Submodule: SPE340c3 — Scientist Training Programme | Curriculum Library

Work-based content

#	Learning outcome	Competency	Action
# 1	Learning outcome 1,2	Competency Develop a detailed functional specification through discussion with the client/users, eg clinician and/or patient and their carer	Action View
# 2	Learning outcome 1,2	Competency Perform and document a design feasibility study from a functional specification	Action View
# 3	Learning outcome 1,2,3	Competency Apply the requirements of the Medical Devices Directive and appropriate standards and legislation to the design and manufacturing process	Action View
# 4	Learning outcome 2,3	Competency Perform a risk assessment; propose a risk management strategy	Action View
# 5	Learning outcome 2,3	Competency Develop technical documentation for development of a medical device	Action View
# 6	Learning outcome 2	Competency Source components and materials in the preparation of an estimate or quotation	Action View
# 7	Learning outcome 2	Competency Design and develop a medical device	Action View
# 8	Learning outcome 2	Competency Carry out validation and verification of a medical device realisation	Action View
# 9	Learning outcome 1,2,3	Competency Commission a medical device; produce protocols for its safe and effective introduction into service	Action View
# 10	Learning outcome 1,3	Competency Train and familiarise the client/user in the use of the equipment, including the development of user instructions	Action View
# 11	Learning outcome 1	Competency Review the use of a medical device to enhance function, comfort and safety	Action View

You must complete:

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

Bring new items of equipment, systems, facilities and protocols into service safely and effectively
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
According to established standards, develop and keep up to date the associated documentation, including those relating to technical construction and risk management