Applied Computer Aided Design and Manufacture

Details

Title

Applied Computer Aided Design and Manufacture

Type

Stage One

Module code

HPE401

Requirement

Compulsory

Module objective

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise, evaluate and apply knowledge of appropriate computer aided design (CAD) and computer aided manufacturing (CAM) principles to relevant clinical practice in a healthcare setting. This will include analysis of digital multimodal investigations spanning radiological, photographic and surface data capture systems and the application of the different strands of data to the planning and surgical requirements.

They will be able to manipulate the data to provide concise simulated surgical plans for MDT discussions and the design of devices for surgical planning and guidance to improve treatment outcomes. They will also be able to identify and select materials with the correct qualities for specific custom use and implantation.

Communication is a powerful tool to support patient understanding and consent to treatment. The impact of this plan on patient treatment can be profound and the Clinical Scientist in HSST will need to demonstrate excellent communication skills to transmit this information concisely to senior MDT staff and also to communicate complex information to the patient, carers and their families in a language they can understand. On finalising the design process the Consultant Clinical Scientist in Reconstructive Science will be expected to liaise with the MDT and commission (where appropriate) with commercial partners on behalf of the NHS to manufacture bespoke devices to fulfil a specific patient need and keep up to date with current regulation and statute on the fast moving custom- made devices market.

Knowledge and understanding

By the end of this module the Clinical Scientist in HSST will analyse, synthesise, critically evaluate and apply their specialist knowledge with respect to:

Computer Aided Design (CAD)

• the process and principles of CAD when applied to healthcare settings;
• digital data from multimodal sources;
• multiple data file formats and how they are obtained, e.g. standard triangulation language (STL);
• the composition of the digital data file, e.g. number of voxels and the impact on image quality;
• the wide range of operative procedures and the application of CAD processes in the surgical environment for multiple surgical specialties;
• the relationship of the design process and data to patients, carers and the MDT;
• the role of data interpretation in consenting patients for specific procedures in conjunction with the appropriate medical or dental consultant;
• how to enforce the relevant data protection protocols on the multiple data streams that form part of the CAD and treatment planning phases;
• how to implement the correct protocols for the emergence of software specifically licensed for healthcare use, e.g. the registration of specific software tools as a medical device;
• the implications of the use of non-medical specified software in terms of its evaluation justification and efficacy when utilised in the best interests of the patient.

Computer Aided Manufacture (CAM)

• translating the latest additive and subtractive manufacturing technologies into service transformation to improve patient treatment;
• the application and evidence base underpinning the selection of the technology in relation to specific patient devices to best suit the clinical scenario;
• the anatomical function of the body in relation to its interaction with passive (i.e. onlays) and functioning (i.e. joint replacements) devices produced by CAM;
• the justification for the selection of materials and processes chosen to manufacture in relation to the specific case presented, to include biocompatibility, anatomical function of the device, surgical approach and long-term success;
• the design, implementation and evaluation of patient pathways to incorporate these emerging technologies;
• the role and impact of technology in the public and NHS governance structures, including Health Education England, NHS England, Public Health England and the appropriate equivalents in the devolved administrations;
• the effects of the incorporation of these evolving technologies on the other services supported or carried out by Reconstructive Science on patient pathways;
• the range of stakeholders and their potential requirements, sensitivities and aspirations;
• the effects and reactions to biocompatibility/toxicity associated with materials selected for implantable devices, e.g. titanium, hydroxyapatite, polyetheretherketone (PEEK), etc.;
• factors influencing patient choice in the Clinical Scientist in HSST’s areas of service, including personal and moral beliefs and cultural practices;
• the safety and efficacy of treatment strategies in relation to the design of custom devices, including ethical, regulatory, monitoring, licensing approval from relevant bodies such as the MHRA and NICE, on-site research governance committee and local ethics committee, compliance with Good Clinical Practice (GCP), EU Directive 2001 and Declaration of Helsinki.

