EdgeOne Taps Pioneer to Navigate Drug-Device Regulatory Maze

WHEELING, Ill. – March 11, 2026 – By Patrick Griffin

EdgeOne Medical, a specialized development partner for the biopharmaceutical industry, has secured the expertise of Lee Leichter, a foundational figure in the drug-device combination product sector, who joins the company as a Senior Advisor. The appointment signals a significant strategic move for the firm and highlights a critical reality in modern medicine: as drug delivery systems become more sophisticated, the regulatory and technical pathways to bring them to market have grown profoundly complex.

Drug-device combination products—systems that merge a pharmaceutical substance with a medical device, such as an autoinjector or a wearable pump—represent a frontier of therapeutic innovation. However, their development requires a delicate fusion of pharmaceutical science, device engineering, and stringent quality systems, all under the watchful eye of global regulators. Leichter's arrival at EdgeOne is a direct response to this high-stakes environment.

Navigating the Regulatory Labyrinth

The landscape for combination products is fraught with challenges. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established intricate frameworks to govern these hybrid products. The core of this complexity lies in determining a product's "Primary Mode of Action" (PMOA), which dictates whether it will be primarily regulated as a drug or a device, triggering different review processes and compliance requirements under regulations like the FDA's 21 CFR Part 4 and Europe's Medical Devices Regulation (MDR).

This ambiguity creates significant hurdles for biopharma companies, who must navigate parallel regulatory tracks and manage documentation across siloed systems. Leichter has spent decades guiding organizations through this very maze. His appointment is intended to bolster EdgeOne's ability to provide its clients with a clearer path forward.

"Lee is one of the most respected experts in the combination product field," said Lilli Zakarija, CEO of EdgeOne Medical, in a statement. "His experience across regulatory strategy, engineering realities, and global standards development is incredibly valuable for our team. We are thrilled to have him working alongside EdgeOne as we continue to help companies navigate the growing complexity of drug-device development."

A Legacy of Shaping the Industry

Describing Leichter as a "pioneer" is no exaggeration. With a career spanning over three decades, he has been instrumental in building the very ecosystem he now helps companies navigate. His influence is woven into the fabric of the industry through extensive leadership and participation in key standards-setting organizations.

Leichter serves as an independent expert on ISO technical committees for injection and respiratory products, is the Chairman of the Parenteral Drug Association (PDA) Combination Product Interest Group, and holds active roles within the Association for the Advancement of Medical Instrumentation (AAMI), the Combination Product Coalition (CPC), and the Human Factors and Ergonomics Society (HFES). Through this work, he has directly contributed to the technical standards and regulatory dialogues that define safety, performance, and compliance for drug delivery devices worldwide.

His comprehensive experience covers the full spectrum of combination product platforms, from autoinjectors and wearable delivery systems to inhalers and other advanced technologies. This broad perspective allows him to connect high-level regulatory strategy with the practical realities of device engineering and risk management.

"Combination products continue to evolve as therapies become more advanced and delivery technologies grow more sophisticated," Leichter stated. "EdgeOne has built a strong reputation for technical depth and collaborative problem solving, and I look forward to supporting the team as they continue helping companies address the challenges of modern drug-device development."

The Convergence of Drugs, Devices, and Data

Leichter’s appointment comes as the industry witnesses a rapid convergence of technologies. The next generation of drug delivery is not just about the drug or the device, but about the integrated system—and increasingly, the data it generates. This evolution is driven by several key trends:

• Advanced Autoinjectors: The market for autoinjectors, projected to reach nearly $40 billion by 2033, is shifting towards reusable platforms and connected devices that can handle high-viscosity biologic drugs, track adherence, and reduce waste.

• Wearable Delivery Systems: On-body injectors and smart patches are moving from concept to reality, offering convenient, continuous, and controlled administration of therapies for chronic diseases outside of a clinical setting.

• Connected Devices: The Internet of Medical Things (IoMT) is booming, with the market for connected drug delivery devices projected to grow exponentially. These smart systems provide real-time data to patients and clinicians, enhancing safety and improving therapeutic outcomes.

While these innovations promise to revolutionize patient care, they also introduce new layers of complexity in development, validation, and regulatory approval, particularly concerning software, cybersecurity, and human factors. Leichter's deep experience across these modalities will be critical in guiding EdgeOne and its clients through this evolving technological landscape.

EdgeOne's Integrated Model for a Complex Future

Founded in 2012, EdgeOne Medical has strategically positioned itself as an "Integrated Partner for Combination Products." The company's model is designed to counteract the fragmented nature of device development by housing engineering, consulting, and in-house, FDA-inspected testing laboratories under one roof. This approach aims to provide its more than 135 clients with what the company calls "Combination Product Confidence™."

Leichter's role as Senior Advisor fits seamlessly into this model. He will not be working in a silo but will provide high-level perspective to EdgeOne's internal teams, helping to refine their capabilities and anticipate industry shifts. His guidance on evolving regulations, emerging trends, and new technical standards will directly inform the cross-functional work the company performs for its biopharma clients.

This strategic hire, following other recent leadership additions, underscores a period of focused growth for the Wheeling-based firm. By adding a key architect of the combination product field to its roster, EdgeOne Medical is reinforcing its commitment to providing the deep, integrated expertise required to bring the next generation of therapies from development uncertainty to patients in need.