Peel, S.
Evidence-led Design (Guest Editorial)
2022
https://doi.org/10.1386/dbs_00030_2
Journal of Design, Business & Society, Volume 8, Issue 1.
Abstract:
As design has moved away from siloed practice related to manufacturing and decoration, so too has the perception of who a designer is and what they should do. Indeed, with the expansion of design beyond a narrow focus on the application of technical skills, towards a dynamic and inherently social mediation between often competing stakeholder aims, technological capabilities, ethical questions, governmental policies and regulatory requirements, the perceived need for specialist designers may risk being obfuscated amidst ‘design-led’ hype.
Evidence-led design can build stronger arguments in favour of particular design solutions. As design’s frontiers continue to expand, the routes into practice become more varied, and the processes gain further acceptance across industry, academia and government, the skilful generation and handling of evidence will persist as a consistent and unique characteristic. Designers should embrace this, and its implications for shrinking the gap between design research and design practice. Even where it is not mandated by regulations or standards, the routine justification of design decisions can work to build a more thorough understanding of a context, from which new factors for development might be found.
Wrigley, C., Peel, S., Ko, K., Straker, K.
Patient Names for Mechanical Circulatory Support Devices: Developing Emotional Insights
2021
https://doi.org/10.1016/j.hrtlng.2021.08.003
Heart & Lung, Volume 50, Issue 6
Abstract:
Background: Patients with mechanical circulatory support devices regularly experience positive and negative emotions which are reinforced through interactions with their device. We explored emotional relationships between patients and their MCS devices through the names they assign to those devices.
Objectives: We sought to characterise device naming and suggest future developments which might capitalise on the naming phenomenon to improve patient wellbeing.
Methods: Qualitative online ethnography extracted comments on device names and emotions from a social media group. Thematic analysis grouped the comments according to their explicit or implied emotions, and their potential consequences for designing future MCS treatment.
Results: Thematic analysis identified 28 codes to characterise the names, from which we inferred 4 main themes for proposed emotional relationships. They centred on humour, coping, improving acceptance for family and friends, and reclaiming agency.
Conclusions: We suggest that by deliberately considering these factors in future research and development, clinicians and device manufacturers have scope to improve patient wellbeing.
Peel, S., Ko, K., Nusem, E., Straker, K., Wrigley, C.
A Systematic Review of Psychosocial Design Considerations for the Next Generation of Mechanical Circulatory Support
2021
https://doi.org/10.1016/j.hrtlng.2021.01.021
Heart & Lung, Volume 50, Issue 3
Abstract:
Background: Biomedical engineers are developing new mechanical circulatory support pumps. Clinicians are generating and analysing new evidence for their prescription and management. Industrial designers are generating usable solutions for wearable components and controllers. However, psychosocial considerations may be falling between the cracks of the three disciplines because of their multi-faceted nature.
Objectives: This article seeks to identify psychosocial needs raised in previous work, re-frame them as needs for future products and services, and discuss routes to solutions.
Methods: SLR extracted 225 statements on psychosocial considerations from 42 included articles. 23 codes were inductively generated and applied to relevant data points. Codes were consolidated under 4 main themes and re-framed as solvable problems.
Results: Identified themes: expanded remote care, improved multidisciplinary management tools, creating easier interactions; and extending patient engagement.
Conclusions: Design-driven methods have been used to solve analogous problems in other contexts and can address the identified psychosocial problems if implemented fully.
Straker, K., Peel, S., Nusem, E., Wrigley, C.
Designing a Dangerous Unicorn: Lessons from the Case of Theranos
2021
https://doi.org/10.1016/j.bushor.2021.02.016
Business Horizons, Volume 64, Issue 4
Abstract:
Until its highly publicised downfall, Theranos was a so-called unicorn; with a compelling proposition to popularise routine blood testing by making it more convenient, using a smaller sample of blood, and testing at a lower cost than conventional, often fear-inducing needles. Holmes and Theranos were reliant on their development of new technology to bring their idea to life, however they instead became perhaps one of the most infamous recent example of failed product innovation.
