Kory Dillman
Director, Global Regulatory Consulting
专长:
With over 25 years in business and technology operations, Kory brings a wealth of experience to the ever-evolving medical device field. He partners with companies developing medical devices, leveraging his deep understanding of global regulations, quality systems, software development life cycle (SDLC), and business process management to translate product goals and functionalities into actionable regulatory strategies. His diverse experience spans various diagnostic and therapeutic areas, including cardiology, radiology, neurology, surgery, dental, and women’s health. He’s also well-versed in a variety of medical device types such as digital therapeutics, computer-assisted detection/diagnosis, digital pathology, patient monitoring, artificial intelligence, and consumer products.
Driven by a collaborative approach, Kory has built a strong track record of leading successful regulatory submissions in key global markets including but not limited to Australia, Brazil, Canada, EU, and U.S. He also fosters positive relationships with regulatory bodies, acting as a trusted liaison for his clients. His commitment to ensuring compliance with industry standards like IEC 62304, ISO 13485, and ISO 14971 demonstrates his dedication to developing safe, reliable, and globally marketable medical devices.
Articles by Kory Dillman
Clinical Data Portability for Regulatory Submissions Across Global Markets
Navigating the regulatory landscape for medical devices is complex, especially in relation to using clinical study data from overseas to support regulatory approval and reimbursement in the U.S., EU and U.K. The key question many companies face is whether their completed clinical study in another country can be leveraged for regulatory processes in these regions. […]
Updated Guidance May Ease MDR Transition for SaMD Manufacturers
The regulation of medical devices in the EU has been chaotic since the implementation of Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR). This upheaval has been particularly challenging for manufacturers facing a backlog of MDR transition applications and a dwindling number of Notified Bodies equipped to handle them. As a result, companies […]
Demystifying the New Prescription Drug Use-Related Software Framework
Authors: Martin Culjat, PhD , Kory Dillman and Scott Kellogg The Food and Drug Administration (FDA) unveiled its draft guidance on Regulatory Considerations for Prescription Drug Use-Related Software (PDURS) in September 2023. The document shed light on how the FDA intended to wield its drug-labeling authority over software outputs associated with prescription drugs and drug-device combination products. We […]
The Looming Legacy of Software as a Medical Device (SaMD) Misclassification Under Medical Device Directive (MDD)
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), sent shockwaves through the industry with its stricter oversight and transparency demands. While the implementation challenges like delays, notified body capacity, and EUDAMED implementation have dominated discussions, a potentially bigger issue lurks for software as a medical device (SaMD) previously classified as Class I under the Medical […]
An Impactful Year for Global Regulation of Digital Health
2023 was a busy year with FDA and EU advancing key initiatives focused on AI/ML, cybersecurity, global harmonization, real-world evidence, and pharma companion apps…and more is coming in 2024. While 2023 brought its share of challenges for the digital health sector, it ultimately served as a pivotal year for shaping the future of how digital […]
A Framework for Branded Pharma Companion Apps Is Coming Soon
The FDA just announced plans to release a draft guidance on prescription drug-use-related software later this year. What should the pharma industry expect? The past three years have seen a significant increase in the acceptance and adoption of digital health tools. Much of the focus over this time has been on virtual care using telemedicine […]
Breaking Down Q1 2023 Digital Health Policy Updates
Insights and Implications on AI/ML Software, Companion Apps for Pharma, Digital Diagnostics, VR Software, Breakthrough Devices, and More There was a barrage of activity by FDA in Digital Health at the end of 2022, including the wind-down of the Digital Health Pre-Certification program, final guidance on Clinical Decision Support Software, Mobile Medical Applications, Medical Device […]
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. […]
Regulatory Framework for Digital Therapeutics in the APAC Region
Authored by: Martin Culjat, Kory Dillman, Deval Patel 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 […]
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 […]