ADAM: Anthropomorphic Design for Advanced Manufacture

The loss of a limb, either from a congenital defect or surgical amputation, e.g. through accident or disease, has a devastating effect on a person, from both a physical and emotional viewpoint, resulting in a profound lifestyle effect on the individual. In terms of a congenital defect there is the on-going and developing issue of having a significantly different capability than peers, whereas with later life amputees there is the shock of a sudden reduction in physical ability. The mitigation of this problem is to restore as much function as possible and great strides have been made in recent years in utilizing advanced materials and other technologies to develop lower limb prostheses that aid the mobility of amputees. The current landscape of upper limb prosthesis, however, is dominated by designs which are expensive, heavy and uncomfortable with limited functionality leading to poor uptake, with rejections rates up to 45% reported in some literature. Although some highly advanced designs with apparently impressive functionality have been developed in recent years, these still have problems of high weight, poor comfort and poor human-prosthetic interfacing, alongside costs being prohibitive for most individual. Moreover they are uncomfortable and difficult to control, leading to a high rejection rate and preference for simpler, less functional devices with many patients.

Our view is that the emergence of advanced manufacturing and design techniques and increased understanding of man-machine interfaces should be driving a step-change in the effectiveness of upper limb prosthesis but that this is being hindered by the lack of an appropriate design system, with the result that most of the highly advanced designs are actually of little added benefit to the patient. In this proposal we aim to develop an integrated design system in which the needs of the patient, together with constraints, such as the manufacturing technologies available and requirements for device accreditation for healthcare etc., inform the whole design to manufacture process. The core of the proposed design system is a computational platform that interfaces with the various stakeholders, e.g. clinician, designer, manufacturer, controlling data transfer and analysis and applying optimization algorithms to drive the design to an optimal for each individual patient's needs.

Realising an affordable, customised and high performance prosthesis will transform the lives of thousands of people with upper limb absence in the UK and millions on a global scale. With current advances in technology, manufacturing processes, design methods and data-handling techniques it is now possible to envisage a Design System that can integrate stakeholder input throughout the design process, thereby creating the next generation of anthropomorphic prosthetics and physical enhancements.

The development of a design system for prosthetics and orthotics will benefit the medical device industry through faster, more appropriate and more cost-effective implementation of new technology. An initial system aimed at upper limb prosthesis will be translatable to enable broader impact to other healthcare devices that require integrated design, manufacture and clinical input. Clinical service providers, such as Blatchford, will benefit from the ability to offer improved prosthetics at lower cost. Mark Croysdale, an employee of Blatchford Services, based at the National Orthopeadic Hospital, Stanmore, is a partner on this project to facilitate this impact. With a particular focus in the feasibility study on incorporating advances in Additive Manufacturing (AM) technologies, manufacturers of AM materials and systems will benefit from increased usage of the technology. The EPSRC Centre for Innovative Manufacturing in Additive Manufacturing has a portfolio of current AM industrial partners who will be able to feed directly into this design platform.

End-users will benefit from prosthetic devices with improved functionality and comfort, reducing the current high rejection rates and enabling users to perform tasks currently not possible with existing devices. Both end-users and the National Health Service will benefit from a reduction in the number of visits to clinic to have prosthetics fitted and adjusted and increased patient satisfaction. For patients requiring a series of modified prostheses (growing children for example), this will be of particular importance. The involvement of NHS Nottingham University Hospitals as a project partner and the clinical expertise and network at the University of Strathclyde will ensure clinically relevant impact.

Importantly, the proposed platform will enable advances in technology to be implemented in a safe and efficient way. For example, an increasing number of 3D-printed "Robohands" are being produced by well-intentioned 3D-printing hobbyists for children with amniotic band syndrome; however, many of these devices are being made without the input of medical professionals with no international standards and/or regulatory framework in place. The proposed project will contribute towards building such a framework, aiming to maintain the affordable production of 3d-printed prosthetic devices. Input to this project from the Centre for Healthcare Equipment and Technology Adoption (CHEATA) will facilitate achievement of this goal.