1. society
2. welfare
3. healthcare

Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a
presentation given at
Plenary Session:
Innovation, Know-How,
and Technology at the
EWMA - GNEAUPP
2014, Madrid
Emerging targeted
technology to address
unmet clinical needs
- Implementing a development
and adoption strategy
When faced with a new or challenging clinical
situation, healthcare professionals often, of necessity, innovate by adapting or inventing new care
strategies. Despite having a clear drive to innovate
and create new medical devices and systems of
care, healthcare professionals have frequently not
been in the forefront of product development. As
a result, healthcare systems have received products
and services that were “pushed” to them by industry. These products may not be aligned with the
development strategy of healthcare organisations.
Moreover, they may not address perceived or actual patient needs. As such, they are not “owned”
by clinicians or end users.
Changes that are more radical or disruptive have
a greater likelihood of eliciting resistance to implementation. There will always be early adopters.
However, products or system changes are unlikely
to be widely disseminated if (1) the “technology”
fails to deliver or (2) there are inflated expectations.
WHAT IS INNOVATION?
Innovation is the successful implementation of
new ideas and is divided into three stages:
The CEO of the National Health Technology
Adoption Centre, Sally Chisholm, stated: “The
need for the rapid, widespread, and systematic
adoption of innovation within the NHS has never
been more acute.” The same clearly applies to all
healthcare systems. If this is the case, then why are
innovations not rapidly adopted and universally
applied? Currently, the Innovation/Adoption/Diffusion cycle for new medical devices is too long,
and it takes an estimated average of 17 years for
only 14% of new scientific discoveries to enter dayto-day clinical practice1. This introduces barriers
to full adoption and is often controlled by regulatory requirements, reimbursement, and healthcare
provider acceptance. If the process is too slow,
newer technology becomes available. Innovation
is then discouraged, as manufacturers are unable
to recoup development costs before the next wave
of products launches. The Dutch Royal Academy
of Science has recently produced a report2 entitled
“Evaluation of New Technology in Healthcare,”
in which they offer guidance on the evaluation,
use, and regulation of medical devices. The report
n
Invention or identification – finding new or improved ways of doing things through new devices, therapies, or systems
n Adoption – testing new or improved ways of doing things and putting them into practice
n Diffusion – replicating new or improved
devices, therapies, or processes across the
system
Although innovation is linked to a process of
improvement, it is frequently seen as part of the
change process. Innovation may be:
n
Incremental - building on and improving
existing practices
n Radical – solving existing problems using
a completely new approach
n Disruptive - creating an entirely new and
unexpected therapy, market, or mode of
working
WHAT IS INNOVATION WITHIN
HEALTH CARE?
“An idea, service, or product that is either new
to a healthcare system or applied in a way that is
new to that system and significantly improves the
quality of health and care wherever it is applied”.
Professor Peter Vowden
Consultant Vascular
Surgeon and Visiting
Professor of Wound Healing
Research, Bradford, UK
Clinical Director of the
NIHR Healthcare Technology Co-operative
for Wound Prevention and
Treatment in Bradford, UK.
Correspondence:
[email protected]
Conflicts of interest: None

EWMA Journal 2015 vol 15 no 1
35
The eight National Institute for Health Research (NIHR) Healthcare Technology Co-­‐operatives (HTCs) NHS Organisation Barts Health NHS Trust Cambridge University Hospitals NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust Sheffield Teaching hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust Clinical Area or Theme Chronic gastrointestinal disease Brain injury Cardiovascular disease Devices for Dignity Wound prevention and treatment (WoundTec HTC) Leeds Teaching Hospitals NHS Trust Colorectal therapies Nottinghamshire Healthcare NHS Trust, Institute of Mental health and neurodevelopmental Mental Health disorders University Hospitals of Birmingham NHS Foundation Trust Trauma management Table 1
The eight National Institute for Health Research (NIHR) Healthcare Technology Co-operatives (HTCs)
covers a number of issues that are relevant to all healthcare
systems, irrespective of the country or area in which they
provide services. However, the pressure to rapidly deliver
and adopt innovation must not be at the expense of patient
safety. Good evidence demonstrating clinical and cost effectiveness must be derived from well-constructed clinical
trials. Follow-up post-marketing surveillance data play a
vital role in ensuring that data derived from randomised
studies are repeated in real-world situations3. A criticism
that is frequently raised in medical device-related clinical
trials, particularly in the field of wound care products, is
a lack of consistency and comparability between studies.
