EdgeOne Medical Welcomes Lee Leichter as Senior Advisor

Combination product pioneer and global medical device/regulatory standards contributor Lee Leichter is partnering with EdgeOne Medical as a senior advisor, the company announced.

Drug-device combination products bring together pharmaceutical science, device engineering, regulatory strategy, and quality systems, which creates a level of technical and regulatory complexity that continues to increase across the industry. Leichter has spent decades helping pharmaceutical, biotechnology, and medical device organizations navigate these challenges while advancing the development and commercialization of innovative drug delivery technologies.

Throughout his career, Leichter has worked across a broad range of combination product platforms, including autoinjectors, wearable delivery systems, inhalers, and other advanced drug delivery technologies. His experience spans regulatory strategy, device engineering, risk management, and product lifecycle considerations. This breadth of experience provides a comprehensive perspective on the challenges companies face when developing complex drug-device systems, according to the company.

“Lee is one of the most respected experts in the combination product field,” EdgeOne Medical CEO Lilli Zakarija said. “His experience across regulatory strategy, engineering realities, and global standards development is 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.”

Leichter has played an important role in shaping the broader combination product ecosystem through his leadership and participation in various organizations, including the Parenteral Drug Association (PDA), International Standards Organization (ISO), the Association for the Advancement of Medical Instrumentation (AAMI), Combination Product Coalition (CPC), Human Factors and Ergonomics Society (HFES), and Regulatory Affairs Professionals Society (RAPS). Through these memberships, he has contributed to standards development, regulatory dialogue, and technical education across the global life sciences community.

As senior advisor, Leichter will work closely with EdgeOne’s internal teams to provide perspective on evolving combination product regulations, emerging industry trends, and developments in relevant technical standards. His guidance will help EdgeOne address regulatory and technical changes and continue refining the capabilities it offers clients.

“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.”

EdgeOne Medical is a device development professional services organization supporting healthcare across the full lifecycle of drug-device combination products. The company provides integrated engineering, testing, and consulting services that help clients navigate the development and commercialization pathway for drug-device delivery systems. Backed by seasoned industry experts and a collaborative, client-first mindset, EdgeOne Medical has supported more than 135 clients across a wide range of device modalities, including pre-filled syringes, autoinjectors and pen injectors, inhalers, on-body delivery systems, vial access devices, custom drug delivery platforms, connected devices, and other advanced medical technologies.

EdgeOne Medical bills itself as an integrated partner for combination products, combining a cross-functional device development team with in-house U.S. Food and Drug Administration-inspected device testing laboratories operated by experienced device engineers. This integrated model allows biopharma teams to move from development uncertainty to “Combination Product Confidence,” helping ensure therapies reach patients safely, effectively, and on schedule. Founded in 2012, EdgeOne Medical is headquartered in Wheeling, Ill.