In this paper we contend that, although character failings and alleged criminal activity could not have been realistically mitigated, valuable strategic and operational lessons can be learned for future technology start-ups. By conducting a counterfactual thought experiment and examining Theranos through the lens of Design Innovation (DI) we provide evaluations and predictions across strategic and operational constructs from both an internal and external perspective. A DI approach also applies methods and tools used by designers across a company as a whole – this mirrors an inventor-founder’s path from narrow product influence to broader environmental influences. We show that criticisms through the DI lens have specific and insightful bearing on Theranos because of its markedly poor strategic planning; manifest as a reliance on ideas and spin in place of tangible products and services. We use Theranos to demonstrate the value of DI to future technology-driven entrepreneurs, proposing alternative approaches to medical device start-ups.
Peel, S., Eggbeer, D., Dorrington, P.
Standardising the Patient-Specific Medical Device Design Process via a Paper-Based Design Pro-Forma
2020
https://doi.org/10.1386/dbs_00013_1
Journal of Design, Business & Society, Volume 6, Issue 2.
Abstract:
Purpose / audience: This study targets designers, clinicians, and biomedical engineers who are involved in digital surgical planning and patient specific medical device design; either in hospitals, universities, or companies. A commonly accepted, standardised design process does not exist in this specialised but highly variable field, and this can make regulatory compliance via the implementation of quality standards more difficult.
Methodology / approach: A paper-based design pro-forma was created based on needs identified in previous work. It was structured in order to: broadly standardise the design process; consolidate planning and modelling behaviours into discrete clusters; anticipate decision-making on key product requirements; facilitate focused discussion with clients (surgeons); create a pleasurable experience for the designer; encourage detailed reporting of design decisions; and therefore to lower barriers to Quality Management System (QMS) implementation and adherence.
The performance of the pro-forma was verified using observation, simultaneous verbalisation, and semi-structured interviews. Three participants across two contexts were observed designing without, and then with the pro-forma. Their behaviours and comments were recorded, their designed outcomes evaluated, and their quality compliance assessed.
Findings: The design workflow was shown to be segmented and contained within distinct and repeatable steps when using the pro-forma. Reported participant confidence increased and stress decreased. Contact time between participants and clients was consolidated. Designed outputs and documented records successfully complied with generalisable aspects of the International Organization for Standardization (ISO) 13485 standard. However, it did not, and by definition could never, wholly implement a complete certifiable QMS which must be tailored to a specific organisation.
Implications for practice, society, or research: As demand for patient-specific devices continues to rise, and as regulatory requirements about QMS adherence extend to cover all contexts, organisations will need to react accordingly. This pro-forma offers a clear direction for how to introduce evidence-based best practices, and a starting point for full QMS certification.
Originality / Value: This research marks the first attempt to standardise this highly specialised design process across users, tools, and contexts.
Peel, S.
Human Factors and Design for Medical Devices: A Conversation with Dr Ian Culverhouse, Co-Founder at Rebus Medical
2020
https://doi.org/10.1386/dbs_00015_7
Journal of Design, Business & Society, Volume 6, Issue 2.
Abstract:
The definition of design and the importance of designers are issues in constant flux. Design thinking as strategy, process, and toolbox is finding relevance across new contexts as ever-more complex and multi-faceted problems emerge in businesses, public services, and society as a whole. Medical device design represents perhaps the most challenging of these frontiers, especially as regulatory bodies expand their requirements for evidence-driven product validation across usability and interaction measures, in addition to traditional technical parameters. This high-risk, highly competitive, heavily regulated industry makes significant demands of designers to translate and co-ordinate between medics, academics, and engineers while meeting requirements for quality control, usability, and safety.
Dr Ian Culverhouse is a specialist in human factors (HF) for medical devices. In 2018 He co-founded Rebus Medical (with Chris White) in Bristol, United Kingdom, after working in design consultancies as a usability and HF professional across a variety of sectors. Rebus work internationally, with major medical device and pharmaceutical firms to improve the usability of critical products and to generate evidence in support of obtaining regulatory approvals. In this interview he provides his perspective on how HF and design have mixed, evolved, and to a large degree, merged over the previous decade. He reflects on the most relevant skillsets from a design education, comments on the challenges of collecting appropriate data, the impact of COVID-19, and looks to the future of HF design tools.
Eggbeer, D., Peel, S.
