Journal of Medical Marketing

Marketing Innovation
Prescribing innovations: A
practical framework for effective
marketing of medical device
innovations
Received (in revised form): 10th March, 2006
Peter Appelt
is Vice President of International Product Management at KCI Europe Holding B.V., Amstelveen. In this role, he is also
responsible for clinical marketing and clinical education. Before he joined the KCI International headquarter in The Netherlands,
he was, for four years, the national sales and marketing manager of KCI Germany. He has extensive experience in the healthcare
industry, having worked for W.L. Gore & Associates in Munich from 1986 to 1997. During his time at W.L. Gore & Associates, he
was responsible for business development in consumer and healthcare products on a global basis.
Tino Hauser
is Director of Clinical Marketing at KCI Europe Holding B.V., Amstelveen. He received his PhD in biochemistry at the HumboldtUniversity, Berlin. He also has a postgraduate Diploma in Business Administration. Prior to his position with KCI, he was Director
of the Center for Clinical Research and Scientic Studies of BIOTRONIK GmbH & Co. KG, Germany.
Keywords clinical marketing framework, evidence-based medicine
Peter Appelt
KCI Europe Holding B.V.,
Parktoren, 6th Floor,
Van Heuven Goedhartlaan 11,
PO Box 129,
1180 AC Amstelveen,
The Netherlands
Tel: + 31 (20) 426 0060
Fax: + 31 (20) 426 0097
e-mail:
pappelt@kci-medical.com
Abstract Evidence-based medicine (EBM) will become in the future a fact of

life for the medical device industry. The authors propose the clinical marketing
framework as a strategic tool to optimise product introduction, adoption, life cycle
management and business development of medical device innovations. Clinical
evidence is increasingly important for the healthcare-related decision making and
for the commercial success of medical device innovations. The central aspect of the
clinical marketing framework is to use the principles of EBM to develop and drive the
clinical marketing strategy. The systematic implementation of the proposed framework
starts with a clear denition of the target indication and the potential target user group
for the medical device innovation. The next step is to identify the product claims,
analyse the scientic evidence supporting them and to dene a target evidence level.
The evidence gap analysis compares the required evidence level and the available
evidence level. The results of the evidence gap analysis, the denition of the
required product benets and the target indication are the most important input
for the clinical marketing programme. The key objective of this framework is
to support customer adoption and market penetration of the medical device.
Journal of Medical Marketing (2006) 6, 195202. doi:10.1057/palgrave.jmm.5050041
INTRODUCTION
marketing tools available that can help to

achieve faster adoption and market
penetration? The proposed practical
Why are some medical device innovations

more successful than others? Are there any
2006 Palgrave Macmillan Ltd 1745-7904 $30.00
Vol. 6, 3 195202
Journal of Medical Marketing
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195
Appelt and Hauser
framework can optimise the marketing efforts

with respect to the successful product
introduction, life cycle management and
business development of medical device
innovations. Important critical success factors
that increase the speed of adoption and
therefore market penetration of medical
innovations are:
Generate sufficient evidence for clinical,
economical benefits and quality of life in the

corresponding target indications.
Prove product safety.
Specific marketing strategy to address the
different target groups according to the
technology adoption life cycle.
Efficient transfer of evidence into clinical
practice (eg clinical guideline development).
Targeted reimbursement strategy.
Systematically expand the product use to new
indications.
The clinical marketing framework can be

a strategic tool to systematically address
these critical success factors. The crux of
this framework is to use the principles of
evidence-based medicine (EBM) to
develop and drive the clinical marketing
strategy (for recent definition for EBM see
Strauss et al.1).
Is EBM just a new buzzword or can it
be used to create competitive advantages?
Historically, the medical device industry
is highly innovative with rapid technology
changes. This being very different from
the pharmaceutical companies where
stringent regulatory processes and patent
cycles dictate the sales and marketing
activities.
The medical device regulatory bodies
are now following in the footsteps of the
pharmaceutical requirements; this change
means that EBM is increasingly important
for healthcare-related decisions and
examples including:
Insurance coverage decisions.2
The creation of evidence-based practice
guidelines according to internationally
established quality standards (eg from
196
Vol. 6, 3 195202
the Scottish Intercollegiate Guidelines

Network3).
The subsequent implementation of EBM

principles in a strategic clinical marketing
framework is a lever for medical device
manufacturers to gain competitive
advantages in a changing and
increasingly EBM influenced healthcare
environment.
THE CLINICAL MARKETING

FRAMEWORK
The basic clinical marketing framework
(Figure 1) consists of five important steps:
Identification of the target indication.

