Module - Medical Engineering Design


Work-based learning outcomes


  1. Bring new items of equipment, systems, facilities and protocols into service safely and effectively
  2. Specify, design, build and bring into service pieces of equipment, using formal design processes, to be used either (a) in a biomechanical or functional assessment, including validation against current clinical methods, or (b) to meet a specific clinical need for a particular clinical problem, including measurement of performance
  3. According to established standards, develop and keep up to date the associated documentation, including those relating to technical construction and risk management

Work-based Competencies


Learning outcome Title Knowledge
1 1,2

Develop a detailed functional specification through discussion with the client/users, eg clinician and/or patient and their carer

  • Relevant aspects of medical background or clinical setting
  • How to elicit the clinical requirements from the client/user in a process of contract review
  • Awareness of standards and models, such as British and international standards
  • Awareness of importance of involving the end user in development of the specification and subsequent design stages
2 1,2

Perform and document a design feasibility study from a functional specification

  • Formal design processes, such as from national or international standards or a recognised model
  • Relevance of literature/commercial product reviews
  • Use and application of design evaluation methods, eg weighted matrices
3 1,2,3

Apply the requirements of the Medical Devices Directive and appropriate standards and legislation to the design and manufacturing process

Relevance of Medical Devices Directive (MDD) Essential Requirements to medical devices, including custom made devices

4 2,3

Perform a risk assessment; propose a risk management strategy

Local, national and international risk assessment procedures – assessing, scoring, evaluating and reviewing

5 2,3

Develop technical documentation for development of a medical device

  • Requirements of the MDD and local guidelines
6 2

Source components and materials in the preparation of an estimate or quotation

  • Local procurement guidelines
  • Departmental costing mechanisms, eg workshop time
7 2

Design and develop a medical device

  • Familiarity with limits, fits and tolerances in manufacture, and justification of selection of dimensional specifications
  • Appropriate manufacturing, fabrication and assembly techniques
  • Relevant design and manufacturing quality/safety standards/guidelines and their application
8 2

Carry out validation and verification of a medical device realisation

  • Familiarity of methods of validation and verification in the design process
  • Relevant standards/guidelines and their application
9 1,2,3

Commission a medical device; produce protocols for its safe and effective introduction into service

  • Medical device life cycle
  • The importance of training the end user
  • Documentation, including technical files and user instructions
  • Measurement of outcomes
  • Risk assessment methods/techniques and their application
  • Relevant local guidelines on equipment procurement, commissioning  and maintenance
10 1,3

Train and familiarise the client/user in the use of the equipment, including the development of user instructions

  • Approaches in use locally for client/user training and the inherent limitations of these
  • Mechanisms to establish and use feedback from clients/users
  •  Appropriate justification and control of technical files when changes are made to designs and associated documentation, eg user instructions
  • Mechanisms to establish and use feedback from clients/users
11 1

Review the use of a medical device to enhance function, comfort and safety

  • Approaches in use locally for client/user training and the inherent limitations of these
  • Mechanisms to establish and use feedback from clients/users
  •  Appropriate justification and control of technical files when changes are made to designs and associated documentation, eg user instructions
  • Mechanisms to establish and use feedback from clients/users

Work-based assessment


Complete 3 Case-Based Discussion(s)
Complete 3 of the following DOPS and/or OCEs
Type Title
DOPS Present a functional specification to a project initiator.
DOPS Lead a project design multi-disciplinary meeting to formally appraise the developed design concepts.
DOPS Produce a CAD drawing, or part thereof, from the specification for either a mechanical or electronic piece of equipment
DOPS Demonstrate appropriate analysis/critique/detail development of a design throughout the process.
DOPS Manufacture or assist in the manufacture or direct the manufacturing of the designed equipment.
DOPS Perform verification and validation tests on the equipment produced.
DOPS Commission the piece of equipment, taking account of staff and patient safety issues
DOPS Appraise commercially available products against the design specification in order to justify the development of a custom made device, or part thereof
OCE Present to the project team and other healthcare professionals the final piece of equipment produced, including compromises in the design, risk assessment, test results and competitor analysis.
OCE Provide training to healthcare professionals and/or the patient in the use of the equipment, using both verbal and written instructions.
OCE Lead a meeting to produce a risk assessment for the piece of equipment being commissioned.
OCE Obtain a patient history from a normal volunteer or typical patient referred to your service and present the findings to a colleague or peer.