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Global Medical Device Regulatory Strategy
Driving Successful Commercial
Product Launches
Updated by Michael Reiner, MBA
1
Introduction
Healthcare is undergoing a radical transfor-
mation that is driven by uncontrollable cost
increases, higher healthcare needs, increased
regulatory scrutiny, as well as a shift in pay-
ment systems from a volume of care to value of
care. New payment models that shift financial
risk from payers to providers are evolving.
To succeed in this environment, healthcare
providers are focused more than ever on con-
trolling the cost of care, being more efficient
and delivering improved patient care. As these
shifts in the healthcare system continue, new
payment methodologies will continue to evolve
that place greater emphasis and rewards on
improved patient outcomes and provider effi-
ciencies. A stakeholder’s willingness to pay for
a medical device will be tied to its impact on
patient outcomes, cost-effectiveness and sup-
port for quality-based performance metrics.
To thrive and provide commercially ready
products in this new environment, medical
device manufacturers need to implement a
collaborative and comprehensive approach in
their product development process (PDP), with
customer adoption as the goal. To achieve this
result, medical device manufacturers will need
to understand and demonstrate how their prod-
uct improves patient outcomes while increasing
efficiencies and value to multiple stakeholders
within the healthcare delivery system.
This chapter will provide the reader,
especially those responsible for developing
and building a regulatory strategy, with a
framework to achieve a successful commercial
product launch. Regulatory leaders and leaders
from other cross-functional departments must
recognize that their strategies and tactics should
not be viewed from their perspective alone.
Instead, they must understand that they are
part of a process that has a patient-centered and
market adoption end in mind. To thrive in this
evolving healthcare environment, a collaborative
cross-functional market access approach must
be embraced by everyone in the organization.
Commercialization Through Cross-
Functional Collaboration with Market
Access Mindset
In the past, most medical device manufacturers
rarely considered payment, value or the end
user of their products in their PDP, or may
have only considered some of these at the time
of product launch. As medical device manu-
facturers recognize the complexities of the new
marketplace, they also have discovered this
previous approach has led to poor commercial
results. Increasingly, medical device manufac-
turers are integrating payment, value and other
patient- and customer-focused criteria in their
strategies very early in the process. Marketplace
adoption of medical devices is increasingly
dependent upon a range of stakeholders beyond
the physician. These stakeholders include pay-
ers, patients, regulators, government policy
makers and multiple clinical and economic
decision makers within healthcare provider
systems. Each of these stakeholders brings a
unique set of perspectives on how they expect
a medical device to impact quality and cost
of care. A medical device manufacturer will
need to understand each of these stakeholder
perspectives and demonstrate how their device
meets the demands of improved quality, lower
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
Driving Successful Commercial
Product Launches
Updated by Michael Reiner, MBA
1
Introduction
Healthcare is undergoing a radical transfor-
mation that is driven by uncontrollable cost
increases, higher healthcare needs, increased
regulatory scrutiny, as well as a shift in pay-
ment systems from a volume of care to value of
care. New payment models that shift financial
risk from payers to providers are evolving.
To succeed in this environment, healthcare
providers are focused more than ever on con-
trolling the cost of care, being more efficient
and delivering improved patient care. As these
shifts in the healthcare system continue, new
payment methodologies will continue to evolve
that place greater emphasis and rewards on
improved patient outcomes and provider effi-
ciencies. A stakeholder’s willingness to pay for
a medical device will be tied to its impact on
patient outcomes, cost-effectiveness and sup-
port for quality-based performance metrics.
To thrive and provide commercially ready
products in this new environment, medical
device manufacturers need to implement a
collaborative and comprehensive approach in
their product development process (PDP), with
customer adoption as the goal. To achieve this
result, medical device manufacturers will need
to understand and demonstrate how their prod-
uct improves patient outcomes while increasing
efficiencies and value to multiple stakeholders
within the healthcare delivery system.
This chapter will provide the reader,
especially those responsible for developing
and building a regulatory strategy, with a
framework to achieve a successful commercial
product launch. Regulatory leaders and leaders
from other cross-functional departments must
recognize that their strategies and tactics should
not be viewed from their perspective alone.
Instead, they must understand that they are
part of a process that has a patient-centered and
market adoption end in mind. To thrive in this
evolving healthcare environment, a collaborative
cross-functional market access approach must
be embraced by everyone in the organization.
Commercialization Through Cross-
Functional Collaboration with Market
Access Mindset
In the past, most medical device manufacturers
rarely considered payment, value or the end
user of their products in their PDP, or may
have only considered some of these at the time
of product launch. As medical device manu-
facturers recognize the complexities of the new
marketplace, they also have discovered this
previous approach has led to poor commercial
results. Increasingly, medical device manufac-
turers are integrating payment, value and other
patient- and customer-focused criteria in their
strategies very early in the process. Marketplace
adoption of medical devices is increasingly
dependent upon a range of stakeholders beyond
the physician. These stakeholders include pay-
ers, patients, regulators, government policy
makers and multiple clinical and economic
decision makers within healthcare provider
systems. Each of these stakeholders brings a
unique set of perspectives on how they expect
a medical device to impact quality and cost
of care. A medical device manufacturer will
need to understand each of these stakeholder
perspectives and demonstrate how their device
meets the demands of improved quality, lower