Previous Projects & Experience
Medical Device Consultants
We are experienced consultants whom have helped our clients bring medical device products to the UK and EU Markets. We work with both large and small companies, ensuring results for their projects.
Our Projects
Improving Department and Technical Excellence
Situation
A medium sized, UK based medical device company seeking support to improve consistency and clarity in new product development methodologies to support project delivery and decision making.
Action
Revise ‘Stage Gate’ process to ensure fit with all functions of the business, implement monthly review programme and provide temporary leadership of decision-making meetings. Introduce an easy to use, compulsory project management toolkit for all projects.
Result
Consistent management of projects providing clear expectations for documentation quality and delivery. Management team received clear business updates supporting concise decision-making discussions in monthly ‘Gate meetings’. Internally published 3 year innovation pipeline categorised by product area with realistic and achievable launch dates.
University Faculty Exploring Industry Support
Situation
Health and Social Science faculty wishing to understand the requirements to re-launch an Institute of Woundcare to provide an industry service from bench to bedside product development.
Action
Review current Woundcare Centres of Excellence, interview other University faculty leaders and external sponsor involvement, identify areas within the product development lifecycle most aligned with University’s growing capabilities and perform SWOT analysis.
Result
Business case documenting the aspects of an integrated woundcare service, highlight differentiated service offerings, investment options and value adding activities to industry. Recommend actions and next steps.
Recommendation of Offered Technology
Situation
Large, global medical device company requiring project management expertise to understand whether to progress an offered technology into development stages.
Action
Obtain stakeholder thoughts on offered technology and market space. Manage relationship with technology partner. Use option framework to analyse and compare possibilities, recommend specific course of action and build business case performing risk mitigation activities in parallel.
Result
Business Case documenting recommendation to progress into due diligence with the offered technology. Internal development team allocated on acceptance of recommendation.
Review of Design Control Procedures
Situation
A medium sized, UK based medical device company require support to revise design control process following a minor observation during a routine BSi review.
Action
Review current, independently maintained design control procedures across two UK sites. Understand interaction with Change Control and other site quality processes. Understand stakeholder and project requirements for revised methodology.
Result
One Design Control process across all sites with a suite of procedures containing guidance and flexibility to account for variation in project types. Training delivered to New Product Development Team. Improvement noted by BSi on return visit.