Additive-manufacture for Design-led Efficient Patient Treatment - ADEPT

Lead Research Organisation: Cardiff Metropolitan University
Department Name: Product Design and Development Research

Abstract

The research team created for this project would seek to inform the development of intelligent software systems that
capture the tacit knowledge of designers, engineers and medical specialists into vastly improved laser melting driven
production chain. The academic partner's role in this project is aligned to enabling the design freedoms and IP frameworks
of AM to create successful business transformation. The purpose of research within this project is to improve the
applicability and acceptance of a new service, where the aim is to create a commercially viable output that is significantly
more efficient than competitors. In order to achieve this, structured research based on a Design Research Methodology
(DRM) framework (Blessing and Chakrabarti, 2009) would first seek to define research goals, establish the criteria of
success and identify influences and how they interact.
This first research phase is linked to project work package 1. This is fundamentally about understanding end user (the
medical specialists who would use the new service) requirements in terms of implant design intention and software
interface requirements. The research team would work with the Maxillofacial Unit at Morriston Hospital and other end
users to employ the principles of a User-Centred Design (UCD) approach. UCD is multidisciplinary approach that requires
experts from various disciplines to examine, analyse, interpret and synthesise user needs and behaviours and translate
these to end products, often in an iterative process. It is value-adding both in terms of improved design output (leading to
greater commercial success) and in considering the overall experience of product/service interaction for the user. Crucial to this approach is the involvement of product/service users, in this case medical professionals, in the very early stages of
insight generation, through to the development and evaluation of concepts. This is contrary to more commonly used
approaches that first establish concepts and prototypes before engaging with the end users. The approach significantly
reduces the risk of developing services that do not meet the market needs.
A combination of observational techniques and structured reviews would be used during work package 1 to capture user
requirement at the points of potential application. Stakeholder interaction mapping would be used to define and quantify
how new services developed as part of this project would impact implant production. The data generated would be used to
define an optimum workflow, measures of project impact and a product specification, against which new approaches can
be developed. This information would be used to develop a testable software-based platform based on low-fidelity, 'throw
away' prototyping for evaluation by end users. Low-fidelity prototypes are not constrained by current technical knowledge
and by nature contain no coding that could be used in the final solution; they are, however, an important mechanism that
will be used to assess the user requirements that may make the product successful in the market, without committing the
significant resources required to build a final system. User feedback will be used to filter more viable options into highfidelity,
evolutionary prototypes, with increased function. These prototypes would be evaluated in theoretical clinical case
studies that can be evaluated against the specification developed in work package 2.
User-insight generated research developed during work packages 1-3 would then be used to inform the software
engineering team for final, functional product development.
Benchmark data and the concluded impact measures defined during work package 1 will be used to evaluate the
demonstrator platform created in work package 7. This would determine the effectiveness of the project and research
outcomes.

Planned Impact

The research combines Renishaw's Laser Melting AM technology with patient-specific medical device expertise at PDR
and the supply chain and material expertise of LPW, and evaluates the resulting implant concepts in a challenging clinical
environment. This would have direct impact to the project consortium and indirect benefits to the wider research
community, through which findings can be translated to new areas. The research would have the methodology to create
realistic benchmarks that will enable changes in surgical procedures using AM-enabled services to be measured. Direct
beneficiaries are envisaged to be healthcare service users, patients of the service providers, project industrial partners and
the design and engineering research communities. Appropriate methods for dissemination would ensure that each of these
potential beneficiaries are targeted appropriately:
- Healthcare service users (UK NHS and worldwide)
The project seeks to develop a vastly improve service which healthcare providers will be able to access. By reducing the
barriers of engagement and improving the efficiency of patient specific implant production, healthcare providers would be
become more competitive and agile in planning surgical intervention, reduce cost associated with stock inventory and
access services that offer an improved product quality over those currently available. Based on the service being used for
the calculated addressable market potential of 22,500 worldwide cases per year, an estimated 1,845,000 man hours could
be saved. Impact to this primary, service user group would be ensured through disseminating research in relevant journals
(such as the British J. Oral Maxfac Surg, J. Eng. In Medicine and open access journals such as the Open Neurosurgery J.)
and conferences (such as Advanced Digital Technologies in Head and Neck Reconstruction and the annual British
Association of Oral & Maxfac Surgeons). Professional network events and hospital research group meetings would also be
used to ensure interdisciplinary dissemination.
- Patients
AM production is proven to offer improved product performance in terms of fit. This project would enable these anatomical,
aesthetic advantages to be delivered to more patients, dramatically more efficiently. This would result in a reduced number
of bed days (waiting for surgery), more predictable surgical outcomes (more advanced ability to preview and verify the
optimal surgical outcome) and reduced numbers of invasive procedures (improved communication should result in the ability to achieve an optimal result first time). Information on the project would be made available to patients via the project
website. Further dissemination would be offered via the application of the newly created service.
- Industry lead and partner
Research undertaken as part of this project would enable the lead partner and the industry partner to enter new markets
worth a calculated £18m/yr. The capability enabled through this project would also create a platform to launch into further,
emerging markets where the benefits of an AM approach are constrained due to process inefficiencies and lack of design
user insight. Impact would be ensured throughout the interdisciplinary research during the project with trade events (such
as TCT Live) and a strategic marketing strategy developed towards the latter project phases used to increase market
awareness.
- The Research Community
The design research community would directly benefit from case studies that demonstrate the potential of employing a
structured, user-centric approach to generate a positive economic and social impact. The interdisciplinary nature of the
work would create opportunity for academic dissemination through broadly appealing journals for: the AM/Rapid
Prototyping sector (the Rapid Prototyping J.), the design research sector (Design Management J.) and biomedical design
engineers (J. of Eng. in Med.).

