A decade ago, the pharmaceutical industry experienced a shift in its operating
model as a result of paradigm-shattering market dynamics and new regulations.
The shockwaves continue to impact many large organizations, as specialty
biotech companies enter the market, driving rapid innovation, globalization, and
increased competition. Now, the medical devices and diagnostics industry (MDDI)
is the next in line for dramatic change.
Integra LifeSciences and Veeva
Systems on New Requirements for
Just as the pharmaceutical industry enjoyed steady
growth in the 1990s, the medical device and diag-
nostics industry has maintained attractive operating
margins between 23% and 25% in recent years and 5%
annual growth.1 Established players compete success-
fully in the global market by applying common busi-
ness models without much need for differentiation.
Now, however, disruptive change is knocking on the
industry’s front door largely due to increased regula-
tory scrutiny worldwide.
New compliance requirements are expected to significantly impact medical device and diagnostics opera-
How global compliance requirements will impact the
By Melonie Warfel, VP of Medical Devices & Diagnostics, Veeva Systems