This issue is frequently highlighted in systematic reviews4,
and the need to work in accordance with the CONSORT
statement is further emphasised5. To overcome this, a common platform for evaluation that is similar to the suggested
platform for telemedicine (MAST)6 should be introduced.
This framework would require both a generic “wound
care”-related core and a disease-specific focus that deals
with the characteristics of individual wound types, such
as diabetic foot ulceration, venous leg ulcers, malignant
wounds, or acute traumatic wounds.
“Innovation is an ongoing cycle ……. one without a
beginning or an end, where one idea always leads to
the next.”
Diffusion occurs for a number of reasons;
(1)Bottom-up pressure from patients, public demand, and individual choice;
(2)horizontal pressure from peers, outcome reporting, collaboration, competition, and marketing;
(3)top-down pressure from central requirements,
regulations, incentives, and guidance.
Diffusion is also dependent on the cost-effectiveness
model that supports the launch of the initial product, as
derived from the original clinical trials, which are replicated for general use. This model can be challenged by the
36
slow uptake of educational support within the healthcare
system, changes within the system itself, and the skill of the
general healthcare professional when compared to that of
an experienced research team. The Whole System Demonstrator trial7 of telemedicine has highlighted the need for
careful economic and clinical evaluations of new devices
and systems of care in the management of chronic disease8.
Technology acceptance can be related to two key functions: the perceived usefulness of the innovation and
perceived ease of use. When considering, developing, or
introducing innovation, address the following questions:
n
Is the new behaviour/system/device genuinely useful?
How will the “learner” know if it is useful?
n Is the new behaviour/system/device easy to use?
n If it is not easy to use, can anything be done to improve
it?
n
HEALTHCARE TECHNOLOGY
CO-OPERATIVES (HTCS)
In an attempt to address areas of unmet clinical need in the
NHS, the National Institute for Health Research (NIHR)
has established eight HTCs (Table 1), which have been
established to:
n
Act as a catalyst for the NHS “pull” for the develop ment of new medical devices, healthcare technologies,
and technology-dependent interventions.
n Focus on clinical areas and/or themes of high morbid ity, which have high potentials for improving the qual ity of life for NHS patients and improving the effective ness of healthcare services that support them.
n Work collaboratively with patients, patient groups,
charities, industry, and academics.
The NIHR WoundTec HTC specifically addresses innovation that is related to unmet needs in wound prevention
and treatment9. This HTC has specific aims:
EWMA Journal 2015 vol 15 no 1
Scientific Communication
n
Act as a platform for innovation
To carry out these aims, the NIHR WoundTec HTC is
Identify and develop promising concepts for medical working through a formal collaboration between strate devices
gic partners and a network of key stakeholders (patients,
n Provide theoretical, methodological, and design
patient groups, charities, academics, and industry). The
expertise and a clinical base to develop these concepts
HTC has taken on a leadership role in identifying unmet
into testable interventions and devices
needs and developing and translating integrated clinical
n Test the feasibility, effectiveness, cost effectiveness, and
and research knowledge to patient care, thereby improv acceptability of proposed innovations in NHS settings
ing the life of patients, enhancing standards of wound
and various care pathways and promote the spread of
management, and promoting wealth creation. 
Figure 1
best practice
Identifying areas of need: Patient and Public Involvement
n
Figure 1
Identifying areas
of need:
Figure
2 Patient and Public Involvement
Potential for increased features to impact production schedule, product cost, profit,
complexity, and adoption
Figure 2
Potential for increased features to impact production schedule, product cost, profit, complexity, and adoption.
EWMA Journal 2015 vol 15 no 1
37
“How do you make innovation possible? With a need
that launches an idea.”
