Medical Engineering Design (SPE340)

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
Number Work-based 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

2 1,2

Perform and document a design feasibility study from a functional specification

3 1,2,3

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

4 2,3

Perform a risk assessment; propose a risk management strategy

5 2,3

Develop technical documentation for development of a medical device

6 2

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

7 2

Design and develop a medical device

8 2

Carry out validation and verification of a medical device realisation

9 1,2,3

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

10 1,3

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

11 1

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

You must complete
3 Case-based discussion(s)
3 of the following DOPS / OCEs
Assessment Title Type
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 DOPS
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. OCE