Global Medical Device Regulatory Strategy
1 Regulatory Affairs Professionals Society
1
Driving Successful Commercial
Product Launches
Flora Sandra Siami, MPH
Introduction
In 2025, the global medical device market was valued
at roughly $570 billion and estimated to reach $1
trillion by 2034.1 According to AdvaMed, at 40%, the
United States (US) holds the largest percentage of
the global medical device market.2 Companies can no
longer rely solely on regulatory market authorization
for their products to be competitive, as their com-
mercial success requires pricing, reimbursement, and
market adoption.
However, these elements become challenging as
the healthcare delivery model continues to transform
owing to continued uncontrollable cost increases,
higher healthcare utilization, and increased regulatory
scrutiny. Purchasing decisions have been transferred
from clinical decision-makers to economic buyers.
Payment models have reassigned financial risk from
payers (e.g., Fee-for-Service [FSS]) to providers (e.g.,
Value-Based Care). Therefore, healthcare providers
are focused more than ever on controlling costs, being
more efficient, and delivering improved patient care.
As these foundational shifts in the healthcare
system continue, medical device companies must step
out of their traditional role and evolve, focusing on
solutions that reduce the cost of care, increase effi-
ciencies, and improve patient outcomes by leveraging
data and building intelligence into their products as
essential parts of the new device value proposition
to the multiple stakeholders within the healthcare
delivery system.3 A stakeholder’s willingness to pay
for a medical device will be tied to its impact on
patient outcomes, cost-effectiveness, and support for
quality-based performance metrics.
Companies, more than ever, need to understand
the fluctuating landscape for successful commercial
device launches. This chapter provides readers, espe-
cially 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 per-
spective 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
transforming healthcare environment, a collaborative
cross-functional market access approach must be
embraced by everyone in the organization. While a
considerable portion of this Chapter discusses the
US reimbursement landscape since it is the most
complex, the European Union (EU) and other global
markets are considered.
Commercialization Through
Cross-Functional Collaboration
With Market Access Mindset
In the past, when it came to Product Development
Plans (PDPs), most medical device manufacturers
either rarely considered payment, value, or their end
users or only considered some of these factors during
product launch. However, in recent years, medical
1 Regulatory Affairs Professionals Society
1
Driving Successful Commercial
Product Launches
Flora Sandra Siami, MPH
Introduction
In 2025, the global medical device market was valued
at roughly $570 billion and estimated to reach $1
trillion by 2034.1 According to AdvaMed, at 40%, the
United States (US) holds the largest percentage of
the global medical device market.2 Companies can no
longer rely solely on regulatory market authorization
for their products to be competitive, as their com-
mercial success requires pricing, reimbursement, and
market adoption.
However, these elements become challenging as
the healthcare delivery model continues to transform
owing to continued uncontrollable cost increases,
higher healthcare utilization, and increased regulatory
scrutiny. Purchasing decisions have been transferred
from clinical decision-makers to economic buyers.
Payment models have reassigned financial risk from
payers (e.g., Fee-for-Service [FSS]) to providers (e.g.,
Value-Based Care). Therefore, healthcare providers
are focused more than ever on controlling costs, being
more efficient, and delivering improved patient care.
As these foundational shifts in the healthcare
system continue, medical device companies must step
out of their traditional role and evolve, focusing on
solutions that reduce the cost of care, increase effi-
ciencies, and improve patient outcomes by leveraging
data and building intelligence into their products as
essential parts of the new device value proposition
to the multiple stakeholders within the healthcare
delivery system.3 A stakeholder’s willingness to pay
for a medical device will be tied to its impact on
patient outcomes, cost-effectiveness, and support for
quality-based performance metrics.
Companies, more than ever, need to understand
the fluctuating landscape for successful commercial
device launches. This chapter provides readers, espe-
cially 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 per-
spective 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
transforming healthcare environment, a collaborative
cross-functional market access approach must be
embraced by everyone in the organization. While a
considerable portion of this Chapter discusses the
US reimbursement landscape since it is the most
complex, the European Union (EU) and other global
markets are considered.
Commercialization Through
Cross-Functional Collaboration
With Market Access Mindset
In the past, when it came to Product Development
Plans (PDPs), most medical device manufacturers
either rarely considered payment, value, or their end
users or only considered some of these factors during
product launch. However, in recent years, medical