Anupama Govindarajan Ph.D.

Distinguished Regulatory Advisor - Digital Health and Data Enabled Therapies at Medtronic

Speaker

Dr. Anupama Govindarajan serves as a Distinguished Regulatory Advisor-Digital Health (Technical & Translational Director) for the Neuromodulation and Pelvic Health units within Medtronic. Her position is responsible for providing senior-level direction, leadership, and regulatory strategy in the areas of digital health, cybersecurity, and data-driven therapies that use AI/ML. She interfaces with senior leadership across functional areas to define longer-term technology road maps and new-business development within the Neuromodulation and Pelvic Health operating units. She leads a cross-therapy digital-health regulatory team and oversees the digital health ecosystem development from a regulatory perspective.

Prior to joining Medtronic, Anupama was Senior Advisor to the Digital Health Center of Excellence at FDA’s Center for Devices and Radiological Health (CDRH), where she influenced the regulation of digital-health devices across multiple specialty areas, including the regulation of AI in medical devices, wearables, clinical decision support, and SaMDs. Her regulatory career at CDRH (2014-2021) spans scientific review (Neuromodulation and Digital Health), change management (re-designing CDRH’s recall process as Recall Branch Chief), program building (Recalls, Digital Health Pre-cert and CDRH Innovation), and regulatory policy (Digital Health guidances, Pre-cert and Recalls). Her two-decades-spanning work experience in the healthcare technology field has been enriched by closely participating in the diverse viewpoints of different stakeholders across many cultures and matrixed organizations: FDA, NIH, Industry (Lockheed Martin, startups), research institutes (A*STAR Singapore) and academia. She was invited to a program building sabbatical at NIH: (Jan – July 2021), building supportive ecosystems around new healthcare technologies. This position, hosted by NIDA, enabled a collaborative bridge between the FDA and the NIH, with an emphasis on digital health and neuromodulation for the Opioid Use Disorder. She was part of the core team that launched the NIH BluePrint Medtech Neurotherapeutics Incubator.Anupama received her Ph.D. in Electrical Engineering from the University of Washington (UW), Seattle in micro- and nano- technologies for neural implants and completed her postdoctoral training in paper microfluidics and point-of-care diagnostics (also at UW).

She looks forward to expanding her expertise to leadership roles in the translation and regulation of an ecosystem focused on personalized medicine and digital health.