Navigate Complexity,Launch with Confidence
Accelerate medical device commercialization with AI-powered launch strategies that understand FDA pathways, clinical workflows, and healthcare purchasing dynamics.
Medical Device Launch Challenges
- ✗Complex regulatory pathways slow time to market
- ✗Difficulty translating clinical benefits to economic value
- ✗Multiple stakeholders with different priorities
- ✗Long sales cycles with hospital systems
- ✗Reimbursement strategy complexity
The Commercify Advantage
- Regulatory-aware content generation for 510(k), PMA, De Novo
- Clinical and economic value proposition builders
- Stakeholder-specific messaging for C-suite, clinicians, procurement
- Healthcare system sales enablement tools
- Reimbursement strategy documentation
Your Medical Device Launch Playbook
From regulatory submission to market leadership - a complete commercialization framework
Pre-Market Strategy
- • Regulatory pathway selection
- • Clinical trial messaging
- • KOL engagement content
- • Early access programs
Regulatory Submission
- • FDA submission support
- • Clinical evidence packages
- • Regulatory documentation
- • Predicate comparison
Market Launch
- • Launch announcement
- • Sales enablement
- • Clinical training materials
- • Trade show content
Market Expansion
- • Health economics studies
- • Reimbursement guides
- • Real-world evidence
- • GPO/IDN strategies
Healthcare-Specific Capabilities
Clinical Documentation
Generate clinical evaluation reports, IFUs, technical files, and regulatory submissions aligned with FDA and CE requirements.
Value Analysis Tools
Build compelling value analysis committee presentations with clinical outcomes, economic impact, and workflow improvement data.
Compliance Assurance
All content generated with medical device regulations in mind - FDA, CE Mark, MDSAP, and global compliance standards.
Supporting All Device Categories
Class I Devices
Simple go-to-market strategies for low-risk devices with focus on distribution and market penetration.
Class II Devices
510(k) pathway optimization with predicate comparison and substantial equivalence messaging.
Class III Devices
PMA submission support with comprehensive clinical evidence and safety data presentation.
Digital Health/SaMD
Software as Medical Device commercialization with cybersecurity and interoperability focus.
IVD/Diagnostics
In-vitro diagnostic launch strategies with lab validation and clinical utility emphasis.
Combination Products
Complex product positioning for drug-device and biologic-device combinations.
Ready to Accelerate Your Device Launch?
Join leading medical device companies using Commercify to navigate regulatory complexity and win in healthcare markets.