Abbott Rapid Diagnostics International
Global R&D Leadership from Design Freeze to WHO-PQ Approval
Service
On-schedule WHO-PQ submission and approval in July 2024
Scope
Two NPIs, Chiba and global teams
Year
2024–2025
Result
18-month interim global R&D technical leadership
Brief
Abbott Rapid Diagnostics International required interim R&D leadership for two strategic new product introductions moving from design freeze into verification, validation, regulatory submission and launch. I joined immediately after design freeze to provide continuity of technical leadership across the Chiba-based R&D organisation and global Quality, Regulatory, Manufacturing and Commercial teams.
Approach
As Interim Global R&D Technical Lead, I represented R&D on the programme core team and directed the remaining development work. I prioritised post-design-freeze actions, steered verification and validation, supported formal design reviews, and kept Quality and Regulatory documentation aligned with submission requirements.
For the first NPI, I worked on-site with the Chiba R&D team and the global project manager to complete final design review and prepare the WHO Prequalification package. The team delivered the submission on schedule, after which I coordinated responses to WHO technical reviewer comments through to approval.
For the second NPI, I led technical delivery through verification and validation and supported preparation of the WHO-PQ and IVDR technical dossiers. I also assessed a significant supplier issue affecting a core assay component. By evaluating the technical, quality, regulatory and programme implications of alternative supply options, I gave leadership a clear basis for its supply-strategy decision.
Outcome
The first NPI met its WHO-PQ submission milestone on schedule and received approval in July 2024. Across both programmes, the engagement maintained continuity of R&D leadership and alignment between Japanese and global functions through verification, validation and regulatory submission. The supplier risk assessment also enabled an informed supply decision at a critical stage of the second programme.
Result
18-month interim global R&D technical leadership
Abbott gained experienced diagnostic product-development leadership at a critical point in the NPI lifecycle. By bridging R&D, Quality and Regulatory priorities from design freeze through submission, the engagement protected programme momentum, submission readiness and cross-functional decision-making.
Client Testimonial
"When we needed urgent R&D leadership for two complex projects in Japan, Ciaran stepped in seamlessly. He delivered the technical guidance and design rigour required to ensure all analytical and clinical data met strict regulatory and customer standards. Thanks to his outstanding cross-cultural management and communication skills, he effortlessly aligned our global, cross-functional teams to sustain project delivery."
GK
Gemma Keegan
Senior R&D Manager, Abbott Rapid Diagnostics
Other Testimonials