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Global Medical Device Regulatory Strategy
Global Medical Device
Marketing Strategy
Updated by Charles Tam, MBA
16
Introduction
It is critical for a company selling medical
devices to have an executive business strategy
updated on an annual basis. From the onset of
all projects, it is essential to ensure close inte-
gration between the marketing and regulatory
strategies. Failure to understand the impact of
regulatory requirements supporting the exec-
utive strategy places the entire plan at risk and
can result in unnecessary expense, costly delays
or failure to obtain approval.
Global Executive Strategy
Development for Medical Device
Companies
A medical device company’s executive team
selects its global strategy based on the compa-
ny’s target disease state and medical condition,
focus and technological competency. For exam-
ple, cardiovascular (CV) disease is a very broad
disease state, and CV medtech companies may
specialize in one or more selected areas of CV
treatment or therapy segments. For example,
interventional cardiology is focused on the
treatment of coronary vascular obstructions
(stents, balloons). Electrophysiology devices
are used to treat another CV disease state,
conductive aberrations in the heart (ablations,
pacemakers, etc.) or body these devices may be
diagnostic or interventional. Structural heart
disease includes congenital cardiac defects or
those caused by abnormalities of the valves and
vessels (aortic valve implants, patent foramen
ovale (PFO) closure devices). Each of these
medical conditions, among many others within
CV, is strategically different and requires a
different medical device strategic planning
process. This results from the difference in call
points, technologies, treatments, reimburse-
ment funding discussions (public payor health
systems), service expectations from physicians
and hospitals and even the general personality
of the medical specialty’s physicians. As a broad
generalization, physician specialties tend to have
consistent levels of risk tolerance. Anecdotally,
some specialists are perceived to be risk takers
who are faster and more willing to adopt new
technologies in treating disease than other
medical specialty peers. The medical device
company’s executive team should assess and
adapt to these differences.
A large medical device company could have
a broad CV product portfolio of offerings to
address multiple disease states, while smaller
CV companies may specialize in only a few
or even just one. Once the disease state and
corresponding technologies are selected, the
executive team defines a market strategy further
based on company shareholder and expected
stakeholder returns. There are four basic catego-
ries of products from which to select—existing
product portfolio, new products, products or
services for adjacent markets or whitespace
research (advanced technologies in early devel-
opment stages, i.e., first-in-human clinical
investigational testing)—each requiring a differ-
ent strategy. In some cases, the executive team
will select a mix of product types to support the
company’s growth and profitability goals (Table
16-1). This chapter examines regulatory and
business strategies for the two most common
categories: the existing product portfolio and
new products.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
Global Medical Device
Marketing Strategy
Updated by Charles Tam, MBA
16
Introduction
It is critical for a company selling medical
devices to have an executive business strategy
updated on an annual basis. From the onset of
all projects, it is essential to ensure close inte-
gration between the marketing and regulatory
strategies. Failure to understand the impact of
regulatory requirements supporting the exec-
utive strategy places the entire plan at risk and
can result in unnecessary expense, costly delays
or failure to obtain approval.
Global Executive Strategy
Development for Medical Device
Companies
A medical device company’s executive team
selects its global strategy based on the compa-
ny’s target disease state and medical condition,
focus and technological competency. For exam-
ple, cardiovascular (CV) disease is a very broad
disease state, and CV medtech companies may
specialize in one or more selected areas of CV
treatment or therapy segments. For example,
interventional cardiology is focused on the
treatment of coronary vascular obstructions
(stents, balloons). Electrophysiology devices
are used to treat another CV disease state,
conductive aberrations in the heart (ablations,
pacemakers, etc.) or body these devices may be
diagnostic or interventional. Structural heart
disease includes congenital cardiac defects or
those caused by abnormalities of the valves and
vessels (aortic valve implants, patent foramen
ovale (PFO) closure devices). Each of these
medical conditions, among many others within
CV, is strategically different and requires a
different medical device strategic planning
process. This results from the difference in call
points, technologies, treatments, reimburse-
ment funding discussions (public payor health
systems), service expectations from physicians
and hospitals and even the general personality
of the medical specialty’s physicians. As a broad
generalization, physician specialties tend to have
consistent levels of risk tolerance. Anecdotally,
some specialists are perceived to be risk takers
who are faster and more willing to adopt new
technologies in treating disease than other
medical specialty peers. The medical device
company’s executive team should assess and
adapt to these differences.
A large medical device company could have
a broad CV product portfolio of offerings to
address multiple disease states, while smaller
CV companies may specialize in only a few
or even just one. Once the disease state and
corresponding technologies are selected, the
executive team defines a market strategy further
based on company shareholder and expected
stakeholder returns. There are four basic catego-
ries of products from which to select—existing
product portfolio, new products, products or
services for adjacent markets or whitespace
research (advanced technologies in early devel-
opment stages, i.e., first-in-human clinical
investigational testing)—each requiring a differ-
ent strategy. In some cases, the executive team
will select a mix of product types to support the
company’s growth and profitability goals (Table
16-1). This chapter examines regulatory and
business strategies for the two most common
categories: the existing product portfolio and
new products.