The Role of Computer Aided Design and Three-Dimensional Printing in Post-Traumatic Deformity Correction
2020
https://doi.org/10.1007/978-1-4471-5616-1_11
In: Perry, M. & Holmes, S. (eds.) Atlas of Operative Maxillofacial Trauma Surgery, Post-Traumatic Deformity. Springer-Verlag, London
Abstract:
Computer-aided design (CAD) in combination with additive manufacturing (AM) and computer-aided manufacturing (CAM) can produce precise medical models; virtual surgical plans; custom surgical cutting, drilling and repositioning guides; as well as custom implants. These devices, when designed collaboratively and in a robust, proven workflow, can improve predictability and outcome accuracy and save time in theatre. Whilst not being suited for use in emergency surgery, the numerous benefits demand serious consideration for use in secondary reconstruction.
Budak, I., Kiralj, A., Sokac, M., Santosi, Z., Eggbeer, D., Peel, S.
Computer-Aided Methods for Single-Stage Fibrous Dysplasia Excision and Reconstruction in the Zygomatico-Orbital Complex
2019
https://doi.org/10.1108/RPJ-05-2018-0116
Rapid Prototyping Journal, Volume 25, Issue 4.
Abstract:
Purpose: Computer-aided design and additive manufacture (CAD/AM) technologies are sufficiently refined and meet the necessary regulatory requirements for routine incorporation into the medical field, with long-standing application in surgeries of the maxillofacial and craniofacial regions. They have resulted in better medical care for patients and faster, more accurate procedures. Despite ever-growing evidence about the advantages of computer-aided planning, CAD and AM in surgery, detailed reporting on critical design decisions that enable methodological replication and the development and establishment of guidelines to ensure safety are limited. This paper aims to present a novel application of CAD and AM to a single-stage resection and reconstruction of fibrous dysplasia in the zygoma and orbit.
Design / methodology / approach: It is reported in sufficient fidelity to permit methods replication and design guideline developments in future cases, wherever they occur in the world. The collaborative approach included engineers, designers, surgeons and prosthetists to design patient-specific cutting guides and a custom implant. An iterative design process was used, until the desired shape and function were achieved, for both of the devices. The surgery followed the CAD plan precisely and without problems. Immediate post-operative subjective clinical judgements were of an excellent result.
Findings: At 19 months post-op, a CT scan was undertaken to verify the clinical and technical outcomes. Dimensional analysis showed maximum deviation of 4.73 mm from the plan to the result, while CAD-Inspection showed that the deviations ranged between −0.1 and −0.8 mm and that the majority of deviations were located around −0.3 mm.
Originality / value: Improvements are suggested and conclusions drawn regarding the design decisions considered critical to a successful outcome for this type of procedure in the future.
Burton, H., Peel, S., Eggbeer, D.
Reporting fidelity in the literature for computer aided design and additive manufacture of implants and guides
2018
https://doi.org/10.1016/j.addma.2018.08.027
Additive Manufacturing, Volume 23.
Abstract:
The aim of this study was to critically evaluate the nature and reporting fidelity of literature about applications of computer aided design (CAD) and metal additive manufacture (AM) to surgical guides and implants. Increasingly, non-specialist designers such as surgeons or prosthetists are partaking in some or all of the design process. To comply with local regulations, it is imperative that quality is ensured during the design process, yet it is rare for literature to report on the design process of medical devices with sufficient detail to allow proper evaluation or reproduction.
This study reviewed the CAD/AM literature for implant and guide design, focussing on detailed justifications for design decisions, economic impacts, and production methods. This review showed that the fidelity of reporting in the literature was low; with opportunities to report crucial design decisions, engineering parameters, and how these relate to clinical results being frequently missed.
This research proposes the low detail in reporting is likely due to a combination of: reporting for different specialisms, resulting in a lack of expert knowledge in certain areas and assumed knowledge in others; commercial sensitivity of design and manufacturing methods; low volume of clinical cases; and a large gap in translating research to clinical applications. This study concluded that higher levels of detail in reporting are required when discussing the design of AM medical implants, which would allow comparisons between studies, provide evidence to support design quality, and enable evidence-based decision-making.
Peel, S., Eggbeer, D., Burton, H., Hanson, H., Evans, P. L.
Additively manufactured Vs. conventionally pressed cranioplasty implants - an accuracy comparison
2018
https://doi.org/10.1177%2F0954411918794718
Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, Volume 232, Issue 9.
Abstract:
This paper compared the accuracy of producing patient-specific cranioplasty implants using four different approaches. Benchmark geometry was designed to represent a cranium, and a defect added simulating a craniectomy. An ‘ideal’ contour reconstruction was calculated and compared against reconstructions resulting from the four approaches – ‘conventional’, ‘semi-digital’, ‘digital – non-automated’ and ‘digital –semi-automated’.
