EBME Forums Forums Management Training What to teach undergraduate medical engineers?

Hello
I'm responsible for a 3rd year module (single semester, 10 credits) in a Medical Engineering undergraduate degree. It's called 'Medical Device Evaluation' and currently is aimed at teaching the skills and knowledge that are used in a NICE-style health technology assessment (HTA) of medical devices.
These are the current learning outcomes that I would like to review:

Evaluate the value proposition (benefits and costs) of a medical technology to the UK NHS:
• Explain the reasons, processes, and implications of health technology appraisal for drugs and medical devices
• Design systematic search strategies to find appropriate evidence (clinical studies)
o Read clinical studies and identify their strengths and weaknesses (critical appraisal)
o Summarise the clinical effectiveness
• Build or review the economic case for using a medical technology
• Identify evidence gaps and design a study to address these
• Appraise the clinical evidence for diagnostic tests

My general question in reviewing these is, "What should medical engineering students be able to do by the end of this module?" Are these the most useful skills? I previously removed research ethics as a topic, but is this more important to employers than systematic literature searching?
I'm hoping that I can improve the relevance of my module to the needs of the wider clinical engineering community. What do employers (NHS or industry) want new graduates to be able to do?

(I should point out that our department conducts HTAs, clinical trials, and economic evaluations of medical devices, so don't ask me to teach regulatory procedures or electrical safety! That's a different module.)

Sue Peirce, Cardiff University

Yes; I would say you were right to remove "research ethics" (especially as I'm not even sure what that actually means).

Graduates should be able to systematically read (or at least, scan) documents of the academic type, I would have thought ... and then precis it down into something more useful. Haven't they already spent a fair amount of time doing that?

OK, your module is entitled "Medical Device Evaluation" ... and these are engineering students, right? So how about a couple more bullet points mentioning things like:-

1) Maintainability
2) Redundancy (how long the technology is likely to last)
3) Whole life cost forecasts
4) Resource requirements (tools, test equipment et al)
5) Training commitment (techs and users)

... you know, practical considerations. To be honest, I would regard all the points you list as the domain of the clinical user, rather than the engineer. Unless I have become completely out of touch (which I readily admit could well be the case), I believe that's actually what happens in the Real World (that is, the medics go ahead and buy the kit they want, leaving the engineers to "support" (fix) it sooner or later regardless).

Meanwhile, "What should medical engineering students be able to do by the end of this module?" and "What do employers (NHS or industry) want new graduates to be able to do?" could well generate two conflicting answers, I'm afraid.

Given the need to evaluate a manufacturer/supplier DCB 0129 in order to create a DCB 0160 for digital products in a Health IT System knowledge of risk assessment using ISO 14971, which is in broad alignment with the DCB standard, would be a good idea.

At the moment the scope of DCB is too wide causing issues, so work is under way to try and limit the scope. Until this happens producing DCB 0160 for the NHS in England is going to require a lot of resources!

See https://digital.nhs.uk/services/clinical-safety/clinical-risk-management-standards for background.

Whichever documents are cited ... and there may be many ... I still maintain that Clinical Engineers need to be able to:-

1) Make equipment purchasing recommendations to senior management.

2) Draw up clear equipment specifications against which prospective suppliers can bid.

3) Make sensible interventions when equipment maintenance contracts are being drawn up.

Assuming, of course, that Engineers have the "strength of character" to ensure that their views get heard.

All require an ability to absorb (often too many) pages of "detail" and condense these down into concise, clear requirements (or perhaps, policy directives).

Thanks both.

MikeX - IT systems are outside the scope of my module (and my knowledge), and I try to avoid apps, that may, or may not, be medical devices.

Geoff - I think that I at least mention the 5 points you list. When we talk about weighing up the costs and benefits (the value proposition) I try to emphasis that 'costs' are not just the purchase of the device and 'benefits' are not just clinical.
However, your point about being able to understand and consisely present complex information is something that could be emphasised more.
Procurement and tendering isn't something I have much experience of, but I can see the importance of that to NHS engineers. It uses a lot of the same skills, so I may consider that as an alternative.

Sue

Oh, 'research ethics' is around preserving the rights and safety of patients during clinical studies - consent, study design, confidentiality, risk/benefit balance.
Sue

Hi Sue,
with regard to the learning outcome - 'Summarise the clinical effectiveness'? Is it the function of a a clinical engineer to do that.. or the clinical user.

I would think 'Summarise the effectiveness of the clinical technology' may be a better learning outcome.
i.e. How reliable, ease of maintenance, ease of use, etc.

I am not up to date on the current reality of the NHS, but in my training I would have liked (and I still do not see it being applied in the training of new engineers in my country) to be trained in analyzing costs as clearly as CEP 80151 or similar studies

A practical work on reality would be to take calls for public bidding documents for various devices (in various countries) and the student determine which manufacturer model the order is oriented to. From experience I see that "details" are filtered in all the specifications that can only be satisfied by a single supplier. Finally define if this is really "useful", or cosmetic for choice bias

I may have mentioned on here before that "spec writing is an art".

I too have (in the past) some across many specs that had obviously been written with a particular vendor (manufacturer, supplier) in mind.

I have (re-)written many specs on various projects - often in the face of great hostility - even from clients. Odd that, you might say - until you have ventured unwittingly into the Real World (of brown envelopes, et al).

As a rule of thumb, when reviewing other peoples' (often poorly drafted) specs, if I decided that the requirements could not be met by at least three current vendors of roughly equal merit, then the spec would be rejected and a re-write called for. As may be imagined, I was dearly loved by all concerned (but that's what the client was paying for, whether he realised that or not - usually the latter). Competitive tenders are supposed to be, er, competitive after all.

But ... does a budding medical engineer need training in all that? Not really; all they need is honesty and, if writing specs - an ability to write clearly (which is not so common as some may imagine).

Spec :: equipment specification.