Prosthetic Reconstruction, Rehabilitation & Surgical Planning —
Training activity: 25

Details

Plan and design a cranioplasty implant using advanced CAD planning, and CAM 3D models

Design the custom device ‘in -house’ and research an external manufacturer for the production/manufacture

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Reflective practice guidance

The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.

Before action

• What are the advantages and disadvantages of in-house versus external manufacture?
• What are the key design considerations for a cranioplasty implant?
• What will you learn about using advanced CAD software for cranioplasty implant design?
• What are the technical considerations for 3D printing or milling a cranioplasty implant?
• How will you evaluate the capabilities of external manufacturers?
• What factors will influence the decision between in-house and external production?
• Have you developed skills in using relevant CAD software?
• Have you researched different materials used for cranioplasty implants?
• Have you investigated potential external manufacturers and their capabilities?
• Have you reviewed the surgical requirements and anatomical considerations for the specific cranioplasty case?
• Have you reviewed the medical device regulation and quality standards for a custom made implant?

In action

• While planning and designing the cranioplasty implant using CAD/CAM, are you consciously applying principles of biomechanics, aesthetics, and biocompatibility?
• What immediate design decisions are you making based on the patient’s anatomy and the surgical requirements?
• When researching external manufacturers, are you focusing on factors such as material quality, manufacturing precision, and regulatory compliance?
• Are you finding the CAD planning process to be effective in creating a precise and well-fitting implant design?
• Are you encountering any challenges in utilising the software or translating the design into manufacturing specifications?
• How does this activity connect to your understanding of cranioplasty procedures and medical device manufacturing?
• If your initial implant design encounters technical limitations within the CAD software or if finding a suitable external manufacturer proves challenging, what alternative design features or manufacturing options are you considering?
• Do you need to seek advice from experienced CAD/CAM users or explore different manufacturing vendors?
• Are you ensuring that your design and manufacturing considerations adhere to relevant medical device regulations and quality standards?

On action

• Describe the process of planning and designing the cranioplasty implant using advanced CAD planning and CAM 3D models. What were the key considerations in your design? Describe your experience of designing the device ‘in-house’. What software and techniques did you use? What factors did you consider when researching external manufacturers for production?
• What specific skills or knowledge did you develop or improve in using advanced CAD/CAM for cranioplasty implant design and in understanding the process of external manufacture? What did you learn about the different stages involved in creating a custom medical device, from design to manufacture? Were there any unexpected challenges or successes during the design process or manufacturer research? What did you learn from these? How did you balance the considerations for ‘in-house’ design versus external manufacture?
• What aspects of CAD/CAM design for cranioplasty implants and the medical device manufacturing process will you focus on developing further? How can you apply the knowledge and skills gained to future cases requiring custom-made implants? What resources or support might you need to further develop in this area, such as advanced software training or understanding of regulatory requirements for manufacturing?

Beyond action

• Have you revisited experiences with CAD/CAM designed cranioplasty implants? How has your understanding of digital workflows in prosthetic design and the considerations for in-house versus external manufacturing evolved?
• How have these experiences impacted upon your current practice in utilizing digital technologies and considering different manufacturing options for custom medical devices? Are you more aware of regulatory requirements for outsourced manufacturing?
• How might these experiences contribute towards your future practice in leading the development and production of complex implants, including managing external suppliers? What did you learn about CAD/CAM software and implant materials?

Relevant learning outcomes

#	Outcome
# 1	Outcome Deliver quality patient centred care with the best interests of patients in all elements of practice.
# 2	Outcome Practice in accordance with local and national health and safety policies, regulatory requirements and overall service governance.
# 3	Outcome Communicate effectively with patients, relatives, healthcare professionals and other stakeholders.
# 4	Outcome Identify patients who need further specialist support and refer to the appropriate healthcare specialist.
# 5	Outcome Analyse and interpret patient investigations, multimodal imaging and information.
# 6	Outcome Perform clinical investigations, formulate treatment plans and manufacture medical devices to a safe clinical standard.
# 7	Outcome Prepare surgical treatment plans for complex head and neck surgery.
# 8	Outcome Select appropriate biomedical materials and components/instrumentation used in the treatment of patients and the manufacture of custom-made medical devices.
# 9	Outcome Practice in partnership with other clinical specialisms as part of a multidisciplinary team and understand their roles and their impact on patient care and pathway.
# 10	Outcome Apply the principals of a quality management system to their professional practice.
# 12	Outcome Assess and interpret patients’ needs to provide customised treatment dependent on medical, physical, social and psychological requirements.