N Sikorski

Nick is the Global Program and Solutions Leader for Deloitte’s Medical Device Safety and Security (MeDSS) practice responsible for helping clients secure connected medical devices and additional life sciences products developed by medical device manufacturers. He has designed and developed Deloitte’s Medical Device Security Program framework and used it to build and assess product security organizations and programs at both medical device manufacturers and healthcare providers. Designed, developed, and implemented Medical Device Security Program solutions for global medical device manufacturers in alignment with industry leading practices and guidance on product and information security, as well as both regulatory and customer requirements. Designed and developed Deloitte’s Product Security Maturity Model (PSMM) used to assess the level of maturity of Product Security organizations and programs for medical device manufacturers. Designed and developed Deloitte’s Product Security Risk Assessment framework, including the associated procedure, work instructions, and template for use by global medical device manufacturers and healthcare providers. Leveraged and customized Deloitte’s Product Security Risk Assessment framework to conduct product security risk assessments on connected products of global medical device manufacturers ranging from simplistic glucose monitors and mobile applications to complex laboratory diagnostic devices and implantables. Nick is an active member of the Association for the Advancement of Medical Instrumentation’s (AAMI) Medical Device Security Workgroup, which is responsible for the development of leading practice guidance documents for securing connected medical devices. Nick has his Bachelor’s of Science degree in civil engineering with a concentration on structural design and analysis from the University of Notre Dame & Certified Information System Security Professional (CISSP) and Certified Secure Software Lifecycle Professional (CSSLP).