Linx is the first commercially available system, which features communication between its joints. By communicating as a whole, the limb can react in a coordinated way to changes in gait. This offers the wearer greater stability when descending a ramp and while standing still.

True servitisation is a future reality for now. The beauty of the MovAiD framework is its holistic approach to integrate product and service provision. It considers the overall information and process flow. It is developing technologies to capture body shape and movement, undertaking musculoskeletal modelling to optimise forces acting inside and on the body of an individual wearing a MAD. Through computer simulation, the framework can optimise how a MAD performs, designs tools to define its shape, place the joint mechanisms correctly and automatically define the stiffness of the material it is made of. Then, the MAD design is sent to local and central additive manufacturing machines to create its actual design. But the MovAiD framework does not stop there. It also provides monitoring and support post-fitting. Therefore, working towards the vision of a true servitisation.

We are faced with societal challenges due to ageing populations, rising social and healthcare costs, a lack of qualified personnel in certain industrial sectors, and workplace-related injuries. MovAiD investigates how technology and additive manufacturing can address some of these challenges. This cross-disciplinary project develops technologies for manufacturing passive and highly personalized wearable equipment to assist disabled children, the elderly, and workers in their everyday lives.

Non-invasive technology is used and designed and developed in conjunction with our clinicians. Products that are clinically proven and tested to return users as close as possible to their “pre-event” activity levels whilst minimising cognitive cost, maximising symmetry, allowing users to get their lives back.

Under the current medical device’s regulatory framework, custom-made medical devices are exempt from the requirement to be included in the EU Medical Device Regulation and Australian Register of Therapeutic Goods (ARTG). Since the introduction of the exemption, the technology and manufacturing processes used to produce medical devices have changed dramatically. Higher risk custom-made medical devices, including orthopaedic implants, are now available and their continued supply under the custom-made medical device’s exemption, without independent oversight, is not appropriate.

Custom Build P&O is a patient matched device leading to Adaptable P&O, which is the next objective in personalised P&O. The pathway is clearly to offer a patient-matched medical device – an adaptable medical device at cost and speed of other mass-produced medical devices.

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Sir Saeed Zahedi 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

TAGS: Orthopedics
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