Project Management for a Complex Medical Device Development Program
Medical device group with a complex product development program
A medtech group needed a fast, competitive market launch for a complex medical device, combined with strict cost control of development costs from the very start.
The challenge
The situation
A medtech group needed a fast, competitive market launch for a complex medical device, and therefore strict control and budgeting of product development costs from an early stage. The challenge was to tighten the development process while ensuring high product performance and compliance with regulatory requirements within a limited budget.
Our approach
What we delivered
Process improvement through end-to-end project planning with stage-gate governance and structured milestone evaluation
Cost control integrated into every phase of the project lifecycle, with milestone planning kept close to budget
Optimization through weekly project steering meetings with clear roles and defined escalation paths
The outcome
Results & impact
Product delivered without quality trade-offs
Product delivered as planned, with no compromise on quality or functionality.
20% below budget
Project costs kept more than 20% below the original budget estimate.
10% below the product cost estimate
Product costs reduced by more than 10% against budget.
0 delays to market launch
Planned market launch date met without delay.
In summary
The group delivered the complex medical device development program more than 20% under budget and without delaying the planned market launch, while keeping product quality unchanged.
Related expertise
Research & Development and Engineering →
Feasibility studies, design controls and usability engineering under IEC 62366-1:2015
Design Controls →
Design reviews at defined milestones, verification and validation under ISO 13485:2016 Section 7.3
ISO 13485 Certification →
Gap analysis against the standard and building the QMS through to the certification audit
Quality Management & Operational Excellence →
Quality systems to ISO 13485:2016 and ISO 9001:2015, joined up with operational excellence
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Sources
- Entourage project experience (anonymized)
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