EdgeOne Medical Appoints Industry Veteran Marty Shelton as Chief Operating Officer to Advance Operational Excellence, Client Value, and Long-Term Growth
EdgeOne Medical, a trusted provider of development and testing services for combination products in the biopharmaceutical and life sciences sectors, today announced the appointment of Marty Shelton as Chief Operating Officer (COO). This strategic leadership addition marks an important milestone as the organization continues expanding its technical service capabilities, client portfolio, and operational infrastructure in response to increasing industry demand for high-quality, compliant, and integrated combination product solutions.
Shelton joins EdgeOne Medical with over three decades of experience leading complex operational environments across pharmaceuticals, medical devices, biotechnology, and contract services. Throughout his distinguished career, he has been recognized for his ability to build scalable operational systems, deliver regulatory excellence, foster high-performance teams, and implement process improvements that drive measurable and sustainable business results. His deep cross-functional experience spans quality control, laboratory operations, manufacturing process leadership, regulatory compliance, and enterprise operational strategy, positioning him well to support EdgeOne Medical through its next phase of accelerated growth.
Before joining EdgeOne Medical, Shelton held key senior leadership roles at several prominent life sciences organizations. His professional background includes impactful leadership at Merck & Co., Shire Pharmaceuticals, Alcami Corporation, and Pace Analytical Life Sciences. In each of these positions, he oversaw critical operational and organizational improvements—ranging from the modernization of testing frameworks and compliance standards to the optimization of scientific service delivery models. His work not only strengthened internal business performance but also enhanced the overall client experience, regulatory readiness, and time-to-market efficiency for therapeutic programs spanning multiple therapeutic areas and technical modalities.
Shelton’s proven record in laboratory management, regulatory quality systems, cGMP compliance, digital transformation initiatives, and performance optimization programs aligns seamlessly with EdgeOne Medical’s strategic focus on maintaining operational excellence while enabling regulatory confidence and accelerating customer success in combination product development.
Combination products—therapies that integrate drug, biologic, or device components—require strict compliance with regulatory pathways, technical testing, design verification, usability engineering, and lifecycle manufacturing support. With an evolving regulatory environment and growing market need for injectable, wearable, and patient-centric drug delivery formats, the complexity of design, testing, and commercialization continues to increase. Shelton’s experience provides the strategic leadership required to navigate this increasingly sophisticated regulatory and technical landscape.
“Marty’s leadership brings a renewed focus on operational rigor and innovation, equipping EdgeOne Medical to meet evolving industry demands. His expertise will directly enhance our ability to continue delivering exceptional quality and compliant solutions that accelerate our clients’ combination product programs,” said Lilli Zakarija, President of EdgeOne Medical. “His understanding of laboratory operations, quality process optimization, and organizational alignment will help us scale effectively while maintaining the world-class service standards our clients rely on.”
Zakarija emphasized that the appointment reflects EdgeOne Medical’s forward-focused mission: to remain a trusted leader in combination product testing, design, and development by strengthening operational systems, enabling customer success, and supporting safe and effective medical innovation.
In response to his appointment, Shelton shared his enthusiasm for joining the organization during a period of meaningful transformation and expansion.
“I am honored to join EdgeOne Medical as COO,” shared Shelton. “EdgeOne has built an exceptional foundation rooted in scientific rigor, regulatory integrity, and client partnership. I am committed to strengthening operational execution, enhancing efficiency, and fostering a culture of collaboration, innovation, and accountability. Together with the EdgeOne team, I look forward to building on the company’s momentum and continuing to deliver solutions that meaningfully support patient health and client success.”
Shelton’s strategic vision includes reinforcing organizational alignment, advancing system-based decision-making, optimizing internal operations, and enhancing global service delivery models. He will also support talent development and leadership mentoring initiatives designed to maintain the company’s culture of excellence as the organization grows.
His appointment comes at a pivotal time for EdgeOne Medical. As drug-device combination products continue to expand across therapeutic categories—including autoimmune disease, oncology, diabetes, rare diseases, cell and gene therapies, and neurologic conditions—there is increasing demand for specialized testing, validation, human factors engineering, formulation-device compatibility evaluations, regulatory strategy alignment, and post-market support services. With evolving patient expectations, increasing self-administration trends, and greater emphasis on safety and usability, life science companies are seeking trusted partners like EdgeOne Medical to accelerate development while ensuring compliance.
EdgeOne Medical’s leadership team recognizes that operational excellence is not only essential for compliance—it is a core differentiator in an increasingly competitive and regulated global landscape. Shelton’s appointment further strengthens the organization’s leadership bench and reinforces its commitment to delivering reliable, compliant, and technically sophisticated testing and development support throughout all stages of the combination product lifecycle.
“This leadership enhancement reflects our commitment to both operational excellence and sustainable growth,” the company shared in a statement. “We believe Marty’s experience, values, and strategic mindset will help EdgeOne Medical continue delivering exceptional value across the life sciences ecosystem.”
With Shelton’s guidance, EdgeOne Medical plans to invest further in scalable process frameworks, digital workflow systems, operational governance programs, and advanced scientific capability development. These efforts are intended to ensure the company can support a rapidly expanding customer base while maintaining exceptional standards of quality, scientific integrity, and regulatory compliance.
As the life sciences sector continues to evolve—with increasing regulatory scrutiny, rising development costs, and accelerating innovation—EdgeOne Medical remains committed to supporting clients by bridging scientific service excellence with operational reliability. The addition of an experienced operational leader like Shelton strengthens the company’s ability to serve as a trusted partner in advancing safer, more effective healthcare technologies to market.
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