Novel variable dose combination product

Services provided

Mathematical models, Characterisation testing, Statistical data analysis, Project management, Risk management, Upskilling

Project description

This device development is a collaboration between an established pharma company and a medical device startup. The project has faced technical and organisational challenges and is under significant pressure to bring the product to market. OW have been brought in to advise the technical decision makers, sit on the steering committee for the combination product development and completely rework the risk management documentation.

Impact delivered

OW’s expertise in combination product development is helping the client regain control of the project. This is achieved primarily through OW’s use of product risk management to advise on and prioritise specific development activities. OW are actively unblocking the project by prioritizing key actions and helping the client achieve internal alignment. This strategic guidance ensures the right risk-reduction activities are performed, avoiding costly delays and rework.