This comprehensive case study explores Kymanox’s approach to dual chamber syringe and Autoinjector (AI) combination product development through integrated regulatory and technical solution. Our team of Subject Matter Experts (SMEs) collaborated closely with client stakeholders to implement measurable improvements across device development, supplier coordination, regulatory submissions, and cross-functional team alignment for complex dual-presentation products.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical client required expert support developing two (2) combination product presentations (dual chamber syringe and an AI).
- Outsourced team needed to manage end-to-end device development process, including regulatory strategy, design control, risk management, and technical documentation.
- Oversight and coordination required for multiple third-party suppliers, including device manufacturers and Contract Manufacturing Organization (CMOs).
- Internal resource constraints necessitated external expertise to accelerate development timelines.
- Provided dedicated Combination Product Development Lead ensuring seamless integration with cross-functional stakeholders including Chemistry, Manufacturing, and Controls (CMC), Quality Assurance (QA), Regulatory Affairs, and commercial teams.
- Aligned expectations, streamlined communication channels, and expedited decision-making across internal and external teams.
- Oversaw and accelerated supplier management activities, ensuring timely execution of device development tasks by third party manufacturing and CMOs.
- Led development of comprehensive regulatory strategy, design control processes, and risk management assessment meeting global regulatory requirements.
- Director Human Factors Engineering (HFE) activities to ensure optimal usability and regulatory compliance.
- Achieved successful regulatory submissions in both EU and US markets with positive Notified Body Opinion (NBO) in EU.
- Enabled client to efficiently develop and submit dual combination products while minimizing internal resource constraints.
- Strengthened collaboration between internal teams and external suppliers, ensuring smooth and timely device development process.
- Delivered compliance with stringent global regulatory expectations across both product presentations.