Definition of the required product benefits.
Evidence gap analysis.
Definition and execution of the clinical
marketing programme.
Strategic expansion of the product
indications.
The experience of the authors shows that

if the work on each step is not done in
the right order, it can lead to significant
delays or misjudgment on the business
opportunity.
IDENTIFYING THE TARGET

INDICATION
The first and most important step is a
clear definition of the target indication.
This step underpins the whole framework
as it acts as the base for subsequent
determinations like:
the market sizing.
the selection of the golden standard treatment.
the development of claims based on un-met
need.
the selection and approach of the target user

group.
The comprehensive definition of the

target indication is also a prerequisite for
the evaluation of the business opportunity,
will support the development of the
Todays golden standard
Evidence
gap
analysis
Required Clinical
Efficacy/Safety
Definition
of target
indication
Required Clinical
Effectiveness
Un-met
need
Medical
Device
Clinical
marketing
programme
Required
Cost-Effectiveness
Standard
clinical
practice in
target
indication
Therapy Innovation
Figure 1: The clinical marketing framework
business case and align any product

development requirements.
Moreover, narrowly bounded and wellcharacterised market segments should be
the target of all subsequent clinical
marketing activities. Goeffrey A. Moore4
described in his book critical aspects
regarding marketing and selling of hightech products to mainstream customers.
The market penetration of any new
technology can be described by the
technology adoption life cycle with respect
to different types of users that are applying
the product throughout its life cycle.
Each of the potential target groups are
characterised by a different marketing
response. According to Moore, it is very
critical in the development of the market
to achieve the transition from an early
market dominated by a few visionary
customers (early adopters) to a mainstream
market (early majority) dominated by
pragmatists.
The gap between the early and the
mainstream market is called chasm, which
is very difficult to cross on one side and
essential for the whole business success of
high-tech innovations on the other side.
Vol. 6, 3 195202
For crossing the chasm, it is necessary to

focus exclusively on achieving a dominant
position in one or two narrowly bounded
market segments. To define these market
segments as early and as precise as possible
is therefore, from the authors point of
view, an essential part of the clinical
marketing framework.
DEFINITION OF THE
REQUIRED PRODUCT
BENEFITS
The next step is to define the claims and
analyse the evidence to support them
(the term claim is equal to a product
benefit in the proposed framework).
In order to identify the claims that
really matter, the clinical benefits, safety
and economical outcomes of the medical
device innovation need to be evaluated.
There are also other possible benefits for
the users of the medical device
innovations like the ease of use or the
product service. These categories were not
included in the proposed framework
because they are not closely related to the
principles of EBM.
197
Appelt and Hauser
To help identify the relevant product

benefits, a clinical advisory panel formed
from experts in your defined segment
(Key Opinion Leaders (KOLs)) can
play a vital role in prioritising the real
customer requirements. The KOLs are
also excellent sources for the identification of competitive products and
treatments. Qualitative and quantitative
market research is a valuable tool in
order to evaluate the relevance of the
initially identified product benefits for
a broad range of potential target group
customers.
Additionally, market research provides
a better understanding of the customer
perception of competitive products,
particularly in comparison to the defined
claims of the new product. Internal
evaluations include other functions such
as R&D, medical, product management
and marketing, which can help provide
information about the required product
benefits in addition to the input coming
from the potential market.
The required product benefits can be
prioritised based on input from advisory
boards and market research. The
prioritisation is a key step in order to
efficiently plan and execute the elements
of the subsequent clinical marketing
programme.
relevant for the required product benefits.
Adequate coverage of the relevant literature

sources (Cochrane Library, Embase, Medline).
Appropriate limit for the period of

publications (eg last 10 or 15 years).
Selected studies should include relevant

therapy comparison groups (eg todays
golden standard therapy).
The next step is the classification of the

results of existing publications as strong or
weak evidence with respect to specific
product claim (clinical benefit, safety and
economic outcome). The internationally
accepted Scottish Intercollegiate
Guidelines Network (SIGN) evidence
grading scheme (Table 1) consists of four
main levels of evidence.5,6
According to this particular evidence
grading system and the general principles
of EBM, the randomised clinical trials
(RCTs) or corresponding reviews and
meta-analysis of RCTs have the highest
clinical relevance and are considered as
strong evidence. In addition to the design
(eg RCT or cohort study), other aspects
Table 1: SIGN evidence grading system
1++
1+
1
EVIDENCE GAP ANALYSIS