Technical and clinical skills

Computer Aided Design (CAD)

By the end of this module the Clinical Scientist in HSST will be expected to reflect critically on their practice and knowledge of digital design, planning and manufacture used in Reconstructive Science. They will also be expected to apply in practice a range of clinical and communication skills to advise and communicate effectively  with patients, carers, clinicians, healthcare scientists and other healthcare professionals within the MDT and will:

• analyse and review digital and analogue data from multimodal sources to develop innovative techniques and solutions for patient treatment;
• analyse qualitatively and quantitatively the performance of devices, using computer-based tools such as finite element analysis or pre- and postoperative outcome comparison for audit;
• relate specific information to integrate technology in the clinical and operating theatre environment, e.g. which screw systems and plate systems work with the custom device;
• liaise with the MDT and design protocols for best practice to improve the capture of digital information from sources such as radiology and other services, e.g. the separation of the teeth using a tongue spatula when CT scanning;
• evaluate digital data from computed tomography (CT), cone beam computed tomography (CBCT) and other sources and be able to identify anatomical landmarks and isolate them for 3D build (grey scale Hounsfield Units);
• interpret the digital data files to isolate pathological changes and abnormal structures for multidisciplinary review and patient treatment planning and subsequent manufacturing protocols;
• manipulate multiple types of digital data representing tissue, bone, muscle and soft tissue to build a complex 3D planning environment using CAD tools such as Boolean, mirror and duplication tools, morphology tools;
• utilise analogue dental casts and 3D printed models in the design and predictive planning process to improve patient outcomes;
• review this data in a multidisciplinary environment, manipulating the data to show pre- and postoperative predictive planning;
• review the data with patients and carers in a way that is easily understood, as the CAM models are powerful communication tools to understand treatment options;
• continually evaluate these fast-developing technologies;
• analyse qualitatively and quantitatively the design of devices and surgical plans, using tools such as image processing software for 3D design and modelling;
• lead on the development and integration of these multiple digital work streams into the NHS electronic record systems.

Computer aided manufacture (CAM)

The Clinical Scientist in HSST will also be able to select, use, interpret and adapt if necessary a range of tools and processes to ensure patient care is safe and meets the needs of the service users and will:

• select the appropriate technology in relation to specific patient devices to best suit the patient needs and clinical/operative scenario;
• select the appropriate materials in terms of anatomical function of the body in relation to its interaction with passive (i.e. onlays) and functioning (i.e. joint replacements) devices produced by CAM;
• justify the selection of materials and processes chosen to manufacture in relation to the specific case presented to include biocompatibility, function of the device, surgical approach and long-term success;
• accurately purvey the required design outcome for the patient to commercial and educational institutions, acting as the liaison for the NHS in terms of design, manufacture and cost imperatives after multidisciplinary discussions;
• remain open to advice from other health professionals on the application of technology and computer design and manufacture;
• participate in adverse medical device events and reporting processes;
• remain up to date with MHRA alerts and respond appropriately;
• work in the developing area of custom clinical skills models, identifying the growing importance of life-like teaching models and the use of CAM in their production;
• recognise and develop protocols and procedures for the emerging customisation of commercial products that are subsequently adapted (off license) for use in a specific patient treatment. Identify the need and subsequent justification of the adaption in the best interest of the patient;
• carry out due diligence in relation to the use of emerging products in CAM that are new in healthcare settings, e.g. the use of surgical planning models in theatre or restricted use materials for limited surgical uses;
• develop uses in the best interest of the patient, applying these innovative technologies to improve patient outcomes;
• explain and justify the current custom device interventions, identifying where Reconstructive Science services may be used or changed to improve the patient journey.

In addition they will be aware of their own attitudes, values, professional capabilities and ethics and critically reflect on (i) their professional practice and (ii) the challenges of applying research to practice in relation to these areas of practice, identifying opportunities to improve practice building on a critique of available evidence.