Market success for novel devices requires strong, proactive regulatory planning in order to deftly navigate evolving medical device regulations. Incorporating regulatory and reimbursement strategy into early device development builds a strong foundation for successful testing, regulatory submissions, and commercialization.
Mittal Consulting provides regulatory support throughout the device development lifecycle to help products stay on track for market success.
Our regulatory and reimbursement strategy offerings include:
Regulatory Intelligence
Would you like to better understand how your product fits within the modern, global regulatory landscape? Mittal Consulting prepares actionable regulatory strategy reports that enable smooth market entry.
Regulatory plans include:
- Thorough assessment of the current regulatory landscape for your therapeutic target
- Analysis of regulatory strategies for competing products
- Context on current regulatory requirements for your device
Medical Claims Assessment
Success on the medical device marketplace requires clear, evidence-based communication of your device’s merits to users and patients. Mittal Consulting evaluates proposed claims for accuracy and effectiveness to support seamless market access.
Medical Claims Assessments include:
- Detailed dissection of proposed medical device claims.
- Guidance on developing medical device claims in compliance with the latest regulatory requirements.
- Regulatory strategy for crafting device indications in different target markets
Global Submission Strategy
The best pathway to making your device available is highly dependent on the current regulatory and reimbursement environments across different global markets. Mittal Consulting crafts global submission strategies to help reduce testing burden and effectively gain global market approval.
Global Submission Strategies include:
- Analysis of potential first-market pathways for novel devices.
- Evaluation of proposed testing for acceptability across regulatory jurisdictions.
- Implementation timelines for major regulatory changes in key target markets.
Investor and C-Suite Communication
Clearly expressing the clinical value of your technology is crucial for gaining stakeholder support to bring your transformative medical devices to market. Mittal Consulting develops clear device development messaging to increase stakeholder engagement and trust.
Investor Communication Evaluations include:
- Thorough analysis of the clinical history and unmet need for your therapeutic area.
- Evaluation of proposed device development plans.
- Regulatory insight reflecting potential return on investment throughout your product’s lifecycle.
Mittal Consulting shares strategic regulatory planning resources related to the activities above with clients through both written documents and instructional sessions.
Regulatory Strategy Reports
Instructional Sessions
Working with Mittal Consulting means working with an engaged regulatory partner committed to understanding your goals and the regulatory landscape for a smoother path to market.