The ‘conventional’ approach relied on hand-carving a reconstruction, turning this into a press tool, and pressing titanium sheet. This approach is common in the UK National Health Service (NHS). The ‘semi-digital’ approach removed the hand-carving element. Both of the ‘digital’ approaches utilised Additive Manufacturing (AM) to produce the end use implant. The geometries were designed using a non-specialised Computer Aided Design (CAD) software; and a semi-automated cranioplasty implant-specific CAD software. It was found that all plates were clinically acceptable, and that the digitally designed and AM plates were as accurate as the conventional implants. There were no significant differences between the AM plates designed using non-specialised CAD software, and those designed using the semi-automated tool.
The semi-automated software, and AM production process, were capable of producing cranioplasty implants of similar accuracy to multi-purpose software and AM, and both were more accurate than handmade implants. The difference was not of clinical significance, demonstrating that the accuracy of AM cranioplasty implants meets current best-practice.
Peel, S.
A New Design Process Intervention to Promote Efficient, Evidenced, and Safe Development of Patient Specific Implants and Guides
2018
https://repository.cardiffmet.ac.uk/handle/10369/10064
Ph.D. Thesis
Abstract:
This research identified drivers and barriers to routine National Health Service (NHS) adoption of Computer Aided Design (CAD) and Additive Manufacturing (AM) for the production of patient-specific devices. It proposed and verified a design process intervention, which aimed to overcome the most important barriers and better exploit the drivers. The data generated and recorded in this work spanned qualitative and quantitative findings from fourteen real-world clinical case studies, a fully-realised structure for a Quality Management System (QMS), prototyping of a design intervention in a paper-based format, and verification of its intended impacts with three users across commercial and clinical contexts.
Key barriers to routine adoption were identified as being the nature of existing publications, evolving regulatory requirements, poor awareness of design or design control, and inconsistent approaches to procuring custom devices. The literature featured necessarily short clinical follow-up, and often reported on design and fabrication methods in very poor detail – to the detriment of reproducibility. Health economics evidence was scarce. In the short to medium term future, new regulatory requirements will compel all institutions, including hospitals, to implement a Quality Management System for the design of medical devices. As such, generalisable procedures, forms, and records for compliance with the BS EN ISO 13485 quality standard were devised, and used as the foundation of the design intervention.
The QMS-led design intervention form aimed to: create fully-populated product requirements lists before commencing modelling; introduce project management, identification, traceability, review, verification, and feedback activities; improve the confidence and experience of the designer or acting designer; and prompt record keeping in-line with the requirements of ISO 13485. It achieved all of these aims, at least as far as could be ascertained within the research constraints. Further expansion and verification of the framework is required in future – across different specific surgeries and across more users.
Peel, S., Bhatia, S., Eggbeer, D., Morris, D., Hayhurst, C.
Evolution of design considerations in complex craniofacial reconstruction using patient-specific implants
2017
Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, Volume 231, Issue 6.
http://journals.sagepub.com/doi/full/10.1177/0954411916681346
Abstract:
Previously published evidence has established major clinical benefits from using computer-aided design, computer-aided manufacturing, and additive manufacturing to produce patient-specific devices. These include cutting guides, drilling guides, positioning guides, and implants. However, custom devices produced using these methods are still not in routine use, particularly by the UK National Health Service. Oft-cited reasons for this slow uptake include the following: a higher up-front cost than conventionally fabricated devices, material-choice uncertainty, and a lack of long-term follow-up due to their relatively recent introduction. This article identifies a further gap in current knowledge – that of design rules, or key specification considerations for complex computer-aided design/computer-aided manufacturing/additive manufacturing devices. This research begins to address the gap by combining a detailed review of the literature with first-hand experience of interdisciplinary collaboration on five craniofacial patient case studies.
In each patient case, bony lesions in the orbito-temporal region were segmented, excised, and reconstructed in the virtual environment. Three cases translated these digital plans into theatre via polymer surgical guides. Four cases utilised additive manufacturing to fabricate titanium implants. One implant was machined from polyether ether ketone. From the literature, articles with relevant abstracts were analysed to extract design considerations. In all, 19 frequently recurring design considerations were extracted from previous publications. Nine new design considerations were extracted from the case studies – on the basis of subjective clinical evaluation. These were synthesised to produce a design considerations framework to assist clinicians with prescribing and design engineers with modelling. Promising avenues for further research are proposed.
