Medical technology company BD has announced a strategic collaboration between its ZebraSci testing organisation and combination product consultancy Suttons Creek.
The pair said in a statement that the new partnership has been designed to help pharmaceutical and biotech companies navigate the engineering, testing, quality and regulatory complexities associated with combination product development more efficiently.
ZebraSci, BD's device-agnostic product testing organisation, will partner with Sutton's Creek, a product development and systems integration specialist. Together, they will provide objective, data-driven testing services that will improve decision-making across feasibility, performance, verification and validation.
As pharmaceutical pipelines integrate more biologics and complex drug-device combinations, development teams face fragmented vendor ecosystems and disconnected workstreams.
This new collaboration is aiming to improve coordination in development activities while allowing customers to choose their partners and technologies.
"Combination product development increasingly requires close coordination across strategy, testing and delivery system considerations," said Patrick Jeukenne, Worldwide President, BD Pharmaceutical Systems.
This collaboration brings together complementary expertise from both companies, helping customers reduce development risk and address regulatory considerations while maintaining choice and flexibility in how they move their programmes forward.
By addressing potential gaps and handoffs earlier in the process, the model is intended to support more predictable development pathways and reduce the likelihood of late-stage rework.
"Combination product development spans multiple vendors and siloed workstreams, driving friction, delays, duplication and regulatory risk," added Carolyn Dorgan, Vice President of Solutions Engineering at Suttons Creek.
This fragmentation often drives FDA data requests stemming from misaligned strategy and testing partners — our collaboration enables a more coordinated and efficient path forward.
Under the collaboration, customers will benefit from the following:
- earlier alignment across strategy, testing and delivery device considerations
- strengthening integration and coordination across the planning and execution of key Design History File deliverables, which should reduce development and regulatory risks
- faster decision-making and fewer delays caused by disconnected vendor handoffs
- more efficient management of external partners
- objective device evaluation supported by ZebraSci's testing expertise
- continued flexibility to choose the providers and solutions best suited to their programme.
Suttons Creek collaborates with clients early in product planning and development, enabling the timely integration of testing and delivery considerations.
This approach, it says, helps prevent delays from timing gaps, supplier onboarding issues and misaligned assumptions.
Additionally, ZebraSci can identify customers needing strategic support sooner, promoting a more integrated product lifecycle.