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Editor’s  Corner
Many readers of this Journal will be familiar with the 

field of Health Technology Assessment (HTA), at least 
in principle if not in detail. They may also be aware of 
the three main pillars of HTA: evaluating comparative 
effectiveness; cost-effectiveness, and organizational im-
pact, and that HTA serves to inform decision-making in 
order to promote an equitable, efficient, and high-quality 
health system.

HTA activities often fall within the domain of specialized 
units or agencies – be these in the public or private health 
sectors - with health economists as lead practitioners. The 
questions posed relate primarily to allocative efficiency 
issues and related affordability of new medicines, drugs, 
and procedures for various target populations or groups. 
As such, HTA is downstream to assurance of regulatory 
compliance and upstream of technology dissemination 
and related life-cycle management. 

HTA has recently been redefined by an international 
joint task group as a “multidisciplinary process that uses 
explicit methods to determine the value of a health tech-
nology at different points in its life cycle”.1 

It’s useful to spend a minute unpacking that defi-
nition. What disciplines are involved and who are the 
primary drivers of the process? Health economists play 
an important role, as do health clinical professionals. For 
so-called hospital-based or ‘mini-HTA’, a broader mix of 
stakeholders – including clinical engineering (CE), or 
CE&HTM (Health Technology Management) profession-
als – would be involved. In all cases, it is the HT-related 
questions posed that are the crucial determinant of what 
the process entails and who is involved.

At this point, it’s worth remembering that the first 
technology assessment in the healthcare space was that of 
the artificial human heart, and the second of the CT scan-
ner – both conducted by the (then) Office of Technology 
Assessment of the US Congress and hence the birthplace 
of HTA. One can surmise the key questions posed in each 

case: does the technology work and is it safe in the first 
instance, and can the health system afford the prolifera-
tion of this new and expensive medical imaging system  
in the second. 

What are the ‘explicit methods’ and who gets to define 
these? There are several formal methodology frameworks, 
the most recent being the European collaboration of HTA 
(EUnetHTA) HTA Core Model.2  The ‘value of a technology’ 
is a loaded term, since the needs and value systems of the 
different stakeholders in the outcome of the HTA process 
may not always be aligned. Lastly – and perhaps most 
importantly in our context – is to establish the ‘different 
points in a technology’s life-cycle’.  

Current HTA practice commonly sees the technology 
life-cycle in the generic sense, from embryonic to early 
adoption to market acceptance to mature and eventual 
replacement and/or abandonment. Interestingly, a recent 
publication4 refers to 6 stages for Life-Cycle HTA: preas-
sessment; safety and efficacy assessment; HTA; adoption; 
de-adoption, and reassessment.

What has all this got to do with CE&HTM? Everything! 
CE&HTM practitioners are key stakeholders in – and 
overseers of - the operational Life-Cycle Management 
(LCM) of medical devices, with decision-making an in-
tegral component of all phases, from needs assessment, 
planning, and budgeting to procurement, commissioning, 
maintenance, user support, and training, and eventual 
decommissioning and disposal. Numerous decisions are 
made by CE&HTM practitioners in consultation with other 
stakeholders along the device’s journey from cradle to 
grave. All of this can be done without mention of HTA. 

Should this not be addressed - for both operational 
and strategic reasons - since the HTA ‘toolkit’ can be used 
to select the most appropriate approach in providing 
the evidence needed for specific decisions while also 
serving to support the standardization of institutional 
processes? In addition, by using the language of HTA, 

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3 J Global Clinical Engineering Vol.5 Issue 3, 2023

CE&HTM practitioners can align themselves with existing 
HTA processes where these exist.

There are also broader benefits. As readers may well be 
aware, GCEA and the IFMBE’s Clinical Engineering Division 
are engaged in the important exercise of defining the CE/
HTM Bodies of Knowledge and Practice at the global level, 
both of which would benefit from the addition of HTA 
concepts and principles as being core to both CE/HTM 
knowledge and practice. On a related note, the IFMBE’s 
Health Technology Assessment Division has recently 
suggested greater involvement of biomedical and clinical 
engineers in current HTA activities - and further explored 
related gaps and opportunities - in a recent publication.3  
Another European-based in the HTA domain – EuroScan 
also known as the International HealthTechScan (i-HTS) 
has joined Global Clinical Engineering Alliance on a couple 
of World Health Organization projects. 

Another benefit is linked to the challenges many col-
leagues are facing in raising the importance of CE/HTM 
in their respective countries, needing CE/HTM roles and 
contributions to be recognized in national policy and 
related support of professional recognition, capacity 
development, and appropriate resourcing. 

A different perspective on HTA and related issues is 
informed by the reality that many lesser-resourced set-
tings are well familiar with: “...inefficiency (that) signifies 
the denial of additional citizens of opportunities to realise 
health improvements at zero extra cost. This makes ineffi-
ciency both immoral and unethical.”4  

This begs the question: Are the resources currently in-
vested (allocative efficiency) in the regulation, assessment, 
and management - individually and collectively - of health 
technologies in general and medical devices, in particular, 
achieving the highest return on investment when their 
actual impact is juxtaposed with their potential impact 
given the same levels of investment? There is anecdotal 
evidence that regulatory and assessment agencies in 

some countries are pursuing the implementation of best 
global practices in upstream LCM activities, thereby con-
suming significant resources that could be better utilized 
in addressing proverbial orchards of low-hanging fruit 
associated with the downstream operational life-cycles 
of health technologies and medical devices, and related 
technical efficiency.

This in turn leads us to ask: Why not do an HTA on HTA, 
i.e. consider the cost-effectiveness of current HTA-related 
activities and their resourcing and impact, relative to their 
potential if their scope was broadened and a larger set 
of stakeholders were gathered at the decision-making 
table? Incidentally, the same question could be asked of 
Health Technology Regulation and CE/HTM activities and 
related resourcing. 

Yours thoughts? Let me know at mladen.poluta@up.ac.za

 REFERENCES

1. Mueller D, Gutierrez- Ibarluzea I, Chiumente M, Oortwijn W 
(2021). Toward a common understanding of competencies 
for health technology assessment: enhancing educational 
and training programs around the globe. Int’l J of Technology 
Assessment in Health Care 37, e29, 1–10. 

2. https://www.eunethta.eu/hta-core-model/ 

3. Pecchia L, Pallikarakis N, Magjarevic R, Iadanza E (2019). 
Health Technology Assessment and Biomedical Engineering: 
Global trends, gaps and opportunities. Medical Engineering 
and Physics, 72, 19–26.

4. Kirigia JM, Emrouznejad A, Sambo LG (2002). Measurement 
of technical efficiency of public hospitals in Kenya: Using data 
envelopment analysis. J of Medical Systems, 26(1), pp. 39-45.

Together we are making it better!
Prof.  Mladen Poluta

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