Peel, S., Eggbeer, D., Sugar A. W., Evans, P. L.
Post-Traumatic Zygomatic Osteotomy and Orbital Floor Reconstruction
2016
Rapid Prototyping Journal, Volume 22, Issue 6.
http://dx.doi.org/10.1108/RPJ-03-2015-0037
Abstract:
Purpose: Post-traumatic zygomatic osteotomy, fracture reduction, and orbital floor reconstruction poses many challenges for achieving a predictable, accurate, safe, and aesthetically pleasing result. This paper describes the successful application of Computer Aided Design (CAD) and Additive Manufacturing (AM) to every stage of the process – from planning to surgery.
Approach: A multi-disciplinary team was employed - comprising surgeons, prosthetists, technicians and designers. The patient’s Computed Tomography (CT) scan data was segmented for bone and exported to a CAD software package. Medical models were fabricated using AM for diagnosis, patient communication, and device verification. The surgical approach was modelled in the virtual environment and a custom surgical cutting guide, custom bone-repositioning guide, custom zygomatic implant, and a custom orbital floor implant each designed, prototyped, iterated and validated using polymer AM prior to final fabrication using metal AM.
Findings: Post-operative clinical outcomes were as planned. The patient’s facial symmetry was improved and their inability to fully close their eyelid was corrected. The length of the operation was reduced relative to the surgical team’s previous experiences. Post-operative scan analysis indicated a maximum deviation from the planned location for the largest piece of mobilised bone of 3.65mm. As a result, the orbital floor implant which was fixed to this bone demonstrated a maximum deviation of 4.44mm from the plan.
Originality / value: This represents the first application of CAD and AM to every stage of the process for this procedure - from diagnosis, to planning, and to surgery.
Peel, S., Eggbeer, D.
Additively Manufactured Maxillofacial Implants & Guides - Achieving Routine Use
2016
Rapid Prototyping Journal, Volume 22, Issue 1
http://dx.doi.org/10.1108/RPJ-01-2014-0004
Abstract:
Purpose: The technical efficacy of, and clinical benefits from the use of Computer Aided Design (CAD) and Additive Manufacturing (AM) in the production of patient-specific devices (implants and guides) has been established. Despite this, they are still not in routine clinical use. With AM equipment and CAD tool costs largely outside of the clinician’s or designer’s control, the opportunity exists to explore design process improvement routes to facilitate routine health service implementation. This paper identifies the key design process factors acting as drivers or barriers to this aim.
Methodology / approach: A literature review, three separate clinical case studies, and experience from an institute working on collaborative research and commercial application of CAD/AM in the maxillofacial specialty were analysed to extract a list of key design process factors.
Findings: The semi-digital design and fabrication process is currently the lowest cost. Critical design process factors include and stem from the robustness of the shared understanding of the surgical plan and device design specification.
Implications / limitations: Further research into the relative values of, and best methods to address the key factors is required; in order to work towards the development of new design tools. A wider range of benchmarked case studies is required to assess costs and timings beyond one implant type.
Originality / value: Design process factors are identified (building on previous work largely restricted to technical and clinical efficacy). Additionally, three implant design and fabrication workflows are directly compared for costs and time. Unusually, a design process failure is detailed.
Whitaker, M. Peel, S.
"Interview: Sean Peel"
2014
Bulletin of The Royal College of Surgeons of England, Volume 96, Issue 2
http://dx.doi.org/10.1308/rcsbull.2014.96.7.232
Abstract:
"The Centre for Applied Reconstructive Technologies in Surgery (CARTIS) is a collaboration between the National Centre for Product Design and Development Research at (PDR) Cardiff Metropolitan University and Morriston Hospital. They have been leading the way in developing new techniques and applications for 3D printing in surgery, and improving the accessibility and ease of use of these technologies in the UK.
CARTIS hit the headlines earlier this year for the role they played in a complex facial reconstruction (http://www.bbc.co.uk/news/uk-wales-26534408) in which 3D printing technology was extensively used.
We interviewed Sean Peel, Design and Research Engineer in Surgery and Prosthetics at PDR and a key engineer in recent surgical projects at CARTIS, to get an inside perspective from the frontier of this rapidly developing industry."