The objective of the evidence gap analysis
is to evaluate the highest available level of
evidence for all of the required product
benefits. Many publications provide best
practice descriptions for analysing the
body of existing evidence according to the
principles of EBM.13
The core element of the evidence gap
analysis is a systematic literature review.
A literature search should consider, for
example, the following aspects:3
2++
2+
Definition of the inclusion and exclusion

criteria to select the publications that are
198
Vol. 6, 3 195202
High-quality meta-analyses, systematic

reviews of RCTs or RCTs with a very
low risk of bias
Well-conducted meta-analyses,
systematic reviews of RCTs or RCTs
with a low risk of bias
Meta-analyses, systematic reviews of
RCTs or RCTs with a high risk of bias
High-quality systematic reviews of
casecontrol or cohort studies
High-quality casecontrol or cohort
studies with a very low risk of
confounding, bias or chance, and a
high probability that the relationship
is causal
Well-conducted casecontrol or cohort
studies with a low risk of confounding,
bias or chance, and a moderate
probability that the relationship is
causal
Casecontrol or cohort studies with
a high risk of confounding, bias or
chance, and a signicant risk that the
relationship is not causal
Non-analytic studies, for example, case
reports, case series
Expert opinion
Table 2: Product claims and supporting evidence

Product claima
Evidence
levelb
Importance
of claimc
Required activity
in order to increase
evidence level
Higher incidence of complete wound closure

Accelerated wound closure
Improved cosmetic result of wound healing
Improved disease-related quality of life
Reduced risk for local infections
Reduced nursing costs associated
with wound dressing changes
1++
2+
2++
1++
Animal study
3
High
High
Medium
Medium
Medium
High
No
Yes, critical
Yes
No
No
Yes
Typical claims for a wound healing device. The claims are based on the comparison with the todays golden standard therapy.
Based on the SIGN evidence grading system.
Evaluated by the clinical advisory panel.
of the clinical studies and the

corresponding results should be considered
for the decision if the evidence is weak or
strong for a product benefit.
According to SIGN, these aspects include:
Quantity, quality and consistency of evidence.
Generalisation of the study findings.
Clinical impact.
The final assignment of a level of evidence
will be done by organisations, which are
using EBM principles for generating
clinical practice guidelines by well-selected
clinical experts. Companies developing
medical devices may benefit from running
advisory panels to assist in the evidence
evaluation procedure.
Two aspects the efficacy and the
effectiveness of a new treatment
innovation are particularly important
for the interpretation of the study results.
Efficacy is proven when there is evidence
that the healthcare intervention is
beneficial when applied by experts in a
research setting.2
A healthcare intervention is considered
as clinically effective if there is evidence
that the medical innovation is beneficial
when it is applied by a representative
sample of physicians in a routine clinical
setting.2 There is a clear trend that not
only clinical efficacy is considered relevant
for health-related policy decisions but also
Vol. 6, 3 195202
clinical effectiveness has to be shown for

new therapeutic innovations.2 This means
that both RCTs, which will provide the
highest level of clinical evidence and also
post-marketing studies, are required for a
successful market development of a new
medical device innovation.
The results of the product claim
definition and the subsequent evidence
analysis can be summarised in an evidence
overview. Table 2 illustrates an example of
such a template.
The decision to whether there is an
evidence gap or not depends on the target
evidence level and the available evidence
level for a specific product claim. The
specification of the target evidence level
should consider several aspects such as the
importance of the claim for customers and
if a claim is required for reimbursement
decisions.
DEFINITION AND EXECUTION

OF THE CLINICAL
MARKETING PROGRAMME
The strategic objective of the clinical
marketing programme is to develop the
target market and to support the adoption
of the medical innovation throughout its
life cycle. The identification and
description of the target indication, the
definition of the required product benefits
199
Appelt and Hauser
Core activitie
Key objectives
Clinical research program
Improve the level of evidence for product claims

Support reimbursement decisions
Support product approval
Support value proposition
KOL and professional

society relationship
management
Support the generation of

Clinical treatment guidelines and standards
International and national consensus statements
Scientific contributions to
conferences and symposia
(including publication plan)
Increase awareness and acceptance of product
Clinical education and

training program
benefit
Transfer evidence to clinical practice
Figure 2: Core activities of the clinical marketing programme
and the corresponding evidence gap

analysis are the most important input for
planning the clinical marketing
programme.
Core elements of the clinical marketing
programme and their specific objectives
are summarised in Figure 2.
The clinical marketing framework can
be described as a strategic tool requiring a
multidisciplinary approach and therefore
involves different functions like R&D,
medical, product management and
marketing. It is essential to integrate the
framework early in the research and
development process to gain maximum
leverage.
The target market and the required
product benefits should be defined at an
early stage of the research and
development process. The targets for the
required evidence for the key product
benefits should be defined as well very
early in the R&D cycle.
Corresponding clinical research activities
should be started early in the product
development process to establish the
200
Vol. 6, 3 195202
required body of evidence. The

availability (at the time of the product
launch) of clear product benefits supported
by strong evidence will lead to an optimal
product position during the market launch
and accelerate the adoption of the new
medical innovation.
To achieve increasing market
penetration, particularly the transition from
the early market to the mainstream
market, your target market segment must
be influenced from all sides of the business
and externally where possible, for example,
peer-group stimulus. The implementation
of clinical treatment standards and
guidelines for the product innovation are
an important milestone for this transition.
These guidelines are based on an
increasing frequency of clinical evidence
(evidence-based guidelines). Therefore, the
clinical marketing framework is a powerful
tool to support this process. Even with the
availability of high-level evidence and
clinical guidelines, it is difficult to
implement medical innovations into
routine practice.7
Constant efforts tailored to the specific

