Kory Dillman
Director, Global Regulatory Affairs
Expertise:
Kory is a Regulatory Affairs Associate Director with extensive experience in Software as a Medical Device and Software Development Life Cycle.
Kory has 20+ years of experience in business and technology operations and 9 years of experience in Regulatory Affairs at companies of varying sizes and industries.
Kory has authored and managed submissions for global markets including Australia, Brazil, Canada, EU, Malaysia, Saudi Arabia, and the United States. His other areas of expertise include Quality Systems, Business Process Management, Program Management, and Business Development.
Articles by Kory Dillman
Rounding Up FDA’s Digital Health Actions from 2022 and Looking Forward to 2023
The healthcare sector continued the digitization evolution in 2022. Among the many product launches and technological advances, a recent report from AMA showed that 93% of physicians now see digital health tools as advantageous to patient care and that adoption of telemedicine, remote monitoring, clinical decision support, and patient engagement tools are on the rise. Likewise, pharma companies are increasingly adopting digital companion apps for drugs and pursuing regulated software such as standalone digital therapeutics. And reimbursement for digital health continues to advance in the U.S. and Europe and is beginning to emerge in the Asia Pacific region. As digital health has been maturing, the FDA continues to adapt, helping […]
Regulatory Framework for Digital Therapeutics in the APAC Region
Authored by: Martin Culjat, Kory Dillman, Deval Patel, Rohit Kumar Digital health and digital therapeutics innovation, commercialization, and adoption is accelerating in the APAC region, and this has been in full display at the first-ever DTx Asia conference held in Seoul, South Korea on November 8 and 9, 2022. DTx manufacturers are seeking authorization from global regulatory bodies, particularly in markets with emerging reimbursement opportunities. However, the regulatory hurdles across APAC are still unclear to many, as are the advantages and challenges in approaching these markets. Fortunately, the APAC regulatory bodies have made considerable advances in the oversight of digital health and software-as-a-medical device (SaMD). Emerging examples from trailblazing companies […]
FDA Moves Cybersecurity Into the Product Life Cycle
Due to rising cyber-attacks and the potential to cause harm to patients, medical facilities and hospitals, the U.S. Food and Drug Administration (FDA) has recently increased scrutiny of cyber controls in FDA premarket submissions of medical devices. Manufacturers must prove that devices, including software-as-a-medical device (SaMD), do not present cybersecurity vulnerabilities that may affect the device’s safety, effectiveness or security. The FDA recently summarized the significance of the situation, stating, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally.” Both Congress and the FDA recently introduced actions addressing the problem. The bipartisan PATCH Act (Protecting […]