Publications

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Peel S (2018) Additively manufactured versus conventionally pressed cranioplasty implants: An accuracy comparison. in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine

 
Description We have undertaken benchmarking activities that have compared various methods of producing patient specific implants. We have discovered that lab-based methods of implant production in the UK are competitive in terms of price when compared to current advanced manufacturing alternatives, but that this project has potential to challenge this. We have also helped to develop prototype software that can automate the design of implants and link into a 3D printing production process.
Exploitation Route We have a number of on-going studies that seek to validate the project in terms of: 1. applicability/acceptance to the intended end users (surgeons) 2. design/manufacturing process efficiency. We are using a Design Research Methodology-based approach as a method of identifying the impact of our work on the wider healthcare system.

We have one design-related conference paper accepted that discusses the use of our user-centred design approach to software development. We are also drafting 3 other papers that will discuss the technical aspects of the work and methodological approach we are using to illustrate wider impact.

We will soon be placing an animation of the current software prototype in action on the ADEPT project website along with other information about the project that is relevant professionals and health service users. We will also target medical professionals at conferences and one-to-one meetings to demonstrate the newly developed software and product outputs. Ultimately, we also anticipate the commercial project partners to utilise the results to inform the development of a new service. The public will benefit from the project outputs through the adoption of a more efficient service.

Given the commercial sensitivity of the project at this stage, further details cannot be provided without project partner consent.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

URL http://adept-project.co.uk/
 
Description The research directly informed the creation of a new software that semi-automates the design of patient specific implants. This software has been launched commercially by the lead industry partner and is being used by NHS hospital in the UK. It has created a new business for Renishaw and reduces the time clinicians sped designing implants.
First Year Of Impact 2017
Sector Healthcare,Manufacturing, including Industrial Biotechology
Impact Types Economic

 
Description 3 year research collaboration with Renishaw 
Organisation Renishaw PLC
Country United Kingdom 
Sector Private 
PI Contribution The collaboration was established in March 2017. The collaboration seeks to pioneer new design methods that will bring engineering levels of precision to complex surgical procedures. Improving the accuracy and predictability of medical procedures has the potential for life-changing results and efficiency improvements for healthcare providers. Renishaw's expertise in technologies such as 3d printing in metal - which is used to create highly accurate custom implants and devices - will be harnessed through PDR's experience in research and design of the devices.
Collaborator Contribution This collaboration is an opportunity for Renishaw and PDR to further exploit their respective expertise in metal 3D printing and design of custom medical devices with the aim of improving patient outcomes. Having already collaborated on the InnovateUK and EPSRC funded ADEPT project, it became obvious that by combining the strengths of our two organisations, an opportunity existed to make a positive impact on the delivery of custom medical devices.
Impact none yet.
Start Year 2017
 
Title ADEPT software 
Description The software was developed as part of the ADEPT project. It is now being used by the UK NHS. 
Type Diagnostic Tool - Imaging
Current Stage Of Development Market authorisation
Year Development Stage Completed 2017
Development Status Actively seeking support
Impact none notable at this early stage of commercialisation 
URL http://resources.renishaw.com/en/details/--94165
 
Title ADEPT - software to automate the design of cranioplasty and orbital floor implants 
Description The software allows medical specialists, such as surgeons and technicians, to semi-automatically design cranioplasty and orbital floor implants. It was developed as a direct result of the ADEPT project and unlike current alternatives, provides an easy to use interface with inherent CE requirements built in. ADEPT is offered standalone, as part of Renishaw's LaserImplants service or can be supplied with their proprietary Laser Melting additive manufacture systems. 
Type Of Technology Software 
Year Produced 2017 
Impact Renishaw have provided this software to a growing number of UK-based NHS hospitals who are using it as part of their implant creation workflow. This helps the NHS to improve workflow efficiency and automate what would otherwise be a complex design process that relies on external service suppliers. 
URL http://www.renishaw.com/go/en/craniomaxillofacial-implants-and-software--42111