Full-Lifecycle Medical Device Consulting
From business case to post-market surveillance — Lucent Clinical Consulting covers every stage of your device’s regulatory and clinical journey.
Built for how regulatory and clinical trial work actually gets done.
01
Business Case
Before you spend a dollar on development, know where you stand.
- Due diligence for minority investment or acquisition
- Clinical organization structure and design
- Adapt clinical policies and procedures to current regulatory standards
- Presubmission planning
- Regulatory agency negotiation strategy
02
Feasibility & Design
Build the regulatory foundation before the design is locked.
- Promotional claims optimization
- Labeling strategy
- Literature search and evidence gap analysis
- Lifecycle risk management plan
- Post-market performance plan (IVD)
- Post-market surveillance strategy (medical device)
- Publication and evidence strategy
- Benefit/risk assessment
03
Design Verification
Design the trial right the first time — before it costs you.
- Clinical protocol design
- Statistical analysis plan
- Data management plan
- Risk-based monitoring plan
- Audit plan
- Site selection
- Vendor selection
- Feasibility clinical trial (as applicable)
04
Clinical Validation
Execute with precision. Catch problems before they become deficiencies.
- Clinical trial execution
- Leading indicator trial health metrics
- Risk mitigation
- Final study report
- Regulatory inspection preparation
- Responding to regulatory body questions
05
Commercial Release
Get to market. Then tell the story.
- Post-market performance or surveillance plan
- Abstract and podium presentations
- Peer-reviewed publications
06
Market Sustainment
Stay on the market. Stay ahead of the competitors.
- Post-market performance or surveillance reports
- Publications
- Benefit/risk assessment updates
Your medical device deserves a strategy, not a guess.
No retainer required to start. No sales pitch.