target groups of customers are required.
Clinical training programmes and
continuous discussions of the benefits and
the supporting evidence during congresses
and symposia are only few examples of
initiatives increasing the awareness and
acceptance of the medical device
innovation.
STRATEGIC EXPANSION OF
INDICATIONS
The strategic expansion of indications is a
crucial step in order to expand market
potential and future revenue predictions.
There are numerous examples of
pharmaceutical products and medical
devices with systematically expanding
target indications.
One example from the pharmaceutical
industry is the continuous market
expansion of the two blockbusters,
Rituxan and Gleevec.8
From the medical device industry, the
application of cardiac pacing is regarded as
one of the most important medical
innovations of the 20th century.9
Implantable cardiac pacemakers were
initially only developed for patients with
complete heart blocks (StokesAdams
attacks). Continuous technical
improvements such as the introduction of
dual-chamber pacemakers, more
physiologic pacing algorithms and better
pacing leads offered technical solutions for
an increasing number of clinical
applications. Pacemaker indications have
expanded over the past decades to
indications even beyond symptomatic
bradycardias, and include today
neurocardiogenic syncope and cardiac
resynchronisation therapy for congestive
heart failure.10
The clinical marketing framework can
be extremely helpful for the systematic
exploration of new indication as well for
medical devices that are already established
Vol. 6, 3 195202
for particular target indications. The

proposed work stream is the same
starting with the characterisation of the
target indication followed by the definition
of the required product benefits, the
evidence gap analysis and finally the
definition and execution of the clinical
marketing programme.
CONCLUSION
The authors show that EBM will become
in the future a fact of life for the medical
device industry. The requirements for
reimbursement, with the challenges of
health technology assessment, will lead to
significant changes in the whole
assessment of new medical device
technologies. This is different in the
pharmaceutical industry where the
development of strong evidence is already
part of the product development process.
The commercial success of medical
devices will be determined by the strength
of developed clinical evidence of highest
levels. Therefore, clinical marketing will
become an instrumental part of the
overall marketing strategy and should be
aligned to product development. The
clinical marketing activities will become
as well a source of competitive advantages.
References
1 Strauss, S.E., Richardson, W.S., Glasziou, P. & Haynes,
R.B. (2005) Evidence-Based Medicine, Elsevier Churchill
Livingstone, Edinburgh, 1.
2 Steinberg, E.P. and Luce, B.R. (2005). Evidence
based? Caveat Emptor!. Health Affair (Millwood), 24(1),
8092.
3 Scottish Intercollegiate Guideline Network (1999).
SIGN Guidelines: An Introduction to Sign Methodology for
the Development of Evidence-Based Clinical Guidelines,
SIGN Publication No. 39. SIGN, Edinburgh.
4 Moore, G.A. (2002). Crossing the Chasm: Marketing and
Selling High-Tech Products to Mainstream Customers,
HarperCollins books, NewYork.
5 Harbour, R. & Miller, J. (2001). A new system for
grading recommendations in evidence based guidelines.
BMJ, 323 (7308) 334336.
6 Scottish Intercollegiate Guidelines Network (SIGN)
(1999) Methodology Review Group. Report on the Review
201
Appelt and Hauser
of the Method of Grading Guideline Recommendations,

SIGN, Edinburgh.
7 Grol, R. & Grimshaw, J. (2003). From best evidence to
best practice: effective implementation of change in
patients care, Lancet, 362(9391), 12251230.
8 Behnke, N. (2005). How biotechnology and speciality
pharma companies can beat big pharma in marketing
cancer drugs. J. Med. Market., 5(1), 1014.
202
Vol. 6, 3 195202
9 Pinski, S.L. (2001).

Marcapasos permanents. in
Doval, H.C., Tajer, C.D., Schwartzman, R.A. (eds.)
Evidencias en cardiologia: de los ensayos clinicosa las
conductas terapeuticas, Editorial GEDIC, Buenos Aires,
366403.
10 Trohman, R.G., Kim, M.H. & Pinski, S.L. (2004).
Cardiac pacing: the state of the art. Lancet, 364(9446),
17011719.

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Marketing Innovation

Keywords clinical marketing framework, evidence-based medicine

Abstract Evidence-based medicine (EBM) will become in the future a fact of

marketing tools available that can help to

Why are some medical device innovations

2006 Palgrave Macmillan Ltd 1745-7904 $30.00

Appelt and Hauser

framework can optimise the marketing efforts

Generate sufficient evidence for clinical,

economical benefits and quality of life in the

The clinical marketing framework can be