One of the core strategies in this process is Patient Led
Innovation (PLI), which involves:
n
Transforming patient-identified needs into innovative
medical devices and/or services.
n Innovating existing products and services to meet the
needs of patients and carers.
n Speeding up the development process.
n Providing patient feedback and regular interactions
with designers, engineers, industry healthcare profes sionals, and researchers.
This is achieved by engaging with patients throughout an
innovation-led design process (Fig. 1). However, several
challenges remain. A proper way to engage with patients
to identify need must be implemented. Furthermore, the
conversion from product “push” to need-initiated “pull”
needs to be developed. End-user feedback during the design phase has the potential to improve effectiveness but
may also impact product cost and cost effectiveness when
additional features and functionality are introduced (Fig.
2).
When looking at innovation in wound care products,
Moues et al.10 asked if we, the healthcare professionals,
are one of the barriers to innovation. They commented
that although a greater understanding of wound biology
and technological advances have led to numerous improvements in wound care in the last two decades, the choice
of therapy still largely depends on high-quality marketing, expert opinion, and intuition, rather than scientific
evidence. They state that many healthcare professionals
continue to treat and dress wounds according to age-old
practices, despite the fact that new research shows that this
may not be the best treatment modality for the patient.
In the UK Chief Executive’s report by Sir David Nicholson
for the NHS in England, Sir David Nicholson recognised,
in his forward to Innovation Health and Wealth (2011),
the need for innovation. Paraphrasing some of his comments:
“Our ambition must be for an NHS defined by its commitment to
innovation, demonstrated both in its support for research and its success in
the rapid adoption and diffusion of the best, transformative, most innovative
ideas, products, services, and clinical practice.”
“Now and for the foreseeable future, we must meet health demands from
within our current real terms funding while at the same time improving
quality ……. This means that simply doing more of what we
have always done is no longer an option. We need to do things differently.
We need to radically transform the way we deliver services ……..
Innovation is the way – the only way – we can meet these challenges.
Innovation must become core business for us all.”
References
1. Westfall JM, Mold J, Fagnan L. Practice-based
research-”Blue Highways” on the NIH roadmap.
JAMA 2007;297(4):403-6.
2. KNAW Evaluation of new technology in health care.
In need of guidance for relevant evidence. 2014,
Amsterdam, KNAW.
3. Yera-Alos IB, Alonso-Carbonell L, Valenzuela-Silva
CM, Tuero-Iglesias AD, Moreira-Martinez M,
Marrero-Rodriguez I, et al. Active post-marketing
surveillance of the intralesional administration of
human recombinant epidermal growth factor in
diabetic foot ulcers. BMC Pharmacol Toxicol
2013;14:44.
38
4. Clark M, Black J, Alves P, Brindle C, Call E, Dealey C,
et al. Systematic review of the use of prophylactic
dressings in the prevention of pressure ulcers. Int
Wound J 2014;11(5):460-71.
5. Weller C, McNeil J. CONSORT 2010 statement:
updated guidelines can improve wound care. J
Wound Care 2010;19(8):347-53.
6. Kidholm K, Ekeland AG, Jensen LK, Rasmussen J,
Pedersen CD, Bowes A, et al. A model for assessment
of telemedicine applications: mast. Int J Technol
Assess Health Care 2012;28(1):44-51.
7. Greenhalgh T. Whole System Demonstrator trial:
policy, politics, and publication ethics. BMJ
2012;345:e5280; author reply e305.
8. Henderson C, Knapp M, Fernandez JL, Beecham J,
Hirani SP, Cartwright M, et al. Cost effectiveness of
telehealth for patients with long term conditions
(Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a
pragmatic, cluster randomised controlled trial. BMJ
2013;346:f1035.
9. Vowden P. New wound care HTC launches. J Tissue
Viability 2013;22(1):19-20.
10. Moues CM, Heule F, Legerstee R, Hovius SE. Five
millennia of wound care products--what is new? A
literature review. Ostomy Wound Manag
2009;55(3):16-22.
EWMA Journal 2015 vol 15 no 1