MEDICAL DEVICES
Integra LifeSciences and Veeva Systems on New Requirements for Medical Devices How global compliance requirements will impact the device sector By Melonie Warfel, VP of Medical Devices & Diagnostics, Veeva Systems
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. Just as the pharmaceutical industry enjoyed steady growth in the 1990s, the medical device and diagnostics industry has maintained attractive operating margins between 23% and 25% in recent years and 5% annual growth.1 Established players compete successfully in the global market by applying common busi59 | HS&M FEBRUARY/MARCH 2018
ness models without much need for differentiation. Now, however, disruptive change is knocking on the industry’s front door largely due to increased regulatory scrutiny worldwide. New compliance requirements are expected to significantly impact medical device and diagnostics opera-
