Kory Dillman
Director, Global Regulatory Consulting
Expertise:
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. While it is possible, the answer is nuanced and depends on various factors such as specific indications, risk-benefit profiles, and the type and scope of clinical data. In this comprehensive analysis, we delve into the intricacies of regulatory acceptance in these three major markets and examine primary considerations, including the role of individual reviewers, the […]
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 holding Medical Device Directive—Council Directive 93/42/EEC (MDD) CE Certificates have been anxiously awaiting their transition to the MDR before the 2024 deadline for MDD certificate recognition. Thankfully, the European Commission has provided some relief. If an application with a Notified Body is in place before the 2024 deadline, the EU has extended the transitional provisions […]
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 offered a preview of the PDURS framework in April 2023 in anticipation of the draft guidance release. Now, following the publication of the draft guidance, a review of submitted public comments and engaging extensively with both the FDA and pharmaceutical manufacturers on PDURS, we present an updated overview. The graphic below illustrates the framework. Overview […]
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 Device Directive (MDD). The structure of the MDD allowed for broad and varied interpretations of the Directive, and some SaMD manufacturers relied upon this leeway to self-classify devices as low-risk Class I. Now, with the MDR in effect, these devices are stuck in a loophole and face serious challenges in meeting the rigors of the […]
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 medical devices are developed and regulated. Many new regulations and policies were introduced or issued after years in the making, and others were reactions to sweeping technological and methodological industry advancements that required broad changes in the global regulatory environment. First, we’ll zoom in on key global initiatives poised to shake up digital health. Then, […]
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 and remote monitoring, but individuals are increasingly managing their own health, with a recent Morning Consult survey reporting that 40% of adults now use mobile health apps and 35% use wearables. A wave of innovation is coming from pharmaceutical companies who plan to take advantage of this momentum by seeking to improve the therapy experience […]
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 Data Systems, and Computer-Assisted Detection (CAD) Software, draft guidance on Cybersecurity, resource pages on Augmented Reality/Virtual Reality and Artificial Intelligence/Machine Learning (AI/ML). There were also several notable reimbursement decisions and legislative activities at the end of 2022 and into 2023, including new CPT codes and payer decisions on remote monitoring. There has been another barrage […]
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 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 such as […]
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 […]